Sumavel DosePro Subcutaneous

Generic Name: sumatriptan (Subcutaneous route)

soo-ma-TRIP-tan

Commonly used brand name(s)

In the U.S.

• Alsuma


• Imitrex


• Imitrex Stat Dose Refill


• Sumavel DosePro

Available Dosage Forms:

• Kit


• Solution

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For Sumavel DosePro

Sumatriptan injection is used to treat acute migraine attacks and cluster headaches in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).

Many people find that their headaches go away completely after they use sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using this medicine as well as the good that it can do.

This medicine is available only with your doctor's prescription.

Before Using Sumavel DosePro

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Use of sumatriptan injection is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan


• Dihydroergotamine


• Eletriptan


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Frovatriptan


• Methylergonovine


• Methysergide


• Naratriptan


• Rizatriptan


• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Citalopram


• Desvenlafaxine


• Dexfenfluramine


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Milnacipran


• Paroxetine


• Reboxetine


• Sertraline


• Sibutramine


• St John's Wort


• Tapentadol


• Venlafaxine


• Vilazodone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or


• Blurred vision or


• CNS disorders or


• Kidney disease or


• Liver disease or


• Seizures or epilepsy, history of or


• Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

• Cerebrovascular disease (e.g., stroke, transient ischemic attack), or history of or


• Heart attack, history of or


• Heart disease (e.g., angina) or


• Hemiplegic or basilar types of migraine or


• Hypertension (high blood pressure), uncontrolled or


• Ischemic bowel disease or


• Liver disease, severe—Should not be used in patients with these conditions.

• Coronary artery disease, history of or


• Diabetes or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure), controlled or


• Obesity or


• Raynaud's syndrome—Use with caution. The chance of side effects may be increased. Heart or blood vessel disease sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use this medicine, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of sumatriptan

This section provides information on the proper use of a number of products that contain sumatriptan. It may not be specific to Sumavel DosePro. Please read with care.

Do not use this medicine for a migraine or cluster headache that is different from your usual headaches. Instead, check with your doctor.

To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 2 hours before using another dose. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects. Do not use more than two doses in 24 hours.

This medicine is given as a shot under your skin (usually on the abdomen or stomach, thighs, or upper arms). Sumatriptan injection may sometimes be given at home to patients who do not need to be in a hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems.

This medicine is available in 3 forms. You may use a single dose vial, prefilled syringe, or a prefilled autoinjector.

After you have finished injecting the medicine, be sure to follow the precautions in the patient directions about safely discarding the empty cartridge and the needle. Always return the empty cartridge and needle to their container before discarding them. Do not throw away the autoinjector unit, because refills are available.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For migraine or cluster headaches:
    
    • Adults—One 6-milligrams (mg) injected under the skin. One more 6-mg dose may be injected, if necessary, if the migraine comes back after being relieved. However, the second injection should not be given any sooner than 1 hour after the first one. Do not use more than two 6-mg injections in a 24-hour period (one day). However, some people may be directed to use no more than two 6-mg doses in a 48-hour period (two days).
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used syringes or autoinjectors in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Sumavel DosePro

Check with your doctor if you have used this medicine and have not had good relief. Also, check with your doctor if your migraine or cluster headaches are worse, or if they are occurring more often, than before you started receiving this medicine.

Make sure your doctor knows if you are pregnant. Your doctor may want you to join a pregnancy registry for patients using this medicine.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, if you are over 40, or if you have gone through menopause. People who use this medicine for a long time might also have a higher risk.

You should not receive this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxacid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use this medicine if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., methysergide, D.H.E. 45®, or Migranal®) within the past 24 hours.

Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when used with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor first before taking any other medicines.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have chest discomfort, jaw or neck tightness after receiving this medicine. Also, tell your doctor if you have sudden or severe abdominal or stomach pain after using this medicine.

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Sumavel DosePro Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Blurred vision


• chest pain or discomfort


• chills


• confusion


• difficult or labored breathing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• nervousness


• pounding in the ears


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• slow or fast heartbeat


• sweating


• tight feeling in the head


• tightness or pressure in the chest


• trembling or shaking of the hands or feet


• unusual tiredness or weakness


• wheezing

Rare

• Black, tarry stools


• blood in the urine


• blood in the vomit


• burning while urinating


• cough


• decreased urination


• depression of the skin


• diarrhea


• dry mouth


• feeling of warmth or heat


• fever


• flushing or redness of the skin, especially on the face and neck


• general feeling of discomfort or illness


• inability to move the eyes


• inability to move the legs or arms


• increase in heart rate


• increased blinking or spasms of the eyelid


• increased sensitivity to pain


• increased sensitivity to touch


• indentation of the skin


• joint pain


• loss of appetite


• muscle aches and pains


• nausea and vomiting


• pain in the groin or genitals


• paleness of the skin


• paleness or cold feeling in the fingertips and toes


• paralysis of one side of the body


• rapid breathing


• runny nose


• severe or continuing stomach pain


• sharp back pain just below the ribs


• shivering


• sore throat


• sticking out of the tongue


• sunken eyes


• thirst


• tingling in the hands and feet


• tingling or pain in the fingers or toes when exposed to cold


• trouble with breathing, speaking, or swallowing


• trouble with sleeping


• uncontrolled twisting movements of the neck, trunk, arms, or legs


• unusual facial expressions


• wrinkled skin

Incidence not known

• Abdominal or stomach pain and tenderness


• agitation


• back, leg, or stomach pains


• bleeding gums


• blood in the stools


• bluish color of the fingernails, lips, skin, palms, or nail beds


• changes in skin color


• changes in vision


• coma


• depression


• difficulty with swallowing


• double vision


• general body swelling


• headache, sudden, severe, and continuing


• high fever


• hives


• hostility


• inability to speak


• irritability


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lethargy


• loss of ability to use or understand speech or language


• loss of appetite


• loss of vision


• migraine headache


• muscle twitching


• noisy breathing


• nosebleeds


• overactive reflexes


• pain, tenderness, or swelling of the foot or leg


• pinpoint red spots on the skin


• poor coordination


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid weight gain


• rectal bleeding


• redness, soreness, or itching skin


• restlessness


• seizures


• severe or sudden headache


• slurred speech


• sores, ulcers, or white spots on the lips or in the mouth


• sores, welting, or blisters


• stupor


• swelling of the face, ankles, hands, feet, or lower legs


• swollen glands


• talking or acting with excitement you cannot control


• temporary blindness


• trembling or shaking


• twitching


• unexplained bleeding or bruising


• unusual bleeding or bruising


• unusually warm skin


• weakness in the arm or leg on one side of the body, sudden and severe


• weight loss


• yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• burning or tingling sensation


• drowsiness


• feeling of constant movement of self or surroundings


• feeling of warmth


• redness of the face, neck, arms, and occasionally, upper chest


• relaxed and calm


• sensation of spinning


• sleepiness

Less common

• Abdominal or stomach discomfort


• anxiety


• bad, unusual, or unpleasant (after) taste


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in color vision


• change in taste


• difficulty seeing at night


• difficulty with moving


• discomfort in the jaw, nasal cavity, or throat


• false or unusual sense of well-being


• feeling strange


• heartburn


• increased sensitivity of the eyes to sunlight


• joint pain, stiffness, or swelling


• mental confusion


• muscle aching or cramping


• neck pain or stiffness


• red, sore eyes


• swollen joints


• tearing of the eyes


• thirst


• weakness

Rare

• Backache


• belching


• bloated or full feeling


• changes in patterns and rhythms of speech


• cramps


• dry heaves


• excess air or gas in the stomach or intestines


• extreme thirst


• heavy bleeding


• hiccups


• hunger


• increased thirst


• muscle tiredness


• muscle twitching or jerking


• pain


• passing gas


• reduced appetite


• rhythmic movement of muscles


• severe stomach pain with nausea and vomiting


• tenderness of the skin


• trouble with speaking

Incidence not known

• Deafness


• panic


• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Sumavel DosePro Subcutaneous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Sumavel DosePro Subcutaneous resources

• Sumavel DosePro Subcutaneous Side Effects (in more detail)
• Sumavel DosePro Subcutaneous Use in Pregnancy & Breastfeeding
• Sumavel DosePro Subcutaneous Drug Interactions
• 14 Reviews for Sumavel DosePro Subcutaneous - Add your own review/rating

Compare Sumavel DosePro Subcutaneous with other medications

• Cluster Headaches
• Migraine

aspirin and pseudoephedrine

Generic Name: aspirin and pseudoephedrine (ASP in and soo doe e FED rin)

Brand Names: Ursinus

What is aspirin and pseudoephedrine?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of aspirin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and pain or fever caused by the common cold or flu.

Aspirin and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about aspirin and pseudoephedrine?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Aspirin and pseudoephedrine should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin and pseudoephedrine can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin and pseudoephedrine. Alcohol may increase your risk of stomach bleeding.

What should I discuss with my healthcare provider before taking aspirin and pseudoephedrine?

Aspirin and pseudoephedrine should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin and pseudoephedrine can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to aspirin or pseudoephedrine, or if you have:

• 
  

  a recent history of stomach or intestinal bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

Before taking aspirin and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  asthma or seasonal allergies;

  
  


• 
  

  stomach ulcers;

  
  


• liver or kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease, high blood pressure, or congestive heart failure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  gout; or

  
  


• 
  

  nasal polyps.

  
  

If you have any of these conditions, you may not be able to take aspirin and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin and pseudoephedrine. Aspirin and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin and pseudoephedrine?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take this medication with a full glass of water. Taking aspirin and pseudoephedrine with food or milk can lessen stomach upset. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cold medicine is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an aspirin and pseudoephedrine overdose may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, feeling restless or nervous, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin and pseudoephedrine?

Avoid drinking alcohol while you are taking aspirin and pseudoephedrine. Alcohol may increase your risk of stomach bleeding.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, or pain medication without first asking your doctor or pharmacist. Aspirin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains aspirin or pseudoephedrine.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin and pseudoephedrine. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin and pseudoephedrine. Alcohol may increase your risk of stomach bleeding.

Aspirin and pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


• 
  

  fever lasting longer than 3 days, or swelling or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Continue taking aspirin and pseudoephedrine and talk with your doctor if you have any of these less serious side effects:

• 
  

  upset stomach, heartburn, loss of appetite;

  
  


• 
  

  drowsiness or headache;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  feeling excited or restless;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  skin rash or itching.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect aspirin and pseudoephedrine?

Before taking aspirin and pseudoephedrine, tell your doctor if you are using any of the following drugs:

• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  medication used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), and urokinase (Abbokinase).

  
  

If you are using any of these drugs, you may not be able to take aspirin and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect aspirin and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More aspirin and pseudoephedrine resources

• Aspirin and pseudoephedrine Drug Interactions
• Aspirin and pseudoephedrine Support Group
• 0 Reviews for Aspirin and pseudoephedrine - Add your own review/rating

Compare aspirin and pseudoephedrine with other medications

• Cold Symptoms
• Nasal Congestion
• Sinus Symptoms

Where can I get more information?

• Your pharmacist has information about aspirin and pseudoephedrine written for health professionals that you may read.

What does my medication look like?

Aspiring and pseudoephedrine is available over-the-counter (without a prescription) under the brand name Ursinus Inlay-Tabs. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

CombiPatch Patch (Bi-weekly)

Pronunciation: ES-tra-DYE-ol/nor-ETH-in-drone
Generic Name: Estradiol/Norethindrone
Brand Name: CombiPatch

Estrogens have been reported to increase the chance of womb (endometrial) cancer. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time CombiPatch Patch (Bi-weekly) is used and the amount of estrogen per dose. Therefore, CombiPatch Patch (Bi-weekly) should be used for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.

CombiPatch Patch (Bi-weekly) is used for:

Treating certain symptoms (eg, hot flashes; vaginal itching, burning, or dryness) caused by menopause. It is also used to replace estrogen when your body does not produce enough.

CombiPatch Patch (Bi-weekly) is a combination of progestin and estrogen hormones. It works by replacing natural progestin and estrogen in women who do not produce enough of these hormones.

Do NOT use CombiPatch Patch (Bi-weekly) if:

• you are allergic to any ingredient in CombiPatch Patch (Bi-weekly)


• you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding, have vaginal bleeding of abnormal or unknown cause, or have cancer of the uterus


• you have a history of serious blood clots (eg, in the legs, lungs, eyes), liver problems, or breast cancer; you may have breast cancer; or you have cancers that are estrogen-dependent


• you have had a recent heart attack or stroke

Contact your doctor or health care provider right away if any of these apply to you.

Before using CombiPatch Patch (Bi-weekly):

Some medical conditions may interact with CombiPatch Patch (Bi-weekly). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a family history of breast cancer, or you have breast lumps or disease or an abnormal mammogram


• if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia)


• if you have a vaginal infection or womb problems (eg, uterine fibroids/endometriosis, abnormal vaginal bleeding, other uterine problems)


• if you have abnormal calcium levels in the blood, asthma, cancer, cholesterol or lipid problems, depression, diabetes, gallbladder disease, heart disease or other heart problems, circulation problems, high blood pressure, kidney or liver disease, low thyroid hormone levels, lupus, the blood disease porphyria, migraine headaches, pancreas disease, seizures, or yellowing of the skin or eyes


• if you smoke, are very overweight, or will be having surgery


• if you have had your uterus removed (hysterectomy)

Some MEDICINES MAY INTERACT with CombiPatch Patch (Bi-weekly). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, clarithromycin) because they may increase the risk of CombiPatch Patch (Bi-weekly)'s side effects


• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), nevirapine, rifampin, or St. John's wort because they may decrease CombiPatch Patch (Bi-weekly)'s effectiveness


• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because the risk of their side effects may be increased by CombiPatch Patch (Bi-weekly)


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased by CombiPatch Patch (Bi-weekly)

This may not be a complete list of all interactions that may occur. Ask your health care provider if CombiPatch Patch (Bi-weekly) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use CombiPatch Patch (Bi-weekly):

Use CombiPatch Patch (Bi-weekly) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with CombiPatch Patch (Bi-weekly). Talk to your pharmacist if you have questions about this information.


• The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully.


• Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts, press down to reapply. Wear only 1 system at any one time.


• Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.


• After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.


• Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor right away.


• Grapefruit and grapefruit juice may increase the risk of side effects from CombiPatch Patch (Bi-weekly). Talk with your doctor before including grapefruit or grapefruit juice in your diet while taking CombiPatch Patch (Bi-weekly).


• If you forget to change the patch as scheduled, change it as soon as possible and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use CombiPatch Patch (Bi-weekly).

Important safety information:

• CombiPatch Patch (Bi-weekly) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use CombiPatch Patch (Bi-weekly) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Limit alcoholic beverages.


• CombiPatch Patch (Bi-weekly) may cause dark skin patches on your face. Avoid the sun, sunlamps, or tanning booths until you know how you react to CombiPatch Patch (Bi-weekly). Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• CombiPatch Patch (Bi-weekly) may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years old).


• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.


• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while using CombiPatch Patch (Bi-weekly).


• Follow your doctor's instructions for examining your breasts, and report any lumps immediately.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using CombiPatch Patch (Bi-weekly).


• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.


• CombiPatch Patch (Bi-weekly) may increase the risk of breast and endometrial cancer.


• Diabetes patients - CombiPatch Patch (Bi-weekly) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• CombiPatch Patch (Bi-weekly) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using CombiPatch Patch (Bi-weekly).


• Lab tests, including physical exams and blood pressure, may be performed while you use CombiPatch Patch (Bi-weekly). You should have breast and pelvic exams and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• CombiPatch Patch (Bi-weekly) should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use CombiPatch Patch (Bi-weekly) if you are pregnant. Avoid becoming pregnant while you are using it. If you think you may be pregnant, contact your doctor right away. It is not known if CombiPatch Patch (Bi-weekly) is found in breast milk after topical use. If you are or will be breast-feeding while you use CombiPatch Patch (Bi-weekly), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of CombiPatch Patch (Bi-weekly):

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; headache; irregular vaginal bleeding or spotting; mild breast pain; mild hair loss; nausea; runny or stuffy nose; stomach pain, cramps, or bloating; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; calf pain or tenderness; changes in vision or speech (eg, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent breast pain; severe or unusual vaginal bleeding; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: CombiPatch (Bi-weekly) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of CombiPatch Patch (Bi-weekly):

Store CombiPatch Patch (Bi-weekly) at room temperature, below 77 degrees F (25 degrees C), in the original sealed pouch. Store away from heat, moisture, and light. Do not store in the bathroom. Keep CombiPatch Patch (Bi-weekly) out of the reach of children and away from pets.

General information:

• If you have any questions about CombiPatch Patch (Bi-weekly), please talk with your doctor, pharmacist, or other health care provider.


• CombiPatch Patch (Bi-weekly) is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about CombiPatch Patch (Bi-weekly). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More CombiPatch Patch (Bi-weekly) resources

• CombiPatch Patch (Bi-weekly) Side Effects (in more detail)
• CombiPatch Patch (Bi-weekly) Use in Pregnancy & Breastfeeding
• CombiPatch Patch (Bi-weekly) Drug Interactions
• CombiPatch Patch (Bi-weekly) Support Group
• 0 Reviews for CombiPatch (Bi-weekly) - Add your own review/rating

Compare CombiPatch Patch (Bi-weekly) with other medications

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• Atrophic Vaginitis
• Hypoestrogenism
• Postmenopausal Symptoms

Finacea Gel

Pronunciation: aze-eh-LAY-ik ASS-id
Generic Name: Azelaic Acid
Brand Name: Finacea

Finacea Gel is used for:

Treating lesions due to mild to moderate rosacea.

Finacea Gel is a topical antibacterial. Exactly how Finacea Gel works to treat rosacea is unknown.

Do NOT use Finacea Gel if:

• you are allergic to any ingredient in Finacea Gel, including propylene glycol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Finacea Gel:

Some medical conditions may interact with Finacea Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of asthma or cold sores

Some MEDICINES MAY INTERACT with Finacea Gel. Because little, if any, of Finacea Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Finacea Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Finacea Gel:

Use Finacea Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Finacea Gel is only to be used on the skin. Before using Finacea Gel, wash the affected area with warm water and mild soap or a soap-free cleanser, rinse, and pat dry. Cover the affected area with a thin film of medicine. Gently rub the medicine into your skin.


• Wash your hands immediately before and after using Finacea Gel.


• Do not cover the affected area with gauze or a bandage unless your doctor tells you to do so.


• Continue to use Finacea Gel for the full course of treatment even if your condition improves. Do not miss any doses.


• If you miss a dose of Finacea Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Finacea Gel.

Important safety information:

• It may take several weeks for Finacea Gel to work. If your symptoms do not get better within 12 weeks or if they get worse, check with your doctor.


• Finacea Gel is for external use only. Avoid getting Finacea Gel in your vagina, eyes, nose, or mouth. If Finacea Gel does get into your eyes, wash your eyes immediately with plenty of water. If eye irritation continues, contact your doctor.


• If you use topical products too often, your condition may become worse.


• Finacea Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Makeup may be applied over the affected area after the medicine dries.


• Avoid any food or liquids that may bring on redness, flushing, and blushing of the skin (eg, spicy foods, alcohol, hot drinks).


• Finacea Gel should be used with extreme caution in CHILDREN; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Finacea Gel while you are pregnant. It is not known if Finacea Gel is found in breast milk. If you are or will be breast-feeding while you use Finacea Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Finacea Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; temporary burning, itching, redness, stinging, or tingling at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in skin color; peeling, irritation, or inflammation of skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Finacea side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Finacea Gel:

Store Finacea Gel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Finacea Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Finacea Gel, please talk with your doctor, pharmacist, or other health care provider.


• Finacea Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Finacea Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Finacea resources

• Finacea Side Effects (in more detail)
• Finacea Use in Pregnancy & Breastfeeding
• Finacea Drug Interactions
• Finacea Support Group
• 9 Reviews for Finacea - Add your own review/rating

Compare Finacea with other medications

• Acne
• Rosacea

Epitol

Pronunciation: KAR-ba-MAZ-e-peen
Generic Name: Carbamazepine
Brand Name: Examples include Epitol and Tegretol

Epitol may rarely cause severe blood problems (eg, aplastic anemia, agranulocytosis). Contact your doctor right away if you develop fever, chills, or sore throat; rash; ulcers or sores in the mouth; unusual bruising or bleeding; unusual tiredness; or swollen lymph nodes. Lab tests, including complete blood cell counts, will be performed before and during treatment with Epitol. These tests will be used to check for side effects.

Epitol may rarely cause serious and sometimes fatal skin reactions. Contact your doctor at once if you develop red, swollen, blistered, or peeling skin with or without fever. The risk of this reaction may be greater in Asian patients. Asian patients may need to have a blood test before they start Epitol to determine whether they have a greater risk of developing a severe skin reaction.

Epitol is used for:

Treating certain types of seizures. It is also used to treat severe pain of the jaw or cheek caused by a facial nerve problem (trigeminal neuralgia). It may also be used for other conditions as determined by your doctor.

Epitol is an anticonvulsant. It works to control seizures by blocking certain nerve impulses in the brain. It works to treat trigeminal neuralgia by altering nerve impulses in certain facial nerves, which relieves pain.

Do NOT use Epitol if:

• you are allergic to any ingredient in Epitol


• you are allergic to tricyclic antidepressants (eg, amitriptyline), cyclobenzaprine, or similar medicines


• you have a history of bone marrow problems, the blood disorder porphyria, or other serious blood disorders


• you are taking nefazodone


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Epitol:

Some medical conditions may interact with Epitol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other seizure medicines (eg, phenytoin, phenobarbital)


• if you have a history of other types of seizures (eg, absence, atonic), increased pressure in the eye (eg, glaucoma), liver or kidney problems, mood or mental problems, suicidal thoughts or actions, or multiple sclerosis


• if you have a history of heart problems (eg, heart failure, heart block, irregular heartbeat), an abnormal electrocardiogram (ECG), high blood pressure, or high blood cholesterol


• if you have a history of blood problems, including blood problems caused by other medicine


• if you have been tested and know whether or not you have a gene type called HLA-B*1502


• if you have previously taken Epitol

Some MEDICINES MAY INTERACT with Epitol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because a severe reaction, including severe high blood pressure and high fever, may occur


• Nefazodone because its effectiveness may be decreased by Epitol


• Many other prescription and nonprescription medicines (eg, used for allergies, asthma, blood thinning, cancer, diabetes, infections, inflammation, aches and pains, heartburn or reflux disease, high blood pressure, heart problems, high cholesterol, birth control, hormone replacement, immune system suppression, mental or mood problems, sleep, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with Epitol. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Epitol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epitol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Epitol:

Use Epitol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Epitol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Epitol refilled.


• Take Epitol by mouth with food.


• Eating grapefruit or drinking grapefruit juice may increase the risk of Epitol's side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.


• Do not suddenly stop taking Epitol. You may have an increased risk of seizures. If you need to stop Epitol or add a new medicine, your doctor will gradually lower your dose.


• Take Epitol on a regular schedule to get the most benefit from it.


• Taking Epitol at the same time each day will help you remember to take it.


• Continue to take Epitol even if you feel well. Do not miss any doses.


• If you miss a dose of Epitol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Epitol.

Important safety information:

• Epitol may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Epitol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Epitol; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take more than the recommended dose without checking with your doctor.


• Patients who take Epitol may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Epitol closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Epitol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Epitol may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Epitol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Epitol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Epitol before you receive any medical or dental care, emergency care, or surgery.


• Patients who have a certain gene type called HLA-B*1502 may have an increased risk of serious skin reactions from Epitol. This gene type is found most commonly in Asian patients. Tell your doctor if you have been tested and know whether or not you have the HLA-B*1502 gene type. Discuss any questions or concerns with your doctor.


• Do not switch from the tablet form of Epitol to the suspension form without checking with your doctor. The same dose may not have the same effects.


• Epitol may interfere with certain lab tests, including thyroid function tests. Be sure your doctor and lab personnel know you are using Epitol.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Epitol. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Epitol may interfere with some pregnancy test results. Check with your doctor if you have questions or concerns about your pregnancy test results.


• Lab tests, including complete blood cell counts, liver and kidney function, eye exams, and carbamazepine blood levels, may be performed while you take Epitol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Epitol with caution in the ELDERLY; they may be more sensitive to its effects, especially agitation or confusion.


• PREGNANCY and BREAST-FEEDING: Epitol has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epitol while you are pregnant. Epitol is found in breast milk. Do not breast-feed while taking Epitol.

Possible side effects of Epitol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth; nausea; unsteadiness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; calf pain, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; joint pain; light-headedness; loss of appetite; menstrual changes; new or worsening mental or mood changes (eg, aggression, agitation, anger, anxiety, depression, irritability, restlessness); pain, tenderness, or unusual swelling in the neck, groin, or under the arms; red or purple spots on your body; red, swollen, blistered, or peeling skin; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; speech problems; stomach pain; sudden, unusual weight gain; suicidal thoughts or actions; swelling of the hands, ankles, or feet; swollen lymph nodes; trouble sleeping; ulcers or sores in the mouth; uncontrolled muscle movements; unusual bruising or bleeding (eg, bleeding gums, nosebleeds); unusual tiredness or weakness; vision or eye problems; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Epitol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; fainting; fast or irregular heartbeat; loss of consciousness; muscle twitching or tremor; seizures; severe dizziness, headache, or drowsiness; severe nausea or vomiting; slow, shallow, or irregular breathing.

Proper storage of Epitol:

Store Epitol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epitol out of the reach of children and away from pets.

General information:

• If you have any questions about Epitol, please talk with your doctor, pharmacist, or other health care provider.


• Epitol is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Epitol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Epitol resources

• Epitol Side Effects (in more detail)
• Epitol Dosage
• Epitol Use in Pregnancy & Breastfeeding
• Drug Images
• Epitol Drug Interactions
• Epitol Support Group
• 7 Reviews for Epitol - Add your own review/rating

• Epitol Advanced Consumer (Micromedex) - Includes Dosage Information


• Epitol Prescribing Information (FDA)


• Carbamazepine Prescribing Information (FDA)


• Carbamazepine Professional Patient Advice (Wolters Kluwer)


• Carbamazepine Monograph (AHFS DI)


• Carbatrol Prescribing Information (FDA)


• Equetro Prescribing Information (FDA)


• Equetro Consumer Overview


• Tegretol Prescribing Information (FDA)


• Tegretol Consumer Overview

Compare Epitol with other medications

• Bipolar Disorder
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• Schizoaffective Disorder
• Trigeminal Neuralgia
• Vulvodynia

GEMCITABINE 200 mg, 1g & 2g POWDER FOR SOLUTION FOR INFUSION

GEMCITABINE 200 mg POWDER FOR SOLUTION FOR INFUSION

GEMCITABINE 1 g POWDER FOR SOLUTION FOR INFUSION

GEMCITABINE 2 g POWDER FOR SOLUTION FOR INFUSION

Gemcitabine

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.



• If you have any further questions, ask your doctor.



• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare staff.

In this leaflet:

• 1. What Gemcitabine Powder for Solution for Infusion is and what it is used for



• 2. Before you use Gemcitabine Powder for Solution for Infusion



• 3. How to use Gemcitabine Powder for Solution for Infusion



• 4. Possible side effects



• 5. How to store Gemcitabine Powder for Solution for Infusion



• 6. Further information

What Gemcitabine Powder For Solution For Infusion Is And What It Is Used For

Gemcitabine Powder for Solution for Infusion is an anti-cancer medicinal product.

It is used in the treatment of a number of types of cancer including breast cancer, bladder cancer, a type of lung cancer (non-small cell lung cancer) and cancer of the pancreas.

Gemcitabine may be used in combination with other anti-cancer medicines.

Before You Use Gemcitabine Powder For Solution For Infusion

Do not use Gemcitabine Powder for Solution for Infusion

• If you are allergic to gemcitabine or any of the other ingredients of Gemcitabine Powder for Solution for Infusion



• If you are breast-feeding



• In combination with yellow fever vaccine

Tell the doctor if you think any of the above applies to you.

Take special care with Gemcitabine Powder for Solution for Infusion

• If your blood cell levels are low or your body is unable to replace blood cells at a normal rate (this will be checked through blood tests)



• If you are to have radiotherapy whilst using gemcitabine or you have had radiotherapy within the last 7 days



• If you have kidney problems



• If you have liver problems



• If you have lung cancer or spread of cancer from elsewhere to the lungs

The use of gemcitabine in children is not recommended.

Taking and using other medicines

The following drugs may be affected by taking gemcitabine:

• Anticoagulants e.g. warfarin. Gemcitabine may increase the anticoagulant effect so that blood tests (INR) may need to be done more frequently



• Vaccines. There is a risk of the disease developing. Your doctor will choose to use a particular type of vaccine (inactivated) if there is one available



• Phenytoin (an anti-epileptic medicine). There is an increased risk of convulsions or reduced effectiveness of gemcitabine if the drugs are taken together



• Ciclosporin and tacrolimus (immunosuppressants). There is a risk of increased immunosuppression

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You must not use gemcitabine during pregnancy unless clearly indicated by your doctor.

You must not breast-feed while you are treated with gemcitabine.

If you are a woman of childbearing age you should take steps to avoid pregnancy during and up to 3 months after treatment with gemcitabine. If pregnancy occurs during treatment, you must immediately inform your doctor.

If you are a man, you should avoid fathering a child during treatment with gemcitabine and for 3 months after treatment has stopped. There is a risk that treatment with gemcitabine will lead to male infertility and you may wish to seek advice about sperm storage before the treament starts.

Driving and using machines

Gemcitabine treatment can make you feel drowsy. Alcohol can make this worse. If you feel drowsy you should not drive or operate machinery.

Important information about some of the ingredients of Gemcitabine Powder for Solution for Infusion

This medicinal product contains 35 mg (1.5 mmol) of sodium per 2 g dose. To be taken into consideration by patients on a controlled sodium diet.

How To Use Gemcitabine Powder For Solution For Infusion

Gemcitabine will be prepared and given to you by healthcare staff under the supervision of a doctor with experience in the use of anti-cancer medicines.

This medicine will be made into a solution and given to you as an infusion (slow injection via a drip) over 30 minutes into a vein.

Your initial dose of gemcitabine will be calculated by the doctor. It will depend on the type of cancer you have and your body surface area in square metres (m²). Typically, the dose will be between 1 g/m² and 1.25 g/m².

A number of follow up doses will be given. The dose may change depending on your blood cell levels, which will be checked using blood tests, and any side effects you get. The number of doses and the days when the doses are given will be decided by the doctor.

As gemcitabine will be given to you under the supervision of a doctor, it is unlikely that you will receive an incorrect dose. However, if you have any concerns about the dose you receive, please tell your doctor or healthcare staff.

If you have any further questions on the use of this product, ask your doctor or healthcare staff.

Possible Side Effects

Like all medicines, Gemcitabine Powder for Solution for Infusion can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

• Severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint



• Severe chest pains possibly radiating to the jaw or arm, sweating, breathlessness and nausea



• Severe breathing difficulty



• Yellowing of the skin and eyes because of liver problems (jaundice)



• Kidney failure (the doctor will monitor blood and urine tests for this)

These are all serious side effects. You may need urgent medical attention. These serious side effects are rare (less than 1 in 1,000 patients but more than 1 in 10,000) or very rare (less than 1 in 10,000 patients).

Tell the doctor or healthcare staff immediately if you notice any pain at the injection site during the infusion. Pain around the injection site could mean the needle has not been properly inserted into the vein.

If you receive radiation treatment and gemcitabine within 7 days of each other and you notice any of the following, tell the doctor immediately:

• mouth soreness



• swallowing difficulty or pain on swallowing

Tell the doctor as soon as possible if you notice any of the following side effects:

Very common (more than 1 in 10 patients):

• Blood in the urine



• Swelling (particularly of the ankles or hands)



• Flu like symptoms (fever, shivering, aches and pains)



• Skin rash



• Itchy skin



• Hair loss



• Mild breathing difficulty



• Nausea



• Vomiting

Common (less than 1 in 10 patients but more than 1 in 100):

• Anorexia



• Headache



• Drowsiness



• Difficulty sleeping



• Cough



• Runny nose or nasal congestion



• Diarrhoea



• Constipation



• Mouth soreness



• Ulceration of the mouth



• Sweating



• Muscle pain



• Back pain



• Weakness



• Facial swelling



• Itching

Uncommon (less than 1 in 100 patients but more than 1 in 1,000):

• Wheezing



• Cough with pink frothy sputum/phlegm

Rare (less than 1 in 1,000 patients but more than 1 in 10,000):

• Heart problems, including an abnormal heart beat



• Low blood pressure



• Skin shedding



• Skin blisters



• Skin sores (ulcers)



• Soreness at the injection site after the injection

Very rare (less than 1 in 10,000 patients):

• Problems with blood flow to the limbs (may give tingling, coldness or pain in the hands and feet)



• If this is severe or lasts a long time, the hands or feet may become dead and black (gangrene)

Blood samples will be taken to check for changes in liver function and changes in blood cell levels, which are very common side effects of gemcitabine treatment. Blood and urine tests will be performed to check for changes in kidney function. Severe kidney problems are rare.

It is possible that a man may not be able to father a child after treatment with gemcitabine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare staff.

How To Store Gemcitabine Powder For Solution For Infusion

Keep out of the reach and sight of children.

Do not use Gemcitabine Powder for Solution for Infusion after the expiry date which is stated on the vial and carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

After reconstitution:

This medicine may be stored for 35 days at 25°C. From a microbiological point of view however, it is advised that the product is used immediately.

The reconstituted solution should not be refrigerated.

The prepared solution for infusion should not be used if it contains particles or if it is strongly coloured.

This medicine will be prepared and administered to you by healthcare staff. Any unused medicine must be disposed of by the healthcare staff.

Further Information

What Gemcitabine Powder for Solution for Infusion contains

• The active substance is gemcitabine (as hydrochloride)



• Vials contain either 200 mg, 1 g or 2 g gemcitabine (as hydrochloride)



• The other ingredients are mannitol, sodium acetate trihydrate, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment)



• One ml of the reconstituted solution for infusion contains 38 mg gemcitabine (as hydrochloride)

What Gemcitabine Powder for Solution for Infusion looks like and contents of the pack

This medicinal product is a powder for solution for infusion (a powder which is dissolved before being injected slowly via a drip into a vein). It can also be referred to as a ‘powder for infusion’.

The powder is white to off-white and when dissolved ready for infusion, it produces a colourless or slightly yellow solution.

The 200 mg, 1 g and 2 g vials are sold separately as single packs or packs of 5. Not all pack sizes may be marketed. Vials may be sheathed in protective ONCO-TAIN sleeves.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer is

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

This leaflet was last approved in April 2008 (V1404)

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