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
This leaflet was last approved in April 2008 (V1404)
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