ZELAPAR 1.25 mg
Oral Lyophilisate (Tablet)
Selegiline hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What ZELAPAR is and what it is used for.
2. Before you take ZELAPAR.
3. How to take ZELAPAR.
4. Possible side effects.
5. How to store ZELAPAR.
6. Further information.
What Zelapar Is And What It Is Used For
The name of this medicine is ZELAPAR 1.25 mg oral lyophilisate (tablet). The active ingredient in this medicine is selegiline hydrochloride which belongs to a group of medicines called monoamine oxidase B inhibitors.
ZELAPAR is used to treat Parkinson’s disease and can be used on its own or in combination with other medicines.
Before You Take Zelpar
Do not take ZELAPAR if you:
- Are allergic (hypersensitive) to selegiline hydrochloride or any of the other ingredients of ZELAPAR.
- Have a stomach ulcer.
- Have a condition called phenylketonuria.
- Are taking pethidine or any other opioid painkiller.
- Are taking any medicine for depression.
- Are taking any Monoamine oxidase inhibitors e.g. the antibiotic linezolid.
- Are taking any medicines for migraine e.g. rizatriptan.
If you are already taking a medicine called Levodopa for your Parkinson’s disease and suffer from any of the following conditions you should not take ZELAPAR as well:
- Major heart problems.
- Chest pain (angina).
- High blood pressure.
- An erratic or fast heartbeat.
- An overactive thyroid gland (hyperthyroid disease).
- An eye condition called narrow angle glaucoma.
- A tumour of your prostate gland.
- Major mental health problems e.g. schizophrenia.
Take special care with ZELAPAR
- If you already take Levodopa. It can cause agitation and you should tell your doctor if this happens.
If you have:
- Liver disease.
- High or low blood pressure.
- Erratic heartbeat.
- Chest pain (Angina).
- Severe dementia.
- Mental health problems.
- A history of stomach ulcers.
If any of the above apply to you, you should speak to your doctor before taking this medicine.
Taking ZELAPAR with other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is especially important if you are taking any of the following medicines for:
- High or low blood pressure.
- Anxiety, depression or sleep problems.
- Heart problems.
- Asthma e.g. ventolin inhalers.
or any of the following:
- Medicines to relieve congestion e.g. ephedrine.
- Medicines to relax the gut muscles.
- Medicines having antidepressant or mood elevating properties.
- Oral contraceptives (the pill).
- HRT (hormone replacement therapy).
- Amantadine (used to treat Parkinson’s).
- Altretamine (used to treat ovarian cancer).
Taking ZELAPAR with food and drink
Do not drink alcohol when you are taking ZELAPAR.
Do not eat, drink or rinse your mouth for 5 minutes after taking ZELAPAR.
Pregnancy and breast-feeding
Do not take ZELAPAR if you are pregnant, breast-feeding or planning to become pregnant.
Driving and operating machinery
ZELAPAR may make you feel slow or drowsy, if this happens to you do not drive or operate machinery.
Important information about one of the ingredients of ZELAPAR
ZELAPAR contains a source of phenylalanine. May be harmful for people with phenylketonuria.
How To Take Zelapar
Always take ZELAPAR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is 1.25 mg once a day.
Do not push the tablet through the foil blister. Peel back the foil and carefully remove the tablet.
Place it on your tongue in the morning and allow it to dissolve. The tablet will dissolve rapidly.
Do not eat, drink or rinse your mouth out for 5 minutes after taking it.
If you take more ZELAPAR than you should
If you take too much ZELAPAR you should contact your doctor or go to the nearest hospital emergency department immediately. Take the packet and this leaflet with you so that the doctor will know what you have taken.
If you forget to take ZELAPAR
If you forget to take your dose of ZELAPAR in the morning, ensure you take it as soon as you remember before your next dose is due. Do not take a double dose to make up for a forgotten dose.
Zelapar Side Effects
Like all medicines, ZELAPAR can cause side effects, although not everybody gets them.
Stop taking this medicine and tell your doctor immediately if you have difficulty breathing or your mouth or throat begins to swell or if you start suffering from a severe rash, itching or other skin reactions, as these may be signs of a serious allergic reaction.
The following side effects have been reported:
- Back pain, dizziness, shakes and sore throat.
Less commonly:
- Sore mouth, mouth ulcers, blocked nose.
- Falls, loss of balance, dizziness, problems sleeping, strange dreams, hallucinations, confusion.
- Muscle cramps and joint pains.
- Constipation or diarrhoea, feeling sick.
In addition, the following side effects have also been reported:
- Chest pain, headache, low blood pressure.
- Muscle aches.
- Depression, tiredness.
- Dry mouth.
- Abnormal liver tests.
Taking ZELAPAR with Levodopa
If you take ZELAPAR with Levodopa you may also notice:
- Difficulty controlling your movements or loss of balance.
- Agitation, problems sleeping, confusion, serious mental health problems, hallucinations or abnormal thoughts, anxiety, irritability, depression and tiredness.
- Dizziness or feeling faint, dry mouth, feeling sick, loss of appetite.
- High or low blood pressure, chest pains, erratic or fast heartbeat.
- Headache, blurred vision and excessive sweating.
- Shortness of breath, swollen ankles and problems passing urine.
- Skin rashes or spots.
- Low levels of white blood cells (leucocytopenia) and platelets (thrombocytopenia) in the blood which may make you more vulnerable to infections or bruising.
- Temporary liver problems.
- Hair loss.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Zelapar
Keep out of the reach and sight of children.
Do not store above 25ºC.
Do not use after the expiry date printed on the carton and sachet.
Further Information
What ZELAPAR contains
The active ingredient is Selegiline hydrochloride (1.25 mg). It also contains gelatine, mannitol, aspartame, grapefruit flavour, glycine, anhydrous citric acid and yellow colouring (yellow iron oxide [E172] and hypromellose [E464]) as inactive ingredients.
Discard any unused medicine within 3 months of opening the sachet.
Do not take this medicine after the expiry date shown on the pack.
What ZELAPAR looks like and the contents of the pack
The tablets are pale yellow, round, and embossed with an A on one side.
They come in PVCPE/PVdC blister packs sealed with aluminium foil enclosed in a paper/PE/aluminium foil sachet.
ZELAPAR comes in packs of 10, 30, 60 and 100 tablets.
Marketing Authorisation Holder
Manufacturer
This leaflet was last approved in June 2010
For more information please call free on
0800 783 4869 or
e-mail: UKMedInfo@cephalon.com
0122/8
11EP5536H
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