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 Azilect / Agilect / Rasagiline - Manufacturer's Insert

What Azilect is and what it is used for:
Azilect tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side. The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets. Azilect is used for the treatment of Parkinson’s disease as monotherapy (without levodopa) or as adjunct (with levodopa). In Parkinson’s disease there is a loss of cells producing dopamine in certain areas in the brain. Azilect enables increased and sustained levels of dopamine in these areas.
Before you take Azilect:
Before you take Azilect it is important that you read the following sections and discuss any questions you might have with your doctor.
Do not take Azilect:
- If you are hypersensitive (allergic) to rasagiline or to any of the ingredients of Azilect.
- If you have a severe liver insufficiency.
Do not take monoamine oxidase (MAO) inhibitors whether used as antidepressants, for the treatment of Parkinson’s disease, or for any other indication including medicinal and natural products without prescription (e.g. St Johns Wort), while taking Azilect. Do not take the strong pain killer, pethidine, while taking Azilect. You should wait at least 14 days after stopping Azilect treatment and starting treatment with MAO inhibitors or pethidine.
Take special care with Azilect:
- if you have mild to moderate liver insufficiency
- If you take medicines containing fluoxetine, fluvoxamine, dextromethorphan or sympathomimetics, please see section “Taking other medicines”.
- Azilect is not recommended for use under the age of 18.
Pregnancy:
If you are pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before taking Azilect.
Breast Feeding:
Ask your doctor or pharmacist for advice before taking Azilect.
Taking other medicines:
Please ask your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, even those obtained without prescription.
The following medicines require specific medical advice before being taken together with Azilect: Certain antidepressants (selective serotonin reuptake inhibitors, tricyclic or tretracyclic antidepressants), the antibiotic ciproflaxin used against infections, the cough suppressant dextromethorphan, sympathomimetics such as those present in nasal and oral decongestants and cold medications containing ephedrine or pseudoephedrine. The use of Azilect together with the antidepressants containing fluoxetine or fluvoxamine should be avoided. You should wait at least five weeks after stopping fluoxetine treatment and starting treatment with Azilect. You should wait at least 14 days after stopping Azilect treatment and starting treatment with fluoxetine or fluvoxamine.
How to take Azilect:
Take Azilect exactly as instructed by your doctor. You should talk with your physician or pharmacist if you are unsure. The recommended dose of Azilect is one tablet of 1mg take orally once daily. Azilect may be taken with or without food.
If you take more Azilect than you should:
If you think that you have taken too many Azilect tablets, contact your doctor or pharmacist immediately. Take the Azilect carton/ bottle with you to show the doctor or pharmacist.
If you forget to take Azilect:
If you have forgotten to take a dose of Azilect take the next dose at the usual time. Do not take a double dose to make up for the one you missed.
Possible Side Effects
Like all medicines, Azilect can have side effects.
The following side effects have been reported:
Very common (more than 10% of the patients): Abnormal movements (dyskinesia), headache.
Common (between 1-10% of the patients): Abdominal pain, accidental injury (primarily falls), allergic reaction, fever, flu syndrome, malaise, neck pain, angina pectoris, low blood pressure when rising to a standing position (postural hypotension), anorexia, constipation, dyspepsia, dry mouth, vomiting, abnormal results in blood tests (leucopenia), joint pain (arthralgia) arthritis, tenosynovitis, weight loss, abnormal dreams, difficulty in muscular co-ordination (ataxia) depression, vertigo, prolonged muscle contractions (dystonia) rhinitis, contact dermatitis, rash, vesiculobullous rash, conjunctivitis, urinary urgency.
Uncommon (between 0.1-1% of the patients): Stroke (cerebrovascular accident), myocardial infarct.
In addition, skin cancer was reported in around 1% of patients in the clinical trials.
Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any drug in particular, is associated with higher risk of skin cancer (not exclusively melanoma). You should speak to with your doctor about any suspicious skin changes.
If you notice any side effects not mentioned in this leaflet, please contact your doctor or pharmacist.
Storing Azilect:
Keep out of the reach and sight of children. Do not sore above 25 degrees C. Store in the original package. Do not use after the expiry date stated on the carton, bottle or blister.


The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.

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