Azilect 1 mg Tablets

AZILECT 1 mg is used for the treatment of Parkinson’s disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa). In Parkinson’s disease there is a loss of cells producing dopamine in certain areas in the brain. AZILECT 1 mg enables increased and sustained levels of dopamine in these areas.

If you are taking other medicines on a regular basis, using this medicine at the same time with another medicine may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional.

Do not use AZILECT 1 mg:

• If you are allergic to rasagiline mesylate or any other ingredient.
• If you have moderate to 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. John's Wort), while taking AZILECT 1 mg. Do not take the strong pain killer, pethidine, while taking AZILECT 1 mg. You should wait at least 14 days after stopping AZILECT 1 mg treatment and starting treatment with MAO inhibitors or pethidine.

Take special care with AZILECT 1 mg:

• if you have mild liver insufficiency
• if you take medicines containing fluoxetine, fluvoxamine, dextromethorphan or sympathomimetics, please see section Taking other medicines with AZILECT 1 mg.

AZILECT 1 mg is not recommended for use in patients under the age of 18.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant or are breastfeeding, please consult your doctor, pharmacist or other healthcare professional for advice before taking AZILECT 1 mg.

Always take AZILECT 1 mg exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The recommended dose of AZILECT is one tablet of 1 mg taken orally once daily. AZILECT 1 mg may be taken with or without food.

If you take more AZILECT 1 mg than you should:

If you think that you may have taken too many AZILECT 1 mg tablets, contact your doctor or pharmacist immediately. Take the AZILECT 1 mg carton/bottle with you to show the doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take AZILECT 1 mg:

If you have forgotten to take a dose of AZILECT 1 mg take the next dose at the usual time. Do not take a double dose to make up for the one you missed.

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Very common (more than 10 % of the patients): Abnormal movements (dyskinesia), headache.

Common (between 1 - 10 % of the patients): Stomach pain, accidental injury (primary falls), allergic reaction, fever, flu syndrome, generally feeling unwell (malaise), neck pain, chest pain (angina pectoris), low blood pressure when rising to a standing position (postural hypotension), loss of appetite, constipation, indigestion, dry mouth, vomiting, abnormal results of blood tests (leucopenia), joint pain (arthralgia), arthritis, tenderness and swelling of tendons (tenosynovitis), weight loss, abnormal dreams, difficulty in muscular coordination (ataxia), depression, dizziness, prolonged muscle contractions (dystonia), runny nose (rhinitis), contact dermatitis, rash, vesiculobullous rash, conjunctivitis, urinary urgency.

Uncommon (between 0.1 - 1 % of the patients): Stroke (cerebrovascular accident), heart attack (myocardial infarct). In addition, skin cancer was reported in around 1 % of patients in the placebo controlled clinical trials. Nevertheless, scientific evidence suggests that Parkinson’s disease, and not any medicine in particular, is associated with a higher risk of skin cancer (not exclusively melanoma). You should speak with your doctor about any suspicious skin changes.

In post marketing experience symptoms of hallucinations and confusion have been observed in Parkinson’s disease patients treated with AZILECT 1 mg.

Store at or below 25 °C in the original package. Blisters: Do not remove blisters from outer carton until required for use. Bottles: Keep well closed.

Do not use after the expiry date shown on the carton, blister or bottle. STORE ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN.