AZILECT 1 mg tablets

AZILECT is used for the treatment of Parkinson?s disease. It can be used together with or without Levodopa (another medicine that is used to treat Parkinson?s disease).

With Parkinson?s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. AZILECT helps to increase and sustain levels of dopamine in the brain.

Do not take AZILECT

• if you are allergic (hypersensitive) to rasagiline or any of the other ingredients of AZILECT.
• if you have severe liver problems.

Do not take the following medicines while taking AZILECT:

• monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson?s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.
• pethidine (a strong pain killer). You must 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 problems
• You should speak with your doctor about any suspicious skin changes.

Children
AZILECT is not recommended for use under the age of 18.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.

Ask your doctor for advice before taking any of the following medicines together with AZILECT:

• Certain antidepressants(selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
• the antibiotic ciprofloxacin used against infections
• the cough suppressant dextromethorphan
• sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine

The use of AZILECT together with the antidepressants containingfluoxetine or fluvoxamine should be avoided.
If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping AZILECT treatment.

Taking AZILECT with food and drink

AZILECT may be taken with or without food.

Pregnancy and breast-feeding

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

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Ask your doctor for advice prior to driving or using machines.

Always take AZILECT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of AZILECT is 1 tablet of 1 mg taken by mouth once daily. AZILECT may be taken with or without food.

If you take more AZILECT than you should

If you think that you may 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

Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.

If you stop taking AZILECT

Do not stop taking AZILECT without first talking to your doctor.

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

Like all medicines, AZILECT can cause side effects, although not everybody gets them.

The following side effects have been reported in placebo controlled clinical trials:

The frequency of possible side effects listed below is defined using the following convention Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data

Very common

• abnormal movements (dyskinesia)
• headache

Common:

• abdominal pain
• fall
• allergy
• fever
• flu (influenza)
• general feeling of being unwell (malaise)
• neck pain
• chest pain (angina pectoris)
• low blood pressure when rising to a standing position with symptoms like dizziness/light-headedness (orthostatic hypotension)
• Decreased appetite
• constipation
• dry mouth
• nausea and vomiting
• flatulence
• abnormal results of blood tests (leucopenia)
• joint pain (arthralgia)
• musculoskeletal pain
• joint inflammation (arthritis)
• numbness and muscle weakness of the hand (carpal tunnel syndrome )
• decreased weight
• abnormal dreams
• difficulty in muscular coordination (balance disorder)
• depression
• dizziness (vertigo)
• prolonged muscle contractions (dystonia)
• runny nose (rhinitis)
• irritation of the skin (dermatitis)
• rash
• bloodshot eyes (conjunctivitis)
• urinary urgency

Uncommon:

• stroke (cerebrovascular accident)
• heart attack (myocardial infarction)
• blistering rash (vesiculobullous rash)

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.

Parkinson's disease is associated with symptoms of hallucinations and confusion.
In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with AZILECT.

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 pharmacist.

Keep out of the reach and sight of children.

Do not use AZILECT after the expiry date which is stated on the carton, bottle or blister. The expiry date refers to the last day of that month.

Do not store above 25oC.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What AZILECT contains

• The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as mesilate).
• The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.

What AZILECT looks like and contents of the pack

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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Teva Pharma GmbH Kandelstrasse 10 D-79199 Kirchzarten Germany Manufacturer Teva Pharmaceuticals Europe B.V. Computerweg 10 3542 DR Utrecht The Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Lundbeck S.A.N.V. Avenue Molière 225 B-1050 BruxellesBrusselBrüssel TélTel 32 2 340 2828 LuxembourgLuxemburg Lundbeck S.A. Avenue Molière 225 B-1050 BruxellesBrüssel BelgiqueBelgien TélTel 32 2 340 2828

Magyarország Teva Magyarország Zrt. Rákóczi út 70-72. H-1074 Budapest Tel. 36 1 288 6400 2000 . . 55 1407 . 359 2 962 46 96

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Danmark Lundbeck Pharma AS Dalbergstrøget 5 DK-2630 Taastrup Tlf 45 4371 4270 Nederland Teva Pharma B.V. Swensweg 5 NL-2003 RN Haarlem Tel 31 23 514 7147

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Lietuva

UAB Lundbeck Lietuva
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LT-01122 Vilnius
Tel: +370 5 231 4188

This leaflet was last approved in .