AZILECT 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

AZILECT 1mg tablets

rasagiline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is AZILECT and what is it used for
2. What you need to know before you take AZILECT
3. How to take AZILECT
4. Possible side effects
5. Storage of AZILECT
6. Contents of the pack and other information

1. What is AZILECT and what is it used for

AZILECT contains the active substance rasagiline and is indicated for the treatment of Parkinson's disease in adults. It can be used alone or in combination with levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of cells in the brain that produce dopamine. Dopamine is a brain chemical involved in controlling movement. AZILECT helps to increase and maintain dopamine levels in the brain.

2. What you need to know before you take AZILECT

Do not take AZILECT

• If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver problems.

Do not take the following medicines while taking AZILECT:

• Monoamine oxidase inhibitors (MAOIs) (e.g. for the treatment of depression or Parkinson's disease, or for another indication) including non-prescription medicines and natural products, e.g. St. John's Wort.
• Pethidine (a strong painkiller).

You should wait at least 14 days after stopping treatment with AZILECT before starting treatment with MAOIs or pethidine.

Warnings and precautions

Consult your doctor before starting treatment with AZILECT

• If you have any liver problems.
• You should discuss with your doctor any suspicious changes in your skin. Treatment with AZILECT may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/caregiver notice that you are developing unusual behaviours where you cannot resist the impulse, urge or temptation to perform certain harmful or hazardous activities to yourself or others. These are called impulse control disorders. In patients taking AZILECT and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive or increased sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

AZILECT may cause you to feel dizzy or sleepy, or to suddenly fall asleep. This can happen while doing daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). If you experience drowsiness and/or sudden sleep episodes before or while taking AZILECT, do not drive or use machines (see section 2).

Children and adolescents

The use of AZILECT in children and adolescents is not relevant. Therefore, AZILECT is not recommended for persons under 18 years.

Other medicines and AZILECT

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Inform your doctor especially if you are taking any of the following medicines:

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-noradrenaline reuptake inhibitors, tricyclic or tetracyclic antidepressants).

• The antibiotic ciprofloxacin used against infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal decongestants, and cough and cold medicines that contain ephedrine or pseudoephedrine.

Avoid using AZILECT with antidepressants that contain fluoxetine or fluvoxamine. If you start treatment with AZILECT, you should wait at least 5 weeks after stopping treatment with fluoxetine.

If you start treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping treatment with AZILECT.

Tell your doctor or pharmacist if you smoke or intend to stop smoking. Smoking may decrease the amount of AZILECT in your blood.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the unborn child are not known.

Driving and using machines

Consult your doctor before driving or using machines, as both Parkinson's disease and treatment with AZILECT can affect your ability to perform these activities. AZILECT may cause dizziness or sleepiness, as well as sudden sleep episodes.

This may increase if you take other medicines for Parkinson's disease symptoms, if you take medicines that may cause drowsiness, or if you consume alcohol during treatment with AZILECT. If you have experienced drowsiness and/or sudden sleep episodes before or while taking AZILECT, do not drive or use machines (see section 2).

3. How to take AZILECT

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of AZILECT is 1 tablet of 1 mg taken by mouth, once a day. AZILECT can be taken with or without food.

If you take more AZILECT than you should

If you think you have taken more tablets than you should, tell your doctor or pharmacist immediately. Take the pack or blister with you to show the doctor or pharmacist.

Symptoms reported after an overdose of AZILECT were mildly euphoric mood (a mild form of mania), very high blood pressure, and serotonin syndrome (see section 4).

If you forget to take AZILECT

Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

If you stop taking AZILECT

Do not stop treatment with AZILECT without consulting your doctor first.

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

4. Possible side effects

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

Seek immediate medical attentionif you experience any of the following symptoms. You may need urgent medical treatment:

• If you experience unusual behaviours such as compulsions, obsessive thoughts, gambling, excessive shopping, impulsive behaviour, and an abnormally high sexual drive or increased sexual thoughts or feelings (impulse control disorders) (see section 2).
• If you see or hear things that do not exist (hallucinations).
• Any combination of hallucinations, fever, agitation, tremor, and sweating (serotonin syndrome).

Tell your doctorif you notice any suspicious changes in your skin, as there may be an increased risk of skin cancer (melanoma) with this medicine (see section 2).

Other side effects

Very common (may affect more than 1 in 10 people)

• Involuntary movements (dyskinesia).
• Headache.

Common (may affect up to 1 in 10 people)

• Abdominal pain.
• Falls.
• Allergic reactions.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure when standing up with symptoms such as dizziness/lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Abnormal blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint inflammation (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight decrease.
• Abnormal dreams.
• Muscle coordination problems (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Nasal discharge (rhinitis).
• Skin irritation (dermatitis).
• Rash.
• Eye redness (conjunctivitis).
• Urinary urgency.

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident).
• Heart attack (myocardial infarction).
• Blistering rash (vesiculobullous rash).

Frequency not known: cannot be estimated from the available data

• High blood pressure.
• Excessive sleepiness.
• Sudden sleep episodes.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of AZILECT

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or bottle after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

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 protect the environment.

6. Contents of the pack and other information

What AZILECT contains

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

Appearance and packaging

AZILECT tablets are presented as white or almost white, round, flat, and bevelled tablets with the inscription "GIL" and "1" embossed on one face and plain on the other.

The tablets are available in blister packs of 7, 10, 28, 30, 100, and 112 tablets or in a bottle with 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturers

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Pliva Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Teva Operations Poland Sp.z o.o.

ul. Mogilska 80

31-546 Krakow

Poland

You can request more information about this medicine from the local representative of the marketing authorisation holder:

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