Azilect 1 mg tablets

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What AZILECT is and what it is used for

AZILECT contains the active substance rasagilina and is indicated for the treatment of Parkinson's disease in adults. It can be used with or without levodopa (another medicine used to treat Parkinson's disease).

In Parkinson's disease, there is a loss of dopamine-producing cells in the brain. Dopamine is a chemical substance in the brain involved in the control of movement. AZILECT helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking AZILECT

Do not take AZILECT

• If you are allergic to rasagiline or to any of the other components 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 (MAO inhibitors) (e.g., for the treatment of depression or Parkinson's disease, or for other indications), including prescription and non-prescription medicines and natural products, e.g., St. John’s wort.
• Meperidine (a strong painkiller).

You must wait at least 14 days after stopping AZILECT before starting treatment with MAO inhibitors or meperidine.

Warnings and precautions

Talk to your doctor before starting AZILECT

• If you have any liver problems.
• You should speak with your doctor about 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/carer notice that you are developing unusual behaviors where you cannot resist the impulse, urge, or craving to carry out certain harmful or damaging activities. These are called impulse control disorders. In patients taking AZILECT and/or other medicines used to treat Parkinson’s disease, behaviors such as compulsions, obsessive thoughts, pathological gambling, excessive spending, impulsive behavior, and abnormally high sex drive or increased thoughts or feelings about sex have been observed. Your doctor may need to adjust or stop your dose (see section 4).

AZILECT may cause drowsiness and cause you to fall asleep suddenly during daily activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, see the section “Driving and use of machines”.

Children and adolescents

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

Other medicines and AZILECT

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

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

• Certain antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants).
• The antibiotic ciprofloxacin used for infections.
• The cough suppressant dextromethorphan.
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine.

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

If you are starting treatment with fluoxetine or fluvoxamine, you must wait at least 14 days after stopping treatment with AZILECT.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the fetus are unknown.

Driving and use of machines

Talk to your doctor before driving or operating machinery, as both Parkinson’s disease and treatment with AZILECT may affect your ability to perform these activities. AZILECT may cause dizziness or drowsiness, as well as sudden episodes of falling asleep.

This risk may increase if you take other medicines to treat symptoms of Parkinson’s disease, 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 episodes of falling asleep before or during treatment with AZILECT, do not drive or operate machinery (see section 2).

3. How to take AZILECT

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of AZILECT is 1 tablet of 1 mg taken orally once daily. AZILECT may be taken with or without food.

If you take more AZILECT than you should

If you think you have taken more tablets of AZILECT than you should, inform your doctor or pharmacist immediately. Take the pack/blister or bottle of AZILECT with you so you can show it to the doctor or pharmacist.

Symptoms reported following an overdose of AZILECT include slightly 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 missed doses. Take the next dose as scheduled, at the usual time.

If you stop taking AZILECT

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience any of the following symptoms. You may require urgent medical treatment or attention:

• If you display unusual behaviors such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behavior, abnormally increased sex drive, or increased sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not real (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor, and sweating (serotonin syndrome).

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

Other adverse 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.
• Allergy.
• Fever.
• Flu (influenza).
• General malaise.
• Neck pain.
• Chest pain (angina pectoris).
• Low blood pressure upon standing, with symptoms such as dizziness/lightheadedness (orthostatic hypotension).
• Decreased appetite.
• Constipation.
• Dry mouth.
• Nausea and vomiting.
• Flatulence.
• Changes in blood test results (leucopenia).
• Joint pain (arthralgia).
• Musculoskeletal pain.
• Joint swelling (arthritis).
• Numbness and muscle weakness in the hand (carpal tunnel syndrome).
• Weight loss.
• Abnormal dreams.
• Difficulty with muscle coordination (balance disorder).
• Depression.
• Dizziness (vertigo).
• Prolonged muscle contractions (dystonia).
• Runny nose (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 available data

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the container, bottle, or blister pack following EXP. The expiry date refers to the last day of the month indicated.

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 and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of AZILECT

• The active substance is rasagiline. Each tablet contains 1 mg of rasagiline (as mesilate).
• The other components are mannitol, anhydrous colloidal silica, corn starch, pregelatinized corn starch, stearic acid, and talc.

Appearance of the product and contents of the pack

AZILECT tablets are presented as white or almost white, round, flat, bevelled tablets with the raised inscription “GIL” and “1” on the lower part of 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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturers

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

The 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of last review of this leaflet: {month YYYY}.