Azilect - patient leaflet, side effects, dosage

- 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.

What is in this leaflet

• 1. What AZILECT is and what it is used for

• 2. What you need to know before you take 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 rasagiline and it is used for the treatment of Parkinson’s disease in adults. 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.

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 (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.

Warnings and precautions

Talk to your doctor before taking AZILECT

• – If you have any liver problems

• – You should speak with your doctor about any suspicious skin changes. Treatment with AZILECT may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental 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, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s di­sease). For further information please refer to section driving and using machines.

Children and adolescents

There is no relevant use of AZILECT in children and adolescents. Therefore, AZILECT is not recommended for use under the age of 18.

Other medicines and AZILECT

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

Especially tell your doctor if you are taking any of the following medicines:

• – Certain antidepressants (selective serotonin reuptake inhibitors, selective serotoninnore­pinephrine 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 containing fluoxetine 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.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of AZILECT in the 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

Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.

This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s di­sease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking AZILECT. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking AZILECT do not drive or operate machinery (see section 2).

3. How to take AZILECT

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended 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/ blister or bottle with you to show the doctor or pharmacist.

Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of mania), extremely 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 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor right away if you notice any of the following symptoms. You may need urgent medical advice or treatment:

• – If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).

• – If you see or hear things which are not there (hallucinations).

• – Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome)

Contact your doctor if you notice any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) with the use of 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

• – 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 (may affect up to 1 in 100 people)

• – Stroke (cerebrovascular accident)

• – Heart attack (myocardial infarction)

• – Blistering rash (vesiculobullous rash)

Not known: frequency cannot be estimated from the available data

• – Elevated blood pressure

• – Excessive drowsiness

• – Sudden onset of sleep

Reporting of side effects

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

5. How to store 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, bottle or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30oC.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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 rasagiline (as mesilate).

• – The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised

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

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

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

Belgie/Belgiqu­e/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Etnrapua TeBa OapMa EA^ Ten: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 Danmark Teva Denmark A/S Tlf: +45 44985511

Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Lu­xemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien Tel/Tel: +32 38207373 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117

Deutschland TEVA GmbH Tel: +49 73140208	Nederland Teva Nederland B.V. Tel: +31 8000228400
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EXÀàôa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Teva Pharma, S.L.U. Tel: +34 913873280	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Teva Santé Tél: +33 155917800	Portugal Teva Pharma – Produtos Farmaceuticos, Lda. Tel: +351 214767550
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Teva Pharma Iceland ehf. Sími: +354 5503300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Italia Teva Italia S.r.l. Tel: +39 028917981	Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900
Kùnpoç Specifar A.B.E.E. EUáSa	Sverige Teva Sweden AB Tel: +46 42121100

Tql: +30 2118805000

Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666

United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117

This leaflet was last revised in {month YYYY}.

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