Azilect

Package leaflet: Information for the user

AZILECT 1 mg tablets

rasagiline
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 rasagiline and is used 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 dopaminergic neurons in certain areas of the brain. Dopamine is a substance in the brain responsible for controlling 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 ingredients of this medicine (listed in section 6).
• If you have severe liver impairment.

Do not take the following medicines in combination with AZILECT:

• Monoamine oxidase inhibitors (MAO inhibitors) (used as antidepressants, for the treatment of Parkinson's disease or for any other indication), including over-the-counter medicines and herbal products such as St. John’s wort.
• Meperidine (a strong analgesic).

Wait at least 14 days after stopping treatment with AZILECT before starting treatment with MAO inhibitors or meperidine.
Warnings and precautions
Talk to your doctor before taking AZILECT

• If you have any liver function problems.
• Consult your trusted doctor if you notice any suspicious skin changes. Treatment with AZILECT may increase the risk of skin cancer.

Inform your doctor if you, your family members or your caregivers notice that you are developing unusual behaviors that make you unable to resist the impulse, urge or desire to carry out certain activities that may be dangerous or harmful to yourself or others. These behaviors are known as impulse control disorders. In patients taking AZILECT and/or other medicines used to treat Parkinson’s disease, behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, and abnormally increased sexual desire or increased sexual thoughts or urges have been observed. Your doctor may need to adjust your dose or discontinue treatment (see section 4).
AZILECT may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used to treat Parkinson’s disease). For further information, refer to the section on Driving and use of machines.
Children and adolescents
There is no indication for a specific use of AZILECT in children and adolescents. Therefore, the use of AZILECT is not recommended in patients under 18 years of age.
Other medicines and AZILECT
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor 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 to treat infections
• Dextromethorphan, a medicine used for cough
• Sympathomimetics such as those found in eye drops, nasal and oral decongestants, and cold remedies containing ephedrine or pseudoephedrine. Avoid concomitant use of AZILECT and antidepressants containing fluoxetine or fluvoxamine. Wait at least five weeks after stopping fluoxetine before starting treatment with AZILECT. Wait at least 14 days after stopping treatment with AZILECT before starting treatment with fluoxetine or fluvoxamine.

Inform your doctor or pharmacist if you are a smoker or plan to stop smoking. Smoking may reduce the amount of AZILECT in your blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid taking AZILECT during pregnancy, as the effects of AZILECT on pregnancy and the fetus are unknown.
Driving and use of machines
Ask your doctor for advice before driving or operating machinery, as Parkinson’s disease itself and treatment with AZILECT may affect your ability to do so. AZILECT may cause dizziness and drowsiness; it may also cause sudden onset of sleep episodes.
This effect may be increased if you are taking other medicines to treat symptoms of Parkinson’s disease, or if you are taking medicines that cause drowsiness, or if you drink alcohol while taking AZILECT. If you have previously experienced drowsiness and/or sudden onset of sleep episodes while taking AZILECT, do not drive or operate machinery (see section 2).

3. How to take AZILECT

Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
The recommended dose of AZILECT is one 1 mg tablet 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 AZILECT tablets than you should, contact your
doctor or pharmacist immediately. Take the carton/blister or bottle of AZILECT with you to show the doctor or
pharmacist.
Symptoms reported after an overdose of AZILECT have included slightly euphoric mood (a mild 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 the missed tablet. Take the next dose as scheduled, at the usual time.
If you stop taking AZILECT
Do not stop taking AZILECT without first talking to your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following symptoms. You may need
urgent medical advice or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling addiction, excessive shopping or spending, impulsive behaviours, abnormally increased sex drive or an increase in 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 suspicious skin changes, as the risk of skin cancer (melanoma) may increase 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
• Falls
• Allergic reaction
• Fever
• Flu-like illness (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Drop in blood pressure when standing up, accompanied by 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
• Inflammation of the joints (arthritis)
• Numbness and weakness of the hand muscle (carpal tunnel syndrome)
• Loss of body weight
• Abnormal dreams
• Difficulty with muscle coordination (balance disorders)
• Depression
• Dizziness
• Prolonged muscle contractions (dystonia)
• Runny nose (rhinitis)
• Skin irritation (dermatitis)
• Erythema
• Red eyes (conjunctivitis)
• Urinary urgency

Uncommon (may affect up to 1 in 100 people)

• Stroke (cerebrovascular accident)
• Heart attack (myocardial infarction)
• Skin blisters (vesiculobullous erythema)

Not known: frequency cannot be estimated from the available data

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AZILECT

Keep AZILECT out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, bottle, or carton after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AZILECT contains

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

Description of the appearance of AZILECT and contents of the pack
AZILECT tablets are white to off-white, round, flat, bevelled-edge tablets, smooth on one side and with raised imprints “GIL” and “1” on the other.
Tablets are available in packs of 7, 10, 28, 30, 100 and 112 tablets or in bottles of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers
Teva Pharmaceutical 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB "Sicor Biotech"
Tél/Tel: +32 3 820 73 73 Tel: +370 5 266 0203

България Luxembourg/Luxemburg
Тева Фармасютикълс България ЕООД Teva Pharma Belgium N.V./S.A./AG,
Teл: +359 2 489 95 82 Belgique/Belgien
Tél/Tel: +32 3 820 73 73

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251 007 111 Tel.: +36 1 288 6400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 4498 5511 L-Irlanda
Tel: +353 51 321 740

Deutschland Nederland
Teva GmbH Teva Nederland B.V.
Tel: +800 53 23 66 48 Tel: +31 (0) 800 0228400

Eesti Norge
Teva Eesti esindus Teva Norway AS
UAB Sicor Biotech Eesti filiaal Tlf: +47 66775590
Tel: +372 6610801

Ελλάδα Österreich
Teva Ελλάς Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 210 72 79 099 Tel.: +43 (0)1 97007

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 91 387 32 80 Tel.: +48 22 345 93 00

France Portugal
Teva Santé Teva Pharma - Produtos
Tél: +33 1 55 91 7800 Farmacêuticos Lda
Tel: +351 21 476 75 50

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L
Tel.: + 385 1 37 20 000 Tel: +4021 230 65 24

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +353 51 321 740 Tel: +386 1 58 90 390

Ísland Slovenská republika
Actavis Pharmaceuticals Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 550 3300 Tel: +421 2 572 679 11

Italia Suomi/Finland
Teva Italia S.r.l. ratiopharm Oy
Tel: +39 028917981 Puh/Tel: +358 20 180 5900

Κύπρος Sverige
Teva Ελλάς Α.Ε., Ελλάδα Teva Sweden AB
Τηλ: +30 210 72 79 099 Tel: + 46 42 12 11 00

Latvija United Kingdom
UAB "Sicor Biotech" filiāle Latvijā Teva UK Limited
Tel: +371 67 323 666 Tel: +44(0) 1977 628500