AZILECT 1 mg Tablet

Зміст інструкції

1. AZILECT 1 mg tablets
   1. What is AZILECT and what is it 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. Package contents and other information

AZILECT 1 mg tablets

rasagiline

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 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 is AZILECT and what is it 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 dopamine-producing cells in certain areas of the
brain. Dopamine is a brain substance responsible for controlling movements. AZILECT
helps to increase and maintain constant levels of dopamine in the brain.

2. What you need to know before taking 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 suffer from severe hepatic insufficiency.

Do not take the following medicines in combination with AZILECT:

• Monoamine oxidase inhibitors (MAOIs) (used as antidepressants, for the treatment of Parkinson's disease or for any other indication), including medicines and herbal products available without a prescription, such as St. John's Wort.
• Pethidine (a strong painkiller).

Wait at least 14 days after stopping treatment with AZILECT before starting treatment with MAOIs or pethidine.

Warnings and precautions
Talk to your doctor before taking AZILECT

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

Tell your doctor if you, your family members or your caregiver notice that you are developing unusual behaviours that make you unable to resist the impulse, urge or temptation to carry out certain activities that are dangerous or harmful to yourself or others. These behaviours 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 addiction, excessive spending, impulsive behaviours and an abnormally increased sexual desire or increased sexual thoughts or desires have been observed. Your doctor may need to adjust your dose or stop the treatment (see section 4).
AZILECT can cause drowsiness and may cause you to fall asleep suddenly during the day, especially if you are taking other dopaminergic medicines (used to treat Parkinson's disease). For further information, please refer to the section Driving and using machines.

Children and adolescents
There is no indication for a specific use of AZILECT in children and adolescents. Consequently, the use of AZILECT is not recommended in patients 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:

• Some antidepressants (selective serotonin reuptake inhibitors, serotonin and 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 medicines containing ephedrine or pseudoephedrine. Avoid the concomitant use of AZILECT and antidepressants containing fluoxetine or fluvoxamine. Before starting treatment with AZILECT, wait at least five weeks after stopping treatment with fluoxetine. Before starting treatment with fluoxetine or fluvoxamine, wait at least 14 days after stopping treatment with AZILECT.

Tell your doctor or pharmacist if you are a smoker or intend to quit smoking. Smoking may reduce the amount of AZILECT in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking AZILECT if you are pregnant, because the effects of AZILECT on pregnancy and the fetus are unknown.

Driving and using machines
Ask your doctor for advice before driving and using machines, as Parkinson's disease itself as well as treatment with AZILECT can affect your ability to do so. AZILECT can make you feel dizzy and drowsy; it can also cause sudden onset of sleep.
This may be increased if you are taking other medicines to treat the symptoms of Parkinson's disease or if you are taking medicines that can make you feel sleepy, or if you drink alcohol while taking AZILECT. If you have experienced drowsiness and/or sudden onset of sleep in the past or during treatment with AZILECT, do not drive or use machines (see section 2).

3. How to take AZILECT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, 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 AZILECT tablets than you should, contact your
doctor or pharmacist immediately. Bring with you the carton/blister or bottle of AZILECT to show to the doctor or
pharmacist.
Symptoms reported after an overdose of AZILECT included a slightly euphoric mood
(mild form of mania), extremely high blood pressure and serotonin syndrome (see
paragraph 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 normal, 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 immediatelyif you notice any of the following symptoms. You may need
immediate medical attention or treatment:

• If you develop unusual behaviour such as compulsions, obsessive thoughts, gambling, excessive shopping or spending, impulsive behaviour and an abnormally increased sexual desire or an increase in sexual thoughts (impulse control disorders) (see section 2).
• If you see or hear things that are not there (hallucinations).
• Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome).

Contact your doctorif you notice any 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
• Allergy
• Fever
• Flu-like illness (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Low blood pressure when standing up, leading to dizziness or lightheadedness (orthostatic hypotension)
• Decreased appetite
• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal blood test results (leukopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint inflammation (arthritis)
• Numbness and weakness of the hand muscle (carpal tunnel syndrome)
• Weight loss
• 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)
• Blisters (vesiculobullous erythema)

Not known: frequency cannot be estimated from available data

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed 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 which is stated on the packaging, bottle or
pack after Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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 ingredient is rasagiline. Each tablet contains 1 mg of rasagiline (as mesylate).
• The other ingredients are mannitol, anhydrous colloidal silica, corn starch, pregelatinized corn starch, stearic acid, talc.

Description of the appearance of AZILECT and package contents
AZILECT is presented as white-whitish, round, flat and bevelled tablets
at the edges, smooth on one side and bearing the raised lettering “GIL” and “1” on the other.
The 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 Authorisation 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 3 820 73 73

Lietuva
UAB "Sicor Biotech"
Tel: +370 5 266 0203

България
Тева Фармасютикълс България ЕООД
Teл: +359 2 489 95 82

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG,
Belgique/Belgien
Tél/Tel: +32 3 820 73 73

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251 007 111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 1 288 6400

Danmark
Teva Denmark A/S
Tlf: +45 4498 5511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +353 51 321 740

Deutschland
Teva GmbH
Tel: +800 53 23 66 48

Nederland
Teva Nederland B.V.
Tel: +31 (0) 800 0228400

Eesti
Teva Eesti esindus
UAB Sicor Biotech Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel.: +43 (0)1 97007

España
Teva Pharma, S.L.U.
Tel: +34 91 387 32 80

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 22 345 93 00

France
Teva Santé
Tél: +33 1 55 91 7800

Portugal
Teva Pharma - Produtos
Farmacêuticos Lda
Tel: +351 21 476 75 50

Hrvatska
Pliva Hrvatska d.o.o.
Tel.: + 385 1 37 20 000

România
Teva Pharmaceuticals S.R.L
Tel: +4021 230 65 24

Ireland
Teva Pharmaceuticals Ireland
Tel: +353 51 321 740

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390

Ísland
Actavis Pharmaceuticals Iceland ehf.
Sími: +354 550 3300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 572 679 11

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
ratiopharm Oy
Puh/Tel: +358 20 180 5900

Κύπρος
Teva Ελλάς Α.Ε., Ελλάδα
Τηλ: +30 210 72 79 099

Sverige
Teva Sweden AB
Tel: + 46 42 12 11 00

Latvija
UAB "Sicor Biotech" filiāle Latvijā
Tel: +371 67 323 666

United Kingdom
Teva UK Limited
Tel: +44(0) 1977 628500