PACKAGE LEAFLET: INFORMATION FOR THE USER

Rasagilina Teva 1 mg tablets

Equivalent medicine
Read this leaflet carefully before 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rasagilina Teva is and what it is used for
What you need to know before taking Rasagilina Teva
How to take Rasagilina Teva
Possible side effects
How to store Rasagilina Teva
Contents of the pack and other information

1. What Rasagilina Teva is and what it is used for

Rasagilina Teva contains the active substance rasagilina and is used for the treatment of Parkinson's disease in adults. It may be used with or without Levodopa (another medicine used to treat Parkinson's disease).
In Parkinson's disease, dopaminergic nerve cells are lost in certain areas of the brain. Dopamine is a substance in the brain responsible for controlling movement. Rasagilina Teva helps increase and maintain dopamine levels in the brain.

2. What you need to know before taking Rasagilina Teva

Do not take Rasagilina Teva

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 Rasagilina Teva:

Monoamine oxidase inhibitors (MAOIs) (used as antidepressants, for the treatment of Parkinson's disease, or for any other indication), including medicines and non-prescription natural products such as St. John’s wort.
Pethidine (a strong analgesic).

Wait at least 14 days after stopping treatment with Rasagilina Teva before starting therapy with MAO inhibitors or pethidine.
Warnings and precautions
Talk to your doctor before taking Rasagilina Teva

If you have any liver function problems
Consult your trusted doctor if you notice any suspicious skin changes.

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 you or others. These behaviors are known as impulse control disorders. In patients taking Rasagilina Teva and/or other medicines used to treat Parkinson's disease, behaviors such as compulsions, obsessive thoughts, gambling addiction, excessive spending, impulsive behaviors, abnormally increased sexual desire, or an increase in sexual thoughts or urges have been observed. Your doctor may need to adjust the dose or discontinue treatment (see section 4).
Rasagilina Teva may cause drowsiness and may cause you to fall asleep suddenly during daytime activities, especially if you are taking other dopaminergic medicines (used for the treatment of Parkinson's disease). For further information, refer to the section "Driving and use of machines".
Children and adolescents
There is no indication for specific use of Rasagilina Teva in children and adolescents.
Therefore, use of Rasagilina Teva is not recommended in patients under 18 years of age.
Other medicines and Rasagilina Teva
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 Rasagilina Teva and antidepressants containing fluoxetine or fluvoxamine.
Wait at least five weeks after stopping treatment with fluoxetine before starting therapy with Rasagilina Teva.
Wait at least 14 days after stopping treatment with Rasagilina Teva before starting therapy 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 Rasagilina Teva 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 Rasagilina Teva during pregnancy, as the effects of Rasagilina Teva on pregnancy and the fetus are unknown.
Driving and use of machinery
Ask your doctor for advice before driving or operating machinery, as both Parkinson's disease itself and treatment with Rasagilina Teva may affect your ability to do so.
Rasagilina Teva may cause dizziness and drowsiness; it may also cause sudden episodes of falling asleep.
This effect may be increased if you are taking other medicines to treat symptoms of Parkinson's disease, if you are taking other medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina Teva. If you have previously experienced drowsiness and/or sudden episodes of falling asleep, either before or during treatment with Rasagilina Teva, do not drive or operate machinery (see section 2).

3. How to take Rasagilina Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose of Rasagilina Teva is 1 tablet of 1 mg taken orally once daily.
Rasagilina Teva may be taken with or without food.
If you take more Rasagilina Teva than you should
If you think you have taken more tablets of Rasagilina Teva than you should, contact your
doctor or pharmacist immediately. Take the carton/blister pack or bottle of Rasagilina Teva with you to show to the
doctor or pharmacist.
Symptoms reported after overdose with Rasagilina Teva include slightly euphoric mood (a mild form of mania), extremely high blood pressure, and serotonin syndrome
(see section 4).
If you forget to take Rasagilina Teva
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 Rasagilina Teva
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact your doctor immediately if you notice any of the following symptoms. You may need
immediate 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 there (hallucinations).
Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome).
If you notice suspicious skin changes, as patients with Parkinson's disease have an increased risk of skin cancer (not only melanoma) (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
Influenza-like illness (influenza)
General feeling of being unwell (malaise)
Neck pain
Chest pain (angina pectoris)
Drop in blood pressure upon standing, accompanied by symptoms such as dizziness/light-headedness (orthostatic hypotension)
Decreased appetite
Constipation
Dry mouth
Nausea and vomiting
Flatulence
Abnormal results in blood tests (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 in 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 rash).

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 at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rasagilina Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack, bottle, or blister 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 no longer used. This will help protect the environment.

6. Package contents and other information

What Rasagilina Teva contains

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

Description of the appearance of Rasagilina Teva and package contents
Rasagilina Teva is presented as white to off-white, round, flat, bevel-edged tablets with a diameter of 8 mm, smooth on one side and with embossed characters “GIL” and “1” on the other.
The tablets are available in packs of 7, 10, 28, 30, 100 and 112 tablets, in packs of 10 x 1, 30 x 1 and 100 x 1 tablets (unit dose divisible blisters) or in bottles containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l.
Piazza Luigi Cadorna, 4
20123 Milano
Italy

Manufacturers
Teva Pharmaceutical Europe B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Teva Operations Poland Sp. zo.o
80 Mogilska Str.
31-546 Krakow
Poland
Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium Rasagiline Teva 1 mg Tabletten/Comprimés
Croatia Razagilin Teva 1 mg tablete
Denmark Rasagiline Teva
Estonia Rasagiline Teva
France Rasagiline Teva 1 mg, comprimé
Germany Rasagilin AbZ 1 mg Tabletten
Ireland Rasagiline Teva 1 mg tablets
Italy Rasagilina Teva
Latvia Rasagiline Teva 1 mg tabletes
Malta Rasagiline Teva 1 mg tablets
Portugal Rasagilina Teva 1 mg comprimidos
Slovenia Razagilin Teva 1 mg tablete
Slovakia Razagilin Teva 1 mg tablety
Spain Rasagilina Teva 1 mg comprimidos EFG
Sweden Rasagiline Teva
United Kingdom Rasagiline Teva 1 mg tablets