Rasagiline ratiopharm

Patient Information Leaflet: Information for the User

Rasagilina ratiopharm 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Rasagilina ratiopharm contains the active substance rasagilina 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, dopaminergic neurons are lost in certain areas of the brain. Dopamine is a substance in the brain responsible for controlling movement.
Rasagilina ratiopharm helps increase and maintain stable levels of dopamine in the brain.

2. What you should know before taking Rasagilina ratiopharm

Do not take Rasagilina ratiopharm:

• 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 ratiopharm:

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

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

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

Inform your doctor if you, your family members, or 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 are dangerous or harmful to you or others. These behaviors are known as impulse control disorders. In patients taking Rasagilina ratiopharm 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 desires have been observed.
Your doctor may need to adjust your dose or discontinue treatment (see section 4).
Rasagilina ratiopharm 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 the specific use of Rasagilina ratiopharm in children and adolescents. Therefore, the use of Rasagilina ratiopharm is not recommended in patients under 18 years of age.
Other medicines and Rasagilina ratiopharm
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 medicines containing ephedrine or pseudoephedrine. Avoid concomitant use of Rasagilina ratiopharm and antidepressants containing fluoxetine or fluvoxamine. Wait at least five weeks after stopping fluoxetine before starting treatment with Rasagilina ratiopharm. Wait at least 14 days after stopping treatment with Rasagilina ratiopharm 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 Rasagilina ratiopharm in your blood.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid taking Rasagilina ratiopharm during pregnancy, as the effects of Rasagilina ratiopharm 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 Rasagilina ratiopharm may affect your ability to do so. Rasagilina ratiopharm 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, if you are taking other medicines that cause drowsiness, or if you drink alcohol while taking Rasagilina ratiopharm. If you have previously experienced drowsiness and/or sudden episodes of falling asleep, or if you experience them while taking Rasagilina ratiopharm, do not drive or operate machinery (see section 2).

3. How to take Rasagilina ratiopharm

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 Rasagilina ratiopharm is 1 tablet of 1 mg taken orally once daily.
Rasagilina ratiopharm may be taken with or without food.
If you take more Rasagilina ratiopharm than you should
If you think you have taken more tablets of Rasagilina ratiopharm than you should, contact your
doctor or pharmacist immediately. Take the carton/blister pack or bottle of Rasagilina ratiopharm
with you to show the doctor or pharmacist.
Symptoms reported after overdose of Rasagilina ratiopharm 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 Rasagilina ratiopharm
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 ratiopharm
Do not stop taking Rasagilina ratiopharm without first talking to your doctor.
If you have any doubts about how to use this medicine, consult 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 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 behaviour, 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).

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 syndrome (influenza)
• General feeling of being unwell (malaise)
• Neck pain
• Chest pain (angina pectoris)
• Decrease in blood pressure when standing up, accompanied by symptoms such as dizziness/light-headedness (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 (erythema bullosum).

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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rasagilina ratiopharm

Keep Rasagilina ratiopharm out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton, 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Rasagilina ratiopharm 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 Rasagilina ratiopharm and contents of the pack
Rasagilina ratiopharm tablets are white to off-white, round, flat, bevelled-edged tablets, smooth on one side and marked with the embossed characters “GIL” and “1” on the other.
The tablets are available in packs of 7, 10, 28, 30, 100 and 112 tablets in perforated unit dose blisters, packs of 10 x 1, 30 x 1 and 100 x 1 tablets, or in bottles containing 30 tablets.
Not all pack sizes may be marketed.

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

Manufacturers
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 medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Laboratorios Davur, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666