InfoCons Consumer Protection informs you – Rasagiline ratiopharm – Package Leaflet

Before anything else

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

ℹ️ 1. What Rasagiline ratiopharm is and what it is used for

Rasagiline ratiopharm 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 (anot her 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. Rasagiline ratiopharm helps to increase and sustain levels of dopamine in the brain.

⚠️ 2. What you need to know before you take Rasagiline ratiopharm

Do not take Rasagiline ratiopharm

• 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 Rasagiline ratiopharm

• 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 Rasagiline ratiopharm treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions

Talk to your doctor before taking Rasagiline ratiopharm

• If you have any liver problems
• You should speak with your doctor about any suspicious skin changes. Treatment with Rasagiline ratiopharm 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 ha rmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking Rasagiline ratiopharm and/or other medicines used to treat Parkinson’s disease, beh aviours 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).

Rasagiline ratiopharm 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 Rasagiline ratiopharm in children and adolescents. Therefore, Rasagiline ratiopharm is not recommended for use under the age of 18.

Other medicines and Rasagiline ratiopharm

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

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

• Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin -norepinephrine reuptake inhibitors , tricyclic or tetracyclic antidepressants)
• The antibiotic ciprofloxacin used against infections
• The cough suppressant dextromethorphan
• Sympath omimetics such as those present i n eye drops, nasal and oral decongestants and cold medi cine containing ephedrine or pseudoephedrine The use of Rasagiline ratiopharm together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.

If you are starting treatment with Rasagiline ratiopharm , 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 Rasagiline ratioph arm treatment .

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of Rasagiline ratiopharm 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 Rasagiline ratiopharm if you are pregnant, as the effects of Ra sagiline ratiopharm 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 Rasagiline ratiopharm may influence your ability to do so. Rasagiline ratiopharm 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 Rasagiline ratiopharm . If you have experienced somnolence and/or episodes of sudden sleep onset before , or while taking Rasagiline ratiopharm do not drive or operate machi nery (see section 2).

💊 3. How to take Rasagiline ratiopharm

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 Rasagiline ratiopharm is 1 tablet of 1 mg taken by mouth once daily .

Rasagiline ratiopharm may be taken with or without food.

If you take more Rasagiline ratiopharm than you should

If you think that you may have taken too many Rasagiline ratiopharm tablets, contact your doctor or pharmacist immediately. Take the Rasagiline ratiopharm carton/ blister or bottle with you to show the doctor or pharmacist.

Symptoms reported following overdose of Rasagiline ratiopharm included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).

If you forget to take Rasagiline ratiopharm

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 yo u stop taking Rasagiline ratiopharm Do not stop taking Rasagiline ratiopharm 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 you 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 w hen 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. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Rasagiline ratiopharm

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 30 oC.

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 Rasagiline ratiophar m 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 maize starch, stearic acid, talc.

What Rasagiline ratiopharm looks like and contents of the pack

Rasagiline ratiopharm 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 b lister pack s of 7, 10, 28, 30, 100 and 112 tablets , in perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 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 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 any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Lietuva UAB Teva Baltics Tel: +370 52660203 България Тева Фарма ЕАД Teл.: +359 24899585 Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/ Belgi en Tél/Tel: +32 38207373 Česká republika Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251007111 Magyarország Teva Gyógyszergyár Zrt.

Tel.: +36 12886400 Danmark Teva Denmark A/S Tlf.: +45 44985511 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: + 44 2075407117 Deutschland ratiopharm GmbH Tel: +49 73140202 Nederland Teva Nederland B.V.

Tel: +31 8000228400 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 Ελλάδα TEVA HELLAS A.E. Österreich ratiopharm Arzneimittel Vertriebs -GmbH Τηλ: +30 2118805000 Tel: +43 1970070 España Laboratorios Davur, 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 Farmacêuticos , Lda.

Tel: +351 214767550 Hrvatska Pliva Hrvatska d.o.o .

Tel: +385 13720000 România 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 Κύπρος TEVA HELLAS A.E.

Ελλάδα Τηλ: + 30 2118805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 This leaflet was last revised in MM/YYYY .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Rasagiline ratiopharm (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/977).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.