Rasagiline ratiopharm
rasagiline
rasagiline
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.
What Rasagiline ratiopharm is and what it is used for
What you need to know before you take Rasagiline ratiopharm
How to take Rasagiline ratiopharm
Possible side effects
How to store Rasagiline ratiopharm
Contents of the pack and other information
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 (another 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.
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.
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 harmful 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, behaviours 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.
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.
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:
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
Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine 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 ratiopharm 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.
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 Rasagiline ratiopharm on pregnancy and the unborn child are not known.
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 machinery (see section 2).
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 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).
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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)
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 when 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
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.
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 30oC.
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.
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.
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 blister packs 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.
Teva B.V. Swensweg 5
2031 GA Haarlem Netherlands
Teva Pharmaceuticals Europe B.V. Swensweg 5
2031 GA Haarlem 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 any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД Teл: +359 24899585
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Laboratorios Davur, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf. Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117