Rasagiline Genepharm tablets are presented white to off white round, flat tablets with bevelled edges and engraved with "1" in one side, with a diameter of 8 mm.
The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as tartrate).
Excipients/Inactive Ingredients: The other ingredients are microcrystalline cellulose, (partially) pregelatinised (maize) starch, colloidal anhydrous silica, magnesium stearate.
Rasagiline Genepharm 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 Genepharm helps to increase and sustain levels of dopamine in the brain.
Always take this medicine exactly as prescribed. Patients must be advised.
The recommended dose of Rasagiline Genepharm is 1 tablet of 1 mg taken by mouth once daily. Rasagiline Genepharm may be taken with or without food.
Forgotten intake of Rasagiline Genepharm: A double dose should not be taken to make up for a forgotten dose. The next dose should be taken normally, when it is time to take it.
Stopping intake of Rasagiline Genepharm: Taking Rasagiline Genepharm should not be stopped unless advised.
Patients must be advised regarding further questions on the use of this medicine.
Patients must be advised to seek medical advice immediately if too many Rasagiline Genepharm tablets may have been taken. Advise the patient to show the doctor or pharmacist the Rasagiline Genepharm carton/blister.
Symptoms reported following overdose of rasagiline included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see Side Effects).
Rasagiline Genepharm should not be taken: if the patient is allergic to rasagiline or any of the other ingredients of this medicine (listed Description); if the patient has severe liver problems.
The following medicines should not be taken while taking Rasagiline Genepharm: 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).
The patient must wait at least 14 days after stopping Rasagiline Genepharm treatment and starting treatment with MAO inhibitors or pethidine.
Advise patients to inform the doctor or pharmacist of the following before taking Rasagiline Genepharm: Liver problems; Any suspicious skin changes. Treatment with rasagiline may possibly increase the risk of skin cancer.
Patients or patients' family/carer must be advised to inform the doctor if they notice that the patient is developing unusual behaviours where the patient cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to themselves or others. These are called impulse control disorders. In patients taking rasagiline 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. The dose may be needed to adjust or stop (see Side Effects).
Rasagiline Genepharm may cause drowsiness and may cause the patient to suddenly fall asleep during day time activities, especially if they are taking other dopaminergic medicinal products (used for the treatment of Parkinson's disease). For further information, refer to Driving and using machines as follows.
Driving and using machines: Patients must be advised before driving and operating machines, since Parkinson's disease itself as well as the treatment with Rasagiline Genepharm may influence the ability to do so. Rasagiline Genepharm can make the patient feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
This might be enhanced if the patient takes other medicines to treat the symptoms of Parkinson's disease, or if the patient takes medicines that can cause drowsiness, or drink alcohol while taking Rasagiline Genepharm. If the patient had experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline Genepharm do not drive or operate machinery (see Contraindications).
Use in Children: There is no relevant use of rasagiline in children and adolescents. Therefore, Rasagiline Genepharm is not recommended for use under the age of 18.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she must be advised before taking this medicine.
The patient should avoid taking Rasagiline Genepharm if she is pregnant, as the effects of rasagiline on pregnancy and the unborn child are not known.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Advise the patient to seek medical advice right away in case of any of the following symptoms. Urgent medical advice or treatment may be needed: If the patient develops 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 Contraindications); If the patient sees or hear things which are not there (hallucinations); Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome).
Patients must be advised to contact the doctor in case of any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see Contraindications).
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/lightheadedness (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: Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph. Reporting side effects can help provide more information on the safety of this medicine.
Advise the patient to inform the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Especially if the patient is 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 Genepharm together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
If the patient is starting treatment with Rasagiline Genepharm, the patient should wait at least 5 weeks after stopping fluoxetine treatment.
If the patient is starting treatment with fluoxetine or fluvoxamine, the patient should wait at least 14 days after stopping Rasagiline Genepharm treatment.
Advise the patient to inform the doctor or pharmacist if the patient is smoking or intends to stop smoking. Smoking could decrease the amount of rasagiline in the blood.
Store at temperature ≤ 25°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer in use. These measures will help protect the environment.
N04BD02 - rasagiline ; Belongs to the class of dopaminergic agents, monoamine oxidase B inhibitors. Used in the management of Parkinson's disease.
Rasagiline Genepharm tab 1 mg
2 × 15's
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