Rasagiline tablets are presented as white to off-white, circular, flat tablets with "771" debossed on one side and "G" on other side, approximately 8 mm in diameter.
Each tablet contains 1 mg rasagiline (as tartrate).
Excipients/Inactive Ingredients: microcrystalline cellulose, citric acid, pregelatinised starch, colloidal anhydrous silica, stearic acid, talc.
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 helps to increase and sustain levels of dopamine in the brain.
Rasagiline is used for the treatment of Parkinson's disease in adults. It can be used together with or without Levodopa.
This medicine should always be taken exactly as prescribed.
The recommended dose of rasagiline is 1 tablet of 1 mg taken by mouth once daily. Rasagiline may be taken with or without food.
Forgotten intake of Rasagiline: 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 be taken.
Stopping intake of Rasagiline: Treatment with Rasagiline should not be stopped without doctor's instructions.
Patients should seek medical attention immediately if too many Rasagiline tablets may have been taken. Symptoms reported following overdose of rasagiline included slightly euphoric mood, extremely high blood pressure and serotonin syndrome (see Side Effects).
Rasagiline should not be taken by: Patients who are allergic to rasagiline or any of the other ingredients of this medicine (listed in Description); Patients who have severe liver problems.
The following medicines should not be taken while taking Rasagiline: Monoamine oxidase (MAO) inhibitors, including medicinal and natural products without prescription e.g. St. John's Wort; Pethidine.
Patients must wait at least 14 days after stopping Rasagiline treatment before starting treatment with MAO inhibitors or pethidine.
Before taking Rasagiline, caution should be exercised in case of: Any liver problems; Any suspicious skin changes (treatment with Rasagiline may possibly increase the risk of skin cancer).
Impulse control disorders include the development of unusual behaviours where the impulse, urges or cravings to carry out certain harmful or detrimental activities to oneself or others cannot be resisted. 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 need to be adjusted or stopped (see Side Effects).
Rasagiline may cause drowsiness and may cause sudden sleep onset during day time activities, especially if other dopaminergic medicinal products are being taken. For further information, refer to Driving and using machines as follows.
Driving and using machines: Parkinson's disease as well as the treatment with rasagiline may influence the ability to drive and operate machines. Rasagiline can cause dizziness or drowsiness; it can also cause episodes of sudden sleep onset.
This might be enhanced if other medicines to treat the symptoms of Parkinson's disease or medicines which can cause drowsiness are being taken, or if alcohol is consumed while taking rasagiline. In case of somnolence and/or episodes of sudden sleep onset before or while taking rasagiline, patients should not drive or operate machinery (see as previously mentioned).
Use in Children: There is no relevant use of rasagiline in children and adolescents. Therefore, Rasagiline is not recommended for use under the age of 18.
Patients who are pregnant or breast-feeding, who think they may be pregnant or who are planning to have a baby should be advised before taking this medicine.
Rasagiline should be avoided during pregnancy, 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.
Urgent medical advice or treatment may be needed in case of: Impulse control disorders (see Precautions); Hallucinations; Serotonin syndrome.
Any suspicious skin changes should be monitored because there may be an increased risk of melanoma with the use of this medicine (see Precautions).
Other side effects: Very common (may affect more than 1 in 10 people): Dyskinesia; Headache.
Common (may affect up to 1 in 10 people): Abdominal pain; Fall; Allergy; Fever; Flu (influenza); Malaise; Neck pain; Angina pectoris; Orthostatic hypotension; Decreased appetite; Constipation; Dry mouth; Nausea and vomiting; Flatulence; Leucopenia; Arthralgia; Musculoskeletal pain; Arthritis; Carpal tunnel syndrome; Decreased weight; Abnormal dreams; Difficulty in muscular coordination (balance disorder); Depression; Dizziness (vertigo); Dystonia; Rhinitis; Dermatitis; Rash; Conjunctivitis; Urinary urgency.
Uncommon (may affect up to 1 in 100 people): Cerebrovascular accident; Myocardial infarction; 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: Side effects should be reported. This includes any possible side effects not previously listed. By reporting side effects, patients can help provide more information on the safety of this medicine.
Caution should be exercised if any of the following medicines are being taken: Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants); Ciprofloxacin; Dextromethorphan; Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine.
The use of Rasagiline together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Patients who are starting treatment with Rasagiline should wait at least 5 weeks after stopping fluoxetine treatment.
Patients who are starting treatment with fluoxetine or fluvoxamine should wait at least 14 days after stopping Rasagiline treatment.
Caution should be exercised in patients who are smoking or who intend to stop smoking. Smoking could decrease the amount of rasagiline in the blood.
Medicines should not be thrown away via wastewater or household waste. Patients should be advised how to throw away medicines no longer used. 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.
Rasagilina Farmoz tab 1 mg
4 × 7's
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