RASAGILINE MYLAN Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Rasagiline Mylan 1 mg tablets.
Qualitative and quantitative composition
Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with R9SE on one side and 1 on the other side.
Therapeutic indications
Rasagiline Mylan is indicated for the treatment of idiopathic Parkinsons disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations. ...
Posology and method of administration
Posology The recommended dose of rasagiline is 1 mg (one tablet of Rasagiline Mylan) once daily, to be taken with or without levodopa. Elderly No change in dose is required for elderly patients (see section ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1). Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products ...
Special warnings and precautions for use
Concomitant use of rasagiline with other medicinal products The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5). At least five weeks should elapse between ...
Interaction with other medicinal products and other forms of interaction
MAO Inhibitors Rasagiline is contraindicated along with other MAO inhibitors (including medicinal and natural products without prescription e.g. St. Johns Wort) as there may be a risk of non-selective ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of rasagiline in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a ...
Effects on ability to drive and use machines
In patients experiencing somnolence/sudden sleep episodes, rasagiline may have major influence on the ability to drive and use machines. Patients should be cautioned about operating hazardous machines, ...
Undesirable effects
Summary of the safety profile In clinical studies in Parkinsons disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; ...
Overdose
Symptoms Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome. Overdose can be associated with ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors ATC code: N04BD02 Mechanism of action Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which ...
Pharmacokinetic properties
Absorption Rasagiline is rapidly absorbed, reaching peak plasma concentration (C<sub>max</sub>) in approximately 0.5 hours. The absolute bioavailability of a single rasagiline dose is about 36%. Food does ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on the standard studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, reproduction and development. Rasagiline ...
List of excipients
Cellulose, microcrystalline Tartaric acid Maize starch Starch, pregelatinised maize Talc Stearic acid
Incompatibilities
Not applicable.
Shelf life
30 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
oPA/Al/PVC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets PVC/PVDC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets PVC/PVDC/Al. Perforated unit dose blister packs of 7 1, 10 1, 28 1, ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland
Marketing authorization number(s)
EU/1/16/1090/001 (7 tablets oPA/alu/PVC/alu) EU/1/16/1090/002 (10 tablets oPA/alu/PVC/alu) EU/1/16/1090/003 (28 tablets oPA/alu/PVC/alu) EU/1/16/1090/004 (30 tablets oPA/alu/PVC/alu) EU/1/16/1090/005 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 4 April 2016 Date of latest renewal: 20 November 2020
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