RASAGILINE ACCORD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RASAGILINE TARTRATE

Available from:

Accord Healthcare Limited

ATC code:

N04BD02

INN (International Name):

RASAGILINE TARTRATE

Dosage:

1 Milligram

Pharmaceutical form:

Tablets

Administration route:

oral use

Units in package:

Pack sizes of 7, 10 , 28, 30, 60,100, 112 tablets.

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Accord Healthcare Limited

Therapeutic group:

Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors

Therapeutic area:

rasagiline

Therapeutic indications:

Rasagiline Accord is indicated for the treatment of idiopathic Parkinson’s disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Authorization status:

Marketed

Authorization date:

2015-11-27

Patient Information leaflet

200 mm
300 mm
10 mm
10 mm
Pre-Folded Leaflet H x W mm (300 x 200 mm)
10 mm
10 mm
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dry mouth
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nausea and vomiting
-
flatulence
-
abnormal results of blood tests (leucopenia)
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joint pain (arthralgia)
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musculoskeletal pain
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joint inflammation (arthritis)
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numbness and muscle weakness of the hand (carpal tunnel
syndrome)
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decreased weight
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abnormal dreams
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difficulty in muscular coordination (balance disorder)
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depression
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dizziness (vertigo)
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prolonged muscle contractions (dystonia)
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runny nose (rhinitis)
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irritation of the skin (dermatitis)
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rash
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bloodshot eyes (conjunctivitis)
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urinary urgency
Uncommon _(may affect up to 1 in 100 people)_:
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stroke (cerebrovascular accident)
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heart attack (myocardial infarction)
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blistering rash (vesiculobullous rash)
In addition, skin cancer was reported in around 1% of patients
in the placebo controlled clinical trials. Nevertheless, scientific
evidence suggests that Parkinson’s disease, and not any
medicine in particular, is associated with a higher risk of skin
cancer (not exclusively melanoma). You should speak with
your doctor about any suspicious skin changes.
Parkinson's disease is associated with symptoms of
hallucinations and confusion.
In post marketing experience these symptoms have also been
observed in Parkinson's disease patients treated with
Rasagiline Accord .
There have been cases of patients who, while taking one or
more medications for the treatment of Parkinson’s disease,
were unable to resist the impulse, drive or temptation to
perform an action that could be harmful to themselves or
others. These are called impulse control disorders. In patients
taking Rasagiline Accord and/or other medications used to
treat Parkinson’s disease, the following have been observed:
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Obsessive thoughts or impulsive behaviour.
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Strong impulse to gamble excessively despite serious
personal or family consequences.
-
Altered or increased sexual interest and behaviour of
significant concern to you or to others, for example, an
increased sexual drive.
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Unc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Accord 1mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as rasagiline tartrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevelled tablets (6.5 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Accord is indicated for the treatment of idiopathic
Parkinson’s disease (PD) as monotherapy (without
levodopa) or as adjunct therapy (with levodopa) in patients with end
of dose fluctuations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rasagiline is administered orally, at a dose of 1 mg once daily with
or without levodopa. It may be taken with or
without food.
Elderly: No change in dose is required for elderly patients.
Paediatric population: Rasagiline Accord is not recommended for use in
children and adolescents due to lack of data on
safety and efficacy.
Patients with hepatic impairment: Rasagiline use in patients with
severe hepatic impairment is contraindicated (see
section 4.3). Rasagiline use in patients with moderate hepatic
impairment should be avoided. Caution should be used
when initiating treatment with rasagiline in patients with mild
hepatic impairment. In case patients progress from mild
to moderate hepatic impairment rasagiline should be stopped (see
section 4.4).
Patients with renal impairment: No change in dose is required for
renal impairment.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
see section 6.1.
Concomitant treatment with other monoamine oxidase (MAO) inhibitors
(including medicinal and natural products
without prescription e.g. St. John's Wort) or pethidine (see section
4.5). At least 14 days must elapse between
discontinuation of rasagiline and initiation of treatment with MAO
inhibitors or pethidine.
Rasagiline is contraindicated in patients with severe hepatic
impairment.
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