Rasagiline 1 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC code:

N04BD02

INN (International Name):

RASAGILINE 1 mg

Pharmaceutical form:

TABLET

Composition:

RASAGILINE 1 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-12-27

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE 1 MG TABLETS
rasagiline
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 IS IN THIS LEAFLET:
1.
What Rasagiline Tablet is and what it is used for
2.
What you need to know before you take Rasagiline Tablet
3.
How to take Rasagiline Tablet
4.
Possible side effects
5.
How to store Rasagiline Tablet
6.
Contents of the pack and other information
1.
WHAT RASAGILINE TABLET IS AND WHAT IT IS USED FOR
Rasagiline Tablet 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 Tablet
helps to increase and sustain
levels of dopamine in the brain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE TABLET DO NOT TAKE RASAGILINE TABLET
- 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 Tablet:
- 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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off white, round (diameter about 8.0 mm), flat, beveled
tablets debossed with ''RAS" on one
side and "l" on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline tablet is indicated in adults for the treatment of
idiopathic Parkinson’s disease 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 _
The recommended dose of rasagiline is 1 mg (one tablet) once daily, to
be taken with or without
levodopa.
_Elderly _
No change in dose is required for elderly patients (see section 5.2)
_Hepatic impairment _
Rasagiline is contraindicated in patients with severe hepatic
impairment (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 and 5.2).
_Renal impairment _
No special precautions are required in patients with renal impairment.
_Paediatric population _
_ _
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The safety and efficacy of Rasagiline tablets in children and
adolescents have not been established.
There is no relevant use of Rasagiline tablets in the paediatric
population in the indication Parkinson’s
disease.
Method of administration
_For oral use. _
Rasagiline tablets may be taken with or without food.
4.3
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 without prescription e.g. St. John's Wort)