RASAGILINE APOTEX

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RASAGILINE MESILATE

Available from:

Apotex Europe B.V.

ATC code:

N04BD02

INN (International Name):

RASAGILINE MESILATE

Dosage:

1 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

rasagiline

Authorization status:

Not Marketed

Authorization date:

2017-09-01

Patient Information leaflet

RASAGILINE APOTEX 1 MG TABLETS
MODULE 1.3
Product Information
Version: 2018-03-08
MODULE 1.3.1
Package Leaflet
Replaces : 2017-04-07
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rasagiline Apotex 1 mg Tablets
(Rasagiline)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Apotex is and what it is used for
2.
What you need to know before you use Rasagiline Apotex
3.
How to use Rasagiline Apotex
4.
Possible side effects
5.
How to store Rasagiline Apotex
6.
Contents of the pack and other information
1.
WHAT RASAGILINE APOTEX IS AND WHAT IT IS USED FOR
Rasagiline Apotex is used for the treatment of Parkinson’s disease.
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 Apotex
helps to increase and sustain levels of dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RASAGILINE APOTEX
DO NOT TAKE RASAGILINE APOTEX:
-
if you are allergic (hypersensitive) to rasagiline or any of the other
ingredients of
Rasagiline Apotex.
-
if you have severe liver problems.
Do not take the following medicines while taking Rasagiline Apotex:
RASAGILINE APOTEX 1 MG TABLETS
MODULE 1.3
Product Information
Version: 2018-03-08
MODULE 1.3.1
Package Leaflet
Replaces : 2017-04-07
2
-
monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression
or Parkinson’s
dis

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Apotex 1mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Rasagiline Apotex 1 mg tablets:
Each tablet contains 1.56 mg of Rasagiline Mesylate
equivalent to 1 mg of Rasagiline
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white colored round shaped, flat faced bevel edged
tablets, engraved “APO” on one side and “RAS” over
“1” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Apotex 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 Apotex 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.
Method of administration
Rasagiline is administered orally, at a dose of 1 mg once daily with
or without levodopa.
It may be taken with or without food.
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