RASAGILINE FLYNN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RASAGILINE TARTRATE

Available from:

Flynn Pharma Ltd

ATC code:

N04BD02

INN (International Name):

RASAGILINE TARTRATE

Dosage:

1 Base Milligrams

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

rasagiline

Authorization status:

Not Marketed

Authorization date:

2016-06-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE FLYNN 1 MG TABLETS
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 Flynn is and what it is used for
2.
What you need to know before you take Rasagiline Flynn
3.
How to take Rasagiline Flynn
4.
Possible side effects
5.
How to store Rasagiline Flynn
6.
Contents of the pack and other information
1.
WHAT RASAGILINE FLYNN IS AND WHAT IT IS USED FOR
Rasagiline Flynn 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 Flynn helps to
increase and sustain levels of dopamine
in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE FLYNN
DO NOT TAKE RASAGILINE FLYNN:
-
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 Flynn:

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 treatment and
starti

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Flynn 1 mg 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 or almost white, round, flat and unmarked tablets with a
diameter of 8 mm ± 0.8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Flynn 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 sections 4.4 and 5.2).
_Renal impairment_
No special precautions are required in patients with renal impairment.
_Paediatric population_
The safety and efficacy of Rasagiline Flynn in children and
adolescents have not been established.
There is no relevant
use of Rasagiline Flynn in the paediatric population in the indication
Parkinson’s disease.
Method of administration
For oral use
Rasagiline Flynn may be taken with or without food.
4.3 CONTRAINDICATIONS
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