Rasagiline Genericon 1 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

RASAGILINETARTRAAT SAMENSTELLING overeenkomend met ; RASAGILINE

Beschikbaar vanaf:

GENERICON PHARMA Gesellschaft m.b.H.

ATC-code:

N04BD02

INN (Algemene Internationale Benaming):

RASAGILINETARTRAAT COMPOSITION corresponding to ; RASAGILINE

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; STEARINEZUUR (E 570) ; TALK (E 553 B) ; WIJNSTEENZUUR, (L (+) Vorm) (E 334),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Rasagiline

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; STEARINEZUUR (E 570); TALK (E 553 B); WIJNSTEENZUUR, (L (+) Vorm) (E 334);

Autorisatie datum:

2015-11-27

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE GENERICON 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 Genericon is and what it is used for
2.
What you need to know before you take Rasagiline Genericon
3.
How to take Rasagiline Genericon
4.
Possible side effects
5.
How to store Rasagiline Genericon
6.
Contents of the pack and other information
1
WHAT RASAGILINE GENERICON IS AND WHAT IT IS USED FOR
Rasagiline Genericon 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 Genericon helps to
increase and sustain levels of dopamine
in the brain.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE GENERICON
DO NOT TAKE RASAGILINE GENERICON
-
if you are allergic (hypersensitive) 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 [Product name]:
-
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 Genericon
treatme

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline Genericon 1 mg tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as tartrate).
For a full list of excipients, see section 6.1.
3.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagilin Genericon 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.
_Elderly _
_ _
No change in dose is required for elderly patients.
_ _
_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 _
The safety and efficacy of Rasagiline in children and adolescents have
not been established. There is no relevant
use of Rasagiline in the paediatric population in the indication
Parkinson’s disease.
Method of administration
For oral use.
AZILECT may be taken with or without food.
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
bet