Rasagiline DOC Generici 1 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RASAGILINETARTRAAT 1,4 mg/stuk SAMENSTELLING overeenkomend met ; RASAGILINE 1 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

N04BD02

INN (Algemene Internationale Benaming):

RASAGILINETARTRAAT 1,4 mg/stuk SAMENSTELLING overeenkomend met ; RASAGILINE 1 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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

Page 1 of 7
Proposed var 05
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE DOC GENERICI 1 MG, TABLETTEN
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 DOC Generici is and what it is used for
2.
What you need to know before you take Rasagiline DOC Generici
3.
How to take Rasagiline DOC Generici
4.
Possible side effects
5.
How to store Rasagiline DOC Generici
6.
Contents of the pack and other information
1
WHAT RASAGILINE DOC GENERICI IS AND WHAT IT IS USED FOR
Rasagiline DOC Generici 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 DOC
Generici helps to increase and
sustain levels of dopamine in the brain.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE DOC GENERICI
DO NOT TAKE RASAGILINE DOC GENERICI
-
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 DOC
Generici:
-
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 a

Productkenmerken

Nov 2015: MA in NL – Nov 2016: NL approval var 01 – Dec 2018: NL
approval var02 – Mar 2020: NL approval of
renewal application – Proposed var 05
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline DOC Generici 1 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as tartrate).
For the 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
Rasagiline DOC Generici 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 of Rasagiline
DOC Generici) 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 _
The safety and efficacy of Rasagiline DOC Generici in children and
adolescents have not been established.
There is no relevant use of Rasagiline DOC Generici in the paediatric
population in the indication Parkinson’s
disease.
Method of administration
Nov 2015: MA in NL – Nov 2016: NL approval var 01 – Dec 2018: NL
approval var02 – Mar 2020: NL approval of
renewal application – Proposed var 05
For oral use.
R