Aidex 1 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

RASAGILINETARTRAAT SAMENSTELLING overeenkomend met ; RASAGILINE

Beschikbaar vanaf:

Ecupharma S.R.L. Via Mazzini 20 20123 MILANO (ITALIË)

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

Common Technical Document
AIDEX- Rasagiline (as tartrate) 1 mg
Tablet
M1.3.1_03.RSE.tar.tab1.001.03.core
Page 1 of 6
1.3.1
Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
AIDEX 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 Aidex is and what it is used for
2.
What you need to know before you take Aidex
3.
How to take Aidex
4.
Possible side effects
5.
How to store Aidex
6.
Contents of the pack and other information
1
WHAT AIDEX IS AND WHAT IT IS USED FOR
Aidex 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. Aidex helps to increase and
sustain levels of dopamine in the brain.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AIDEX
DO NOT TAKE AIDEX
-
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 Aidex:
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 Aidex treatment and
starting treatment with MAO

Productkenmerken

Common Technical Document
AIDEX -Rasagiline (as tartrate) 1 mg
Tablet
M1.3.1_01.RSE.tar.tab1.001.03.Core
Page 1 of 12
1.3.1 Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Aidex 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
[Product name] 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 _
[Product name] 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
Common Technical Document
AIDEX -Rasagiline (as tartrate) 1 mg
Tablet
M1.3.1_01.RSE.tar.tab1.001.03.Core
Page 2 of 12
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.
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