Methylfenidaat HCl CF 30 mg, harde capsules met gereguleerde afgifte

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

METHYLFENIDAATHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METHYLFENIDAAT

Beschikbaar vanaf:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ATC-code:

N06BA04

INN (Algemene Internationale Benaming):

METHYLFENIDAATHYDROCHLORIDE COMPOSITION corresponding to ; METHYLPHENIDATE

farmaceutische vorm:

Capsule met gereguleerde afgifte, hard

Samenstelling:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN METHACRYLZUUR-METHYLMETHACRYLAAT (1:1) ; ETHYLCELLULOSE (E 462) ; GELATINE (E 441) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505) ; ZOUTZUUR (E 507) ; ZWARTE INKT

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Methylphenidate

Autorisatie datum:

2018-12-14

Bijsluiter

MODULE 1.3.1.4
PACKAGE LEAFLET – PROCEDURE VERSION
January 2020
Mod. 1.3.1.4, Page
1
C O N F I D E N T I A L
PACKAGE LEAFLET
MODULE 1.3.1.4
PACKAGE LEAFLET – PROCEDURE VERSION
January 2020
Mod. 1.3.1.4, Page
2
C O N F I D E N T I A L
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHYLFENIDAAT HCL CF 10 MG, HARDE CAPSULES MET GEREGULEERDE AFGIFTE
METHYLFENIDAAT HCL CF 20 MG, HARDE CAPSULES MET GEREGULEERDE AFGIFTE
METHYLFENIDAAT HCL CF 30 MG, HARDE CAPSULES MET GEREGULEERDE AFGIFTE
METHYLFENIDAAT HCL CF 40 MG, HARDE CAPSULES MET GEREGULEERDE AFGIFTE
METHYLFENIDAAT HCL CF 60 MG, HARDE CAPSULES MET GEREGULEERDE AFGIFTE
Methylphenidate hydrochloride
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
is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
is used to treat ‘Attention Deficit Hyperactivity
Disorder’ (ADHD).
-
it is used in children and adolescents between the ages of 6 and 18,
and in adults.
-
it is used only after treatments which do not involve medicine, such
as counselling and
behavioural therapy, and which have been insufficient.
is not for use as a treatment for ADHD in children
under 6 years of age. It is not
known if it is safe or of benefit in these children under 6 years of
age.
HOW IT WORKS

Lees het volledige document

Productkenmerken

MODULE 1.3.1.1
SUMMARY OF PRODUCT CHARACTERISTICS – PROCEDURE VERSION
January 2020
Mod. 1.3.1.1, Page 1
C O N F I D E N T I A L
SUMMARY OF PRODUCT CHARACTERISTICS
MODULE 1.3.1.1
SUMMARY OF PRODUCT CHARACTERISTICS – PROCEDURE VERSION
January 2020
Mod. 1.3.1.1, Page 2
C O N F I D E N T I A L
1.
NAME OF THE MEDICINAL PRODUCT
Methylfenidaat HCl CF 10 mg, harde capsules met gereguleerde afgifte
Methylfenidaat HCl CF 20 mg, harde capsules met gereguleerde afgifte
Methylfenidaat HCl CF 30 mg, harde capsules met gereguleerde afgifte
Methylfenidaat HCl CF 40 mg, harde capsules met gereguleerde afgifte
Methylfenidaat HCl CF 60 mg, harde capsules met gereguleerde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg modified-release hard capsules
Each
modified-release
capsule
contains
8.65 mg
methylphenidate
as
10 mg
methylphenidate
hydrochloride.
20 mg modified-release hard capsules
Each
modified-release
capsule
contains
17.3 mg
methylphenidate
as
20 mg
methylphenidate
hydrochloride.
30 mg modified-release hard capsules
Each
modified-release
capsule
contains
25.95 mg
methylphenidate
as
30 mg
methylphenidate
hydrochloride.
40 mg modified-release hard capsules
Each
modified-release
capsule
contains
34.6 mg
methylphenidate
as
40 mg
methylphenidate
hydrochloride.
60 mg modified-release hard capsules
Each
modified-release
capsule
contains
51.9 mg
methylphenidate
as
60 mg
methylphenidate
hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release capsule, hard.
10 mg modified-release hard capsules
Opaque hard gelatine capsule (size 3) with rich yellow cap and white
body imprinted “10” with black
ink, filled with white to off-white spherical pellets. Capsule length:
15.9 mm.
20 mg modified-release hard capsules
Opaque hard gelatine capsule (size 3) with white cap and white body,
imprinted “20” with black ink,
filled with white to off-white spherical pellets. C