País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
METHYLFENIDAATHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METHYLFENIDAAT
Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR
N06BA04
METHYLFENIDAATHYDROCHLORIDE COMPOSITION corresponding to ; METHYLPHENIDATE
Capsule met gereguleerde afgifte, hard
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
Oraal gebruik
Methylphenidate
2018-12-14
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
Leia o documento completo
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 COMPOSITION10 mg modified-release hard capsules Each modified-release capsule contains 8.65 mg methylphenidate as 10 mg methylphenidate hydrochloride. Leia o documento completo20 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