Methylphenidate Generis 36 mg Depottablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

metylfenidathydroklorid

Tillgänglig från:

Generis Farmacêutica, SA

ATC-kod:

N06BA04

INN (International namn):

methylphenidate hydrochloride

Dos:

36 mg

Läkemedelsform:

Depottablett

Sammansättning:

metylfenidathydroklorid 29,52 mg Aktiv substans; laktosmonohydrat Hjälpämne; metylfenidathydroklorid 6,48 mg Aktiv substans

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

Förpacknings: Burk, 30 tabletter; Burk, 60 (2 x 30) tabletter; Burk, 90 (3 x 30) tabletter

Bemyndigande status:

Godkänd

Tillstånd datum:

2022-02-10

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHYLPHENIDATE GENERIS 18 MG PROLONGED RELEASE TABLETS
METHYLPHENIDATE GENERIS 27 MG PROLONGED RELEASE TABLETS
METHYLPHENIDATE GENERIS 36 MG PROLONGED RELEASE TABLETS
METHYLPHENIDATE GENERIS 54 MG PROLONGED RELEASE TABLETS
methylphenidate hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START 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 or your child only. Do not
pass it on to others. It may
harm them, even if their signs of illness are the same as yours/your
child’s.
-
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 or your child take

3.
How to take

4.
Possible side effects
5.
How to store

6.
Contents of the pack and other information
1.
WHAT < INVENTED NAME> IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
< invented name> is used to treat ‘attention deficit hyperactivity
disorder’ (ADHD).
•
It is used in children aged 6 years and over and in adults.
•
It is used only after trying treatments which do not involve
medicines, such as counselling and
behavioural therapy.
< invented name> is not for use as a treatment for ADHD in children
under 6 years of age.
HOW IT WORKS
< invented name> improves the activity of certain parts of the brain
which are under-active. The
medicine can help improve attention (attention span), concentration
and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually
includes:
•
psychological
•
educational and
•
social therapy.
It is prescribed only by doctors who have experience in children,
adolescents or adults with behaviour
probl

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methylphenidate Generis 18 mg prolonged release tablets
Methylphenidate Generis 27 mg prolonged release tablets
Methylphenidate Generis 36 mg prolonged release tablets
Methylphenidate Generis 54 mg prolonged release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 18 mg; 27 mg; 36 mg; 54 mg of
methylphenidate
hydrochloride.
Excipients with known effect:
- For the strenght of 18 mg, one prolonged release tablet contains 4
mg of lactose monohydrate
- For the strenght of 27 mg, one prolonged release tablet contains 3.4
mg of lactose
monohydrate
- For the strenght of 36 mg, one prolonged release tablet contains 6.6
mg of lactose
monohydrate
- For the strenght of 54 mg, one prolonged release tablet contains 6.8
mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
18 mg
Round, biconvex, yellow film-coated tablets of approximately 9 mm of
diameter with a hole in
one side of the tablet.
27 mg
Round, biconvex, grey film-coated tablets of approximately 9 mm of
diameter with a hole in
one side of the tablet.
36 mg
Round, biconvex, white film-coated tablets of approximately 10 mm of
diameter with a hole in
one side of the tablet.
54 mg
Round, biconvex, pink film-coated tablets of approximately 10 mm of
diameter with a hole in
one side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Attention-Deficit/Hyperactivity Disorder (ADHD)
is indicated as part of a comprehensive treatment
programme for Attention
Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age
and over and adults
when remedial measures alone prove insufficient.
TREATMENT MUST BE INITIATED AND SUPERVISED BY A PHYSICIAN SPECIALISED
IN THE TREATMENT OF
ADHD SUCH AS AN EXPERT PAEDIATRICIAN, A CHILD AND ADOLESCENT
PSYCHIATRIST OR AN ADULT
PSYCHIATRIST
.
Special Diagnostic Considerations for ADHD in children
Diagnosis should be made according