Methylphenidate Orion 18 mg Depottablett

Krajina: Švédsko

Jazyk: švédčina

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktívna zložka:

metylfenidathydroklorid

Dostupné z:

Orion Corporation

ATC kód:

N06BA04

INN (Medzinárodný Name):

methylphenidate hydrochloride

Dávkovanie:

18 mg

Forma lieku:

Depottablett

Zloženie:

laktosmonohydrat Hjälpämne; metylfenidathydroklorid 3,24 mg Aktiv substans; metylfenidathydroklorid 14,76 mg Aktiv substans

Typ predpisu:

Receptbelagt

Prehľad produktov:

Förpacknings: Burk, 30 tabletter

Stav Autorizácia:

Godkänd

Dátum Autorizácia:

2020-05-18

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHYLPHENIDATE ORION 18 MG PROLONGED-RELEASE TABLETS
METHYLPHENIDATE ORION 27 MG PROLONGED-RELEASE TABLETS
METHYLPHENIDATE ORION 36 MG PROLONGED-RELEASE TABLETS
METHYLPHENIDATE ORION 54 MG PROLONGED-RELEASE TABLETS
methylphenidate hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS
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 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 or
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 Methylphenidate Orion is and what it is used for
2.
What you need to know before you or your child takes Methylphenidate
Orion
3.
How to take Methylphenidate Orion
4.
Possible side effects
5.
How to store Methylphenidate Orion
6.
Contents of the pack and other information
1.
WHAT METHYLPHENIDATE ORION IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
Methylphenidate Orion is used to treat ‘attention deficit
hyperactivity disorder’ (ADHD)
-
in children aged 6 years and over and in adults
-
only after trying treatments which do not involve medicines, such as
counselling and
behavioural therapy.
Methylphenidate Orion is not for use as a treatment for ADHD in
children under 6 years of age.
HOW IT WORKS
Methylphenidate Orion 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

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methylphenidate Orion 18 mg prolonged-release tablets
Methylphenidate Orion 27 mg prolonged-release tablets
Methylphenidate Orion 36 mg prolonged-release tablets
Methylphenidate Orion 54 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methylphenidate Orion 18 mg:
Each prolonged-release tablet contains 18 mg of methylphenidate
hydrochloride.
Excipient with known effect: each tablet contains 4 mg lactose
monohydrate.
Methylphenidate Orion 27 mg:
Each prolonged-release tablet contains 27 mg of methylphenidate
hydrochloride.
Excipient with known effect: each tablet contains 3 mg lactose
monohydrate.
Methylphenidate Orion 36 mg:
Each prolonged-release tablet contains 36 mg of methylphenidate
hydrochloride.
Excipient with known effect: each tablet contains 7 mg lactose
monohydrate.
Methylphenidate Orion 54 mg:
Each prolonged-release tablet contains 54 mg of methylphenidate
hydrochloride.
Excipient with known effect: each tablet contains 7 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet (tablet).
Methylphenidate Orion 18 mg:
round, biconvex, yellow film-coated tablets of approximately 8.5 mm of
diameter with a hole on one
side of the tablet.
Methylphenidate Orion 27 mg:
round, biconvex, grey film-coated tablets of approximately 8.5 mm of
diameter with a hole on one
side of the tablet.
Methylphenidate Orion 36 mg:
round, biconvex, white film-coated tablets of approximately 10 mm of
diameter with a hole on one
side of the tablet.
Methylphenidate Orion 54 mg:
round, biconvex, pink film-coated tablets of approximately 10 mm of
diameter with a hole on one side
of the tablet.
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Attention-deficit/hyperactivity disorder (ADHD)
Methylphenidate Orion 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 w