Medanef 5 mg Tablett

Valsts: Zviedrija

Valoda: zviedru

Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)

Aktīvā sastāvdaļa:

metylfenidathydroklorid

Pieejams no:

Viatris Limited

ATĶ kods:

N06BA04

SNN (starptautisko nepatentēto nosaukumu):

methylphenidate hydrochloride

Deva:

5 mg

Zāļu forma:

Tablett

Kompozīcija:

metylfenidathydroklorid 5 mg Aktiv substans

Receptes veids:

Receptbelagt

Produktu pārskats:

Förpacknings: Blister, 20 tabletter; Blister, 60 tabletter; Blister, 30 tabletter; Blister, 100 tabletter

Autorizācija statuss:

Godkänd

Autorizācija datums:

2016-04-14

Lietošanas instrukcija

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEDANEF 5 MG TABLETS
MEDANEF 10 MG TABLETS
MEDANEF 20 MG 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 childs.
-
If you or your child 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 Medanef is and what it is used for
2.
What you need to know before you or your child takes Medanef
3.
How to take Medanef
4.
Possible side effects
5.
How to store Medanef
6.
Contents of the pack and other information
1.
WHAT MEDANEF IS AND WHAT IT IS USED FOR
Medanef contains the active substance methylphenidate.
MEDANEF
IS USED TO TREAT “ATTENTION DEFICIT HYPERACTIVITY DISORDER”
(ADHD).
•
It is used in children and young people between the ages of 6 and 18
•
It is used only after trying treatments which do not involve
medicines. Such as counselling and
behavioural therapy
Medanef is not for use as a treatment for ADHD in children under 6
years of age or in adults. It is not
known if it is safe or of benefit in these people.
HOW IT WORKS
Medanef improves the activity of certain parts of the brain which are
underactive. 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
MEDANEF MUST ONLY BE INITIATED BY, AND USED UNDER THE SUPERVISION OF,
A SPECIALIST IN
CHILDHOOD/AND OR ADOLESCENT BEHAVIOURAL DISORDERS.
Although there

Produkta apraksts

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Medanef 5 mg Tablets
Medanef 10 mg Tablets
Medanef 20 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg methylphenidate hydrochloride.
Each tablet contains 10 mg methylphenidate hydrochloride.
Each tablet contains 20 mg methylphenidate hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat tablet marked with “RU” on one side and “5”
on the other side, approximately
6 mm in diameter.
White, round, flat, scored tablet marked with “RU 10” on one side,
approximately 7 mm in diameter.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
White, round, flat, scored tablet marked with “RU 20” on one side,
approximately 9 mm in diameter.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
Methylphenidate is indicated as part of a comprehensive treatment
programme for attention-deficit
hyperactivity disorder (ADHD) in children aged 6 years of age and over
when remedial measures alone
prove insufficient. Treatment must be under the supervision of a
specialist in childhood behavioural
disorders. Diagnosis should be made according to DSM criteria or the
guidelines in ICD-10 and should
be based on a complete history and evaluation of the patient.
Diagnosis cannot be made solely on the
presence of one or more symptom.
The specific aetiology of this syndrome is unknown, and there is no
single diagnostic test. Adequate
diagnosis requires the use of medical and specialised psychological,
educational, and social resources.
A comprehensive treatment programme typically includes psychological,
educational and social
measures as well as pharmacotherapy and is aimed at stabilising
children with a behavioural syndrome
characterised by sym