Medikinet 10 mg tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Methylphenidate hydrochloride

Disponible depuis:

Medice Arzneimittel Putter GmbH & Co. K.G

Code ATC:

N06BA; N06BA04

DCI (Dénomination commune internationale):

Methylphenidate hydrochloride

Dosage:

10 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may not be renewed (A)

Domaine thérapeutique:

Centrally acting sympathomimetics; methylphenidate

Statut de autorisation:

Marketed

Date de l'autorisation:

2011-02-25

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDIKINET_ _ 5 MG
tablets
MEDIKINET_ _10 MG
tablets
MEDIKINET_ _20 MG
tablets
Methylphenidate hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD 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 or your child. Do not pass
it on to others. It may
harm them, even if their symptoms 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 MEDIKINET is and what it is used for
2.
What you need to know before you or your child takes MEDIKINET
3.
How to take MEDIKINET
4.
Possible side effects
5.
How to store MEDIKINET
6.
Contents of the pack and other information
1. WHAT MEDIKINET IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
MEDIKINET 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.
MEDIKINET 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
MEDIKINET 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.
MEDIKINET treatment must only be initiated by, and used under the
supervision of, a specialist in
childhood and/or adolescent behavioural disorders. Although there is
no cure for ADHD, it can be
managed using treatment programmes.
ABO

Résumé des caractéristiques du produit

Health Products Regulatory Authority
07 November 2022
CRN00D5MD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medikinet 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg methylphenidate hydrochloride, equivalent
to 8.65 mg methylphenidate.
Excipient with known effect: 40.85 mg lactose/tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet with a break score on both sides and notches at
the edges embossed with ”M” on both halves.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
Medikinet 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 initiated under the
supervision of a specialist in childhood behaviour disorders.
Diagnosis should be made according to current 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 symptoms.
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 symptoms which may
include chronic history of short attention span, distractibility,
emotional lability, impulsivity, moderate to severe hyperactivity,
minor neurological signs and abnormal EEG. Learning may or may not be
impaired.
Methylphenidate treatment is not indicated in all children with ADHD
and the decision to use the medicinal product must be
based on a very thorough assess