Medikinet 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methylphenidate hydrochloride

Available from:

Pilsco Ltd

ATC code:

N06BA04

INN (International Name):

Methylphenidate hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04040000; GTIN: 05060669870869

Patient Information leaflet

PIL0377.3
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDIKINET
®
10 MG Tablets
(methylphenidate hydrochloride)
The name of your medicine is Medikinet
®
10 mg Tablets. It contains the active substance
‘methylphenidate hydrochloride’. The name ‘Medikinet’ will
also be used in the leaflet.
This medicine is also available in other strengths.
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.
ABOUT ADHD
Children and young people with ADHD find it:

hard to sit still and

hard to concentrate.
It is not their fault that they cannot do these things.
Many children and young people struggle to do these things. However,
with ADHD they can
cause problems with everyday life. Children and young people with ADHD
may have
difficulty learning and doing homework. They find it hard to behave
well at home, at school or
in other places.
ADHD does not affect the intelligence of a child or young person.
DO NOT TAKE MEDIKINET
IF YOU OR YOUR CHILD

is allergic to methylphenidate or any of the other ingredients of this
medicine (listed in
section 6)

has a thyro

Summary of Product characteristics

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
assessment of
the severity and chronicity of the child’s symptoms in relation to