Methylphenidate 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Methylphenidate hydrochloride

Available from:

Viatris UK Healthcare Ltd

ATC code:

N06BA04

INN (International Name):

Methylphenidate hydrochloride

Dosage:

5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04040000; GTIN: 5016695006864

Patient Information leaflet

Package Leaflet: Information for the user
TRANQUILYN 5 mg, 10 mg or 20 mg Tablets
Methylphenidate
The name of your medicine is Tranquilyn. It contains the active
substance ‘methylphenidate hydrochloride’. The name
‘methylphenidate’ will also
be used in this leaflet.
Important things you need to know about your medicine
This medicine is used to treat ADHD
Read Section 1 for more information.
Before you take this medicine, talk to your doctor if:
Read Section 2 for more information.
While taking this medicine:
Read Sections 3 and 4 for more information.
Talk to your doctor straight away if any of the following happen:
Read Section 4 for more information.
The rest of this leaflet includes more detail and other important
information on the safe and effective use of this medicine. Read
all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
same as yours.
The leaflet has been written in sections:
What is in this leaflet:
1. What Tranquilyn is and what it is used for
2. What you need to know before you take Tranquilyn
3. How to take Tranquilyn
4. Possible side effects
5. How to store Tranquilyn
6. Contents of the pack and other information
Information for children and young people
Now read the rest of this leaflet before you start taking this
medicine.
1. What Tranquilyn is and what it is used for
What it is used for
How it works
concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually
includes:
be managed using treatment programmes.
About ADHD
It is not their fault that they cannot do these things.
2. What you need to know before you take Tranquilyn
Do not take Tranquilyn if:
were born with a heart problem
o severe depression, where you feel very sad, worthless and hopeless
Checks that your doctor will make before you start taking
Tranquilyn
It is important that you provide as much information as you can. This
will help your doctor decide if methylphenidate is the correct
medicine
Having an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methylphenidate Hydrochloride 5mg Tablets
Tranquilyn 5mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of the active ingredient methylphenidate
hydrochloride.
Methylphenidate (INN) is chemically defined as methyl
α
·phenyl-2-piperidine acetate
hydrochloride.
For the full list of excipients, see Section 6. 1.
3. PHARMACEUTICAL FORM
Tablet.
White, flat, round tablets, marked ‘RU’ on one side and ‘5’ on
the other.
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 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 drug must be based on a very thorough assessment
of the severity
and chronicity of the child’s symptoms in relation to the child’s
age.
Appropriate
educational
pla