Delmosart PR 18 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methylphenidate hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N06BA; N06BA04

INN (International Name):

Methylphenidate hydrochloride

Dosage:

18 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Centrally acting sympathomimetics; methylphenidate

Authorization status:

Not marketed

Authorization date:

2016-09-16

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DELMOSART PR 18 MG PROLONGED-RELEASE TABLETS
DELMOSART PR 27 MG PROLONGED-RELEASE TABLETS
DELMOSART PR 36 MG PROLONGED-RELEASE TABLETS
DELMOSART PR 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 ones.
-
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 DELMOSART PR IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD TAKE DELMOSART PR
3.
HOW TO TAKE DELMOSART PR
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DELMOSART PR
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DELMOSART PR IS AND WHAT IT IS USED FOR
WHAT IT IS USED FOR
Delmosart PR 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.
Delmosart PR is not for use as a treatment for ADHD in children under
6 years of age or for initiation of
treatment in adults. When treatment was started at a younger age, it
might be appropriate to continue taking
Delmosart PR when you become an adult. Your doctor will advise you
about this.
HOW IT WORKS
Delmosart PR 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 progra

Summary of Product characteristics

Health Products Regulatory Authority
01 December 2019
CRN009CY9
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Delmosart PR 18 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 18 mg of methylphenidate
hydrochloride equivalent to 15.6 mg of methylphenidate.
Excipient with known effect: contains 183.8 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
18 mg Tablet: Capsule-shaped, biconvex, yellow tablet, 6.6 mm x 11.9
mm, with "2392" printed on one side in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Attention-Deficit/HyperactivityDisorder(ADHD)
Delmosart PR 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-IV 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.
Delmosart PR treatment is not indicated in all children with ADHD and
the decision to use the medicinal product must be
base