Equasym XL 50 mg modified-release capsules, hard

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Methylphenidate hydrochloride

Pieejams no:

Shire Pharmaceuticals Ireland Limited

ATĶ kods:

N06BA; N06BA04

SNN (starptautisko nepatentēto nosaukumu):

Methylphenidate hydrochloride

Deva:

50 milligram(s)

Zāļu forma:

Modified-release capsule, hard

Receptes veids:

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

Ārstniecības joma:

Centrally acting sympathomimetics; methylphenidate

Autorizācija statuss:

Not marketed

Autorizācija datums:

2013-02-08

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EQUASYM
® XL 40 MG, 50 MG AND 60 MG MODIFIED-RELEASE CAPSULES, HARD
methylphenidate hydrochloride
The name of your medicine is Equasym XL, 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
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
THIS MEDICINE IS USED TO TREAT ADHD:
-
The full name for ADHD is ‘Attention Deficit Hyperactivity
Disorder’.
-
The medicine helps with your brain activity. It can help improve your
attention, help you concentrate,
and make you less impulsive.
-
You need to have other treatments for ADHD as well as this medicine.
Read Section 1 for more information.
BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF:
-
You have heart, circulation, or mental health problems - you may not
be able to take this medicine.
-
You are taking any other medicines - this is because methylphenidate
can affect how other medicines
work.
Read Section 2 for more information.
WHILE TAKING THIS MEDICINE:
-
See your doctor regularly. This is because your doctor will want to
check how the medicine is
working.
-
Do not stop taking the medicine without first talking to your doctor.
-
Your doctor may stop your medicine to see if it is still needed, if
you take it for more than a year.
-
The most common side effects are feeling nervous, not being able to
sleep or having a headache.
Read Sections 3 and 4 for more information.
TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN:
-
Your mood and how you feel changes.
-
You feel any problems with your heart.
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.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine

Produkta apraksts

Health Products Regulatory Authority
24 August 2021
CRN00CH98
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Equasym XL 50 mg modified-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg methylphenidate hydrochloride
corresponding to 43.24 mg methylphenidate.
Excipients with known effect:
225 mg sucrose/capsule for Equasym 50 mg
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Modified release capsule, hard.
Equasym 50 mg capsule: The capsule has a purple opaque cap imprinted
with “S544” in white and a white opaque body
imprinted with “50 mg” in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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-IV criteria or
the guidelines in ICD-10 and should be based on a complete history or
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 this
syndrome and the decision to use the drug must be based
on a very thorough asse