Tentin 5mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DEXAMPHETAMINE SULFATE

Available from:

Medice Arzneimittel Putter GmbH & Co. K.G

ATC code:

N06BA; N06BA04

INN (International Name):

DEXAMPHETAMINE SULFATE

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Centrally acting sympathomimetics; methylphenidate

Authorization status:

Not marketed

Authorization date:

2014-10-24

Patient Information leaflet

Tentin January 2016
MODULE 1.3.1
Module 1.3.1
Confidential
Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENTIN 5 MG TABLETS
Dexamfetamine sulphate
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same.

If your child gets 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 Tentin 5 mg is and what it is used for
2.
What you need to know before you use Tentin 5 mg
3.
How to use Tentin 5 mg
4.
Possible side effects
5.
How to store Tentin 5 mg
6.
Contents of the pack and other information
1. WHAT TENTIN IS AND WHAT IT IS USED FOR
WHAT TENTIN 5 MG IS
Tentin 5 mg tablets contain the active substance dexamfetamine
sulphate.
Tentin 5 mg is a psychostimulant. It improves activity in parts of the
brain. This medicine can help to
improve attention span, concentration, and reduce impulsive behaviour.
WHAT IT IS USED FOR
Tentin is used to treat attention-deficit/hyperactivity disorder
(ADHD).

it is used in children and adolescents aged 6-17 years.

it is not indicated in all children with ADHD

it is used only after when another medicine called methylphenidate was
not sufficiently effective.

It
should
be
used
as
part
of
a
treatment
programme
which
typically
includes
psychological,
educational and social measures.
_ _
Tentin treatment must only be initiated by, and used under the
supervision of a specialist in chil

Summary of Product characteristics

Health Products Regulatory Authority
21 November 2018
CRN008HZ4
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tentin 5mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg dexamfetamine sulphate.
Excipient with known effect:
Isomalt (E953) 147.5 mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
White, round, cloverleaf-shaped tablets of 8.4 mm diameterwith a
notched,
cross-scored line on the top side and a cross-scored line embossed
with “S” on each
quarter on the rear side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamfetamine is indicated as part of a comprehensive treatment
programme for
attention-aeficit/hyperactivity disorder (ADHD) in children and
adolescents aged 6 to
17 years when response to previous methylphenidate treatment is
considered
clinically inadequate. A comprehensive treatment programme typically
includes
psychological, educational and social measures.
Diagnosis should be made according to DSM-5 criteria or the guidelines
in ICD-10
and should be based on a comprehensive multidisciplinary evaluation of
the patient.
Dexamfetamine is not indicated in all children with ADHD and the
decision to use
dexamfetamine 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
and potential for
abuse, misuse or diversion.
Health Products Regulatory Authority
21 November 2018
CRN008HZ4
Page 2 of 19
Treatment should be under the supervision of a specialist in childhood
and/or
adolescent behavioural disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment must be under the supervision of a specialist in childhood
and/or
adolescent behaviour disorders.
Careful dose titration is necessary at the start of treatment with
dexamfetamine. Dose
titration should be started at the lowest possible dose.
The rec