Tyvense 60mg Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisdexamfetamine dimesylate

Available from:

Shire Pharmaceuticals Ireland Limited

ATC code:

N06BA

INN (International Name):

Lisdexamfetamine dimesylate

Dosage:

60 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

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

Therapeutic area:

Centrally acting sympathomimetics

Authorization status:

Marketed

Authorization date:

2015-07-31

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVENSE 20 MG CAPSULES, HARD
TYVENSE 30 MG CAPSULES, HARD
TYVENSE 40 MG CAPSULES, HARD
TYVENSE 50 MG CAPSULES, HARD
TYVENSE 60 MG CAPSULES, HARD
TYVENSE 70 MG CAPSULES, HARD
lisdexamfetamine dimesylate
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.
.

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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you 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 Tyvense is and what it is used for
2.
What you need to know before you take Tyvense
3.
How to take Tyvense
4.
Possible side effects
5.
How to store Tyvense
6.
Contents of the pack and other information
7.
Information for children and young people
1.
WHAT TYVENSE IS AND WHAT IT IS USED FOR
WHAT TYVENSE IS
Tyvense contains the active substance lisdexamfetamine dimesylate
which helps with your brain
activity. It helps improve your attention, helps you concentrate and
makes you less impulsive.
Tyvense is a long acting medicine which works gradually over a 13 hour
time period.
WHAT IT IS USED FOR
Tyvense is a treatment for ‘attention deficit hyperactivity
disorder’ (ADHD). It is used:

in children and young people between the ages of 6 and 18 who have
previously taken a
methylphenidate treatment that inadequately treated their ADHD. You
may continue to take
Tyvense into adulthood if your doctor thinks you are benefiting from
treatment.
You must talk to a doctor if you do not feel better or if you feel
worse after one month of treatment.
2
Tyvense is not used as a treatment for ADHD in children under 6 years
of age because it is not known
if i

Summary of Product characteristics

Health Products Regulatory Authority
28 May 2021
CRN00986C
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tyvense 60mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg lisdexamfetamine dimesylate, equivalent to
17.8 mg of dexamfetamine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Aqua blue opaque body and aqua blue opaque cap, printed ‘S489’ and
‘60 mg’ in black ink.
Each capsule measures approximately 16mm long and 6 mm wide.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tyvense is indicated as part of a comprehensive treatment programme
for attention deficit/hyperactivity disorder (ADHD) in
children aged 6 years and over when response to previous
methylphenidate treatment is considered clinically inadequate.
Treatment must be under the supervision of a specialist in childhood
and/or adolescent behavioural disorders. Diagnosis
should be made according to DSM criteria or the guidelines in ICD 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.
Tyvense 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 and poten