Tyvense 40mg Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisdexamfetamine dimesylate

Available from:

Takeda Pharmaceuticals International AG Ireland Branch

ATC code:

N06BA

INN (International Name):

Lisdexamfetamine dimesylate

Pharmaceutical form:

Capsule, hard

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 part of a comprehensive treatment programme for
‘attention deficit hyperactivity
disorder’ (ADHD)

for children and young people between the ages of 6 and 18 who have
previously taken a
methylphenidate treatment that inadequately treated their ADHD.

for adults who have had ADHD since childhood. If you have not been
treated for ADHD before,
the doctor will check if you have had ADHD since childhood before
prescribing Tyvense.
You must talk to a doctor if you do not feel better or if you feel
worse after one month of treatment.
Tyvense i

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2023
CRN00DF2J
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tyvense 40mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 40 mg lisdexamfetamine dimesylate, equivalent to
11.9 mg of dexamfetamine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
White opaque body and blue/green opaque cap, printed ‘S489’ and
‘40 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.
Tyvense is also indicated as part of a comprehensive treatment
programme for attention deficit/hyperactivity disorder (ADHD)
in adults with pre-existing symptoms of ADHD in childhood.
Treatment must be under the supervision of a specialist in childhood
and/or adolescent behavioural disorders (for paediatric
patients) or a specialist in behavioural disorders (for adult
patients). Diagnosis should be based on a complete history and
evaluation of the patient according to current DSM criteria or ICD
guidelines. Diagnosis cannot be made solely on the presence
of one or more symptoms.
In adults, the presence of pre-existing symptoms of ADHD in childhood
is required and should be confirmed retrospectively
(according to the patient's medical record or, if not available,
through appropriate and structured instruments or interviews).
Based on clinical judgment, patients should have ADHD of at least
moderate severity as indicated by at least moderate
functional impairment in two or more settings (for example, social,
academic, and/or occupational functioning), affecting
several aspects of an individual's life.
The specific aetiology of this syndrome is unknown, and there is no
single diagnost