TYVENSE 40 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LISDEXAMFETAMINE DIMESYLATE

Available from:

Shire Pharmaceutical Contracts Ltd

ATC code:

N06BA

INN (International Name):

LISDEXAMFETAMINE DIMESYLATE

Dosage:

40 Milligram

Pharmaceutical form:

Capsules Hard

Administration route:

Oral use

Units in package:

Pack sizes: 28 or 30

Prescription type:

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

Manufactured by:

Shire Pharmaceuticals Limited

Therapeutic group:

Centrally Acting Sympathomimetics

Therapeutic area:

PHENYLETHYLAMINE DERIVATIVES

Therapeutic indications:

It 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

Authorization status:

Authorised

Authorization date:

2015-07-31

Patient Information leaflet

FONTS USED:
Frutiger-55 Roman
Frutiger-65 Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
Wingdings-Regular
SMALLEST POINT SIZED USED:
6.0 pt
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
SHI50561V6
50561v6
Elvanse PIL Ireland 20 40 60MG 28ct 161208025524943
611
601317A03
3
300 x 685 mm
20-11-17
45907.1357
Wasdell
P7447
Black
GFW-045 00
turn
over
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVENSE
® 20 MG CAPSULES, HARD
TYVENSE
® 40 MG CAPSULES, HARD
TYVENSE
® 60 MG CAPSULES, HARD
Lisdexamfetamine dimesylate
ADHD can make you:
•
run about too much
•
be unable to pay attention
•
act quickly without thinking about what will happen next (impulsive).
It affects learning, making friends and how you think about yourself.
It is not your fault.
While you are taking this medicine
•
As well as giving you this medicine, your doctor will arrange for you
to learn ways to cope with your
ADHD such as talking to people who can give you tips or teach you
different ways to do things.
•
The medicine should help your ADHD.
•
You will need to go to your doctor several times for check ups. This
is to make sure the medicine is
working and that you are growing and developing OK.
7.
Information for children and young people
This information is to help you learn the main things about your
medicine called Tyvense.
If you don’t enjoy reading, someone like your mum, dad or carer
(sometimes called ‘your guardian’)
can read it to you and answer any questions.
It may help if you read small bits at a time.
Why has the doctor given me this medicine?
This medicine can help your ‘ADHD’.
•
If you take the medicine for more than one year, your doctor may stop
your medicine to see if you
still need it. This will probably happen in a school holiday.
•
Girls must ask their doctor for advice before taking this medicine if
they think they may be
pregnant, or are planning to have a baby.
Some people cannot have this medicine
You cannot have this medicine if you:
•
have a problem with your heart
•
feel unusually excited or over-active
Som

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
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 16 mm long and 6 mm wide.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tradename 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.
Tradename is not indicated in all childr