TYVENSE 50 Milligram Capsules Hard

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

LISDEXAMFETAMINE DIMESYLATE

Dostupno od:

Shire Pharmaceutical Contracts Ltd

INN (International ime):

LISDEXAMFETAMINE DIMESYLATE

Doziranje:

50 Milligram

Farmaceutski oblik:

Capsules Hard

Tip recepta:

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

Područje terapije:

06BA12

Status autorizacije:

Authorised

Datum autorizacije:

2013-02-08

Uputa o lijeku

FONTS USED:
Frutiger LT Std-55 Roman
Frutiger LT Std-65 Bold
NimbusSanLOT-Bold
NimbusSanLOT-Italic
NimbusSanLOT-Regular
Wingdings-Regular
SMALLEST POINT SIZED USED:
6.0 pt
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
SHI46140V6
46140v6
Elvanse PIL Ireland 30 50 70mg 28ct 161208025524943
612
601350A02
2
300 x 685 mm
20-11-17
45907.1357
Wasdell
P7447
Black
GFW-045 00
turn
over
turn
over
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYVENSE
® 30 MG CAPSULES, HARD
TYVENSE
® 50 MG CAPSULES, HARD
TYVENSE
® 70 MG CAPSULES, HARD
Lisdexamfetamine dimesylate
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.
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 (such as counselling and
behavioural therapy) 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.
•
are taking any other medicines - this is because Tyvense 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.
•
If you take your medicine for more than a year, your doctor may stop
your medicine to see if it is
still needed.
•
The most common side effects are decreased appetite, weight loss,

Svojstava lijeka

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 50 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to
14.8 mg of dexamfetamine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
White opaque body and blue opaque cap, printed ‘S489’ and ‘50
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 children wi