Elvanse 30mg capsules

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Lisdexamfetamine dimesylate

থেকে পাওয়া:

Shire Pharmaceuticals Ltd

এটিসি কোড:

N06BA12

INN (আন্তর্জাতিক নাম):

Lisdexamfetamine dimesylate

ডোজ:

30mg

ফার্মাসিউটিকাল ফর্ম:

Oral capsule

প্রশাসন রুট:

Oral

শ্রেণী:

Schedule 2 (CD)

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: 04040000

তথ্য লিফলেট

Technical Info
Profile
46076v4
Elvanse PIL UK MultiS 28ct 16092605134901
181
542945A01
NA
1
300x685mm
04-10-16
N/A
N/A
N/A
N/A
N/A
N/A
N/A
P7447
Black
GFW-045 00
FONTS USED:
Frutiger-55 Roman
Frutiger-65 Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
Wingdings-Regular
SMALLEST POINT SIZED USED:
9.0 pt
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
FONTS USED:
Frutiger-55 Roman
Frutiger-65 Bold
NimbusSanLOT-Bold
NimbusSanLOT-Regular
Wingdings-Regular
SMALLEST POINT SIZED USED:
9.0 pt
AVERAGE TEXT SIZE (BODY TEXT):
9.0 pt
turn
over
turn
over
4. Possible side effects
5. How to store Elvanse
6. Contents of the pack and other information
7. Information for children and young people
1.
What Elvanse is and what it is used for
What Elvanse is
Elvanse 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.
Elvanse is a long acting medicine which works gradually over a 13 hour
time period.
What it is used for
Elvanse 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
Elvanse 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.
Elvanse is not used as a treatment for ADHD in children under 6 years
of age because it is not known
if it is safe or of benefit in such young people.
How it works
Elvanse improves the activity of certain parts of the brain which are
under-active. The medicine can
help improve attention, concentration and reduce impulsive behaviour.
The medicine is given as part of a treatment programme, which usually
includes the following:
•
psychological therapy
•
educational therapy
•
social therapy
It is prescribed only by doctors who have experience in treating
peo

পণ্য বৈশিষ্ট্য

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
Elvanse 30 mg capsules, hard.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg lisdexamfetamine dimesylate, equivalent to
8.9 mg of
dexamfetamine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
White opaque body and pink opaque cap, printed ‘S489’ and ‘30
mg’ in black ink.
Each capsule measures approximately 16 mm long and 6 mm wide.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Elvanse 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.
Elvanse is not indicated in all children with A