Elvanse Adult 30mg capsules

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Lisdexamfetamine dimesylate

Доступна з:

Takeda UK Ltd

Код атс:

N06BA12

ІПН (Міжнародна Ім'я):

Lisdexamfetamine dimesylate

Дозування:

30mg

Фармацевтична форма:

Oral capsule

Адміністрація маршрут:

Oral

Клас:

Schedule 2 (CD)

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04040000; GTIN: 5022690008895

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELVANSE ADULT 30 MG CAPSULES, HARD
ELVANSE ADULT 50 MG CAPSULES, HARD
ELVANSE ADULT 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 Elvanse Adult 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 in adults are decreased appetite, being
unable to sleep, dry mouth
or headache.
Read Sections 3 and 4 for more information.
TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN:

Your mood or how you feel changes.

You feel any problems with your heart.
Read Section 4 for more information.
THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT
INFORMATION TO HELP YOU U

Характеристики продукта

OBJECT 1
ELVANSE ADULT 30MG CAPSULES, HARD
Summary of Product Characteristics Updated 03-Nov-2017 | Shire
Pharmaceuticals Limited
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 Adult 30 mg capsules, hard.
Elvanse Adult 50 mg capsules, hard.
Elvanse Adult 70 mg capsules, hard.
2. Qualitative and quantitative composition
30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine
dimesylate, equivalent to 8.9 mg of
dexamfetamine.
50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine
dimesylate, equivalent to 14.8 mg of
dexamfetamine.
70 mg Capsules: Each capsule contains 70 mg lisdexamfetamine
dimesylate, equivalent to 20.8 mg of
dexamfetamine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
Elvanse Adult 30 mg capsule: white opaque body and pink opaque cap,
printed 'S489' and '30 mg' in
black ink.
Elvanse Adult 50 mg capsule: white opaque body and blue opaque cap,
printed 'S489' and '50 mg' in
black ink.
Elvanse Adult 70 mg capsule: blue opaque body and pink opaque cap,
printed 'S489' and '70 mg' in black
ink.
Each capsule measures approximately 16 mm long and 6 mm wide.
4. Clinical particulars
4.1 Therapeutic indications
Elvanse Adult is indicated as part of a comprehensive treatment
programme for attention
deficit/hyperactivity disorder (ADHD) in adults.
Elvanse Adult is not indicated in all adult patients and the decision
to use the medicinal product must take
into consideration the profile of the patient, including a thorough
assessment of the severity and
chronicity of the patient's symptoms, the potential for abuse, misuse
or diversion and clinical response to
any previous pharmacotherapies for the treatment of ADHD.
Treatment must be under the supervision of a specialist in behavioural
disorders. Diagnosis should be