Elvanse 30mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lisdexamfetamine dimesylate

Available from:

Takeda UK Ltd

ATC code:

N06BA12

INN (International Name):

Lisdexamfetamine dimesylate

Dosage:

30mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04040000; GTIN: 5022690006266

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ELVANSE 20 MG CAPSULES, HARD
ELVANSE 30 MG CAPSULES, HARD
ELVANSE 40 MG CAPSULES, HARD
ELVANSE 50 MG CAPSULES, HARD
ELVANSE 60 MG CAPSULES, HARD
ELVANSE 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 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,
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

Summary of Product characteristics

OBJECT 1
ELVANSE 20MG CAPSULES, HARD
Summary of Product Characteristics Updated 03-Apr-2018 | 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 20 mg capsules, hard.
Elvanse 30 mg capsules, hard.
Elvanse 40 mg capsules, hard.
Elvanse 50 mg capsules, hard.
Elvanse 60 mg capsules, hard.
Elvanse 70 mg capsules, hard.
2. Qualitative and quantitative composition
20 mg Capsules: Each capsule contains 20 mg lisdexamfetamine
dimesylate, equivalent to 5.9 mg of
dexamfetamine.
30 mg Capsules: Each capsule contains 30 mg lisdexamfetamine
dimesylate, equivalent to 8.9 mg of
dexamfetamine.
40 mg Capsules: Each capsule contains 40 mg lisdexamfetamine
dimesylate, equivalent to 11.9 mg of
dexamfetamine.
50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine
dimesylate, equivalent to 14.8 mg of
dexamfetamine.
60 mg Capsules: Each capsule contains 60 mg lisdexamfetamine
dimesylate, equivalent to 17.8 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 20 mg capsule: ivory opaque body and ivory opaque cap, printed
'S489' and '20 mg' in black ink.
Elvanse 30 mg capsule: white opaque body and pink opaque cap, printed
'S489' and '30 mg' in black ink.
Elvanse 40 mg capsule: white opaque body and blue/green opaque cap,
printed 'S489' and '40 mg' in
black ink.
Elvanse 50 mg capsule: white opaque body and blue opaque cap, printed
'S489' and '50 mg' in black ink.
Elvanse 60 mg capsule: aqua blue opaque body and aqua blue opaque cap,
printed 'S489' and '60 mg' in
black ink.
Elvanse 70 mg capsule: blue opaque body and pink opaque cap, printed
'S489' and '70 mg' in black ink.
Each capsule me