Dexamfetamine 5mg tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Dexamfetamine sulfate

Dostępny od:

Phoenix Healthcare Distribution Ltd

Kod ATC:

N06BA02

INN (International Nazwa):

Dexamfetamine sulfate

Dawkowanie:

5mg

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

Schedule 2 (CD)

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04040000

Ulotka dla pacjenta

300 mm
180 mm
Stramien 300 x 180 mm.indd 1
01-08-18 13:48
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXAMFETAMINE
SULFATE 5 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need
to read it again.
• If you have any further
questions, ask your doctor or
pharmacist.
• This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Dexamfetamine is and
what it is used for
2. What you need to know before
you take Dexamfetamine
3. How to take Dexamfetamine
4. Possible side effects
5. How to store Dexamfetamine
6. Contents of the pack and other
information. 1. WHAT DEXAMFETAMINE IS AND WHAT IT IS USED FOR
Dexamfetamine belongs to a
group of medicines called
stimulants. These work by
increasing activity in the brain.
Dexamfetamine works by
affecting some of the natural
chemicals that are found in the
brain. In particular, it increases
the activity of chemicals called
dopamine and noradrenaline in
areas of the brain that play a part
in controlling attention and
behaviour. Dexamfetamine
stimulates activity in the brain,
helping to keep people alert and
active during the day.
Dexamfetamine is used:
• To treat narcolepsy (being
unable to stop yourself falling
asleep)
• In children, to treat attention
deficit hyperactivity disorder
(ADHD).
Dexamfetamine may seem an odd
treatment for hyperactive
children, as stimulants normally
make people more active.
However, at the doses
recommended for children with
ADHD, Dexamfetamine can have
the opposite effect, helping some
children to learn to control their
behaviour. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMFETAMINE
DO NOT TAKE DEXAMFETAMINE IF:
• You are allergic to
dexamfetamine sulfate o

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dexamfetamine Sulfate 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg Dexamfetamine Sulfate
Excipients with known effect:
Each tablet contains 177 mg lactose and 14 mg sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Half scored circular white tablets with bevelled edges marked
‘Evans’ above and
‘DB5’ below.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dexamfetamine sulfate is a symphathomimetic amine with central
stimulant
and anorectic activity. It is indicated in narcolepsy. It is also
indicated for
children with refractory hyperkinetic states under the supervision of
a
physician specialising in child psychiatry.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: In narcolepsy, the usual starting dose is 10mg dexamfetamine
sulfate a day,
given in divided doses. Dosage may be increased if necessary by 10mg a
day at
weekly intervals to a suggested maximum of 60mg a day.
Elderly: Start with 5mg a day, and increase by increments of 5mg at
weekly intervals.
Children: In hyperkinetic states, the usual starting dosage for
children aged 3-5 years
is 2.5mg a day, increased if necessary by 2.5mg a day at weekly
intervals; for
children aged 6 years and over, the usual starting dose is 5-10mg a
day increasing if
necessary by 5mg at weekly intervals.
The usual upper limit is 20mg a day though some older children have
needed 40mg or
more for optimal response.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to dexamfetamine or other amfetamine derivatives or
any of the
excipients listed in section 6.1.
•
Patients with symptomatic cardiovascular disease, structural cardiac
abnormalities and/or moderate or severe hypertensive disease.
•
Patients with advanced arteriosclerosis.
•
During or for 14 days after treatment with an MAO inhibitor.
•
Patients with a history of drug abuse or alcohol abuse.
•
Patients with hyperthyroi