TERRY WHITE CHEMISTS SUMATRIPTAN sumatriptan 50 mg (as succinate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sumatriptan succinate

Available from:

Apotex Pty Ltd

INN (International Name):

sumatriptan succinate

Authorization status:

Registered

Patient Information leaflet

TERRY WHITE CHEMISTS
SUMATRIPTAN
_Sumatriptan succinate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about sumatriptan. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Sumatriptan is used to relieve a
migraine attack. This medicine may
be used for migraine headaches with
or without what is known as 'aura'.
Sumatriptan belongs to a group of
drugs called serotonin agonists.
_HOW IT WORKS_
It is thought that a migraine headache
is due to widening of certain blood
vessels in the head. Sumatriptan
works by narrowing the affected
vessels, to ease the symptoms of
migraine.
This medicine does not work in other
types of headache which are not a
migraine. It should not be used to
prevent migraine attacks from
occurring.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
The effectiveness of this medicine
has not been established in
adolescents between 12 and 17; and
the safety and effectiveness of this
medicine in children under the age of
12 years has not been established.
Sumatriptan is not recommended for
use in people aged over 65 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
sumatriptan succinate
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of brea

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –TERRY WHITE
CHEMISTS SUMATRIPTAN (SUMATRIPTAN SUCCINATE)
TABLETS
1
NAME OF THE MEDICINE
Sumatriptan succinate.
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains 50 mg sumatriptan (as succinate), as the active
ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose monohydrate,
microcrystalline cellulose, crospovidone, croscarmellose sodium,
colloidal anhydrous silica,
magnesium stearate and Opadry 03B84755 Pink (50 mg) or Opadry 03B28796
White (100
mg) as coating material. The coating material contains hypromellose,
titanium dioxide,
polyethylene glycol, iron oxide red (50 mg only) and iron oxide black
(50 mg only).
Terry White Chemists Sumatriptan tablets are intended for oral
administration.
Each tablet contains 50 mg sumatriptan (as succinate), as the active
ingredient.
50 mg Tablets:
Pink coloured, capsule shaped, biconvex film coated tablets, debossed
with “50” on one side
and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sumatriptan tablets are indicated for the acute relief of migraine
attacks with or without aura.
There is no information available on the use of Sumatriptan tablets in
the treatment of basilar
or hemiplegic migraine.
4.2
DOSE AND METHOD OF ADMINISTRATION
Sumatriptan is indicated for the acute intermittent relief of both
migraine and cluster headache.
It should not be used prophylactically.
Ergotamine
or
ergotamine
derivatives
and
sumatriptan
should
not
be
administered
concurrently (see SECTION 4.3 - CONTRAINDICATIONS).
MIGRAINE
It is recommended to start the treatment at the first sign of a
migraine headache or associated
symptoms
such
as
nausea,
vomiting
or
photophobia.
The
efficacy
of
sumatriptan
is
independent of the duration of the attack when starting treatment.
Administration during a
migraine aura prior to other symptoms occurring may not prevent the
development of a
headache.
2
If a patient does not respond to the first dose of sumatript