APO-SUMATRIPTAN sumatriptan 50 mg (as succinate) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sumatriptan succinate, Quantity: 70 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

sumatriptan succinate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; lactose; microcrystalline cellulose; crospovidone; croscarmellose sodium; titanium dioxide; hypromellose; iron oxide red; iron oxide black; macrogol 400

Administration route:

Oral

Units in package:

4 tablets, 2 tablets

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: Pink coloured, capsule shaped, biconvex film-coated tablets debossed with"50" one side and plain on the other side which contain Sumatriptan (as succinate) 50 mg.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-06-18

Patient Information leaflet

APO-SUMATRIPTAN
1
APO-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 worksIt is thought that a
migraine headache is due to
widening of certain blood vessels in
the head. Sumatriptan works by
making the affected vessels normal
again, 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:
•
shortn

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-
SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLETS
1
NAME OF THE MEDICINE
Sumatriptan succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg sumatriptan (as succinate), as the active
ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose, microcrystalline
cellulose,
crospovidone,
croscarmellose
sodium,
colloidal
anhydrous
silica,
magnesium
stearate and Opadry 03B84755 Pink as coating material. The coating
material contains
hypromellose, titanium dioxide, macrogol 400, iron oxide red and iron
oxide black.
APO-Sumatriptan tablets are intended for oral administration.
Excipients with known effect: contains sugars (as lactose).
3
PHARMACEUTICAL FORM
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.
If a patient does not respond to the first dose of sumatriptan, a
second dose should not be
taken for the same attack. Sumatriptan may be used for subsequent
attacks.
2
The initial recommended adult dose of oral Sumatriptan t