SUMATRIPTAN GENERICHEALTH 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:

Lupin Australia Pty Limited

INN (International Name):

sumatriptan succinate

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; crospovidone; lactose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; 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:

Registered

Authorization date:

2010-06-18

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
SUMATRIPTAN GENERICHEALTH
(SUMATRIPTAN SUCCINATE) TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
Sumatriptan generichealth.
This leaflet answers some
common questions about
Sumatriptan generichealth. It
does not contain all of 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 expected benefits
of you taking Sumatriptan
generichealth against the risks
this medicine could 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 NEED TO
READ IT AGAIN.
WHAT SUMATRIPTAN
GENERICHEALTH IS USED FOR
Sumatriptan generichealth
contains the active ingredient
sumatriptan succinate. This
medicine belongs to a group of
drugs called serotonin agonists.
Sumatriptan generichealth are
used to relieve a migraine
attack. They should not be used
to prevent migraine attacks from
occurring. Sumatriptan
generichealth may be used for
migraine headaches with or
without what is known as 'aura'.
It is thought that migraine
headache is due to widening of
certain blood vessels in the
head. Sumatriptan generichealth
work by making those vessels
normal again and ease the
symptoms of migraine.
Your Sumatriptan generichealth
tablets do not work in other
types of headache which are not
a migraine.
Sumatriptan generichealth are
not addictive.
BEFORE YOU TAKE
SUMATRIPTAN
GENERICHEALTH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SUMATRIPTAN
GENERICHEALTH IF:
•
you have ever had an allergic
reaction to sumatriptan
succinate (see "Side effects")
or any of the ingredients
listed toward the end of this
leaflet (see "Ingredients").
•
you have or have had:
-
heart disease or heart
attack;
-
shortness of breath, pain
or tightness in the chest,
jaw or upper arm;
-
peripheral vascular
disease (pain in the back
of the legs) or are prone to
cold, tingling or numb
hands and feet;
-
Prinzmetal's

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – SUMATRIPTAN GENERICHEALTH
(SUMATRIPTAN SUCCINATE) TABLET
1
NAME OF THE MEDICINE
Sumatriptan succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg sumatriptan (as succinate).
List of excipients with known effects: Contains sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Sumatriptan generichealth 50 mg tablets are pink coloured, capsule
shaped, biconvex film-coated
tablets, debossed with “50” on one side and plain on the other
side which contain sumatriptan (as
succinate) 50 mg.
Sumatriptan
generichealth
100
mg
tablets
are
white
coloured,
capsule
shaped,
biconvex
film-coated tablets debossed with “100” on one side and plain on
the other side which contain
sumatriptan (as succinate) 100 mg.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sumatriptan generichealth tablets are indicated for the acute relief
of migraine attacks with or without
aura.
There is no information available on the use of Sumatriptan
generichealth 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
Sumatriptan generichealth v4.0
Page 2 of 13
(sumatriptan succinate) tablet
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 at