CHEMMART SUMATRIPTAN sumatriptan 100 mg (as succinate) tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

sumatriptan succinate, Quantity: 140 mg

Доступна с:

Arrotex Pharmaceuticals Pty Ltd

ИНН (Международная Имя):

sumatriptan succinate

Фармацевтическая форма:

Tablet

состав:

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

Администрация маршрут:

Oral

Штук в упаковке:

2 tablets

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

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.

Обзор продуктов:

Visual Identification: White coloured, capsule shaped, biconvex film-coated tablets debossed with"100" one side and plain on the other side which contain Sumatriptan (as succinate) 100 mg.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Licence status A

Дата Авторизация:

2010-06-18

Характеристики продукта

1
AUSTRALIAN PRODUCT INFORMATION –CHEMMART
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).
Chemmart Sumatriptan tablets are intended for oral administration.
Each tablet contains 50 mg or 100 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.
100 mg Tablets:
White coloured, capsule shaped, biconvex film coated tablets debossed
with “100” 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
2
independent of the duration of the attack when starting treatment.
Administration during a
migraine aura prior to oth