SUMATRAN Tablet Ref.[49831] Active ingredients: Sumatriptan

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Product name and form

SUMATRAN 50 mg Tablets.

Pharmaceutical Form

Tablet.

Pink, oblong tablet with a break notch on both sides.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 50 mg sumatriptan (as succinate).

Excipients with known effect: Each tablet contains 176.20 mg lactose (as monohydrate) and up to 0.15 micrograms of sulphites per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sumatriptan

Sumatriptan has been demonstrated to be a specific and selective 5-Hydroxytryptamine1 (5HT1D) receptor agonist with no effect on other 5HT receptor (5-HT2 - 5-HT7) subtypes. The vascular 5-HT1D receptor is found predominantly in cranial blood vessels and mediates vasoconstriction.

List of Excipients

Ammonium methacrylate copolymer type A
Carboxymethylcellulose sodium (E466)
Microcrystalline cellulose (E450)
Croscarmellose sodium (E468)
Lactose monohydrate
Magnesium stearate (E470b)
Flavouring (grapefruit) (contains sulphites)
Red iron oxide (E172)
Yellow iron oxide (E172)

Pack sizes and marketing

The tablets are packed in aluminium/aluminium blister strips and inserted in a cardboard carton.

2, 3, 4, 6, 8, 12, 18, 20, 24, 30, 50, 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0711/081/001

Date of first authorisation: 27 January 2006
Date of last renewal: 1 December 2009

Drugs

Drug Countries
SUMATRAN Australia, Ireland, Singapore

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