ZOLMITRIPTAN Orodispersible tablets Ref.[8080] Active ingredients: Zolmitriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Zolmitriptan 5mg Orodispersible Tablets.

Pharmaceutical Form

Orodispersible tablet.

Zolmitriptan 5mg Orodispersible Tablets are white and round flat tablets with the diameter 9.5 mm.

Qualitative and quantitative composition

Each 5mg orodispersible tablet contains 5mg zolmitriptan.

Excipient with known effect: Each 5mg orodispersible tablet contains 8 mg aspartame.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zolmitriptan

Zolmitriptan has been demonstrated to be a selective agonist for the vascular human recombinant 5HT1B and 5HT1D receptor subtypes. Zolmitriptan is a high affinity 5HT1B/1D receptor agonist with modest affinity for 5HT1A receptors.
List of Excipients

Mannitol (E421)
Calcium silicate
Microcrystalline cellulose
Aspartame (E951)
Sodium starch glycolate Type A
Crospovidone Type B
Colloidal anhydrous silica
Magnesium stearate
Orange Cream Flavour (containing e.g. maltodextrin (maize), acacia (E414), ascorbic acid (E300), butylhydroxyanisole (E320))

Pack sizes and marketing

Peelable aluminium/aluminium blisters.

Pack sizes: 2, 3, 6 or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

0142/1207

28/07/2009

Renewal Approved: 03/07/2013

Drugs

Drug Countries
ZOLMITRIPTAN Austria
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈