ZOLMITRIPTAN Film-coated tablet Ref.[8079] 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 2.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Zolmitriptan 2.5 mg film-coated tablets are light yellow, round, biconvex tablets with ‘ZL 2.5’ debossed on one side.

Qualitative and quantitative composition

Each 2.5 mg film-coated tablet contains 2.5 mg zolmitriptan

Excipient with know effect: Each 2.5 mg film-coated tablet contains 87.7 mg lactose anhydrous.

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

Tablet core:

Lactose, anhydrous
Microcrystalline cellulose
Sodium starch glycolate (Type A)
Magnesium stearate

Tablet coating:

Hypromellose (E464)
Titanium dioxide (E171)
Polydextrose
Talc
Maltodextrin
Medium chain triglycerides
Iron oxide yellow (E172)
Iron oxide black (E172)

Pack sizes and marketing

Aluminium/aluminium blisters.

Pack sizes: 3, 6, 12 or 18 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

PL 0142/1196

28/07/2009 / 03/07/2013

Drugs

Drug Countries
ZOLMITRIPTAN Austria

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