MAXALT Tablet Ref.[7522] Active ingredients: Rizatriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

MAXALT 5 mg Tablets.

MAXALT 10 mg Tablets.

Pharmaceutical Form

Tablet.

MAXALT 5 mg tablets: 5 mg tablets are pale pink, capsule shaped, coded MSD on one side and 266 on the other.

MAXALT 10 mg tablets: 10 mg tablets are pale pink, capsule-shaped, coded MAXALT on one side and MSD 267 on the other.

Qualitative and quantitative composition

MAXALT 5 mg Tablets

Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg of the rizatriptan).

Excipient(s) with known effect: Lactose monohydrate 30.25 mg in the 5 mg tablet.

MAXALT 10 mg Tablets

Each tablet contains 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of the rizatriptan).

Excipient(s) with known effect: Lactose monohydrate 60.5 mg in the 10 mg tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rizatriptan

Rizatriptan binds selectively with high affinity to human 5-HT1B and 5-HT1D receptors. The therapeutic activity of rizatriptan in treating migraine headache may be attributed to its agonist effects at 5-HT1B and 5-HT1D receptors on the extracerebral intracranial blood vessels that are thought to become dilated during an attack and on the trigeminal sensory nerves that innervate them.

List of Excipients

Lactose monohydrate
Microcrystalline cellulose (E460a)
Starch, pregelatinised
Iron oxide red (E172)
Magnesium stearate (E572)

Pack sizes and marketing

All aluminium blister push through, packs of 2, 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

Tablet 5 mg: PL 00025/0369

Tablet 10 mg: PL 00025/0370

Date of first authorisation: June 1998

Date of latest renewal: 12 May 2014

Drugs

Drug Countries
MAXALT Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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