RELPAX Film-coated tablet Ref.[8135] Active ingredients: Eletriptan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Upjohn UK Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

RELPAX 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Round, convex orange tablets debossed with ‘REP 20’ on one side and ‘Pfizer’ on the other.

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg eletriptan (as hydrobromide).

Excipients with known effect: Each film-coated tablet contains 23 mg lactose and 0.036 mg Sunset yellow.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eletriptan

Eletriptan is a selective agonist at the vascular 5-HT1B and neuronal 5-HT1D receptors. Eletriptan also exhibits high affinity for the 5-HT1F receptor which may contribute to its anti-migraine mechanism of action.

List of Excipients

Core Tablet:

Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Magnesium stearate

Film Coat:

Titanium dioxide (E171)
Hypromellose
Lactose monohydrate
Glycerol triacetate
Sunset Yellow FCF Aluminium Lake (E110)

Pack sizes and marketing

Opaque PVC/Aclar/Aluminium blister packs containing 2, 3, 4, 5, 6, 10, 18, 30 and 100 tablets.

HDPE bottles with child-resistant HDPE/PP closures containing 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Upjohn UK Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 50622/0053

Date of First Authorisation: 12 February 2001
Date of Last Renewal: 12 February 2011

Drugs

Drug Countries
RELPAX Austria, Australia, Canada, Germany, Spain, France, Hong Kong, Croatia, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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