RANTUDIL FORTE Hard capsule Ref.[51125] Active ingredients: Acemetacin

Source: Medicines Authority (MT)  Revision Year: 2023  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Product name and form

Rantudil forte 60 mg hard capsules.

Pharmaceutical Form

Hard capsule; colour of the upper capsule shell is L 570 red (orange-brown), colour of the lower capsule shell is opaque yellow (yellow-beige); size 4.

Qualitative and quantitative composition

Each hard capsule contains 60 mg acemetacin.

Other ingredients with known effects: Each hard capsule contains 73.9 mg lactose-monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Acemetacin

Acemetacin is a glycolic acid ester of indomethacin and the pharmacological activity resulting from acemetacin administration in man is derived from the presence of both acemetacin and indomethacin. The precise pharmacological mode of action of acemetacin is not known. However, unlike other NSAIDs, acemetacin is only a relatively weak inhibitor of prostaglandin synthetase.

List of Excipients

Ferric oxy-hydroxide hydrate (E172)
Ferric(III) oxide (E172)
Gelatine
Lactose monohydrate
Magnesium stearate (Ph. Eur.)
Sodium dodecyl sulphate
Highly dispersed silicon dioxide
Talc
Titanium dioxide (E171)

Pack sizes and marketing

Package with 20 hard capsules.

Package with 50 hard capsules.

Package with 100 hard capsules.

Not all package sizes may be placed on the market.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Marketing authorization dates and numbers

MA1507/01801

Date of first authorisation: 18 January 2008
Date of latest renewal: 30 November 2012

Drugs

Drug Countries
RANTUDIL Germany, Croatia, Japan, Malta, Mexico, Poland, Turkey

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