RUPAFIN Tablet Ref.[51013] Active ingredients: Rupatadine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: J. Uriach y Compania S.A., Av. Cami Reial 51-57, 08184 Palau-solita i Plegamans, Barcelona, Spain

Product name and form

Rupafin 10 mg tablets.

Pharmaceutical Form

Tablet.

Round, light salmon coloured tablets.

Qualitative and quantitative composition

Each tablet contains: 10 mg of rupatadine (as fumarate).

Excipient with known effect: lactose 57.57 mg as lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Rupatadine

Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor antagonist activity. Some of the metabolites (desloratadine and its hydroxylated metabolites) retain an antihistaminic activity and may partially contribute to the overall efficacy of the drug.

List of Excipients

Pregelatinised maize-starch
Microcrystalline cellulose
Red iron oxide (E172)
Yellow iron oxide (E172)
Lactose monohydrate
Magnesium stearate

Pack sizes and marketing

PVC/PVDC/aluminium blister.

Packs of 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

J. Uriach y Compania S.A., Av. Cami Reial 51-57, 08184 Palau-solita i Plegamans, Barcelona, Spain

Marketing authorization dates and numbers

PA1129/001/001

Date of first authorisation: 09 January 2004
Date of last renewal: 19 July 2016

Drugs

Drug Countries
RUPAFIN Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Singapore, Turkey

© 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.