RINIALER Tablet Ref.[51103] Active ingredients: Rupatadine

Source: Medicines Authority (MT) Revision Year: 2020 Publisher: BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

Product name and form

Rinialer 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 (E-172) Yellow iron oxide (E-172) 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

BIAL – Portela & Cª, S.A., À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

Marketing authorization dates and numbers

MA004/00601

Date of first authorisation: 23^rd August 2007
Date of last renewal: 11^th April 2011

Drugs

Drug	Countries
RINIALER	Spain, Malta

Next: Usage >

© 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.