RUPATADINE Tablet Ref.[7355] Active ingredients: Rupatadine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: J. Uriach y Compañía, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain)

Product name and form

Rupatadine 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 Compañía, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain)

Marketing authorization dates and numbers

PL 11906/0007

24/10/2007

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