CLARITYN ALLERGY Tablet Ref.[49992] Active ingredients: Loratadine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Product name and form

Clarityn Allergy 10mg Tablets.

Pharmaceutical Form

White to off-white, oval tablet with a score on one side and plain on the other side.

The score line of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 10mg loratadine.

Excipients with known effect: The quantity of lactose monohydrate in the loratadine 10 mg tablet composition is 71.3 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Loratadine

Loratadine is a tricyclic antihistamine with selective, peripheral H1-receptor activity. Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

List of Excipients

Lactose monohydrate
Maize starch
Magnesium stearate

Pack sizes and marketing

Blister comprising 20μm aluminium foil with vinyl heat coating and a 250 μm clear, transparent polyvinylchloride (PVC) film or a 250μm clear, transparent polyvinyl chloride (PVC) film with polyvinylidene chloride (PVdC) coating.

Pack sizes of 7, 10, 14, 20 and 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer plc, 400 South Oak Way, Reading, RG2 6AD

Marketing authorization dates and numbers

PL 00010/0657

10/06/1992

Drugs

Drug Countries
CLARITYN Ireland, Italy, Malta, United Kingdom

© 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.