LORATADINE Tablet Ref.[7506] Active ingredients: Loratadine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Ranbaxy (UK) Limited, 5<sup>th</sup> floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom

Product name and form

Loratadine 10 mg Tablets.

Pharmaceutical Form

Tablets.

White to off-white, round, uncoated tablets debossed with “R” on one side and “10” on the other.

Qualitative and quantitative composition

Each tablet contains 10 mg loratadine.

Excipients with known effect: Each tablet also contains 78.25mg lactose monohydrate.

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
Pregelatinised maize starch
Magnesium stearate

Pack sizes and marketing

Blister strip comprising of clear transparent PVC film (coated uniformly with PVdC on the inner side) with a backing of aluminium foil (coated with heat seal lacquer).

7, 10, 14, 20, 21, 30, and 100 tablets per pack.

Not all pack sizes are marketed.

Marketing authorization holder

Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom

Marketing authorization dates and numbers

PL 14894/0112

19/09/2003 / 18/09/2008

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