MUNTEL Film-coated tablet Ref.[49855] Active ingredients: Levocetirizine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: UCB (Pharma) Ireland Limited, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

Product name and form

Muntel 5 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

White to off-white, oval, film-coated tablet with a Y logo on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.

Excipient with known effect: 63.50 mg lactose monohydrate/tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levocetirizine

Levocetirizine, the ® enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.

List of Excipients

Core:

Microcrystalline cellulose
Lactose monohydrate
Colloidal anhydrous silica
Magnesium stearate

Coating:

Opadry Y-1-7000 consisting of:

Hypromellose (E464)
Titanium dioxide (E171)
Macrogol 400

Pack sizes and marketing

Aluminium – OPA/aluminium/PVCblister.

Pack sizes of 1, 2, 4, 5, 7, 10, 2 × 10, 10 × 10, 14, 15, 20, 21, 28, 30 40, 50, 60, 70, 90, 100.

Not all pack sizes may be marketed.

Marketing authorization holder

UCB (Pharma) Ireland Limited, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland

Marketing authorization dates and numbers

PA0891/006/001

Date of first authorisation: 2nd July 2004
Date of last renewal: 3rd January 2012

Drugs

Drug Countries
MUNTEL Spain, Ireland

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