CLIPPER Gastro-resistant prolonged-release tablet Ref.[27637] Active ingredients: Beclometasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Product name and form

Clipper 5 mg gastro-resistant prolonged-release tablets.

Pharmaceutical Form

Gastro-resistant prolonged-release tablets.

Each ivory white, coated tablet is round and convex.

Qualitative and quantitative composition

Each tablet contains 5 mg of beclometasone dipropionate.

Excipient with known effect: lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Beclometasone

Beclometasone is a pro-drug with weak glucocorticoid receptor binding affinity. It is extensively hydrolysed via esterase enzymes to the active metabolite beclometasone-17-monopropionate (B-17-MP), which has potent topical anti-inflammatory activity.

List of Excipients

In Tablet Core:

Lactose monohydrate
Hypromellose (E.464)
Microcrystalline cellulose
Maize starch
Magnesium stearate

In Tablet Coat:

Macrogol 4000
Methacrylic acid-methyl methacrylate copolymer (1:1)
Titanium dioxide (E.171)
Talc

Pack sizes and marketing

PVC/PVDC/Al/PVDC blister.

Packs of 10 or 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom

Marketing authorization dates and numbers

PL 08829/0153

7th January 2005

Drugs

Drug Countries
CLIPPER Spain, Italy, United Kingdom

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