OMNIC Modified release capsule, hard Ref.[51034] Active ingredients: Tamsulosin

Source: Web Search  Revision Year: 2019  Publisher: Astellas Pharmaceuticals A.E.B.E., 6-8 Agisilaou Str., 15123 Marousi, Athens-Greece Tel: +30 210 8189900 Fax: +30 216 8008998

Product name and form

Omnic 0,4, 0.4 mg, modified release capsules, hard.

Pharmaceutical Form

Modified release capsule, hard.

Orange/olive-green coded 0.4 and logo and 701.

Qualitative and quantitative composition

Each capsule contains as active ingredient tamsulosin hydrochloride 0.4 mg.

Excipient(s): For a full list of excipients, see section 6.1.

Active Ingredient Description
Tamsulosin

Tamsulosin binds selectively and competitively to post-synaptic α1-adrenoreceptors, prevailingly their subtypes designated α1A and α1D. Thus relaxation of smooth muscles of the prostate and urethra is achieved, which leads to a reduction of tonus and an improvement of the urinary flow.
List of Excipients

Capsule content:

Microcrystalline Cellulose E460
Methacrylic acid – ethyl acrylate copolymer (1:1)
Polysorbate 80 E433
Sodium laurilsulfate
Triacetin E1518
Calcium Stearate E470a
Talc E553b

Capsule shell:

Hard gelatin
Indigotine E132
Titanium dioxide E171
Yellow iron oxide E172
Red iron oxide E172
Printing ink
Shellac E904
Propylene glycol E1520
Black iron oxide E172

Pack sizes and marketing

Polypropylene-aluminium blister packs containing 10 capsules per strip; cardboard boxes containing 10, 20, 30, 50, 60, 90, 100 and 200 capsules.

PVC/PVDC-aluminium blister packs containing 5 capsules per strip: cardboard boxes containing 50 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharmaceuticals A.E.B.E., 6-8 Agisilaou Str., 15123 Marousi, Athens-Greece
Tel: +30 210 8189900
Fax: +30 216 8008998

Marketing authorization dates and numbers

MA1387/00101

18th January 2006

Drugs

Drug Countries
OMNIC Brazil, Cyprus, Germany, Estonia, Spain, Finland, Croatia, Israel, Italy, Malta, Netherlands, Poland, Romania, Tunisia
 
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