OMSULA Prolonged-release capsule, hard Ref.[49715] Active ingredients: Tamsulosin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Product name and form

Omsula 0.4 mg prolonged-release capsules, hard.

Pharmaceutical Form
Prolonged-release capsule, hard. White or off-white pellets are filled in the capsules with size No. 2 (about 18 mm lengthwise and 6.3 mm in external diameter), which upper part is brown opaque, lower part is buff opaque.

Qualitative and quantitative composition

Each prolonged-release capsule, hard contains 0.4 mg tamsulosin hydrochloride.

For the 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 α_1A and α_1D. 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 Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent (including: polysorbate 80 sodium laurylsulfate) Talc Triethyl citrate Calcium stearate Capsule shell: Yellow iron oxide (E172) Black iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171) Gelatin

Pack sizes and marketing

30, 90 or 100 capsules are packed into clear or white opaque PVC/PVDC//Aluminium blisters.

The blisters are packed into folding box with a package leaflet.

Not all pack sizes may be marketed.

Marketing authorization holder

Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary

Marketing authorization dates and numbers

PL 04854/0134

14/12/2012

Drugs

Drug	Countries
OMSULA	Germany, United Kingdom

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