TAMSULOSIN ZENTIVA Prolonged-release capsule, hard Ref.[7114] Active ingredients: Tamsulosin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Tamsulosin Zentiva 400 microgram, prolonged-release hard capsules.

Pharmaceutical Form

Prolonged-release capsule, hard.

Hard gelatin capsules, no. 3 size with orange body and olive cap containing white to off-white pellets.

Qualitative and quantitative composition

Each capsule contains tamsulosin hydrochloride at an amount of 0.4 mg, which equals to tamsulosin 0.367 mg.

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 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:

Cellulose microcrystalline
Metacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30% (contains sodium laurilsulfate, polysorbate 80)
Dibutyl sebacate
Silica, colloidal hydrous
Polysorbate 80
Calcium stearate

Capsule body:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172)

Capsule cap:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)
Black iron oxide (E172)
Indigotine – FD&C Blue2 (E132)

Pack sizes and marketing

Transparent PVC/PVDC-Al blister, folding box.

Size of package: 10, 20, 30, 50, 90, 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom

Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 17780/0805

13 March 2017

 
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