TANYZ Hard modified-release capsule Ref.[50006] Active ingredients: Tamsulosin

Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

TANYZ 400 micrograms hard modified-release capsules.

Pharmaceutical Form
Hard modified-release capsule Orange/olive-green capsule. The capsules contain white to off-white pellets. Capsule dimensions: 19.3 mm x 6.4 mm.

Qualitative and quantitative composition

Each hard modified-release capsule contains 400 micrograms 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 contents: Microcrystalline cellulose (E460) Methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent Polysorbate 80 (E433) Sodium laurilsulfate Triethyl citrate (E1505) Talc (E553b) Capsule shell: Gelatin (E441) Indigo carmine (E132) Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172) Black iron oxide (E172)

Pack sizes and marketing

PVC/PE/PVDC/Aluminium blisters in boxes containing 20, 30, 90 and 100 hard modified-release capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

PA1347/086/001

Date of first authorisation: 13^th August 2019

Drugs

Drug	Countries
TANYZ	Albania, Estonia, Croatia, Ireland, Lithuania, Poland, Romania

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