CONTIFLO XL Prolonged release capsule Ref.[50634] Active ingredients: Tamsulosin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW

Product name and form

Contiflo XL 400 micrograms capsules.

Pharmaceutical Form
Prolonged release capsule. Brown/Orange size “2” capsules imprinted with “R” on cap and “TSN400” on body in black. The capsules contain white to off-white granules.

Qualitative and quantitative composition

Each prolonged release capsule contains as active ingredient 400 micrograms of tamsulosin hydrochloride.

Excipients with known effect: One prolonged release capsule contains 0.0353 mg of sunset yellow, 0.0013 mg of Ponceau 4R, 0.0008 mg of brilliant blue and 0.0019 mg of azorubine

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: Cellulose microcrystalline PH101 Magnesium stearate Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion Sodium hydroxide Triacetin Titanium dioxide (E171) Purified talc Capsule body: Gelatine Sunset yellow Ponceau 4R (E124) Quinoline yellow (E104) Brilliant blue (E133) Titanium dioxide (E171) Cap composition: Gelatine Yellow iron oxide (E172) Brilliant blue (E133) Azorubine (E122) Titanium dioxide (E171) Printing ink: Shellac Black Iron oxide (E172) Potassium Hydroxide

Pack sizes and marketing

PVC/PVdC/Alu blisters.

Packs of 1, 2, 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or 200 prolonged release capsules.

Not all packs sizes may be marketed.

Marketing authorization holder

SUN PHARMA UK LIMITED, 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW

Marketing authorization dates and numbers

PL 14894/0466

04/11/2010

Drugs

Drug	Countries
CONTIFLO	Ecuador, Nigeria, Romania, United Kingdom

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