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TAMSULOSIN ZENTIVA Prolonged-release capsule, hard (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tamsulosin Zentiva 400 microgram, prolonged-release hard capsules.

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.

Pharmaceutical form

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

Therapeutic indications

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

Posology and method of administration

Posology One capsule daily after breakfast or after the first daily meal. Hepatic/renal impairment No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with ...

Contraindications

Hypersensitivity to the active substance including drug-induced angioedema or to any of the excipients listed in section 6.1. History of orthostatic hypotension. Severe hepatic insufficiency. Micturition ...

Special warnings and precautions for use

As with other α1-adrenoceptors antagonists, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin hydrochloride as a result of which, rarely, syncope can occur. At ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril or theophylline. Concomitant ...

Pregnancy and lactation

Tamsulosin is not indicated for use in women. Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be aware of the fact that dizziness can occur.

Undesirable effects

Tabulated list of adverse reactions The frequency of adverse reactions of tamsulosin listed below is defined using the following convention: Common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare ...

Overdose

Symptoms Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive effects. Severe hypotensive effects have been observed at different levels of overdosing. Treatment In case ...

Pharmacodynamic properties

Pharmacotherapeutic category: Adrenergic α<sub>1</sub>-receptors antagonist ATC: G04CA02 The product is designed exclusively for the treatment of diseases of the prostate. Mechanism of action Tamsulosin ...

Pharmacokinetic properties

Absorption Tamsulosin is absorbed from the intestinal tract and its bioavailability is almost complete. The absorption of tamsulosin decreases if the product is administered shortly after the meal. The ...

Preclinical safety data

Toxicity after a single dose and multiple dosing has been investigated in mice, rats and dogs. Reproductive toxicity has also been investigated in rats, carcinogenicity in mice and rats, and genotoxicity ...

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 ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Transparent PVC/PVDC-Al blister, folding box. Size of package: 10, 20, 30, 50, 90, 100 capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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 number(s)

PL 17780/0805

Date of first authorization / renewal of the authorization

13 March 2017

Date of revision of the text

29/08/2018

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