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SPC: UROREC Capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Urorec 4 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 4 mg silodosin. For the full list of excipients, see section 6.1.

Pharmaceutical form

Hard capsule. Yellow, opaque, hard gelatin capsule, size 3.

Therapeutic indications

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.

Posology and method of administration

Posology The recommended dose is one capsule of Urorec 8 mg daily. For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below). Elderly No dose adjustment is required in ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Intraoperative Floppy Iris Syndrome (IFIS) IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α<sub>1</sub>-blockers or previously treated with α<sub> ...

Interaction with other medicinal products and other forms of interaction

Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7. Silodosin is also a substrate for P-glycoprotein. Substances that inhibit (such as ketoconazole, itraconazole, ...

Fertility, pregnancy and lactation

Pregnancy and breast-feeding Not applicable as silodosin is intended for male patients only. Fertility In clinical studies, the occurrence of ejaculation with reduced or no semen has been observed during ...

Effects on ability to drive and use machines

Urorec has minor or moderate influence on the ability to drive and use machines. Patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) ...

Undesirable effects

Summary of the safety profile The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients ...

Overdose

Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects. The dose-limiting adverse reaction was postural hypotension. If ingestion is recent, induction of vomiting or gastric lavage ...

Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists ATC code: G04CA04 Mechanism of action Silodosin is highly selective for α<sub>1A</sub>-adrenoreceptors that are primarily located ...

Pharmacokinetic properties

The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 48 ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, carcinogenic, mutagenic and teratogenic potential. Effects in animals (affecting the thyroid ...

List of excipients

Capsule content: Starch, pregelatinised (maize) Mannitol (E421) Magnesium stearate Sodium laurilsulfate Capsule shell: Gelatin Titanium dioxide (E171) Yellow iron oxide (E172)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from light and moisture.

Nature and contents of container

The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons. Packs of 5, 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

Recordati Ireland Ltd., Raheens East, Ringaskiddy Co. Cork, Ireland

Marketing authorization number(s)

EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007

Date of first authorization / renewal of the authorization

Date of first authorisation: 29/01/2010 Date of latest renewal: 18/09/2014

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