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SPC: TADALAFIL / MYLAN Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tadalafil Mylan 2.5 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 2.5 mg tadalafil. Excipient with known effect: Each coated tablet contains 29.74 mg of lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm) debossed with M on one side of the tablet and TL over 1 on the other side.

Therapeutic indications

Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women.

Posology and method of administration

Posology Adult men In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result ...

Special warnings and precautions for use

Before treatment with Tadalafil Mylan A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological ...

Interaction with other medicinal products and other forms of interaction

Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions ...

Fertility, pregnancy and lactation

Tadalafil Mylan is not indicated for use by women. Pregnancy There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect ...

Effects on ability to drive and use machines

Tadalafil has negligible influence on the ability to drive or use machines. Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should ...

Undesirable effects

Summary of the safety profile The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, ...

Overdose

Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction ATC Code: G04BE08 Mechanism of action Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific ...

Pharmacokinetic properties

Absorption Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (C<sub>max</sub>) is achieved at a median time of 2 hours after dosing. Absolute bioavailability ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. There ...

List of excipients

Tablet core: Lactose, anhydrous Poloxamer 188 Cellulose, microcrystalline (pH101) Povidone (K-25) Croscarmellose sodium Magnesium stearate Sodium laurilsulfate Silica, colloidal anhydrous Film-coat: Lactose ...

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

PVC/PE/PVdC-Alu blisters. Pack sizes of 28 and 56 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Mylan S.A.S., 117 Allée des Parcs, 69800 Saint-Priest, France

Marketing authorization number(s)

EU/1/14/961/008 EU/1/14/961/009

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 November 2014

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