TADALAFIL TEVA 20 Milligram Film Coated Tablet

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

TADALAFIL

Disponible desde:

Teva B.V.

Código ATC:

G04BE08

Designación común internacional (DCI):

TADALAFIL

Dosis:

20 Milligram

formulario farmacéutico:

Film Coated Tablet

Vía de administración:

oral use

Unidades en paquete:

Pack sizes of 2, 4, 5, 8, 10, 12, 15 , 28 or 56

tipo de receta:

Product subject to prescription which may not be renewed (A)

Fabricado por:

TEVA Gyógyszergyár Zrt

Grupo terapéutico:

Urologicals, Drugs used in erectile dysfunction

Área terapéutica:

Drugs used in erectile dysfuntion

indicaciones terapéuticas:

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

Estado de Autorización:

Authorised

Fecha de autorización:

2015-10-23

Información para el usuario

2
PACKAGE LEAFLET: INFORMATION FOR THE USER TADALAFIL TEVA 10 MG FILM-COATED TABLET
TADALAFIL TEVA 20 MG FILM-COATED TABLET
tadalafil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tadalafil teva is and what it is used for
2.
What you need to know before you take Tadalafil teva
3.
How to take Tadalafil teva
4.
Possible side effects
5.
How to store Tadalafil teva
6.
Contents of the pack and other information
1.
WHAT TADALAFIL TEVA IS AND WHAT IT IS USED FOR
Tadalafil teva is used for treatment of erectile dysfucntion and /or
urinary symptoms associated with benign
prostatic hyperplasia. Tadalafil teva contains the active substance
tadalafil which belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
ERECTILE DYSFUNCTION
Tadalafil teva 2.5mg, 5 mg, 10 mg and 20 mg is a treatment for adult
men with erectile dysfunction. This is
when a man cannot get, or keep a hard, erect penis suitable for sexual
activity. Tadalafil teva has been
shown to significantly improve the ability of obtaining a hard erect
penis suitable for sexual activity.
Following sexual stimulation Tadalafil teva works by helping the blood
vessels in your penis to relax,
allowing the flow of blood into your penis. The result of this is
improved erectile function. Tadalafil teva
will not help you if you do not have erectile dysfunction.
IT IS IMPORTANT TO NOTE THAT TADALAFIL TEVA DOES NOT WORK IF THERE IS
NO SEXUAL STIMULATION. You and your
partner will need to engage in foreplay, just as you would if yo

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Teva 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg tadalafil.
Excipients with known effect:
Each 20 mg film-coated tablet contains 353 mg of lactose (as
monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Ochre to yellow, oval shaped film coated tablet. On one side scored
and debossed with “2” on the left side of the score
and with “0” on the right side of the score. The other side of the
tablet is plain. Length: 14.0 mm, width: 8.0 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile
dysfunction, sexual stimulation is required.
Tadalafil Teva is not indicated for use by women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Erectile dysfunction in 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 effect, 20 mg might be tried.
It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 mg and 20 mg is intended for use prior to anticipated
sexual activity and it is not recommended for
continuous daily use.
In patients who anticipate a frequent use of Tadalafil Teva (i.e., at
least twice weekly) a once daily regimen with the
lowest doses of Tadalafil Teva might be considered suitable, based on
patient choice and the physician’s judgement.
In these patients the recommended dose is 5 mg taken once a day at
approximately the same time of day. The dose may
be decreased to 2.5 mg once a day based on individual tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
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