Tadalafil biomo 5mg film-coated tablets

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

TADALAFIL

Disponível em:

biomo pharma GmbH Josef-Dietzgen-Straße 3, D-53773, Hennef,, Germany

Código ATC:

G04BE08

DCI (Denominação Comum Internacional):

TADALAFIL 5 mg

Forma farmacêutica:

FILM-COATED TABLET

Composição:

TADALAFIL 5 mg

Tipo de prescrição:

POM

Área terapêutica:

UROLOGICALS

Status de autorização:

Withdrawn

Data de autorização:

2017-06-22

Folheto informativo - Bula

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL BIOMO 5 MG FILM-COATED TABLETS
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Tadalafil biomo 5 mg film-coated tablets is and what it is used
for
2.
What you need to know before you take Tadalafil biomo 5 mg film-coated
tablets
3.
How to take Tadalafil biomo 5 mg film-coated tablets
4.
Possible side effects
5
How to store Tadalafil biomo 5 mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT TADALAFIL BIOMO 5 MG FILM-COATED TABLETS IS AND WHAT IT IS USED
FOR
Tadalafil biomo 5 mg film-coated tablets contains the active substance
tadalafil which belongs to a group
of medicines called phosphodiesterase type 5 inhibitors.
Tadalafil biomo 5 mg film-coated tablets 5 mg is used to treat adult
men with:
-
erectile dysfunction. This is when a man cannot get, or keep a hard,
erect penis suitable for
sexual activity. Tadalafil biomo 5 mg film-coated tablets has been
shown to significantly
improve the ability of obtaining a hard erect penis suitable for
sexual activity.
Following sexual stimulation Tadalafil biomo 5 mg film-coated tablets
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 biomo 5 mg film-coated tablets will not help you if you do
not have erectile dysfunction.
It is important to note that Tadalafil biomo 5 mg film-coated tablets
for the treatment of erectile
dysfunction does not wor

Características técnicas

Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil biomo 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of tadalafil.
Excipient with known effect:
Each film-coated tablet contains 66 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow coloured, oval shaped, one side scored and other side debossed
with “T 5” biconvex
film-coated tablet of 8.70 x 4.50 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.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadalafil biomo 5 mg film-coated tablets 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 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 biomo 5 mg
film-coated tablets (i.e., at least
twice weekly) a once daily regimen with the lowest doses of Tadalafil
biomo 5 mg film-coated tablets
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.
Page 2 of 13
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
_Benig