Tadalafil Uropharm 20mg film-coated tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

TADALAFIL

Tillgänglig från:

Uropharm AG Erfurtstrasse 64, 53125, Bonn,, Germany

ATC-kod:

G04BE08

INN (International namn):

TADALAFIL 20 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

TADALAFIL 20 mg

Receptbelagda typ:

POM

Terapiområde:

UROLOGICALS

Bemyndigande status:

Withdrawn

Tillstånd datum:

2017-07-31

Bipacksedel

PL112800103
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PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL UROPHARM 20 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 UROPHARM is and what it is used for
2.
What you need to know before you take TADALAFIL UROPHARM
3.
How to take TADALAFIL UROPHARM
4.
Possible side effects
5
How to store TADALAFIL UROPHARM
6.
Contents of the pack and other information
1.
WHAT TADALAFIL UROPHARM IS AND WHAT IT IS USED FOR
TADALAFIL UROPHARM 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
UROPHARM has been shown to significantly improve the ability of
obtaining a hard erect penis
suitable for sexual activity.
TADALAFIL UROPHARM contains the active substance tadalafil which
belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation TADALAFIL UROPHARM 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 UROPHARM will not help you if you do not
have erectile
dysfunction.
It is important to note that TADALAFIL UROPHARM does not work if there
is no sexual
stimulation. You and your partner will need to engage in foreplay,
just as you would if you were
not taking a medicine for erectile dysfunction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL UROPHARM
DO NOT TAKE TADALAFIL UROPHARM IF YOU:
-
are aller

Produktens egenskaper

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1.
NAME OF THE MEDICINAL PRODUCT
TADALAFIL UROPHARM 10 MG FILM-COATED TABLETS
TADALAFIL UROPHARM 20 MG FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of tadalafil.
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect:
Each film-coated tablet contains 133 mg of lactose (as monohydrate).
Each film-coated tablet contains 265 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 10” biconvex
film-coated tablet of 11.50 x 5.90 mm. The tablet can be divided into
equal doses.
Yellow coloured, oval shaped, one side scored and other side debossed
with “T 20” biconvex
film-coated tablet of 13.90 x 7.20 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, sexual stimulation is
required.
TADALAFIL UROPHARM is not indicated for use by women.
4.2
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
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 UROPHARM (i.e.,
at least twice weekly) a once
daily regimen with the lowest doses of TADALAFIL UROPHARM might be
considered suitable, based on
Page 2 of 12
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 d