Tadalafil Uropharm 5mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

Uropharm AG Erfurtstrasse 64, 53125, Bonn,, Germany

ATC code:

G04BE08

INN (International Name):

TADALAFIL 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2017-07-31

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL UROPHARM 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 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 contains the active substance tadalafil which
belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
TADALAFIL UROPHARM 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 UROPHARM has been shown to
significantly improve
the ability of obtaining a hard erect penis suitable for sexual
activity.
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 for the treatment of
erectile
dysfunction 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.
-
urinary symptoms associated with a common condition called benign
pr

Summary of Product characteristics

Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
TADALAFIL UROPHARM 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 UROPHARM 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 UROPHARM (i.e.,
at least twice weekly) a once
daily regimen with the lowest doses of TADALAFIL UROPHARM 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.
_Benign prostatic hyperplasia in adult men _
The recommended dose is