Tadalafil Genericon 5mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

Genericon Pharma Gesellschaft m.b.H Hafnerstrasse 211, 8054 Graz, Austria

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Withdrawn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:

2017-06-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL GENERICON 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 Genericon is and what it is used for
2.
What you need to know before you take Tadalafil Genericon
3.
How to take Tadalafil Genericon
4.
Possible side effects
5
How to store Tadalafil Genericon
6.
Contents of the pack and other information
1.
WHAT
Tadalafil Genericon IS AND WHAT IT IS USED FOR
Tadalafil Genericon contains the active substance tadalafil which
belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
Tadalafil Genericon 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 Genericon has been shown to
significantly improve the
ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation Tadalafil Genericon 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 Genericon will not help you if you do not have erectile
dysfunction. It is
important to note that Tadalafil Genericon 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

1
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Genericon 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 Genericon 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 Genericon
(i.e., at least twice weekly) a once
daily regimen with the lowest doses of Tadalafil Genericon 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.
2
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
_Benign prostatic hyperplasia in adult men _
The recommended dose is 5 mg, taken at app