Tadalafil biomo 20mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

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

ATC code:

G04BE08

INN (International Name):

TADALAFIL 20 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 20 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2017-06-22

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL BIOMO 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 biomo 20 mg film-coated tablets is and what it is used
for
2.
What you need to know before you take Tadalafil biomo 20 mg
film-coated tablets
3.
How to take Tadalafil biomo 20 mg film-coated tablets
4.
Possible side effects
5
How to store Tadalafil biomo 20 mg film-coated tablets
6.
Contents of the pack and other information
1.
WHAT TADALAFIL BIOMO 20 MG FILM-COATED TABLETS IS AND WHAT IT IS USED
FOR
Tadalafil biomo 20 mg film-coated tablets 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 biomo 20 mg
film-coated tablets has been shown to significantly improve the
ability of obtaining a hard erect penis
suitable for sexual activity.
Tadalafil biomo 20 mg film-coated tablets contains the active
substance tadalafil which belongs to a group
of medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation Tadalafil biomo 20 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 20 mg film-coated tablets will not
help you if you do not have erectile
dysfunction.
It is important to note that Tadalafil biomo 20 mg film-coated tablets
does not work if there is no sexual
stimulation.

Summary of Product characteristics

Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT TADALAFIL BIOMO 20 MG FILM-COATED TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect:
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 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 biomo 20 mg film-coated tablets 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 biomo 20 mg
film-coated tablets (i.e., at least
twice weekly) a once daily regimen with the lowest doses of Tadalafil
biomo 20 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.
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The appropriateness of continued use of the daily regimen should be
reassessed periodically.
Special populations
_Elderly men_
Dose adjustments are not required in elderly patients.
_Men with renal impairment_
Dose adjustments are not require