Tadalafil Aristo Pharma 10mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

Aristo Pharma GmbH Wallenroder Straße 8–10, 13435, Berlin, Germany

ATC code:

G04BE08

INN (International Name):

TADALAFIL 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 10 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2017-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL ARISTO PHARMA 10 MG FILM-COATED TABLETS
TADALAFIL ARISTO PHARMA 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 Aristo Pharma is and what it is used for
2.
What you need to know before you take Tadalafil Aristo Pharma
3.
How to take Tadalafil Aristo Pharma
4.
Possible side effects
5
How to store Tadalafil Aristo Pharma
6.
Contents of the pack and other information
1.
WHAT TADALAFIL ARISTO PHARMA IS AND WHAT IT IS USED FOR
Tadalafil Aristo Pharma 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 Aristo Pharma has
been shown to significantly improve the ability of obtaining a hard
erect penis suitable for sexual
activity.
Tadalafil Aristo Pharma contains the active substance tadalafil which
belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
Following sexual stimulation Tadalafil Aristo Pharma 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 Aristo Pharma will not help you if you do not have
erectile dysfunction.
It is important to note that Tadalafil Aristo Pharma 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

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Aristo Pharma 10 mg film-coated tablets
Tadalafil Aristo Pharma 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Aristo Pharma 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of tadalafil.
Excipient with known effect:
Each film-coated tablet contains 133 mg of lactose (as monohydrate).
Tadalafil Aristo Pharma 20 mg film-coated tablets
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
Tadalafil Aristo Pharma 10 mg film-coated tablets
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.
Tadalafil Aristo Pharma 20 mg film-coated tablets
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 Aristo Pharma is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men_
2
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 Aristo Pharma
(i.e., at least twice weekly) a once
daily regimen with the lowest doses of Tadalafil Aristo Pharma might
be co