Tadalafil Aristo 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:

Authorised

Authorization date:

2017-06-08

Patient Information leaflet

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

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Aristo 10 mg film-coated tablets
Tadalafil Aristo 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Aristo 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of tadalafil.
_Excipient with known effect _
Each film-coated tablet contains 126 mg of lactose (as monohydrate).
Tadalafil Aristo 20 mg film-coated tablets
Each film-coated tablet contains 20 mg of tadalafil.
_Excipient with known effect _
Each film-coated tablet contains 252 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Tadalafil Aristo 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. The tablet can be divided into equal
doses.
Tadalafil Aristo 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 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
2
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 mg 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 (i.e.,
at least twice weekly) a once daily
regimen with the lowest doses of Tadalafil Aristo might be considered
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