Tadalafil Aristo 5mg 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 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TADALAFIL 5 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 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 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 contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Aristo 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 Aristo has been shown to significantly improve the
ability of obtaining a hard
erect penis suitable for sexual activity.
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 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
prostatic hyperplasia. This is
wh

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Aristo 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 63 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 Aristo 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 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
suitable, based on patient choice
and the physician’s judgement.
2
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.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
_Benign prostatic hyperplasia in adult men _
The recommended d