Tadalafil Acino 20 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TADALAFIL

Available from:

Acino AG Im Windfeld 35, Miesbach, 83714, 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:

Authorised

Authorization date:

2017-06-15

Patient Information leaflet

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

Summary of Product characteristics

PAGE 1 OF 13
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Acino 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg 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 Acino 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 Acino (i.e., at
least twice weekly) a once daily
regimen with the lowest doses of Tadalafil Acino 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.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
PAGE 2 OF 13
Special populations
_ _
_Elderly men_
Dose adjustments are not required in elderly patients.
_Men with renal impairment_
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients
with s