Tadalafil Acino 5 mg film-coated tablets

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

TADALAFIL

Tersedia dari:

Acino AG Im Windfeld 35, Miesbach, 83714, Germany

Kode ATC:

G04BE08

INN (Nama Internasional):

TADALAFIL 5 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

TADALAFIL 5 mg

Jenis Resep:

POM

Area terapi:

UROLOGICALS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2017-06-15

Selebaran informasi

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL ACINO 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 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 contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Acino 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 Acino has been shown to significantly improve the
ability of obtaining a hard
erect penis suitable for sexual activity.
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 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 when

Karakteristik produk

PAGE 1 OF 14
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Acino 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg tadalafil.
Excipient with known effect:
Each film-coated tablet contains 66 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 Acino 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 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
PAGE 2 OF 14
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 dose is 5 mg, taken at