Tadalafil Actavis 20mg film-coated Tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

TADALAFIL

Предлага се от:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

АТС код:

G04BE08

INN (Международно Name):

TADALAFIL 20 mg

Лекарствена форма:

FILM-COATED TABLET

Композиция:

TADALAFIL 20 mg

Вид предписание :

POM

Терапевтична област:

UROLOGICALS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2016-08-09

Листовка

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

Данни за продукта

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Actavis 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 250 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
20 mg film-coated tablets are: Pale yellow, oval shape, film-coated
tablets, debossed with ‘20’ on
one side and plain on the other side. The tablet is 12 mm x 7.4 mm in
diameter and 4.60 – 5.20 mm
in thickness.
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 Actavis 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.
Page 2 of 14
In patients who anticipate a frequent use of Tadalafil Actavis (i.e.,
at least twice weekly) a once
daily regimen with the lowest doses of Tadalafil Actavis 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.
Special populations
_Elderly men _
Dose adjustments are not required in elderly patients.
_Men with renal impairment _
Dose adjustments are not required