TADALAFIL ACTAVIS 2.5 Milligram Film Coated Tablet

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

TADALAFIL

متاح من:

Actavis Group PTC ehf

ATC رمز:

G04BE08

INN (الاسم الدولي):

TADALAFIL

جرعة:

2.5 Milligram

الشكل الصيدلاني:

Film Coated Tablet

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Drugs used in erectile dysfuntion

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-06-24

نشرة المعلومات

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL ACTAVIS 2.5 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 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 tadal

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Actavis 2.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 84 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film
-
coated tablet (tablet).
2.5 mg film
-
coated tablets are:
Light
yellow,
oval
shape,
film
-
coated tablets,
debossed with “2.5” on one side and
plain on the other side. The tablet is 9 mm x 5.2 mm in diameter and
2.7 – 3.3 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.
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.
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