Tadalafil 20 mg Film-coated Tablets

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Tadalafil

Beszerezhető a:

Accord Healthcare Limited

ATC-kód:

G04BE; G04BE08

INN (nemzetközi neve):

Tadalafil

Adagolás:

20 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Recept típusa:

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

Terápiás terület:

Drugs used in erectile dysfunction; tadalafil

Engedélyezési státusz:

Marketed

Engedély dátuma:

2016-05-20

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tadalafil 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 is and what it is used for
2.
What you need to know before you take Tadalafil
3.
How to take Tadalafil
4.
Possible side effects
5.
How to store Tadalafil
6.
Contents of the pack and other information
1.
WHAT TADALAFIL IS AND WHAT IT IS USED FOR
Tadalafil contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil is used to treat:

ERECTILE DYSFUNCTION IN ADULT MEN
:
This is when a man cannot get, or keep a hard, erect penis suitable
for sexual activity. Tadalafil
has been shown to significantly improve the ability of obtaining a
hard erect penis suitable for
sexual activity. Following sexual stimulation Tadalafil 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 will not help you if you do not have erectile
dysfunction. It is important to note
that Tadalafil 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.

PULMONARY ARTERIAL HYPERTENSION IN ADULTS
:
It works by helping the blood vessels around your lungs relax,
improving the flow of blood into
your lungs. The result of this is an improved ability to do physical
activity.
2.
WHAT

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg tadalafil.
Excipient(s) with known effect:
Lactose (as monohydrate)
Each 20 mg film-coated tablet contains 367.584 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, capsule shaped, approximately 14.3 mm in length and 7 mm in
width, biconvex, bevelled edged, film coated
tablet, debossed with "T 20" on one side and plain on other side.
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.
It is indicated in adults for the treatment of pulmonary arterial
hypertension (PAH) classified as WHO functional class
II and III, to improve exercise capacity (see section 5.1).
Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to
collagen vascular disease.
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.
_Pulmonary arterial hypertension_
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
PAH.
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