Tadalafil Rowex 20 mg Film-coated Tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Tadalafil

Tillgänglig från:

Rowex Ltd

ATC-kod:

G04BE; G04BE08

INN (International namn):

Tadalafil

Dos:

20 milligram(s)

Läkemedelsform:

Film-coated tablet

Receptbelagda typ:

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

Terapiområde:

Drugs used in erectile dysfunction; tadalafil

Bemyndigande status:

Marketed

Tillstånd datum:

2016-01-20

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL ROWEX 2.5 MG FILM-COATED TABLETS
TADALAFIL ROWEX 5 MG FILM-COATED TABLETS
TADALAFIL ROWEX 10 MG FILM-COATED TABLETS
TADALAFIL ROWEX 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 Rowex is and what it is used for
2. What you need to know before you take Tadalafil Rowex
3. How to take Tadalafil Rowex
4. Possible side effects
5. How to store Tadalafil Rowex
6. Contents of the pack and other information
1. WHAT TADALAFIL ROWEX IS AND WHAT IT IS USED FOR
Tadalafil Rowex contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors.
TADALAFIL ROWEX 2.5 MG, 5 MG, 10 MG AND 20 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 Rowex
has been shown to significantly improve the ability of obtaining a
hard erect penis suitable for sexual
activity.
Following sexual stimulation Tadalafil Rowex 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 Rowex will not help you if you do not have erectile
dysfunction.
It is important to note that Tadalafil Rowex 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

Produktens egenskaper

Health Products Regulatory Authority
22 June 2021
CRN00C3LS
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Rowex 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect
Each tablet contains 335.4 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Ochre to yellow, oval shaped film-coated tablet of approximately 15 x
9 mm. On one side debossed with "20". The other side of
the tablet is bi-scored.
The tablet can be divided into equal halves and/or quarters.
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 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.
In patients who anticipate a frequent use of tadalafil (i.e., at least
twice weekly) a once daily regimen with the lowest doses of
tadalafil 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