Tadalafil Rowex 10 mg Film-coated Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Tadalafil

Διαθέσιμο από:

Rowex Ltd

Φαρμακολογική κατηγορία (ATC):

G04BE; G04BE08

INN (Διεθνής Όνομα):

Tadalafil

Δοσολογία:

10 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

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

Θεραπευτική περιοχή:

Drugs used in erectile dysfunction; tadalafil

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2016-01-20

Φύλλο οδηγιών χρήσης

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 takin

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
24 August 2020
CRN009NFP
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Rowex 10 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 177 mg lactose 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 11 x
6 mm. On one side debossed with “10”. The other side of
the tablet is plain.
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.
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 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 approximately the same time
every day with or without food. For adult men being
treated for both benign prostatic hyperplasia and erectile dysfunct