Quator 10 mg Film-coated tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Tadalafil

Commercializzato da:

Rowex Ltd

Codice ATC:

G04BE; G04BE08

INN (Nome Internazionale):

Tadalafil

Dosaggio:

10 milligram(s)

Forma farmaceutica:

Film-coated tablet

Area terapeutica:

Drugs used in erectile dysfunction; tadalafil

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2019-07-19

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUATOR 10 MG FILM-COATED TABLETS
QUATOR 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 Quator is and what it is used for
2. What you need to know before you take Quator
3. How to take Quator
4. Possible side effects
5. How to store Quator
6. Contents of the pack and other information
1. WHAT QUATOR IS AND WHAT IT IS USED FOR
Quator contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors.
Quator
10 MG AND 20 MG
film-coated tablets are 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. Quator has been
shown to significantly improve the ability of obtaining a hard erect
penis suitable for sexual activity.
Following sexual stimulation Quator 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. Quator will
not help you if you do not have erectile dysfunction. It is important
to note that Quator 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 a medicine for erectile
dysfunction.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUATOR
DO NOT TAKE QUATOR IF YOU:
-
are allergic to tadalafil or any of the other ingredients of this
medicine (lis

Scheda tecnica

Health Products Regulatory Authority
17 December 2021
CRN00CNKT
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quator 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.
Quator is not indicated for use by women.
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 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.
Special populations
_Elderly men_
Dose adjustments are not required in elderly patients.
Health Products Regulatory Authority
17 December 2021
CRN00CNKT
Page 2 of 12
_Men with renal impairment_
Dose adjus