Tadalafil Clonmel 20 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Tadalafil

Disponible depuis:

Clonmel Healthcare Ltd

Code ATC:

G04BE08

DCI (Dénomination commune internationale):

Tadalafil

Dosage:

20 milligram(s)

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

tadalafil

Statut de autorisation:

Marketed

Date de l'autorisation:

2020-07-24

Notice patient

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL CLONMEL 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 Clonmel is and what it is used for
2. What you need to know before you take Tadalafil Clonmel
3. How to take Tadalafil Clonmel
4. Possible side effects
5. How to store Tadalafil Clonmel
6. Contents of the pack and other information
1. WHAT TADALAFIL CLONMEL IS AND WHAT IT IS USED FOR
Tadalafil Clonmel contains the active substance tadalafil which
belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Clonmel 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 has been shown to significantly improve your
ability to obtain this.
Following sexual stimulation Tadalafil Clonmel 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 Clonmel will not help you if you do not have erectile
dysfunction. It is important to note
that Tadalafil Clonmel 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 CLONMEL
DO NOT TAKE TADALAFIL CLONMEL IF YOU

are allergic to tadalafil or any of the other ingredients of this
medic

Résumé des caractéristiques du produit

Health Products Regulatory Authority
08 January 2021
CRN009X7V
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Clonmel 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Clonmel 20 mg: Each film-coated tablet contains 20 mg
tadalafil.
Excipient with known effect
Each 20 mg tablet contains 232.6 mg of lactose (as lactose
monohydrate) and 2.2 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow, round, biconvex, film-coated tablet with cross line on both
sides, white at the cross section with 10.1 ± 0.2 mm
diameter.
The tablet can be divided into equal doses.
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 Clonmel 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.
Doses of 10 and 20 mg are intended for use prior to anticipated sexual
activity and are 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 A