Tadalafil Clonmel 2.5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tadalafil

Available from:

Clonmel Healthcare Ltd

ATC code:

G04BE; G04BE08

INN (International Name):

Tadalafil

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Drugs used in erectile dysfunction; tadalafil

Authorization status:

Not marketed

Authorization date:

2017-01-20

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
TADALAFIL CLONMEL 2.5 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 is a treatment for 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 the ability of obtaining a hard erect penis
suitable for sexual activity.
Tadalafil Clonmel contains the active substance tadalafil which
belongs to a group of medicines
called phosphodiesterase type 5 inhibitors. 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 t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Clonmel 2.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg tadalafil.
Excipient with known effect:
Each 2.5 mg tablet contains 81.325 mg of lactose (as lactose anhydrous
and lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow-orange coloured, caplet shaped, biconvex, film coated tablet,
debossed with “T 2” on one side and plain on the
other, with nominal dimensions 8.2 mm x 4.1 mm.
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.
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