Tadalafil Krka 5 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
29-01-2022
Summary of Product characteristics
(SPC)
29-01-2022
Active ingredient:
Tadalafil
Available from:
KRKA, d.d., Novo mesto
ATC code:
G04BE; G04BE08
INN (International Name):
Tadalafil
Dosage:
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:
2017-06-09
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Tadalafil Krka
3.
How to take Tadalafil Krka
4.
Possible side effects
5.
How to store Tadalafil Krka
6.
Contents of the pack and other information
1.
WHAT TADALAFIL KRKA IS AND WHAT IT IS USED FOR
Tadalafil Krka contains the active substance tadalafil which belongs
to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Krka 5 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 has been shown to significantly improve the
ability of obtaining a
hard erect penis suitable for sexual activity.
Following sexual stimulation Tadalafil Krka 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 will not help you if you do not have erectile
dysfunction. It is important to
note that Tadalafil Krka 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.
-
urinary symptoms associated with a common condition called
BENIGN PROSTATIC HYPERPLASIA
.
This is when the prostate gland gets bigger
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
28 January 2022
CRN00CDV4
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil Krka 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg tadalafil.
Excipient with known effect:
Each film-coated tablet contains 0.750 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Light yellow, biconvex, oval, film-coated tablets, scored on one side
and with sign 5 on the other side. The tablet can be
divided into equal doses. Tablet dimensions: approximately 9 mm long
and 6 mm wide.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile
dysfunction, sexual stimulation is required.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadalafil Krka 5 mg 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 Krka (i.e., at
least twice weekly) a once daily regimen with the lowest
doses of Tadalafil Krka 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 sho
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