Tadalafil 10mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Tadalafil

Beschikbaar vanaf:

Brillpharma (Ireland) Limited

ATC-code:

G04BE; G04BE08

INN (Algemene Internationale Benaming):

Tadalafil

Dosering:

10 milligram(s)

farmaceutische vorm:

Film-coated tablet

Therapeutisch gebied:

Drugs used in erectile dysfunction; tadalafil

Autorisatie-status:

Not marketed

Autorisatie datum:

2017-05-12

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL 10 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, pharmacist or
nurse.
−
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Tadalafil is and what it is used for
2. What you need to know before you take Tadalafil
3. How to take Tadalafil
4. Possible side effects
5. How to store Tadalafil
6. Contents of the pack and other information
1. WHAT TADALAFIL IS AND WHAT IT IS USED FOR
Tadalafil 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.
This medicine contains the active substance tadalafil which belongs to
a group of medicines
called phosphodiesterase type 5 inhibitors. Following sexual
stimulation tadalafil 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 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
DO NOT TAKE TADALAFIL IF YOU:
•
are allergic to the active substance or any of the other ingredients
of this medicine
(listed in section 6).
•
are taking

Productkenmerken

Health Products Regulatory Authority
08 February 2024
CRN00DYHY
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of tadalafil.
Excipient(s) with known effect:Also contains 163.4 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Yellow to light yellow, round shaped, bevelled edge, film-coated
tablets debossed with ‘338’ on one side and plain on other
side.The tablet dimensions are 3.90 mm ± 0.40 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 10 mg Film-coated Tablet 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 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 judgment.
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.
_Men with renal impairment_
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients with severe renal
impairment 10 mg is the maximum recommended dose. Once-a-day dosing of
tadalafil is not recommended