Tadalafil 5mg film-coated tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Tadalafil

Доступна с:

Brillpharma (Ireland) Limited

код АТС:

G04BE; G04BE08

ИНН (Международная Имя):

Tadalafil

дозировка:

5 milligram(s)

Фармацевтическая форма:

Film-coated tablet

Терапевтические области:

Drugs used in erectile dysfunction; tadalafil

Статус Авторизация:

Not marketed

Дата Авторизация:

2017-05-12

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL 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, 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 contains the active substance tadalafil which belongs to a
group of medicines
called phosphodiesterase type 5 inhibitors.
Tadalafil 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 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.
BENIGN PROSTATIC HYPERPLASIA
Tadalafil 5 mg is a treatment for urinary symptoms associated with a
common condition
called
BENIGN PROSTATIC HYPERPLASIA
. This is when the prostate gland gets bigger with age.
Sy

Характеристики продукта

Health Products Regulatory Authority
08 February 2024
CRN00DYHY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tadalafil 5mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of tadalafil.
Excipient(s) with known effect:Also contains 81.7 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 ‘337’ on one side and plain on other
side.The tablet dimensions are 2.70 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 for the treatment of erectile
dysfunction, sexual stimulation is required.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadalafil 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 judgment.
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.
_Benign prostatic hyperplasia in adult men _