TADALAFIL

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

TADALAFIL

可用日期:

Accord Healthcare Limited

ATC代码:

G04BE08

INN（国际名称）:

TADALAFIL

剂量:

5 Milligram

药物剂型:

Film Coated Tablet

处方类型:

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

治疗领域:

tadalafil

授权状态:

Authorised

授权日期:

2016-05-20

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 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 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.
Urinary symptoms associated with a common condition called BENIGN
PROSTATIC HYPERPLASIA.
This is when the prostate gland gets bigger with age. Symptoms include
difficulty in starting
to pass water, a feeling of not completely emptying

产品特点

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 tadalafil.
Excipient(s) with known effect:
Lactose (as monohydrate)
Each film-coated tablet contains 91.572 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, capsule shaped, approximately 8.6 mm in length and 4.8
mm in width, biconvex, bevelled edged, film
coated tablet, debossed with "T 5" on one side and plain on other
side.
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 5mg 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 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 tablets 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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___