Tadalafil 10mg Film-coated Tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Tadalafil

متاح من:

Accord Healthcare Limited

ATC رمز:

G04BE; G04BE08

INN (الاسم الدولي):

Tadalafil

جرعة:

10 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

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

المجال العلاجي:

Drugs used in erectile dysfunction; tadalafil

الوضع إذن:

Marketed

تاريخ الترخيص:

2016-05-20

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TADALAFIL
DO NOT TAKE TADALAFIL IF YOU:
­
are allergic to tadalafil or any of the other ingredients of this
medicine (listed in section 6).
­
are taking any form of organic nitrate or nitric

خصائص المنتج

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 tadalafil.
Excipient(s) with known effect:
Lactose (as monohydrate)
Each film-coated tablet contains 183.144 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 11 mm in length and 5.5 mm
in width, biconvex, bevelled edged, film
coated tablet, debossed with "T 10" 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.
Tadalafil 10 mg 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.
Tadalafil 10 mg and 20 mg is intended for use prior to anticipated
sexual activity and it is not recommended for
continuous daily use.
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 for on-demand
treatment.
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