Cialis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

tadalafil

Available from:

Eli Lilly Nederland B.V.

ATC code:

G04BE08

INN (International Name):

tadalafil

Therapeutic group:

Urologicals

Therapeutic area:

Erectile Dysfunction

Therapeutic indications:

Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.

Product summary:

Revision: 32

Authorization status:

Authorised

Authorization date:

2002-11-12

Patient Information leaflet

61
B. PACKAGE LEAFLET
62
PACKAGE LEAFLET: INFORMATION FOR THE USER
CIALIS 2.5 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 CIALIS is and what it is used for
2.
What you need to know before you take CIALIS
3.
How to take CIALIS
4.
Possible side effects
5
How to store CIALIS
6.
Contents of the pack and other information
1.
WHAT CIALIS IS AND WHAT IT IS USED FOR
CIALIS 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. CIALIS has been
shown to significantly improve the
ability of obtaining a hard erect penis suitable for sexual activity.
CIALIS contains the active substance tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors. Following sexual stimulation
CIALIS 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. CIALIS will not help you if you do not
have erectile dysfunction.
It is important to note that CIALIS 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 CIALIS
DO NOT TAKE CIALIS 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 oxide donors such as

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CIALIS 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains 2.5 mg tadalafil.
Excipient with known effect
_ _
Each coated tablet contains 87 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light orange-yellow and almond shaped tablets, marked "C 2 ½" on one
side.
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.
CIALIS 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 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 CIALIS (i.e., at least
twice weekly) a once daily regimen
with the lowest doses of CIALIS 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 should be
reassessed periodically.
3
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 in pati