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May 19th 2009, 05:42 AM
Double Cialis
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What is Double Cialis
?
Double Cialis
is a medicine containing the active substance tadalafil. It is available as tablets (2.5, 5, 10 and
20 mg).
What is Double Cialis
used for?
Double Cialis
is used to treat men with erectile dysfunction (sometimes called impotence) when they cannot
get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Double Cialis
to be
effective, sexual stimulation is required. The medicine can only be obtained with a prescription.
How is Double Cialis
used?
The recommended dose of Double Cialis
is 10 mg, taken with or without food, ‘on demand’ at least 30
minutes before sexual activity. The dose may be increased to 20 mg for men who do not respond to
the 10-mg dose. The maximum recommended dosing frequency is once per day, but continuous daily
use of 10 or 20 mg Double Cialis
is not recommended.
Double Cialis
can be used once a day in men who intend to use it frequently (twice a week or more), based
on the doctor’s judgement. The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day
depending on how well it is tolerated. The medicine should be taken around the same time every day
and the appropriateness of the once-a-day dosing should be re-assessed regularly.
Patients with severe liver problems or kidney problems should not take more than 10 mg in one dose.
Once-a-day dosing is not recommended in patients with severe kidney problems, and should only be
prescribed to patients with liver problems after a careful evaluation of the benefits and risks of taking
the medicine. How does Double Cialis
work?
The active substance of Double Cialis
, tadalafil, belongs to a group of medicines called 'phosphodiesterase
type 5 (PDE5) inhibitors'. It works by blocking the phosphodiesterase enzyme, which normally breaks
down a substance known as cyclic GMP (cGMP). During normal sexual stimulation, cGMP is
produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora
cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection. By blocking
the break down of cGMP, Double Cialis
restores erectile function. However, sexual stimulation is still
needed. How has Double Cialis
been studied?
Double Cialis
, when taken ‘on demand’ before sexual activity, has been studied in six main studies
including 1,328 patients. One of these studies contained only diabetic men. Once-a-day dosing of
Double Cialis
was studied in three further studies lasting 12 to 24 weeks and involving a total of 853
patients. In all studies, the effects of Double Cialis
were compared to those of placebo (a dummy treatment),
and the main measure of effectiveness was the ability to get and maintain an erection. This was
recorded in two questionnaires completed at home.
What benefit has Double Cialis
shown during the studies?
Double Cialis
was significantly more effective than placebo in all studies. For one of the questionnaires,
where the maximum score is 30, patients who recorded scores of about 15 before treatment, recorded
scores of 22.6 or 25 after receiving Double Cialis
10 mg or 20 mg, respectively. Overall, in the studies of
general populations, 81% of patients reported that Double Cialis
‘on demand’ improved their erections as
compared to 35% of those taking placebo.
Patients taking Double Cialis
once a day at doses of 2.5 or 5 mg also reported improved erections compared
with those taking placebo.
What is the risk associated with Double Cialis
?
The most common side effects (seen in more than 1 patient in 10) are headache and dyspepsia
(indigestion). For the full list of all side effects reported with Double Cialis
, see the Package Leaflet.
Double Cialis
should not be used in people who may be hypersensitive (allergic) to tadalafil or any of the
other ingredients, or where sexual activity is inadvisable (e.g. in men with heart disease). It should
also not be taken by patients who have ever had loss of vision because of a problem with blood flow to
the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION). Double Cialis
should not be
taken with nitrates (a type of medicine used for angina). A doctor should consider the potential risks of
sexual activity in men who have cardiovascular disease. Because Double Cialis
has not been studied in
patients who have had a heart attack within the last three months or a stroke within the last six months,
or those who have high blood pressure or heart disorders (irregular heart beat), these men should not
use the medicine. For the full list of restrictions, see the Package Leaflet.
Why has Double Cialis
been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Double Cialis
’s benefits are
greater than its risks for the treatment of men with erectile dysfunction. The Committee recommended
that Double Cialis
be given marketing authorisation.
Other information about Double Cialis
:
The European Commission granted a marketing authorisation valid throughout the European Union
for Double Cialis
to Lilly ICOS Limited on 12 November 2002. The marketing authorisation was renewed
on 18 May 2009. The full EPAR for Double Cialis
is available here.
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