PACKAGE LEAFLET : INFORMATION FOR THE USER
CIALIS 20 mg film-coated tablets
tadalafil
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What CIALIS is and what it is used for
2. Before you take CIALIS
3. How to take CIALIS
4. Possible side effects
5 How to store CIALIS
6. Further information
1. WHAT CIALIS IS AND WHAT IT IS USED FOR
CIALIS is a treatment for men with erectile dysfunction. This is when a man cannot get, or keep a
hard, erect penis suitable for sexual activity.
CIALIS 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. BEFORE YOU TAKE CIALIS
Do not take CIALIS
- if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a
group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). CIALIS
has been shown to increase the effects of these drugs. If you are taking any form of nitrate or are
unsure tell your doctor.
- if you have serious heart disease or have had a recent heart attack.
- if you have had a recent stroke.
- if you have low blood pressure or uncontrolled high blood pressure.
- if you are allergic (hypersensitive) to tadalafil or any of the other ingredients of CIALIS.
- if you have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy
(NAION).
Take special care with CIALIS
Sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on
your heart. If you have a heart problem you should tell your doctor.
The following are reasons why CIALIS may also not be suitable for you. If any of them apply to you,
talk to your doctor before you take the medicine:
- You have sickle cell anaemia (an abnormality of red blood cells), multiple myeloma (cancer of
the bone marrow), leukaemia (cancer of the blood cells) or any deformation of your penis.
- You have a serious liver or kidney problem.
If you experience sudden decrease or loss of vision, stop taking Cialis and contact your doctor
immediately.
Taking other medicines
As a general rule, always tell your doctor if you are taking or have recently taken any other medicine,
even those not prescribed, because occasionally they might interact. This is particularly important if
you are treated with nitrates as you should not take CIALIS if you are taking these medicines. A type
of medicine called an alpha blocker is sometimes used to treat high blood pressure and enlarged
prostate. Tell your doctor if you are being treated for either of these conditions. Do not take CIALIS
with other medicines if your doctor tells you that you may not.
You should not use CIALIS together with any other treatments for erectile dysfunction.
CIALIS is not intended for use by women or by children under the age of 18.
Driving and using machines
As dizziness has been reported in men taking CIALIS in clinical studies, you should be aware of how
you react to CIALIS before you drive or use machinery.
Information for men intolerant of lactose, one of the ingredients of CIALIS:
CIALIS contains lactose and should not be taken by patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
3. HOW TO TAKE CIALIS
Always take CIALIS exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is
too weak your doctor may increase the dose to 20 mg. CIALIS tablets are for oral use. Swallow the
tablet whole with some water. You may take CIALIS with or without food.
You may take a CIALIS tablet at least 30 minutes before sexual activity. CIALIS may still be effective
up to 36 hours after taking the tablet. 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.
Drinking alcohol may affect your ability to get an erection. Drinking alcohol may temporarily lower
your blood pressure. If you have taken or are planning to take CIALIS, avoid excessive drinking
(blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing
up.
You should NOT take CIALIS more than once a day. CIALIS 10 and 20 mg is intended for use prior
to anticipated sexual activity and is not recommended for continuous daily use.
If you take more CIALIS than you should
Tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, CIALIS can cause side effects, although not everybody gets them. These effects are
normally mild to moderate in nature.
The most common undesirable effects are headache and indigestion. Less commonly reported side
effects are back pain, muscle aches, nasal congestion, facial flushing and dizziness. Uncommon effects
are swelling of the eyelids, eye pain and red eyes.
If you have any of these side effects and they are troublesome, severe, or do not go away, tell your
doctor.
Allergic reactions (including skin rashes, swelling of the face and hives) could occur.
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking
CIALIS. If you have such an erection, which lasts continuously for more than 4 hours, you should
contact a doctor immediately.
In case of chest pain occurring during or after sexual activity you should NOT use nitrates but you
should seek immediate medical assistance.
Heart attack, stroke, irregular heart beats, pounding heartbeat sensation, high blood pressure and low
blood pressure have been reported rarely in men taking CIALIS. Most, but not all of these men had
known heart problems before taking this medicine. It is not possible to determine whether these events
were directly related to CIALIS.
Partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes has been
reported.
Blurred vision, fainting, increased sweating, migraine and nose bleeds have been reported rarely.
Effects were seen in one animal species that might indicate impairment of fertility. Subsequent studies
in man suggest that this effect is unlikely in humans, although a decrease in sperm concentration was
seen in some men.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE CIALIS
Keep out of the reach and sight of children.
Store in the original package. Do not store above 30°C.
Do not use CIALIS after the expiry date stated on the carton and blister.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What CIALIS contains
The active substance is tadalafil. Each tablet of CIALIS contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline
cellulose, sodium laurilsulfate, magnesium stearate.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow
(E172), talc.
What CIALIS looks like and contents of the pack
CIALIS comes as yellow film-coated tablets. They are in the shape of almonds and have "C 20"
marked on one side. These tablets are available in blister packs containing 2, 4, 8 or 12 tablets. Not all
pack sizes may be marketed in every country.
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