Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CIALIS. It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking CIALIS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What CIALIS is used for
CIALIS is used to treat erectile dysfunction, also known as impotence, in men. This is when a man cannot get, or maintain, a hard erect penis suitable for sexual activity.
The active ingredient in CIALIS tablets, tadalafil, 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.
CIALIS will only work if you are sexually aroused.
CIALIS Once-A-Day is for patients who anticipate frequent use of CIALIS (i.e. at least twice weekly). Your Doctor can advise on the appropriateness of once-a-day treatment.
Ask your doctor if you have any questions about why CIALIS has been prescribed for you. Your doctor may have prescribed it for another reason. CIALIS is available only with a doctor's prescription.
CIALIS is not intended for use by women or by children under the age of 18 years.
Before you take CIALIS
When you must not take it
Do not take CIALIS if you are currently taking any nitrates or amyl nitrite. Nitrates are medicines used for the treatment of angina ("chest pain") or other heart conditions. CIALIS has been shown to increase the effects of these medicines.
If you are taking any form of nitrate or are unsure talk to your doctor.
Do not take CIALIS:
if you have heart or blood vessel problems that make sexual intercourse inadvisable.
Sexual activity carries a possible risk to patients with a heart
condition because it puts extra strain on the heart
if you have suffered a heart attack or stroke in the last 6 months
if your blood pressure is unusually high or low or is not effectively treated
if you have vision loss in one
eye because of non-arteritic interior ischaemic optic neuropathy (NAION)
if you use recreational drugs called "poppers" or "amyl" like amyl nitrite and butyl nitrite that are normally taken through inhalation
Do not take CIALIS if you have an allergy to:
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack.
If it has expired, return it to your pharmacist for disposal.
Do not take this medicine if the packaging is torn or if the seals over the carton ends are missing or broken. There are no seals over the carton ends of the 5mg physician sample pack.
If it is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking CIALIS, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. CIALIS tablets contain a small amount of lactose.
Tell your doctor if you have or have had any of the following medical conditions:
liver or kidney problems
heart problems such as angina, arrhythmias (changes in the rhythm or rate of the heart beat), heart failure, or if you have had a heart attack
blood vessel problems
sickle cell anaemia (an abnormality of red blood cells)
multiple myeloma (cancer of the bone marrow)
leukaemia (cancer of the blood cells)
any deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease)
loss of vision in one or both eyes
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking CIALIS.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some medicines may be affected by CIALIS or may affect how it works. These include:
Nitrates, medicines such as glyceryl trinitrate used to treat angina and other heart conditions
Some antibiotic medicines such as rifampicin, erythromycin and clarithromycin
Some medicines used to treat seizures such as phenytoin, phenobarbitone and carbamazepine
Some medicines used to treat
fungal infections such as ketoconazole and itraconazole
Protease inhibitors used to treat HIV such as ritonavir and saquinavir
Medicines used to treat hypertension (high blood pressure)
Alpha blockers (used to treat hypertension and some prostate problems)
Warfarin, a medicine used to prevent or treat blood clots
High doses of alcohol
These medicines may be affected by CIALIS or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines.
You should not take CIALIS together with any other treatments for erectile dysfunction.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take CIALIS
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
CIALIS can be taken as either
on-demand dosing or once-a-day dosing. Do not take once-a-day dosing and on-demand dosing concurrently.
If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.
How much to take
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 for continuous daily use.
The maximum recommended dose of CIALIS is one 20 mg tablet taken before sexual activity.
If you have kidney disease, the recommended dose of CIALIS is one 10 mg tablet. This dose may be increased up to 20 mg. For patients with severe renal impairment 10 mg is the maximum recommended dose.
If you have liver disease, the recommended dose of CIALIS is one 10mg tablet. Patients with severe hepatic impairment should follow their doctor's advice.
You should not take CIALIS more than once a day.
Always take CIALIS exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
The recommended dose of CIALIS is one 5 mg tablet taken once per day.
Dosage adjustments are not required in patients with kidney disease. Once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment.
Patients with liver disease should follow their doctor's advice.
No special consideration is needed for the elderly or people with diabetes.
How to take it
Swallow the tablet whole with a full glass of water.
When to take it
CIALIS can be taken with or without food or alcohol.
CIALIS should be taken prior to anticipated sexual activity.
The amount of time CIALIS takes to work varies from person to person.
In some men CIALIS can work as early as 30 minutes after taking the
tablet but it is recommended that you allow 1 hour the first time you take it. CIALIS has been proven to be effective for up to 36 hours. This means you can take CIALIS and choose when you want to have sex over the next 36 hours.
For example, you can take CIALIS at Friday lunchtime and you can choose to engage in sexual activity on Friday afternoon, Friday night or anytime
on Saturday including Saturday night.
Sometimes if you're feeling anxious or nervous you may not respond to the first tablet. Don't give up, it may take a few doses before you get the full benefit of CIALIS.
CIALIS will only work if you are sexually aroused.
Take CIALIS with water every day at approximately the same time, either with or without food.
When taken once a day, CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. 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, so avoid excessive drinking with CIALIS.
If you have any questions about taking CIALIS, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or the Australian Poisons Information Centre (telephone 13 11 26) or the New Zealand National Poisons Centre (0800 POISON or 0800 764 766), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CIALIS.
Do this even if there are no signs of discomfort or poisoning. You may
need urgent medical attention. Symptoms of an overdose may include headache, dyspepsia (indigestion), back pain, muscular aches, nasal congestion and facial flushing.
While you are taking CIALIS
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking CIALIS. Tell any other doctors, dentists and pharmacists who treat you that you are taking CIALIS.
Things you must not do
Do not take CIALIS to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery until you know how CIALIS affects you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CIALIS. CIALIS helps most people with erectile dysfunction, but it may have unwanted side effects in a few people. All medicines can have side effects.
Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following
list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
The following side effects are usually mild and short-lived. In clinical trials, the number of patients taking CIALIS who discontinued due to side effects (1.7%) was not different from the number of patients taking placebo (dummy treatment) (1.1%).
Tell your doctor or pharmacist if you notice any of the following and they worry you:
allergic reactions, including skin rash, swelling of the face and hives
headache or migraine
sore throat and discomfort when swallowing
red eyes, eye pain and swelling of eyelids are uncommon
changes in colour vision are rare
decreases or loss of vision are very rare
If you experience chest pain during or after sexual activity, stop what you are doing, sit up and sit forward. Call an ambulance if the pain does not resolve. Do not use nitrates.
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking CIALIS.
If you have an erection which lasts longer than usual, you should contact a doctor immediately.
When taking CIALIS with large amounts of alcohol, some men may experience dizziness.
Sudden loss or decrease in hearing has been reported in people taking CIALIS. It is not possible to determine whether these events are related directly to the CIALIS, to other diseases or medications, to other factors, or to a combination of factors.
If you experience these symptoms, stop taking CIALIS and contact a doctor immediately.
This is not a complete list of all possible side effects. Others may occur in some people and there may be side effects not yet known.
Potential withdrawal effects from daily use have not been examined. It is recommended that patients continue to be monitored by their doctor after discontinuation of CIALIS.
If you notice any symptoms that worry you, check with your doctor.
Ask your doctor or pharmacist if you don't understand anything on this list.
After taking CIALIS
Keep your tablets in the original pack until it is time to take them. If you take the tablets out of the pack they may not keep as well.
Keep your tablets in a cool dry place where the temperature stays below 25 °C.
Do not store CIALIS or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep your medicine where children cannot reach. A locked cupboard at least
one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
CIALIS 5 mg tablets are yellow, film coated, almond shaped tablets, marked "C5" on one side.
CIALIS 10 mg tablets are light yellow, film coated, almond shaped tablets, marked "C10" on one side.
CIALIS 20 mg tablets are yellow, film coated, almond shaped tablets, marked "C20" on one side.
5 mg tablet - tadalafil 5 mg
10 mg tablet - tadalafil 10 mg
20 mg tablet - tadalafil 20 mg
iron oxide yellow CI77492
cellulose - microcrystalline
sodium lauryl sulfate
talc - purified
glycerol triacetate (triacetin)
Opadry II complete film coating system Y-30-12863-A Yellow
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
CIALIS is a product of:
Eli Lilly Australia Pty Limited
112 Wharf Road
WEST RYDE, NSW 2114
CIALIS is distributed in New Zealand by:
Eli Lilly and Company (NZ) Limited
Level 3, Axon House
414-422 Khyber Pass Road,
PO Box 109 197, Newmarket
® = Registered Trademark
Australian Registration Number
CIALIS 5 mg tablet - AUST R 128496
CIALIS 10 mg tablet - AUST R 90590
CIALIS 20 mg tablet - AUST R 81137
For further information on this product please visit the following websites
This leaflet was revised in May 2008