Cialis Prescribing Information Australia


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Cialis Prescribing Information Australia

Some medicines may be affected by CIALIS or may affect how it works. These include:

CIALIS®

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

  • 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. 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 only treat erectile dysfunction if you are sexually aroused. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
  • urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass urine, a feeling of not completely emptying the bladder and a more frequent need to pass urine even at night. CIALIS improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia.

Your doctor may have prescribed you CIALIS to treat either, or both of these conditions.

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.

The active ingredient in CIALIS tablets, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

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.

  • 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 heart problems such as angina , arrhythmias (changes in rhythm or rate of heart beat), heart failure.
  • if you have suffered a heart attack in the last 3 months
  • if you have suffered a 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
  • if you use guanylate cyclase stimulators such as riociguat, used to treat pulmonary arterial hypotension

Do not take CIALIS if you have an allergy to:

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 are aged 75 years and over. You have a higher chance of experiencing side effects like dizziness and diarrhoea.

Your doctor will assess if CIALIS is suitable for you.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver or kidney problems
  • heart problems 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, medicine such as glyceryl trinitrate, isosorbide mononitrate and sodium nitroprusside 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) such as metoprolol, irbesartan and enalapril
  • Alpha blockers (used to treat hypertension and some prostate problems) such as prazosin and doxazosin
  • A 5-alpha reductase inhibitor, such as finasteride (used to treat prostate and hair loss problems)
  • Warfarin, a medicine used to prevent or treat blood clots
  • High doses of alcohol
  • Grapefruit juice
  • Other PDE5 inhibitors such as sildenafil used to treat erectile dysfunction or pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs)
  • Guanylate cyclase stimulators such as riociguat, used to treat pulmonary arterial hypotension.

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.

For Erectile Dysfunction
CIALIS can be taken as either on-demand dosing or once-a-day dosing.

CIALIS on-demand (10 mg and 20 mg) is intended for use prior to anticipated sexual activity and is not for continuous daily use.

CIALIS once-a-day (5 mg) 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. 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. Do not take once-a-day dosing and on-demand dosing concurrently.

When taking CIALIS once-a-day (5mg), it may take up to 1 week for a full effect on Erectile Dysfunction.

For urinary symptoms associated with Benign Prostate Hyperplasia
CIALIS once-a-day (5mg) is taken daily. For urinary symptoms associated with benign prostatic hyperplasia it may take up to a week to notice an improvement and 1 month for a full effect on urinary symptoms such as; urinating too frequently during the day or at night, the need to urinate being too urgent, or too soon after relieving your bladder. CIALIS must be taken daily to maintain effect.

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.

Always take CIALIS exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

ON-DEMAND DOSING FOR ERECTILE DYSFUNCTION
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.

No special dosing consideration is needed for the elderly or people with diabetes.

ONCE-A-DAY DOSING FOR ERECTILE DYSFUNCTION AND/OR URINARY SYMPTOMS ASSOCIATED WITH BENIGN PROSTATE HYPERPLASIA
The recommended dose of CIALIS is one 5 mg tablet taken once per day.

Dosage adjustments are not required in patients with kidney disease, unless you have severe renal impairment. 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. Once-a-day dosing of CIALIS is not recommended in patients with severe hepatic impairment.

No special dosing consideration is needed for the elderly or people with diabetes.

How to take it

Swallow one tablet whole with a full glass of water.

When to take it

CIALIS can be taken with or without food or alcohol. However, drinking alcohol may affect your ability to get an erection, so avoid excessive drinking.

ON-DEMAND DOSING FOR ERECTILE DYSFUNCTION
CIALIS (10 mg or 20 mg) should be taken at least 30-60 minutes 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 16 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 it will allow you to obtain an erection when sexually stimulated, at any time during the 36 hours after taking it. 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.

ONCE-A-DAY DOSING FOR ERECTILE DYSFUNCTION AND/OR URINARY SYMPTOMS ASSOCIATED WITH BENIGN PROSTATE HYPERPLASIA
Cialis 5 mg should be taken daily at approximately the same time of day. CIALIS must be taken daily to maintain effect.

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 have emergency treatment for any suspected heart condition tell the emergency medical or ambulance staff that you are taking CIALIS. 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.

Side effects

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 or urinary symptoms associated with benign prostatic hyperplasia 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.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • facial flushing
  • indigestion
  • chest pain
  • increased heart beat
  • back pain
  • tiredness (fatigue)
  • feeling sick (nausea) or vomiting
  • muscle aches, including pain in the arms and legs
  • stomach pain
  • diarrhoea
  • heart burn
  • allergic reactions, including skin rash, swelling of the face and hives
  • sweating
  • headache or migraine
  • nasal congestion
  • dizziness
  • fainting
  • infection
  • 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
  • blurred vision
  • bleeding nose
  • prolonged erection

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. Penile bleeding or presence of blood in semen may occur rarely.

If you have an erection which lasts longer than 4 hours 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 which may be accompanied by ringing in the ears and dizziness, loss of vision in one or both eyes and seizures have been reported in people taking CIALIS. It is not possible to determine whether these events are related directly to 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 CIALI
S.

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

Storage

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.

Disposal

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.

Product description

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.

Ingredients

  • croscarmellose sodium
  • hyprolose
  • hypromellose
  • iron oxide yellow
  • lactose monohydrate
  • magnesium stearate
  • microcrystalline cellulose
  • sodium lauryl sulfate
  • purified talc
  • titanium dioxide
  • triacetin

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Eli Lilly Australia Pty Limited
112 Wharf Road
West Ryde, NSW 2114
AUSTRALIA

CIALIS is distributed in New Zealand by:

Eli Lilly and Company (NZ) Limited
Level 1, 123 Ormiston Rd
Botany South, Auckland 2016
NEW ZEALAND

Australian Registration Number

If you have any questions about CIALIS, contact Eli Lilly at 800 454 559 (Australia) or 0800 500 909 (New Zealand) or your healthcare professional for assistance.

This leaflet was revised in November 2017.

Cialis

NOTE: After selecting this product, you will need to complete a short assessment, so we can make sure this medication is suitable for you.

Overview

Cialis Online

You can buy Cialis in Australia with our Australian registered online doctor and pharmacy service. Complete an online assessment and our Australian doctor team will then review your request and make sure it is appropriate to prescribe. If approved, our pharmacy team will dispense and dispatch your medication to your chosen address.

If the medicine is deemed not suitable for you by the doctor or they believe you would benefit more from a face to face review, a full refund is issued.

Cialis has come off patent meaning generic Cialis (Tadalafil) is now available.

Cialis Summary

Take ONE tablet 30-60 minutes before required or as directed.

Can include nasal congestion, dizziness, headaches, facial flushing.

Cialis Prices

*Standard pack sizes including online doctors assessment (prescription) and medication.

FAQ

Are Cialis and Tadalafil the same?

Yes, they both contain the same active ingredient tadalafil. The Australian medicines regulation body, the TGA, require all generic medicines to prove they are as effective as the original before they are registered for use in Australia.

How long does Cialis take to work?

The effect can take between 15-45 minutes in most men.

How long does Cialis last?

The effect of Cialis will last between 24-36 hours in most men.

Why is Cialis so expensive in Australia?

Cialis remains expensive in Australia as Eli Lilly have not significantly dropped their wholesale price for Cialis.

The medicines creator Eli Lilly long held the patent for Cialis meaning they were the only company that could create and sell Cialis. This made the price expensive as there was no competition.

Cialis is now off-patent and generic versions of the medicine are now available at a much lower price.

Is it safe to buy Cialis online?

If you have been diagnosed and prescribed Cialis by an Australian registered doctor and provided medicine from an Australian pharmacy, buying Cialis online poses no greater risk than usual.

If you buy Cialis from a non-Australian source such as overseas from India or Southeast Asia it can be potentially dangerous. Many overseas companies source their tablets from low quality and dangerous overseas suppliers.

It has been found by the TGA that some of these overseas tablets are cut with other medicines such as sildenafil to cut costs.

Is it legal to buy Cialis Online in Australia?

Yes, it is legal to buy Cialis from an online pharmacy in Australia.

It is important however that you use an Australian registered doctor and pharmacy service.

Buying Cialis from overseas suppliers is illegal and if found in customs the tablets will be confiscated.

Only buy Cialis online from Australian regulated doctor and pharmacy services like Simple Online Doctor where you can be sure you are being prescribed medicine by an Australian doctor and receiving high-quality Australian regulated medicines.

Can I buy Cialis over the counter in Australia?

No. Cialis remains prescription only in Australia. Cialis may be bought online after an assessment which is reviewed by a doctor or from any pharmacy with a valid Australian prescription.

Where can I find cheap Cialis in Australia?

Cialis remains expensive in Australia however Simple Online Doctor aims to provide the best value Cialis online. Prices are checked regularly against legitimate competitors to ensure a low price.

When will the Cialis price drop in Australia?

When the wholesale price drops, the Cialis price will become much cheaper. Simple Online Doctor will always aim to pass on savings to customers where possible. Generic Cialis has already become cheaper since Cialis has come off patent.

Where in Australia can you buy Cialis?

You can buy Cialis anywhere in Australia online. Orders for Cialis to Sydney, Melbourne, Brisbane, Adelaide, Canberra, Perth and Darwin may arrive sooner than orders to rural Australia. If approved, orders should arrive within 1-5 business days.

How to get Cialis in Australia

To get Cialis in Australia you will need to answer a series of questions from a doctor online or in person. This will include information relating to symptoms, general health, medical conditions and current medicines. The doctor can use this to diagnose and prescribe appropriate medicine.

Does Cialis work for women?

No. Cialis has not been proven effective for women but may cause side effects. For this reason, it is not prescribed to women. For appropriate treatment, talk to a doctor about options for your condition.

Can you drink alcohol while taking Cialis?

When consumed in moderation, alcohol can be consumed while taking Cialis. However, excessive consumption can lead to worsening side effects such as dizziness that can be potentially dangerous. Alcohol consumption may also worsen the condition.

Info Leaflet

Whichever medications you use, it is important you read the patient information leaflet carefully and take note of the side effects which may occur.

Healthdirect Free Australian health advice you can count on.

healthdirect Australia is a free service where you can talk to a nurse or doctor who can help you know what to do.

Cialis is an erectile dysfunction medicine.

Cialis

What is Cialis?

Cialis is an erection medicine used to treat erectile dysfunction (ED, also called impotence) and problems with urination caused by enlarged prostate (benign prostatic hypertrophy). It is sometimes known by its generic name, Tadalafil.

It works by helping to relax the blood vessels in the penis, allowing blood to flow into the penis causing an erection. If you plan to use Cialis, you should take it 20 to 30 minutes before planned sexual activity.

An erection is possible for up to 36 hours after taking it (this means the ability to have an erection may last this long, but the actual erections will only last a normal period of time).

It can also be taken as a daily low dose pill.

Cialis cause erections on its own — sexual stimulation is still needed. Cialis does not cure ED, increase a man’s sexual desire, protect from sexually transmitted diseases or serve as a male form of birth control.

If you use Cialis, you should not take any more than 1 tablet in 24 hours and it should not be taken with other ED medicines.

Does Cialis have side effects?

The most common side effects of Cialis include:

These side effects usually go away after a few hours.

Very occasionally, Cialis can cause a painful erection or an erection that won’t go away. If this happens, and the erection lasts for more than 4 hours, you should go to the nearest emergency department. Prolonged erections can be dangerous.

Cialis may not be safe to take for men with certain medical conditions, including men who have had a stroke, have heart disease or retinitis pigmentosa (an eye disease).

It can also interact with many medicines, particularly nitrates (used in heart disease) and blood pressure medicines. Men who use nitrates in any form or are being treated for pulmonary hypertension should not take Cialis.

If you are thinking about using Cialis, please discuss it with your doctor.

Buying Cialis

You need a prescription from a doctor to buy Cialis. You can buy it from a store-based pharmacy or reputable online pharmacy with a prescription.

Some people buy Cialis online, often without a prescription. However, you cannot be sure whether these pills contain the drug or are counterfeit.

See healthdirect’s medicines section for more information about Cialis.

Source s :

Tadalafil

Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer’s approved product information, a drug information centre or some other appropriate source.

Cialis (Eli Lilly)
10 mg and 20 mg tablets
Approved indication: erectile dysfunction
Australian Medicines Handbook section 13.3

The treatment of impotence changed when sildenafil was launched in 1998.Over 17 million men have been prescribed sildenafil and in 2001 it generated sales of US$1.5 billion. There is therefore a large potential market for oral treatments of erectile dysfunction.

Although it has a different structure, tadalafil acts in the same way assildenafil. It inhibits the phosphodiesterase type 5 enzyme to reduce the inactivation of cyclic guanosine monophosphate (cGMP). This inhibition helps to maintain the smooth muscle relaxation, in the corpus cavernosum of the penis, which produces an erection. As the production of cGMP requires the release of nitricoxide in response to sexual arousal, tadalafil will have no effect in the absence of sexual stimulation.

Tadalafil is more slowly absorbed than sildenafil. The median time to the maximum concentration is two hours compared to one hour. In addition, tadalafil has a much longer half-life than sildenafil (17.5 hours versus 4 hours). It can still be effective 36 hours after a dose. Tadalafil is mainly eliminated by metabolism. This metabolism involves cytochrome P450 3A4 so there is a potential for interactions with drugs which inhibit or induce this enzyme.

Few of the clinical trials of tadalafil have been published in full. Overall the efficacy of tadalafil 20 mg for successful sexual intercourse is 75% compared with a placebo response of 32%. The efficacy is likely to be less in patients with diabetes.

Only 1.7% of patients in clinical trials stopped treatment because of adverse events, but 26% had at least one adverse effect. Headache and dyspepsia are the commonest adverse effects. As tadalafil causes vasodilatation it can provoke flushing and falls in blood pressure. It may therefore potentiate the effect of antihypertensive drugs. Tadalafil is contraindicated in patients taking nitrates. As the clinical trials excluded men with unstable cardiovascular disease, tadalafil should not be prescribed for these patients. These contraindications include men with a recent history of stroke, heart failure or myocardial infarction and those with unstable angina or uncontrolled hypertension or arrhythmia.

Although tadalafil is a more potent inhibitor of phosphodiesterase type 5than sildenafil is, the clinical relevance is uncertain. There appear to be no published trials which compare the two drugs or investigate if patients who do not respond to one drug will respond to the other. As tadalafil causes fewer ocular adverse effects it may have a role in patients who have developed abnormal vision while taking sildenafil, however there are no reports of this usage.