Cialis film-coated tablets Patient Leaflet

This Patient Information Leaflet is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Cialis 20 mg film-coated tablets 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 because it contains important information for you.

This leaflet contain information about:

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.

What you need to know before you take Cialis

Do not take Cialis if you:

Warnings and precautions

Talk to your doctor before taking Cialis.

Be aware that 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.

Before taking the tablets, tell your doctor if you have:

It is not known if Cialis is effective in patients who have had:

If you experience sudden decrease or loss of vision, stop taking Cialis and contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Cialis and contact your doctor immediately.

Cialis is not intended for use by women.

Children and adolescents

Cialis is not intended for use by children and adolescents under the age of 18.

Other medicines and Cialis

Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take Cialis if you are already taking nitrates.

Some medicines may be affected by Cialis or they may affect how well Cialis will work. Tell your doctor or pharmacist if you are already taking:

Cialis with Grapefruit juice

Grapefruit juice may affect how well Cialis will work and should be taken with caution. Talk to your doctor for further information.

Fertility

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

Some men taking Cialis in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.

Cialis contains lactose:

If you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Cialis

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

Cialis tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.

The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak.

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.

Do not take Cialis more than once a day. Cialis 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.

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 and 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.

If you take more Cialis than you should

Contact your doctor. You may experience side effects described in this Leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

Other side effects have been reported:

Common (seen in 1 to 10 in every 100 patients)

Uncommon (seen in 1 to 10 in every 1,000 patients)

Rare (seen in 1 to 10 in every 10,000 patients)

Heart attack and stroke have also been reported rarely in men taking Cialis. Most of these men had known heart problems before taking this medicine.

Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.

Some additional rare side effects have been reported in men taking Cialis that were not seen in clinical trials. These include:

The side effect dizziness has been reported more frequently in men over 75 years of age taking Cialis. Diarrhoea has been reported more frequently in men over 65 years of age taking Cialis.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Cialis

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture. Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Cialis contains

What Cialis looks like and contents of the pack

Cialis 20 mg is a yellow film-coated tablet in the shape of an almond and has "C 20" marked on one side.

Cialis 20 mg is available in blister packs containing 2, 4, 8, 10 or 12 tablets.

Not all pack sizes may be marketed.

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

This leaflet was last revised in January 2019