CIALIS 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

CIALIS 20mg film-coated tablets

tadalafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is CIALIS and what is it used for
2. What you need to know before you take CIALIS
3. How to take CIALIS
4. Possible side effects
5. Storing CIALIS
6. Contents of the pack and other information

1. What is CIALIS and what is it used for

CIALIS is indicated for the treatment of erectile dysfunction in adult men. 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 to obtain 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. After sexual stimulation, CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction.

It is important to note that CIALIS is not effective 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. What you need to know before you take CIALIS

Do not take CIALIS if:

• you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).

• 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”). It has been shown that CIALIS increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.

• you have a severe heart condition or have had a recent heart attack (within the last 90 days).

• you have had a recent stroke (within the last 6 months).

• you have low blood pressure or uncontrolled high blood pressure.

• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.

• you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). Phosphodiesterase type 5 inhibitors, such as CIALIS, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before taking CIALIS.

Be aware that sexual activity carries a possible risk to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, tell your doctor.

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

• sickle cell anemia (a disorder of the red blood cells).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

It is not known if CIALIS is effective in patients who have undergone:

• pelvic surgery.
• a surgical procedure in which all or part of the prostate gland has been removed and the nerve tissue removed (radical prostatectomy without preservation of neurovascular bundles).

If you experience a sudden decrease or loss of vision or your vision is distorted, blurred while taking CIALIS, stop taking CIALIS and contact your doctor immediately.

A decrease or loss of hearing has been observed in some patients taking tadalafil.

Although it is not known if the event is directly related to tadalafil, if you experience a decrease or loss of hearing, stop taking CIALIS and contact your doctor immediately.

CIALIS is not intended for use in women.

Children and adolescents

CIALIS should not be used in children and adolescents under 18 years of age.

Other medicines and CIALIS

Tell your doctor or pharmacist 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 affect the way CIALIS works or CIALIS may affect the way they work. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate).
• medicines such as ketoconazole tablets (for fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking CIALIS with drinks and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect how CIALIS works and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated with tadalafil, a decrease in sperm production was observed. A reduction in sperm count has been observed in some men. It is unlikely that these effects will lead to infertility.

Driving and using machines

Some men taking CIALIS during clinical trials experienced dizziness. Check carefully how you react to the tablets before driving or using machines.

CIALIS contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult him before taking this medicine.

CIALIS contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take CIALIS

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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

When taking CIALIS, you can initiate sexual activity from at least 30 minutes after taking it.

CIALIS may still be effective up to 36 hours after taking the tablet.

Do not take CIALIS more than once a day. CIALIS 10 and 20 mg will be used before anticipated sexual activity and is not recommended for continuous daily use.

It is important to note that CIALIS is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming 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 alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more CIALIS than you should

Consult your doctor. You may experience side effects described in section 4.

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

4. Possible side effects

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

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

• allergic reactions including rash (uncommon).
• chest pain - do not use nitrates but seek medical help immediately (uncommon).
• priapism, a prolonged and possibly painful erection after taking CIALIS (rare). If you experience this type of erection, which can last for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central blurred vision or sudden loss of vision (frequency not known).

Other side effects that have been reported:

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

• headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

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

• dizziness, stomach pain, nausea, vomiting, reflux, blurred vision, eye pain, difficulty breathing, blood in urine, prolonged erection, palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of hands, feet, or ankles, and feeling tired.

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

• fainting, seizures, and transient memory loss, eyelid swelling, red eyes, sudden or decreased hearing loss, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Myocardial infarction and stroke have also been reported rarely in men taking CIALIS. Most of these men had pre-existing heart problems before taking this medicine.

Rarely, cases of decreased or loss of vision, partial, transient, or permanent in one or both eyes have been reported.

Some additional rare side effectshave been reported in men taking CIALIS that were not reported during clinical trials. These include:

• migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• distorted, blurred, central blurred vision or sudden loss of vision (frequency not known).

In men over 75 years of age treated with CIALIS, the most frequently reported adverse effect was dizziness. In men over 65 years of age treated with CIALIS, the most frequently reported adverse effect was diarrhea.

Reporting of side effects

If you experience 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 Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 to protect from moisture. Do not store above 30°C.

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 protect the environment.

6. Contents of the pack and other information

Composition of CIALIS

• The active substanceis tadalafil. Each tablet contains 20 mg of tadalafil.
• The other ingredientsare:Core of the tablet: lactose monohydrate (see the end of section 2), croscarmellose sodium, hypromellose, microcrystalline cellulose, lauryl sulfate, magnesium stearate, see section 2 “CIALIS contains lactose”.

Coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Appearance and packaging

CIALIS 20 mg is a yellow, almond-shaped, film-coated tablet marked with “C 20” on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer: Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For further information on this medicine, contact the local representative of the marketing authorization holder:

Spain

Lilly S.A.

Tel: +34-91 663 50 00

Date of last revision of this leaflet: August 2023

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.