CIALIS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

CIALIS 5mg 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 get 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 CIALIS is and what it is 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 CIALIS is and what it is used for

CIALIS contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

CIALIS 5 mg is used to treat adult men with:

• erectile dysfunction. This is when a man cannot get, or keep a hard erection that is sufficient for satisfactory sexual activity. CIALIS has been shown to significantly improve the ability to obtain a hard erection sufficient for satisfactory sexual activity.

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.

• urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland enlarges with age, causing urinary symptoms such as difficulty in starting to urinate, a feeling of not completely emptying the bladder, a need to urinate often, or in the middle of the night. CIALIS improves blood flow to the prostate and relaxes the muscles in the prostate and the bladder, which can reduce the symptoms of benign prostatic hyperplasia. CIALIS has been shown to improve these urinary symptoms in a short period of time, such as 1-2 weeks after starting treatment.

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 for the treatment of angina pectoris (“chest pain”). CIALIS has been shown to increase 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 heart attack in the last 90 days.

• you have had a stroke in 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 “eye stroke”.

• 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 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.

Since benign prostatic hyperplasia and prostate cancer can have the same symptoms, your doctor will check you for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia. CIALIS does not treat prostate cancer.

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.
• severe liver problems.
• severe kidney problems.

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

• undergone pelvic surgery.
• undergone a radical prostatectomy (removal of the prostate gland) without preserving the nerve endings.

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

A sudden 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 sudden decrease or loss of hearing, stop taking CIALIS and contact your doctor immediately.

CIALIS is not intended for use by 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 be affected by CIALIS or may affect how well CIALIS works. Tell your doctor or pharmacist if you are taking:

• an alpha-blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medicines such as ketoconazole tablets (for the treatment of 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 well 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 your doctor before taking this medicine.

CIALIS contains sodium

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

3. How to take CIALIS

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

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.

Consuming alcohol 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.

For the treatment of erectile dysfunction

The recommended doseis one 5 mg tablet taken once a day, approximately at the same time. Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS. This will be done by taking a 2.5 mg tablet.

Do not take CIALIS more than once a day.

CIALIS taken daily allows you to obtain an erection at any time during the 24 hours of the day, provided that you are sexually stimulated. CIALIS taken daily may be useful for men who anticipate having sexual activity twice or more per week.

It is important to note that CIALIS is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate each other in the same way as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

The doseis one 5 mg tablet taken once a day, approximately at the same time.

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day.

Do not take CIALIS more than once a day.

If you take more CIALIS than you should

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

If you forget to take CIALIS

Take your dose as soon as you remember, but do not take a double dose to make up for forgotten doses. Do not take CIALIS more than once a day.

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 skin 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 have an erection that lasts for more than 4 hours, contact a doctor immediately.
• sudden loss of vision (rare), blurred vision, or 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 aches, 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 temporary memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (red itchy patches on the skin), bleeding from the penis, blood in the semen, and increased sweating.

Additionally, the following rare side effects have been reported in men taking CIALIS:

• migraine, swelling of the face, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeat, chest pain, and sudden cardiac death.
• blurred vision, or loss of vision (frequency not known).

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

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 Spanish Medicines Surveillance 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 25°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 5 mg of tadalafil.
• The other ingredientsare:Tablet core: lactose monohydrate (see the end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, see section 2 “CIALIS contains lactose”. Film coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), yellow iron oxide (E172), talc.

Appearance and packaging

CIALIS 5 mg is a yellow, film-coated tablet in an almond shape, marked with “C 5” on one side.

CIALIS 5 mg is available in blister packs of 14, 28, or 84 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 authorisation 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.