Cialis 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CIALIS 20mg film-coated tablets

tadalafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What CIALIS is and what it is used for

CIALIS is indicated for the treatment of erectile dysfunction in adult men. Erectile dysfunction occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. CIALIS has demonstrated significant improvement in the ability to achieve a durable penile erection 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 to relax the blood vessels in the penis, allowing blood to flow into the penile tissue. The result is improved erectile function. CIALIS will not help you if you do not have erectile dysfunction.

It is important to warn you that CIALIS is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in sexual stimulation in the same way as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before taking CIALIS

Do not take CIALIS if:

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

• you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medicines ("nitrates") used to treat angina pectoris ("chest pain"). CIALIS has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.

• you have a serious heart condition or have recently had a heart attack, within the last 90 days.

• you have recently had a stroke, within the last 6 months.

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

• you have ever experienced sudden vision loss 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). PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor before starting to take CIALIS.

Be aware that sexual activity involves a possible risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

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

• sickle cell anemia (an abnormality of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of blood cells).
• any deformity of the penis.
• a serious liver problem.
• a serious kidney problem.

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

• pelvic surgery.
• surgery in which the prostate was completely or partially removed and the nerves to the prostate were cut (radical prostatectomy without neurovascular bundle preservation).

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

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

Although it is not known if this event is directly related to tadalafil, if you experience sudden 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 must not be used in children or adolescents under 18 years of age.

Other medicines and CIALIS

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

Do not take CIALIS if you are already using nitrates.

Some medicines may interact with CIALIS or may affect how well CIALIS works. Inform 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 treating 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 AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking CIALIS with food and alcohol

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testes was observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would lead to infertility.

Driving and use of machines

Some men who took CIALIS during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

CIALIS contains lactose

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

CIALIS contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".

3. How to take CIALIS

Follow exactly the dosing instructions for this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose is one 10 mg tablet taken prior to anticipated sexual activity. However, you have been given a dose of one 20 mg tablet because your doctor has determined that the recommended 10 mg dose is too weak for you.

When you take CIALIS, you may initiate sexual activity at least 30 minutes after taking the tablet.

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

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

It is important to warn you that CIALIS is not effective in the absence of sexual stimulation. Therefore, you and your partner must engage in the same level of sexual stimulation as you would if you were not taking a medicine for erectile dysfunction.

Alcohol consumption may affect your ability to obtain 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 levels of 0.08% or higher), as it may increase the risk of dizziness upon standing.

If you take more CIALIS than you should

Contact your doctor. You may experience adverse effects described in section 4.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These effects are generally mild to moderate in intensity.

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

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

Other adverse effects that have been reported:

Frequent (observed in 1 to 10 out of every 100 patients)

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

Uncommon (observed in 1 to 10 out of every 1,000 patients)

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

Rare (observed in 1 to 10 out of every 10,000 patients)

• fainting, seizures, transient memory loss, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red, itchy welts on the skin), penile bleeding, blood in the semen, and increased sweating.

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

Rare cases of decreased or lost vision, partial, transient or permanent, in one or both eyes have also been reported.

Some additional rare adverse effects have been reported in men taking CIALIS that were not observed during clinical trials. These include:

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

In men over 75 years of age receiving CIALIS, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving CIALIS, the most frequently reported adverse effect was diarrhoea.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CIALIS

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

Do not use this medicine after the expiry date stated on the carton and blister after "CAD" and "EXP", respectively. The expiry date refers to the last day of the month indicated.

Store in the original packaging 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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CIALIS

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are:
  Tablet core: monohydrate lactose (see end of section 2), sodium croscarmellose, hydroxypropylcellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate; see section 2 “CIALIS contains lactose”.

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

Appearance of the product and contents of the container

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:

Spain

Lilly S.A.

Tel: +34-91 663 50 00

Date of the most recent revision of this leaflet: August 2023

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