Prospecto: information for the user

CIALIS 5mg film-coated tablets

tadalafilo

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is CIALIS and what it is used for

2.What you need to know before starting to take CIALIS

3.How to take CIALIS

4.Possible side effects

5.Storage of CIALIS

6.Contents of the pack and additional information

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

CIALIS 5mg is used to treat adult men with:

• erectile dysfunction. This occurs when a man is unable to obtain or maintain a firm erection, suitable for satisfactory sexual activity. CIALIS has shown a significant improvement in the ability to obtain a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, CIALIS acts by helping to relax the blood vessels of the penis, allowing blood to flow into the penis. The result is an improvement in erectile function. CIALIS will not help if you do not have erectile dysfunction. It is essential to inform you that CIALIS is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This occurs when the prostate gland increases in size over time. Symptoms include difficulty starting to urinate,sensation that the bladder has not been completely emptied, need to urinate more frequently, even at night. CIALIS improves blood flow and relaxes the muscles of the prostate and bladder, which may reduce the symptoms of benign prostatic hyperplasia. CIALIS has shown to improve these urinary symptoms in as little as 1‑2weeks after starting treatment.

Do not take CIALIS if:

• you are allergic to tadalafil or any of the other ingredients in 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 (chest pain). CIALIS has been seen to increase the effects of these medicines. If you are taking any type of nitrates or are unsure, tell your doctor.

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

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

• you have low or high blood pressure that is not controlled.

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

-you are taking riociguat. This medicine is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as CIALIS, have shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor before starting to take CIALIS.

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

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

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

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

CIALIS is not known to be effective in patients who have undergone:

• pelvic surgery.
• prostatectomy (removal of the prostate gland) either totally or partially, and in which the nerves of the prostate have been cut.

If you experience a sudden decrease or loss of vision or your vision is distorted or blurred 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 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 in women.

Children and adolescents

CIALIS should not be used in children or adolescents under 18 years.

Other medicines and CIALIS

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Do not take CIALIS if you are already using nitrates.

Some medicines may be affected by CIALIS or may affect the proper functioning of CIALIS. Inform your doctor or pharmacist if you are using:

• an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
• other medicines to treat high blood pressure.
• riociguat.
• an inhibitor of 5-alpha reductase (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/AIDS or HIV infection.

• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).

• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking CIALIS with beverages and alcohol

Information about the effect of alcohol can be found in section 3. Grapefruit juice may affect the proper functioning of CIALIS and should be taken with caution. Consult your doctor for more information.

Fertility

In dogs treated, a decrease in sperm production by the testicles was observed. A decrease in sperm count has been observed in some men. It is unlikely that these effects will cause infertility.

Driving and operating machinery

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

CIALIS contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

CIALIS contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

CIALIS tablets are for oral administration only in men. Swallow the tablet whole with a little water. CIALIS 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 5mg tablet once a day, approximately at the same time. Your doctor may adjust the dose to 2.5mg based on your response to CIALIS. This will be done by taking one 2.5mg tablet.

Do not take CIALIS more than once a day.

CIALIS taken daily allows you to get an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. CIALIS taken daily may be useful for men who expect to engage in sexual activity two or more times a week.

It is essential to inform you that CIALIS is not effective without sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would without taking a medication for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection.

For the treatment of benign prostatic hyperplasia

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

If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5mg tablet 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 adverse effects described in section 4.

If you forgot to take CIALIS

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These side effects are generally mild to moderate in intensity.

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

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

Other side effects that have been reported:

Frequent(observed between 1 and 10 in every 100 patients)

• headache, back pain, muscle pain, arm and leg pain, facial flushing, nasal congestion and indigestion.

Infrequent(observed between 1 and 10 in every 1,000 patients)

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

Rare(observed between 1 and 10 in every 10000 patients)

• syncope, convulsions and transient loss of memory, eyelid swelling, red eyes, sudden decrease or loss of hearing, urticaria (red itchy patches on the skin's surface), bleeding in the penis, blood in the semen and increased sweating.

Also, rare cases of heart attack and stroke have been reported in men taking CIALIS. Most of these men had some heart problem before taking this medicine.

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

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

• migraine, facial swelling, severe allergic reaction that causes facial or throat swelling, severe skin rashes, certain disorders affecting blood flow to the eyes, irregular heartbeat, angina and sudden cardiac death.
• distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

In men over 75 years old taking CIALIS, the most frequently reported side effect was dizziness. In men over 65 years old taking CIALIS, the most frequently reported side effect was diarrhea.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD” and “EXP” respectively. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Do not store at a temperature above 25?°C.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of CIALIS

• Theactive ingredientis tadalafil. Each tablet contains 5mg of tadalafil.
• Theother componentsare:
  Core of the tablet: lactose monohydrate (see the end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, lauryl sulfate sodium, magnesium stearate, see section 2 “CIALIS contains lactose”.
  Coating: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.

Appearance of the product and contents of the packaging

CIALIS 5mg is a yellowish pale-coated tablet, almond-shaped, and marked with “C5” on one side.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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

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

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Spain

Lilly S.A.

Phone: + 34-91 663 50 00

Last revision date of this leaflet: August 2023

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