Prospecto: information for the user

CIALIS 20mg film-coated tablets

tadalafilo

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

1.What is CIALIS and for what it is used

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

3.How to take CIALIS

4.Possible adverse effects

5.Storage of CIALIS

6.Contents of the package and additional information

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

CIALIS contains the active ingredient tadalafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors. After sexual stimulation, CIALIS acts by helping to relax the blood vessels of your penis, allowing blood to flow into the penis. The result is an improvement in erectile function. CIALIS will not be effective 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 you would without taking a medication for erectile dysfunction.

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, in the last 90 days.

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

• you have low or uncontrolled high blood pressure.

• 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 to patients with heart problems, due to the additional strain it puts on the heart. If you have a heart condition, consult your doctor.

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

• thalassemia (a blood disorder).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cancer).
• any penile deformity.
• serious liver disease.
• serious kidney disease.

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

• pelvic surgery.
• surgeries in which the prostate has been completely or partially removed and the nerves of the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

If you experience a sudden decrease or loss of visionor 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 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 old.

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 machines

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

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. Tablets can be taken with or without food.

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

You can initiate sexual activity at least 30 minutes after taking CIALIS.

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

You should not take CIALIS more than once a day. CIALIS 10 and 20mg will be used before expected sexual activity and are not recommended for continuous daily use.

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 achieve 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 adverse effects described in section 4.

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

Like all medicines, this medicine may 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 may 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 10,000 patients)

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

It has also been reported rarelyheart attack and stroke in men taking CIALIS. Most of these men had some heart problem before taking this medicine.

Rarely reported 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 30?°C.

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

Composition of CIALIS

• Theactive ingredientis tadalafil. Each tablet contains 20mg of tadalafil.
• Theother componentsare:
  Tablet core: lactose monohydrate (see the end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, laurilsulfate of 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 20mg is a yellow-coated tablet with almond shape and marked with “C 20” on one side.

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

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

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