Cialis 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CIALIS 5mg 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 others, 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.

Leaflet contents

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

CIALIS 5 mg is used in adult men for the treatment of:

• Erectile dysfunction. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. CIALIS has been shown to significantly improve the ability to achieve a durable penile erection suitable for sexual activity.

Following sexual stimulation, CIALIS works by helping to relax the blood vessels in the penis, allowing blood to flow into it. 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 in the absence of 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.

• Urinary symptoms associated with a common condition called benign prostatic hyperplasia. This occurs when the prostate gland enlarges over time. Symptoms include difficulty starting to urinate, a sensation that the bladder has not emptied completely, and the 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 been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

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 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 carries a potential risk for patients with heart problems, due to the additional strain placed on the heart. If you have a heart condition, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer can have similar symptoms, your doctor will perform a prostate cancer evaluation 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 (cancer of the bone marrow).
• leukemia (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.
• a surgical procedure in which the prostate has been partially or completely removed and the nerves to the prostate have been severed (radical prostatectomy without preservation of neurovascular bundles).

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 whether 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

Inform 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 be affected by 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 to treat 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 provided in section 3. Grapefruit juice may affect how well CIALIS works 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. A reduction in sperm has been observed in some men. 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 of an intolerance to certain sugars, consult with him before taking this medicine.

CIALIS contains sodium

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

3. How to take CIALIS

Follow exactly the instructions for use of this medicine given 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.

Alcohol consumption may temporarily reduce 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 this may increase the risk of dizziness upon standing.

For the treatment of erectile dysfunction

Recommended dose: One 5 mg tablet once daily, at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg depending on your response to CIALIS. This will be achieved by taking a 2.5 mg tablet.

Do not take CIALIS more than once a day.

Daily administration of CIALIS allows you to achieve an erection at any time during the 24-hour day, provided sexual stimulation occurs. Daily use of CIALIS may be beneficial for men who anticipate having sexual activity two or more times per week.

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

Alcohol consumption may affect your ability to obtain an erection.

For the treatment of benign prostatic hyperplasia

Dose: One 5 mg tablet once daily, at approximately the same time each day.

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

You must not take CIALIS more than once a day.

If you take more CIALIS than you should

Contact your doctor. You may experience adverse effects 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. You must not take CIALIS more than once a day.

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 take 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:

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

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

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

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

Rare cases of heart attack and stroke have also been reported in men taking CIALIS. Most of these men had pre-existing heart conditions before taking this medicine.

Rarely, cases of decreased or lost vision, partial, temporary or permanent, in one or both eyes have 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 which is 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 25°C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that 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 5 mg of tadalafil.
• The other components are:
  Tablet core: lactose monohydrate (see end of section 2), sodium croscarmellose, hydroxypropyl cellulose, 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 of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 from the local representative of the Marketing Authorisation Holder:

Spain

Lilly S.A.

Tel: +34-91 663 50 00

Date of the most recent review of this summary: August 2023

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