TADALAFIL NORMON 5 mg FILM-COATED TABLETS

1. What Tadalafilo Normon is and what it is used for

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

Tadalafilo Normon 5 mg is used to treat adult men with:

• erectile dysfunction. This occurs when a man cannot obtain or maintain a firm erection sufficient for satisfactory sexual activity. Tadalafilo Normon has been shown to significantly improve the ability to obtain a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, Tadalafilo Normon acts by helping to relax the blood vessels in the penis, allowing blood flow to the penis. The result is an improvement in erectile function. Tadalafilo Normon will not help if you do not have erectile dysfunction. It is essential to note that Tadalafilo Normon 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 medication for erectile dysfunction.

• symptoms of benign prostatic hyperplasia. This occurs when the prostate gland enlarges with age. Symptoms include difficulty starting to urinate, feeling that the bladder has not been fully emptied, needing to urinate more frequently, even at night. Tadalafilo Normon improves blood flow and relaxes the muscles of the prostate and bladder, which can reduce the symptoms of benign prostatic hyperplasia. Tadalafilo Normon has been shown to improve these urinary symptoms in as little as 1-2 weeks after starting treatment.

2. What you need to know before taking Tadalafilo Normon

Do not take Tadalafilo Normon:

• if you are allergic to tadalafil or any of the other ingredients of this medication (listed in section 6).
• you are taking any form of nitrates or nitric oxide donors, such as amyl nitrite. This is a group of medications ("nitrates") used to treat angina pectoris ("chest pain"). It has been seen that tadalafil increases the effects of these medications. If you are taking any form of nitrate or are unsure, tell your doctor.
• you have a severe heart disease 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 had a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as "eye infarction".
• you are taking riociguat. This medication 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 tadalafil, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tadalafilo Normon.

Be aware that sexual activity carries a possible risk for patients with heart problems, due to the additional effort it entails for the heart. If you have a heart problem, consult your doctor.

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

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

• sickle cell anemia (a red blood cell abnormality).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformation.
• a severe liver problem.
• a severe kidney problem.

It is not known if Tadalafilo Normon is effective in patients who have undergone:

• surgery in the pelvic area.
• a surgical procedure in which the prostate was completely or partially removed and the prostate nerves were cut (radical prostatectomy without preservation of neurovascular bundles).

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

Tadalafilo Normon is not intended for use in women.

Children and adolescents

Tadalafilo Normon should not be used in children or adolescents under 18 years of age.

Using Tadalafilo Normon with other medications

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

Do not take Tadalafilo Normon if you are already using nitrates.

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

• an alpha-blocker (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medications for treating high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
• medications such as ketoconazole tablets (for treating fungal infections) and protease inhibitors for treating AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medications).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Normon with beverages and alcohol

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

Fertility

In dogs treated with tadalafil, a decrease in sperm production by the testicles was observed. A reduction in sperm has been observed in some men. It is unlikely that these effects will produce a lack of fertility.

Driving and using machines

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

Tadalafilo Normon contains lactose and sodium:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

3. How to take Tadalafilo Normon

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

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

Do not take Tadalafilo Normon more than once a day.

Tadalafilo Normon administered daily allows you to obtain an erection at any time during the 24 hours of the day, provided there is sexual stimulation. Tadalafilo Normon administered daily may be useful in men who anticipate having sexual activity two or more times a week.

It is essential to note that Tadalafilo Normon 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 medication for erectile dysfunction.

Consuming alcohol may affect your ability to have an erection.

For the treatment of benign prostatic hyperplasia

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

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

Do not take Tadalafilo Normon more than once a day.

If you take more Tadalafilo Normon than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tadalafilo Normon

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

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

4. Possible side effects

Like all medications, Tadalafilo Normon can cause side effects, although not everyone experiences them. These effects are generally mild to moderate.

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

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

Other side effects that have been reported:

Common(observed in 1 to 10 out of 100 patients)

• headache, back pain, muscle pain, pain in the 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 the urine, prolonged erection, palpitations, rapid pulse, high blood pressure, low blood pressure, nosebleeds, ringing in the ears, swelling of the 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, hives (red itchy rashes on the skin surface), bleeding in the penis, blood in the semen, and increased sweating.

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

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

Some additional rare side effectshave been reported in men taking tadalafil that were not observed during clinical trials. These include:

• Migraine, facial swelling, severe allergic reaction that causes swelling of the face or throat, severe skin rashes, certain disorders that affect blood flow to the eyes, irregular heartbeats, angina pectoris, and sudden cardiac death.
• Distorted, blurred, or sudden decrease in vision (frequency not known).

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Tadalafilo Normon

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tadalafilo Normon

• The active substanceis tadalafil. Each tablet contains 5 mg of tadalafil.
• The other ingredientsare:

Tablet core: lactose monohydrate (see the end of section 2), lactose monohydrate spray-dried, hydroxypropylcellulose, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Coating: lactose monohydrate, hypromellose 606, triacetin, titanium dioxide, yellow iron oxide, talc.

Appearance and packaging of the product

Tadalafilo Normon 5 mg are film-coated tablets of yellow color, elongated, biconvex, and marked with "T5" on one face.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of last revision of this package leaflet: October 2023

Other sources of information:

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone.

You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/83537/P_83537.html