TADALAFIL NORMON 10 mg FILM-COATED TABLETS

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

Tadalafilo Normon is indicated for the treatment of erectile dysfunction in adult men. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafilo Normon has been shown to significantly improve the ability to get a hard erect penis suitable for sexual activity.

Tadalafilo Normon contains the active substance tadalafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. After sexual stimulation, Tadalafilo Normon works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result is improved erectile function. Tadalafilo Normon will not help you if you do not have erectile dysfunction.

It is important to note that Tadalafilo Normon is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

2. What you need to know before you take Tadalafilo Normon

Do not take Tadalafilo Normon:

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). It has been shown that tadalafil increases the effects of these medicines. If you are taking any form of nitrate or are unsure, tell your doctor.
• if you have had a severe heart attack or stroke in the last 90 days.
• if you have had a recent stroke, in the last 6 months.
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• if 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 tadalafil, have shown that they increase the hypotensive effect of this medicine. 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 to patients with heart problems because it puts extra strain on the heart. If you have a heart problem, consult your doctor.

Before taking the tablets, inform your doctor if you:

• have sickle cell anemia (a disorder of the red blood cells).
• have multiple myeloma (cancer of the bone marrow).
• have leukemia (cancer of the blood cells).
• have any deformation of the penis.
• have severe liver problems.
• have severe kidney problems.

It is not known if Tadalafilo Normon is effective in patients who have been surgically treated:

• in the pelvic area.
• with a surgical intervention in which the prostate has been completely or partially removed and the prostate nerves have been cut (radical prostatectomy without preservation of neurovascular bundles).

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

A 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 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.

Using Tadalafilo Normon with other medicines

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

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

Some medicines may be affected by Tadalafilo Normon or may affect the good functioning of Tadalafilo Normon. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of benign prostatic hyperplasia).
• other medicines for 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 Tadalafilo Normon with drinks and alcohol

Information about the effect of alcohol is in section 3. Grapefruit juice may affect the 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Tadalafilo Normon

Follow exactly the administration instructions of this medicine 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.

The recommended initial doseis one 10 mg tablet before sexual activity. If the effect of this dose is too weak, your doctor may increase the dose to 20 mg. Tadalafilo Normon tablets are for oral administration.

When taking Tadalafilo Normon, you can initiate sexual activity from at least 30 minutes after taking it.

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

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

It is important to note that Tadalafilo Normon is not effective if there is no sexual stimulation. Therefore, you and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.

Consuming alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafilo Normon, avoid excessive consumption of alcohol (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

If you take more Tadalafilo Normon than you should

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

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

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

4. Possible side effects

Like all medicines, Tadalafilo Normon can cause side effects, although not everybody gets them. These effects are generally mild to moderate.

If you experience any of the following side effects, stop using the medicine 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 for more than 4 hours, you should contact a doctor immediately.
• sudden loss of vision (rare), distorted, blurred, central blurred vision, or sudden decrease in vision (frequency not known).

Other side effects that have been reported:

Common(seen in 1 to 10 in every 100 patients)

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

Uncommon(seen in 1 to 10 in every 1,000 patients)

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

Rare(seen in 1 to 10 in every 10,000 patients)

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

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

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

Some additional rare side effectshave been reported in men taking tadalafil that were not reported 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, central blurred vision, or sudden decrease in vision (frequency not known).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafilo Normon

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 after “EXP”. The expiry date refers to the last day of that month.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the blister packs and any unused medicinal products in the SIGRE collection point at your pharmacy. If you have any further questions on the disposal of unused medicinal products or waste, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Normon

• The active substanceis tadalafil. Each tablet contains 10 mg of tadalafil.
• The other ingredientsare:

Core of the tablet: 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 of the product and contents of the pack

Tadalafilo Normon 10 mg are yellow, elongated, biconvex film-coated tablets marked with “T10” on one face.

Tadalafilo Normon 10 mg is available in blister packs with 4 tablets.

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 leaflet: October 2023

Other sources of information:

Detailed information on this medicine 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 on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone.

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

https://cima.aemps.es/cima/dochtml/p/83535/P_83535.html