TADALAFIL NORMON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Tadalafilo Normon 20 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tadalafilo Normon and what is it used for
2. What you need to know before you take Tadalafilo Normon
3. How to take Tadalafilo Normon
4. Possible side effects
5. Storage of Tadalafilo Normon
6. Contents of the pack and other information

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

• if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
• you are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines.
• you have a severe heart disease or have had a recent heart attack within the last 90 days.
• you have had a recent stroke within the last 6 months.
• you have low blood pressure or uncontrolled high blood pressure.
• you have ever had loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “eye stroke”.
• 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). Phosphodiesterase type 5 inhibitors, such as tadalafil, have shown an increase in the hypotensive effect of this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking 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).
• multiple myeloma (cancer of the bone marrow).
• leukemia (cancer of the blood cells).
• any deformation of the penis.
• a severe liver problem.
• a severe kidney problem.

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

• in the pelvic area.
• in a surgical procedure in which the prostate was totally or partially removed and the nerves of the prostate 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 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 and adolescents under 18 years of age.

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 taking nitrates.

Some medicines may affect the way Tadalafilo Normon works or Tadalafilo Normon may affect the way other medicines work. Tell your doctor or pharmacist if you are using:

• an alpha-blocker (used to treat high blood pressure or symptoms of an enlarged prostate).
• other medicines for high blood pressure.
• riociguat.
• a 5-alpha reductase inhibitor (used to treat an enlarged prostate).

• medicines such as ketoconazole tablets (for the treatment of fungal infections) and protease inhibitors for the treatment of HIV or AIDS.
• 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 way Tadalafilo Normon works and should be taken with caution. Consult your doctor for more information.

Fertility

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

Driving and using machines

Some men taking Tadalafilo Normon during clinical trials experienced dizziness. Check carefully how you react to 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 your doctor 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

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Tadalafilo Normon tablets are for oral use only in men. Swallow the tablet whole with a little water. The tablets can be taken with or without food.

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

When taking Tadalafilo Normon, you can start sexual activity 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 anticipated sexual activity and is 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 large amounts of 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 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 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

4. Possible side effects

Like all medicines, Tadalafilo Normon can cause side effects, although not everybody gets them. These effects are usually 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 loss of 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 memory loss, eyelid swelling, red eyes, sudden or temporary 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.

Rarely, cases of partial, temporary, or permanent loss of vision have been reported.

Some additional rare side effectshave been reported in men taking tadalafil that were not seen in 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, and sudden cardiac death.
• distorted, blurred, central blurred vision, or sudden loss of vision (frequency not known).

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) 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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafilo Normon

• The active substanceis tadalafil. Each tablet contains 20 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 pack contents

Tadalafilo Normon 20 mg are yellow, elliptical, biconvex film-coated tablets marked with “T20” on one side.

Tadalafilo Normon 20 mg is available in blister packs with 2, 4, 8, 10, or 12 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 leaflet: October 2023

Other sources of information:

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

You can access detailed and up-to-date information about 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/83536/P_83536.html.