Leaflet: information for the user

Tadalafilo Normon 5 mg film-coated tablets EFG

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Tadalafilo Normon

3. How to take Tadalafilo Normon

4. Possible side effects

5. Storage of Tadalafilo Normon

6. Contents of the pack and additional information

Tadalafilo Normon contains the active ingredient tadalafilo, 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 is when a man cannot get or keep an erection firm enough for satisfying sexual activity. Tadalafilo Normon has shown a significant improvement in the ability to get a lasting erection of the penis suitable for sexual activity.

After sexual stimulation, Tadalafilo Normon acts by helping to relax the blood vessels in your penis, allowing blood to flow into 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 inform you that Tadalafilo Normon is not effective if there is no sexual stimulation. Therefore, you and your partner should stimulate yourselves in the same way as you would if you were not taking a medicine for erectile dysfunction.

• urinary symptoms associated with a common disease calledbenign prostatic hyperplasia. This is when the prostate gland increases in size with age. Symptoms include difficulty starting to urinate, feeling that the bladder is not 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 may reduce the symptoms of benign prostatic hyperplasia. Tadalafilo Normon has shown to improve these urinary symptoms in as short a time as 1-2 weeks after starting treatment.

Do not take Tadalafilo Normon:

• if you are allergic to tadalafil or any of the other ingredients of this medication (listed in section 6).
• if you are taking any type of organic nitrates or nitric oxide donors such as amyl nitrite. This is a group of medications (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been seen to increase the effects of these medications. If you are taking any type of nitrates or are unsure, tell your doctor.
• if you have a serious heart disease or have had a heart attack recently, within the last 90 days.
• if you have had a recent stroke, within the last 6 months.
• if you have low or uncontrolled high blood pressure.
• if you have ever had vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a disease described as “eye infarction”.
• if you are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). Phosphodiesterase type 5 inhibitors, such as tadalafil, have been shown to 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 may pose a possible risk for patients with heart problems, due to the additional strain it puts on the heart. If you have a heart problem, consult your doctor.

Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will perform a prostate cancer review 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 (an abnormality of red blood cells).
• multiple myeloma (bone marrow cancer).
• leukemia (blood cell cancer).
• any penile deformity.
• severe liver disease.
• severe kidney disease.

It is not known if Tadalafilo Normon is 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 vision or your vision is distorted, blurred while taking Tadalafilo Normon, stop taking this medication and immediately contact your doctor.

A decrease or sudden 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 sudden loss of hearing, stop taking Tadalafilo Normon and immediately contact your doctor.

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 old.

Use of Tadalafilo Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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 urinary symptoms associated with benign prostatic hyperplasia).
• other medications to treat high blood pressure.
• riociguat.
• an inhibitor of 5-alpha reductase (used to treat benign prostatic hyperplasia).
• medications 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 medications).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Normon with beverages and alcohol

The information about the effect of alcohol is 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, 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 Tadalafilo Normon during clinical trials experienced dizziness. Check carefully how you react when taking the tablets before driving or operating 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 him before taking this medication.

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

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

Tadalafilo Normon tablets are for oral administration only in men. Swallow the tablet whole with a little water. 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.

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 tadalafilo. This will be done by taking one 2.5 mg tablet.

Do not take Tadalafilo Normon more than once a day.

Tadalafilo Normon taken daily allows you to obtain an erection at any time during the 24 hours of the day, as long as there is sexual stimulation. Tadalafilo Normon taken daily may be useful for men who expect to engage in sexual activity two or more times a week.

It is essential to inform you that Tadalafilo Normon 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 have an erection.

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 adverse effects described in section 4.

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 medication and the amount ingested.

If you forgot to take Tadalafilo Normon

Take your dose as soon as you remember, but do not take a double dose to compensate for the 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.

Like all medicines, Tadalafilo Normon may cause side effects, although not everyone will experience them. These 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 tadalafilo (rare). 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), distorted, blurred, central vision blurred or sudden decrease in vision (unknown frequency).

Other side effects that have been reported:

Frequent(observed in 1 to 10 of every 100 patients)

-headache, back pain, muscle pain, pain in the arms and legs, facial flushing, nasal congestion and indigestion.

Infrequent(observed in 1 to 10 of 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 in 1 to 10 of every 10,000 patients)

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

Also, rare cases of heart attack and stroke have been reported in men taking tadalafilo. Most of these men had some heart problem before taking this medicine.

Rarely, 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 tadalafilo 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 tadalafilo, the most frequently reported side effect was dizziness. In men over 65 years old taking tadalafilo, 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Tadalafilo Normon Composition

• Theactive ingredientis tadalafilo. Each tablet contains 5 mg of tadalafilo.
• Theother componentsare:

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

Capsule coating: lactose monohydrate, hydroxypropyl methylcellulose 606, triacetin, titanium dioxide, yellow iron oxide, talc.

Appearance of the product and contents of the packaging

Tadafilo Normon 5 mg are yellow-coated, elongated, biconvex tablets marked with “T5” on one face.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

LABORATORIOS NORMON, S.A.

C/Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Last review date of this leaflet: October 2023

Other sources of information:

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