Tadalafil Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafil Normon 5 mg film-coated tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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 adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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 for the treatment of adult men with:

• Erectile dysfunction. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity. Tadalafilo Normon has demonstrated a significant improvement in the ability to achieve a durable penile erection suitable for sexual activity.

After sexual stimulation, Tadalafilo Normon works by helping to relax the blood vessels in the penis, allowing blood to flow into it. 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 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 urination, a sensation that the bladder has not emptied completely, and the need to urinate more frequently, even during the 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 been shown to improve these urinary symptoms within as little as 1–2 weeks after starting treatment.

2. What you need to know before starting to take Tadalafil Normon

Do not take Tadalafil Normon:

• if you are allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking any organic nitrates or nitric oxide donors such as amyl nitrite. These are a group of medicines (“nitrates”) used to treat angina pectoris (“chest pain”). Tadalafil has been shown to increase the effects of these medicines. If you are taking any type of nitrate or are unsure, tell your doctor.
• if you have a severe heart disease or have recently had a heart attack (within the last 90 days).
• if you have recently had a stroke (within the last 6 months).
• if you have low blood pressure or uncontrolled high blood pressure.
• if you have ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
• 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 been shown to 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 poses 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 the same symptoms, your doctor will examine you for prostate cancer 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 the red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a cancer of the blood cells).
• any penile deformity.
• a severe liver problem.
• a severe kidney problem.

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

• pelvic surgery.
• a surgical procedure in which the prostate has been completely or partially removed and the nerves to the prostate have been cut (radical prostatectomy without neurovascular bundle preservation).

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

Tadalafilo Normon is not intended for use in women.

Children and adolescents

Tadalafil Normon must not be used in children or adolescents under 18 years of age.

Use of Tadalafil Normon with other medicines

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

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

Some medicines may interact with Tadalafil Normon or may affect how well Tadalafil Normon 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 (used to treat fungal infections) and protease inhibitors used to treat AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Taking Tadalafilo Normon with food and alcohol

Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafilo Normon and should be used with caution. Please consult your doctor for further information.

Fertility

In treated dogs, a decrease in sperm production by the testes has been observed. A reduction in sperm has been observed in some men. It is unlikely that these effects would cause infertility.

Driving and operating machinery

Some men who took Tadalafil Normon during clinical trials experienced dizziness. Carefully assess how you react when taking the tablets before driving or operating machinery.

Tadalafilo Normon contains lactose and sodium:

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him 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 Tadalafil Normon

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Alcohol consumption may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Normon, avoid excessive alcohol consumption (blood alcohol level of 0.08% or higher), as it may increase the risk of dizziness when standing up.

The tablet may be divided into two equal doses.

For the treatment of erectile dysfunction

The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day. Your doctor may adjust the dose to 2.5 mg based on your response to tadalafil. This will be achieved by taking half a tablet of 5 mg.

Do not take Tadalafilo Normon more than once a day.

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

It is important to warn you that Tadalafilo Normon is not effective in the absence of sexual stimulation. Therefore, you and your partner should engage in sexual stimulation just as you would if you were not taking a medication for erectile dysfunction.

Alcohol consumption may affect your ability to obtain an erection.

For the treatment of benign prostatic hyperplasia

The dose is one 5 mg tablet once daily, taken 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 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 Toxicology Information Service at telephone number: 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. You should not take Tadalafilo Normon 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, Tadalafil Normon 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 medication and seek medical help immediately:

• allergic reactions including rashes (uncommon).
• chest pain – do not use nitrates, but seek immediate medical help (uncommon).
• priapism, a prolonged and possibly painful erection after taking tadalafil (rare frequency). 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 frequency), distorted, dimmed, blurred central vision, or sudden decrease in vision (frequency not known).

Other adverse effects that have been reported:

Frequent (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 of fatigue.

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 welts on the skin), bleeding in the penis, blood in semen, and increased sweating.

Rare cases of heart attack and stroke have also been reported in men taking tadalafil. Most of these men had pre-existing heart problems before taking this medication.

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

Some additional rare adverse effects have been reported in men taking tadalafil 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 heartbeat, 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 tadalafil, the most frequently reported adverse effect was dizziness. In men over 65 years of age receiving tadalafil, the most frequently reported adverse effect was diarrhea.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Normon

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tadalafilo Normon

• 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), spray-dried lactose monohydrate, hydroxypropylcellulose, sodium croscarmellose, 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

Tadalafil Normon 5 mg are yellow, film-coated, elongated, biconvex tablets, marked with “T5” on one side and scored on both sides.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid (Spain)

Date of the most recent review of this leaflet: October 2023

Other sources of information:

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

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

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