Tadalafil Normogen 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tadalafilo Normogen 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 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 must not be given to other people, 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.

Contents of the leaflet

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

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

Tadalafilo Normogen contains the active substance tadalafil.

Tadalafil is indicated for the treatment of pulmonary arterial hypertension in adults and children from 2 years of age.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which work by helping to relax the blood vessels around the lungs, thereby improving blood flow in the lungs. This results in improved ability to exercise.

2. What you need to know before taking Tadalafilo Normogen

Do not take Tadalafilo Normogen

• If you are allergic to tadalafil or to any of the other ingredients (see section 6).
• If you are taking any type of nitrates, such as amyl nitrite, which are administered to relieve "chest pain." This medicine may increase the effects of these drugs. If you are taking any type of nitrate or are unsure, consult your doctor.
• If you have previously experienced vision loss—a condition described as "eye stroke" (non-arteritic anterior ischemic optic neuropathy - NAION).
• If you have had a heart attack within the last 3 months.
• If you have low blood pressure.
• 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 before starting to take this medicine.

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

• Any heart problems other than your pulmonary hypertension.
• Problems with your blood pressure.
• Any hereditary eye disease.
• A red blood cell disorder (sickle cell anemia).
• Bone marrow cancer (multiple myeloma).
• Blood cell cancer (leukemia).
• Any deformity of your penis, or unexpected and unwanted erections lasting more than 4 hours.
• Severe liver problems.
• Severe kidney problems.

If you experience sudden decrease or loss of vision, or if your vision becomes distorted or dimmed while taking Tadalafilo Normogen, 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, contact your doctor immediately.

Children and adolescents

Tadalafil is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age, as it has not been studied in this age group.

Other medicines and Tadalafilo Normogen

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

DO NOT take these tablets if you are being treated with nitrates.

Some medicines may be affected by Tadalafilo Normogen or may affect how this medicine works. Inform your doctor or pharmacist if you are taking:

• Bosentan (another treatment for pulmonary arterial hypertension).

• Nitrates (for chest pain).

• Alpha-blockers for treating high blood pressure or prostate problems.

• Riociguat.

  • Rifampicin (to treat bacterial infections).
  • Ketoconazole tablets (to treat fungal infections).
  • Ritonavir (for the treatment of AIDS – HIV).
  • Tablets for the treatment of erectile dysfunction (PDE5 inhibitors).

Taking Tadalafilo Normogen with alcohol

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take this medicine, avoid excessive alcohol consumption (more than 5 units of alcohol), as it may increase the risk of dizziness upon standing.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Do not take this medicine during pregnancy unless strictly necessary and only after discussing it with your doctor.

Do not breastfeed while taking these tablets, as it is unknown whether the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.

In treated dogs, a decrease in sperm production by the testes was observed. Some men have shown reduced sperm count. These effects are unlikely to result in infertility.

Driving and use of machines

Dizziness has been reported. Carefully assess how you react to this medicine before driving or operating machinery.

Tadalafilo Normogen contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Tadalafilo Normogen contains sodium

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

3. How to take Tadalafil Normogen

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

This medicine comes in 20 mg tablets. Swallow the tablet(s) whole with a glass of water. The tablet(s) may be taken with or without food.

Pulmonary arterial hypertension in adults

The recommended dose is 2 tablets of 20 mg taken once daily. You should take the 2 tablets at the same time, one after the other. If you have mild to moderate liver or kidney problems, your doctor may advise you to take only 1 tablet of 20 mg daily.

Pulmonary arterial hypertension in children (from 2 years of age) weighing at least 40 kg

The recommended dose is 2 tablets of 20 mg taken once daily. You should take the 2 tablets at the same time, one after the other. If you have mild to moderate liver or kidney problems, your doctor may advise you to take only 1 tablet of 20 mg daily.

Pulmonary arterial hypertension in children (from 2 years of age) weighing less than 40 kg

The recommended dose is 1 tablet of 20 mg taken once daily. If you have mild to moderate liver or kidney problems, your doctor may advise you to take 1 tablet of 10 mg daily.

Other pharmaceutical forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

If you take more Tadalafil Normogen than you should

If you or someone else takes more tablets than prescribed, consult your doctor or go immediately to a hospital, taking the medicine or its packaging with you. You may experience any of the adverse effects described in section 4.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tadalafil Normogen

Take your dose as soon as you remember, if it is within 8 hours of the time you were supposed to take it. DO NOT take a double dose to make up for the missed dose.

If you stop taking Tadalafil Normogen

Do not stop taking the tablets unless your doctor has advised you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. These effects are generally mild to moderate in intensity.

If you experience any of the following adverse effects, stop using the medicine and seek immediate medical help:

• Allergic reactions, including skin rashes (frequent).
• Chest pain – do not use nitrates, but seek immediate medical help (frequent).
• Priapism, a prolonged and possibly painful erection after taking this medicine (uncommon). If you experience this type of erection lasting continuously for more than 4 hours, you must contact a doctor immediately.
• Sudden loss of vision (rare frequency), distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

The following adverse effects have been reported very frequently in patients taking this medicine (may affect more than 1 in 10 people): headache, flushing, nasal and sinus congestion (stuffy nose), nausea, indigestion (including abdominal pain and discomfort), muscle pain, back pain, and limb pain (including limb discomfort).

Other adverse effects that have been reported:

Frequent (may affect up to 1 in 10 people)

• Blurred vision, low blood pressure, nosebleeds, vomiting, increased or abnormal uterine bleeding, facial swelling, reflux, migraine, irregular heartbeat, and fainting.

Uncommon (may affect up to 1 in 100 people)

• Seizures, transient memory loss, urticaria, excessive sweating, penile bleeding, presence of blood in semen and/or urine, high blood pressure, rapid pulse, sudden cardiac death, and tinnitus.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. The following adverse effects have been rarely reported:

• Decrease or partial, temporary or permanent loss of vision in one or both eyes, and severe allergic reaction causing facial or throat swelling. Cases of sudden decrease or loss of hearing have also been reported.

Some adverse effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These effects were not observed during clinical trials for pulmonary arterial hypertension, and therefore their frequency is unknown:

• Eyelid swelling, eye pain, red eyes, heart attack, and stroke.

Some additional rare adverse effects have been reported in men taking tadalafil that were not reported during clinical trials. These include:

• Distorted, diminished, blurred central vision, or sudden decrease in vision (frequency not known).

Most of the men who reported rapid pulse, irregular heartbeat, heart attack, stroke, and sudden cardiac death had pre-existing heart conditions before taking tadalafil. It is not possible to determine whether these events were directly related to tadalafil.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tadalafil Normogen

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

Do not use this medicine after the expiry date stated on the carton and blister after “CAD” and “EXP”, respectively. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Tadalafil Normogen

• The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.
• The other components are:

• Tablet core: monohydrate lactose, spray-dried lactose, sodium croscarmellose, hydroxypropylcellulose (E-463), microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

• Tablet coating: monohydrate lactose, hypromellose 2910, triacetin, titanium dioxide (E-171), yellow iron oxide (E-172), talc.

Appearance of the product and contents of the pack

Yellow, film-coated, elliptical, biconvex tablets marked "T20" on one side.

This medicine is available in blister packs containing 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

Spain

Date of the most recent review of this leaflet: December 2025

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (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 carton. You can also access this information at the following web address:

https://cima.aemps.es/cima/dochtml/p/85659/P_85659.html