Prospect: information for the patient

Sildenafilo Normon 20 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Sildenafilo Normon 20 mg and what is it used for

2. What you need to know before starting to take Sildenafilo Normon 20 mg

3. How to take Sildenafilo Normon 20 mg

4. Possible adverse effects

5. Storage of Sildenafilo Normon 20 mg

6. Contents of the pack and additional information

Sildenafilo Normon 20 mg contains the active ingredient sildenafilo which belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors.

Sildenafilo reduces blood pressure in the lungs by dilating the blood vessels in the lungs.

Sildenafilo is used to treat high blood pressure in the blood vessels of the lung (pulmonary arterial hypertension) in adults, children and adolescents, between 1 to 17 years.

Do not take Sildenafilo Normon 20 mg

• If you are allergic to sildenafil or any of the other components of this medication (listed in section 6).

• If you are taking medications that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medications are often used to relieve chest pain (or angina). Sildenafilo Normon 20 mg may increase the effects of these medications. Inform your doctor if you are taking any of these medications. If you are unsure, consult your doctor or pharmacist.

• If you are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Sildenafilo Normon 20 mg, have been shown to increase the hypotensive effect of this medication. Consult your doctor if you are taking riociguat or are unsure.

• If you have recently had a stroke, a heart attack, or if you have severe liver disease or very low blood pressure (<90 mmHg).

• If you are taking a medication to treat fungal infections such as ketoconazole or itraconazole or medications that contain ritonavir (for HIV/AIDS).

• If you have previously experienced vision loss due to a problem with blood flow to an eye nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo Normon 20 mg if

• You have a disease caused by a blockage or narrowing of a vein in the lungs instead of a blockage or narrowing of an artery.
• You have a serious heart problem.
• You have a problem with the heart's pumping chambers.
• You have high blood pressure in the blood vessels of the lungs.
• You have low blood pressure at rest.
• You lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with fever, vomiting, or diarrhea.
• You have a rare inherited eye disease (retinitis pigmentosa).
• You have an abnormality of red blood cells (sickle cell anemia), blood cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• You have an active stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.
• You are using medications for erectile dysfunction.

When PDE5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with an unknown frequency: sudden, temporary, or permanent partial or complete loss of vision in one or both eyes. If you experience a sudden loss of vision, stop taking Sildenafilo Normon 20 mg and inform your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection that lasts more than 4 hours, stop taking Sildenafilo Normon 20 mg and consult your doctor immediately (see also section 4).

Special precautions in patients with kidney or liver problems

Inform your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children

Sildenafilo Normon 20 mg should not be administered to children under 1 year.

Taking Sildenafilo Normon 20 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• Medications that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medications are often used to relieve chest pain or angina (see section 2. What you need to know before taking Sildenafilo Normon 20 mg).
• Inform your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
• Medications that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
• Medications that inhibit blood coagulation (e.g., warfarin) although no adverse effects have been reported.
• Medications that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV/AIDS), or nefazodone (for depression) as a dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of hypertension or prostate problems, as the combination of the two medications may cause symptoms of reduced blood pressure (e.g., dizziness, fainting).
• Medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Normon 20 mg with food and drinks

Do not take grapefruit juice while being treated with Sildenafilo Normon 20 mg.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Sildenafilo Normon 20 mg should not be used during pregnancy unless absolutely necessary.

Sildenafilo Normon 20 mg should not be administered to women of childbearing age unless adequate contraceptive methods are used.

Sildenafilo Normon 20 mg passes into breast milk at very low levels and is not expected to harm your baby.

Driving and operating machinery

Sildenafilo Normon 20 mg may cause dizziness and affect vision. You should know how you react to this medication before driving vehicles or operating machinery.

Sildenafilo Normon 20 mg contains sodium

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

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

For adults, the recommended dose is 20 mg three times a day (taken at intervals of 6 to 8 hours) taken with or without food.

Use in children and adolescents

For children and adolescents from 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg or 20 mg three times a day for children and adolescents > 20 kg, administered with or without food. In children, higher doses than those recommended should not be used.This medication should only be used for cases in which 20 mg three times a day should be administered. For administration in patients ≤ 20 kg and in other younger patients who cannot swallow the tablets, other more suitable pharmaceutical forms may be used.

If you take more Sildenafilo Normon 20 mg than you should

You should not take more medication than your doctor tells you to.

If you have taken more medication than advised, consult your doctor immediately.

Taking more sildenafilo than advised may increase the risk of known side effects.

If you forgot to takeSildenafilo Normon 20 mg

If you have forgotten to take sildenafilo, take the dose as soon as you remember and continue taking your medication at the usual hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Sildenafilo Normon 20 mg

Stopping treatment with sildenafilo abruptly may lead to worsening of your symptoms.

Do not stop taking sildenafilo unless your doctor tells you to. Your doctor will instruct you on how to reduce the dose over a few days before stopping it completely.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking Sildenafilo Normon 20 mg and inform your doctor immediately (see also section 2):

-if you experience a sudden reduction or loss of vision (unknown frequency).

-if you have an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported after taking sildenafilo in men (unknown frequency).

Adults

The side effects reported very frequently (may affect more than 1 in 10 patients) were, headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The side effects reported frequently (may affect up to 1 in 10 patients) are: skin infection, flu-like symptoms, nasal congestion, reduction in red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision, and light sensitivity, color perception effects, eye irritation, red or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, burning sensation, hemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

The side effects reported infrequently (may affect up to 1 in 100 patients) included: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.

Also, skin eruptions, sudden decrease or loss of hearing, and reduction in blood pressure have been reported with an unknown frequency (the frequency cannot be estimated with the available data).

Children and adolescents

Frequent side effects (may affect up to 1 in 10 patients) included: pneumonia, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral infections in the stomach and intestines, urinary tract infections, and tooth perforations.

Severe side effects considered related to treatment and reported infrequently (may affect up to 1 in 100 patients) included: allergic reaction (such as skin rash, facial inflammation, lips and tongue, sneezing, difficulty breathing or swallowing), convulsions, irregular heartbeat, hearing disturbances, shortness of breath, digestive tract inflammation, and sneezing due to airway obstruction.

The side effects reported very frequently (may affect more than 1 in 10 patients) were headache, vomiting, sore throat, fever, diarrhea, flu, and nasal bleeding.

The side effects reported frequently (may affect up to 1 in 10 patients) were nausea, increased erections, pneumonia, and runny nose.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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.

Keepthis medicationout 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.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

• The active ingredient is sildenafilo. Each tablet contains 20 mg of sildenafilo (as citrato).
• The other components are:

- Core: calcium dihydrogen phosphate, microcrystalline cellulose, magnesium stearate, colloidal silica, and sodium croscarmellose.

- Coating: hypromellose, titanium dioxide (E-171), macrogol 6000, and talc.

Appearance of the product and contents of the packaging

Sildenafilo Normon 20 mg: round, white, biconvex tablets, coated with a film, marked with “20” on one face.

It is presented in PVC/Al blisters containing 90 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of the last review of thisleaflet:May 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/