Sildenafil Normon 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Sildenafilo Normon 20 mg film-coated tablets EFG

Read the entire 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 should not give it 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 Sildenafilo Normon 20 mg is and what it is used for
2. What you need to know before taking Sildenafilo Normon 20 mg
3. How to take Sildenafilo Normon 20 mg
4. Possible side effects
5. How to store Sildenafilo Normon 20 mg
6. Contents of the pack and other information

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

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

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

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

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

Do not take Sildenafilo Normon 20 mg

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

• If you are taking medicines containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often used to relieve chest pain (or angina). Sildenafilo Normon 20 mg may significantly increase the effects of these medicines. You must inform your doctor if you are taking any of these medicines. If you are unsure, consult your doctor or pharmacist.

• 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 Sildenafilo Normon 20 mg, have been shown to increase the hypotensive effect of this medicine. Consult your doctor if you are taking riociguat or if you are unsure.

• If you have recently had a stroke or myocardial infarction, or if you have severe liver disease or very low blood pressure (<90/50 mmHg).

• If you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole, or medicines containing ritonavir (for AIDS).

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

Warnings and precautions

Consult your doctor or pharmacist before taking Sildenafilo Normon 20 mg if:

• You have a disease caused by obstruction or narrowing of a vein in the lungs rather than an artery.
• You have a serious heart condition.
• You have a problem with the pumping chambers of the heart.
• You have high blood pressure in the blood vessels of the lungs.
• You have low resting blood pressure.
• You are losing large amounts of body fluids (dehydration), which may occur with excessive sweating or insufficient fluid intake. This can happen if you are ill with fever, vomiting, or diarrhea.
• You suffer from a rare inherited eye disease (retinitis pigmentosa).
• You have a red blood cell disorder (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• You currently have a stomach ulcer, bleeding disorders (such as hemophilia), or nosebleeds.
• You are using medicines for erectile dysfunction.

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

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection lasting longer than 4 hours, stop taking Sildenafilo Normon 20 mg and seek immediate medical advice (see also section 4).

Special precautions in patients with kidney or liver problems

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

Children

Sildenafilo Normon 20 mg must not be given to children under 1 year of age.

Taking Sildenafilo Normon 20 mg with other medicines

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

• Medicines containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines 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).
• Medicines containing St. John's wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
• Medicines that inhibit blood coagulation (e.g., warfarin), although no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for AIDS), or nefazodone (for depression), as dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of these two medicines may cause symptoms of low blood pressure (e.g., dizziness, fainting).
• Medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Normon 20 mg with food and drinks

You should not drink grapefruit juice while being treated with Sildenafilo Normon 20 mg.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Sildenafilo Normon 20 mg must not be given 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 using machines

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

Sildenafilo Normon 20 mg contains sodium

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

3. How to take Sildenafil Normon 20 mg

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

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

Use in children and adolescents

For children and adolescents aged 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, doses higher than those recommended must not be used. This medicine should only be used in cases where a dose of 20 mg three times a day must be administered. For administration in patients ≤ 20 kg and in younger patients who cannot swallow tablets, other more suitable pharmaceutical forms may be used.

If you take more Sildenafil Normon 20 mg than you should

Do not take more medicine than your doctor has prescribed.

If you have taken more medicine than recommended, consult your doctor immediately.

Taking more sildenafil than you should may increase the risk of known adverse effects.

If you forget to take Sildenafil Normon 20 mg

If you forget to take sildenafil, take the dose as soon as you remember and then continue taking your medicine at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Sildenafil Normon 20 mg

Suddenly stopping treatment with sildenafil may lead to worsening of your symptoms.

Do not stop taking sildenafil unless instructed by your doctor. Your doctor will advise you on how to gradually reduce the dose over several days before stopping completely.

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 experiences them.

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

• If you experience sudden reduction or loss of vision (frequency not known).
• If you have an erection lasting continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults

Very commonly reported adverse effects (may affect more than 1 in 10 patients) were: headache or facial flushing, indigestion, diarrhoea, and pain in arms and legs.

Commonly reported adverse effects (may affect up to 1 in 10 patients) are: skin infection, flu-like symptoms, sinus inflammation, reduced number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, vision disturbances, blurred vision and light sensitivity, effects on colour perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, rhinorrhoea, cough, nasal congestion, stomach inflammation, gastroenteritis, burning sensation, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

Uncommonly reported adverse effects (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.

Skin rashes, sudden decrease or loss of hearing, and reduction in blood pressure have also been reported with unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents

The following serious adverse effects have been frequently reported (may affect up to 1 in 10 patients): pneumonia, right heart failure, cardiogenic shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral infection of the stomach and intestine, urinary tract infections, and dental perforations.

The following serious adverse effects considered related to treatment have been reported uncommonly (may affect up to 1 in 100 patients): allergic reaction (such as skin rash, swelling of the face, lips and tongue, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, inflammation of the gastrointestinal tract, and sneezing due to airflow disturbances.

Very commonly reported adverse effects (may affect more than 1 in 10 people) were: headache, vomiting, throat infection, fever, diarrhoea, flu, and nosebleeds.

Commonly reported adverse effects (may affect up to 1 in 10 patients) were: nausea, increased erections, pneumonia, and runny nose.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can 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 Sildenafil Normon 20 mg

Keep this medicine out of 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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).

• The other components are:

• Core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, and sodium croscarmellose.

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

Appearance of the product and contents of the pack

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

Supplied in PVC/Al blisters containing 90 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
C/ Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of the most recent revision of this package leaflet: May 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health 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 package leaflet and outer packaging with your mobile phone (smartphone).

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82571/P_82571.html