Sildenafil Normon 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sildenafil Normon 50 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, 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 it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into it when you are sexually stimulated. Sildenafil will only help you achieve an erection if you are sexually stimulated.

Sildenafil is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man cannot achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafilo Normon

Do not take Sildenafilo Normon

• If you are allergic (hypersensitive) to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination may lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve angina pain (or “chest pain”). If you are unsure, consult your doctor or pharmacist.
• If you are using any medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may cause a dangerous drop in your 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 Sildenafilo Normon, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have a serious heart or liver problem.
• If you have recently had a stroke, cerebral infarction, or heart attack, or if you have low blood pressure.
• If you have a rare inherited eye disease (such as retinitis pigmentosa).
• If you have previously experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Sildenafilo Normon:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
• If you have a penile deformity or Peyronie’s disease.
• If you have heart problems. In such cases, your doctor must carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience sudden decrease or loss of vision, stop taking Sildenafilo Normon and contact your doctor immediately.

It is not recommended to use sildenafil simultaneously with any other oral or local treatment for erectile dysfunction.

You must not take Sildenafilo Normon with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You must not take Sildenafilo Normon if you do not have erectile dysfunction.

The use of Sildenafilo Normon is not indicated in women.

Special considerations in patients with kidney or liver problems

Inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo Normon is not indicated in individuals under 18 years of age.

Other medicines and Sildenafilo Normon

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Sildenafilo Normon tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform any healthcare professional that you are taking Sildenafilo Normon and when you took it. You should not take Sildenafilo Normon with other medicines unless advised by your doctor.

Do not take Sildenafilo Normon if you are taking medicines called nitrates, as the combination of these products may lead to a dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pain (or “chest pain”).

Do not take Sildenafilo Normon if you are taking medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of Sildenafilo Normon.

Some patients receiving an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafil with alpha-blockers. This is more likely to occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of an alpha-blocker before starting Sildenafilo Normon. Your doctor may advise you to start treatment with the lowest dose (25 mg) of Sildenafilo Normon.

Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Normon with food, drinks, and alcohol

Sildenafilo Normon can be taken with or without food. However, you may notice that Sildenafilo Normon takes slightly longer to work if taken with a heavy meal.

Alcohol consumption may temporarily impair the ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking Sildenafilo Normon.

Pregnancy, breastfeeding, and fertility

The use of Sildenafilo Normon is not indicated in women.

Driving and using machines

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

Sildenafilo Normon 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 Sildenafil Normon

Follow exactly the dosage instructions for sildenafil given by your doctor. If in doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Sildenafil Normon must not be taken more than once a day.

Do not take sildenafil together with other medications containing sildenafil.

You should take sildenafil approximately one hour before planning to have sexual intercourse.

Swallow the tablet whole with a glass of water.

If you notice that the effect of sildenafil is too strong or too weak, inform your doctor or pharmacist.

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time required for sildenafil to take effect varies from person to person, usually between half an hour and one hour. The effect of this medicine may be delayed if taken with a heavy meal.

If sildenafil does not help you achieve an erection or if the erection does not last long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafil Normon than you should

You may experience an increase in the frequency and severity of side effects. Doses higher than 100 mg do not increase efficacy.

Do not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

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

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

4. Possible adverse effects

Like all medicines, Sildenafilo Normon may have adverse effects, although not everyone experiences them. The adverse effects reported with sildenafil are generally mild to moderate in intensity and of short duration.

If you experience any of the following serious adverse effects, stop taking Sildenafilo Normon and seek immediate medical attention:

• Allergic reaction – this occurs uncommonly (may affect up to 1 in 100 people)

Symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain – this occurs uncommonly

If chest pain occurs during or after sexual activity:

• Sit in a semi-upright position and try to relax.

• Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people)

If you have an erection lasting longer than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision – this occurs rarely

• Severe skin reactions – this occurs rarely

Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – this occurs rarely

Other adverse effects:

Very common (may affect more than 1 in 10 people): headache.

Common (may affect up to 1 in 10 people): nausea, facial flushing, feeling hot (including sudden sensation of warmth in the upper body), indigestion, abnormal colour vision, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sensation to touch, vertigo, ringing in the ears, dry mouth, nasal blockage or congestion, nasal mucosal swelling (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling of warmth, and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, throat tightness, oral numbness, bleeding behind the eye, double vision, decreased visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in vision, seeing halos around lights, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to Sildenafilo Normon.

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 can also report them directly via the national reporting system included in the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Normon

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafilo Normon

• The active substance is sildenafil. Each tablet contains 50 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, talc, and indigo carmine lake (E-132).

Appearance of the product and contents of the pack

Sildenafilo Normon 50 mg: blue, film-coated, elongated tablets with imprint (50).

Available in packs of 1, 2, 4, 8, and 12 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: May 2024

Detailed information on this medicinal product 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 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/72231/P_72231.html