SILDENAFIL MABO-FARMA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil MABO-FARMA 100 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take the medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Sildenafil MABO-FARMA is and what it is used for.
2. What you need to know before taking Sildenafil MABO-FARMA.
3. How to take Sildenafil MABO-FARMA.
4. Possible side effects.
5. Storage of Sildenafil MABO-FARMA.
6. Contents of the pack and further information.

1. What Sildenafil MABO-FARMA is and what it is used for

Sildenafil belongs to a group of medications called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafil will only help you achieve an erection if you are sexually stimulated. You should not take this medication if you do not have erectile dysfunction. The use of this medication is not indicated in women.

Sildenafil is indicated for the treatment of male erectile dysfunction, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil MABO-FARMA

Do not takeSildenafil MABO-FARMA

• If you are allergic (hypersensitive) to sildenafil or any of the other components of this medication (listed in section 6).
• If you are taking medications called nitrates, as the combination can cause a potentially dangerous decrease in blood pressure. Consult your doctor if you are taking any of these medications, which are often administered to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a potentially dangerous decrease in blood pressure.
• If you are taking riociguat. This medication 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 sildenafil, have shown that they increase the hypotensive effect of this medication. 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 or heart attack, or if you have low blood pressure.
• If you have suffered from 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, pharmacist, or nurse before starting to take this medication.

Inform your doctor:

• If you have sickle cell anemia (a red blood cell abnormality), leukemia (blood cell cancer), or multiple myeloma (bone marrow cancer).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should carefully check if your heart can withstand the extra effort of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking this medication and contact your doctor immediately.

This medication should not be used simultaneously with any other oral or local treatment for erectile dysfunction.

You should not take this medication with treatments for pulmonary arterial hypertension (PAH) that contain sildenafil or any other PDE5 inhibitor.

You should not take this medication if you do not have erectile dysfunction.

The use of this medication is not indicated in women.

Special considerations in patients with renal or hepatic impairment

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

Children and adolescents

The use of this medication is not indicated in persons under 18 years of age.

Other medications and Sildenafil MABO-FARMA

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

The tablets of this medication may interfere with some medications, especially those used to treat chest pain. In case of a medical emergency, you should inform any healthcare professional that you are taking this medication and when you took it. You should not take sildenafil with other medications unless your doctor advises you to do so.

You should not take this medication if you are taking medications called nitrates, as the combination of these products can cause a potentially dangerous decrease in blood pressure. You should always inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve angina pectoris (or "chest pain").

You should not take this medication if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products can also cause a potentially dangerous decrease in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medications known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of this medication.

Some patients who are receiving an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a decrease 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 of taking this medication. To minimize the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting this medication. Your doctor may recommend that you start treatment with the lower dose (25 mg) of sildenafil.

Caution should be exercised when starting treatment with sildenafil in patients treated with medications containing sacubitril/valsartan, used to treat heart failure.

Using Sildenafil MABO-FARMA with food and drinks

This medication can be taken with or without food. However, you may notice that sildenafil takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to achieve an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking this medication.

Pregnancy and breastfeeding

The use of sildenafil is not indicated in women.

Driving and using machines

This medication can cause dizziness and affect vision. You should know how you react to this medication before driving vehicles or using machinery.

Sildenafil MABO-FARMA contains sodium

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

3. How to take Sildenafil MABO-FARMA

Follow the administration instructions for sildenafil indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not takethis medicationmore than once a day.

Do not take sildenafil film-coated tablets with sildenafil orodispersible tablets.

You should take this medication approximately one hour before you plan to have sex. Swallow the tablet whole with a little water.

If you think 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 it takes for this medication to work varies from person to person, usually between half an hour and one hour. The effect of this medication can be delayed if you take it with a large meal.

In the event that sildenafil does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take moreSildenafil MABO-FARMAthan you should

You may experience an increase in side effects and their severity. Doses above 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.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone 915 620 420 (indicating the medication and the amount ingested).

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The side effects reported in association with the use of sildenafil are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking this medication and seek medical attention immediately:

If you experience chest pain during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat your chest pain.
• Contact your doctor immediately.

All medications, including sildenafil, can cause allergic reactions - this occurs rarely(may affect up to 1 in 100 people). You should contact your doctor immediately if you experience any of the following symptoms after taking this medication: sudden wheezing, difficulty breathing, or dizziness, swelling of the eyelids, face, lips, or throat.

There have been reports of prolonged and sometimes painful erections after taking this medication, this occurs rarely(may affect up to 1 in 1,000 people). If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

If you experience a sudden decrease or loss of vision, stop taking this medication - this occurs rarely- and contact your doctor immediately.

Severe skin reactions have been reported - this occurs rarely. The symptoms can include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.

Seizures or convulsions have also been reported - this occurs rarely.

Other side effects:

Very common side effects(may affect more than 1 in 10 patients) include:

headache.

Common side effects(may affect up to 1 in 100 patients) include:

nausea, facial flushing, hot flushes (including a sudden feeling of heat in the upper body), indigestion, effects on vision (including abnormal color perception, blurred vision, or visual impairment), nasal congestion, and dizziness.

Uncommon side effects(may affect up to 1 in 100 patients) include:

vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, vision of flashing lights, visual clarity, sensitivity to light, watery eyes, irregular or rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or congested sinuses, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), chest pain, feeling of fatigue, pain in arms or legs, nosebleeds, feeling of warmth, and presence of blood in the urine.

Rare side effects(may affect up to 1 in 1,000 patients) include:

irregular heartbeat, transient decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness of the mouth, bleeding in the back of the eye, double vision, decrease in visual acuity, abnormal sensation in the eye, eye or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling of the inside of the nose, feeling of irritability, fainting, stroke, heart attack, nosebleeds, and sudden decrease or loss of hearing.

Side effects reported from post-marketing experience include rare cases of unstable angina (heart disease) and sudden death: Most, but not all, had pre-existing heart problems before taking this medication. It is not possible to determine if these events were directly related to this medication.

There have also been reports of seizures or convulsions and severe skin reactions that include rash, blisters, skin peeling, and pain that require immediate medical attention.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Sildenafil MABO-FARMA

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

Store in the original package to protect it from moisture.

Do not use this medication after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition ofSildenafil MABO-FARMA100 mg

The active ingredient of this medication is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).

The other components are:

Core tablet: microcrystalline cellulose, calcium phosphate dibasic, sodium croscarmellose, and magnesium stearate.

Film coating: polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, and aluminum lake indigo carmine.

Appearance of the product and pack size

Sildenafil MABO-FARMA 100 mg film-coated tablets are elliptical in shape and blue in color. They are engraved with "+" on one side.

Sildenafil MABO-FARMA 100 mg is available in blister packs of 4, 8, and 12 tablets per pack.

Not all pack sizes may be marketed.

Other presentations:

Sildenafil MABO-FARMA 50 mg, packs with 1, 2, 4, 8, and 12 tablets.

Marketing authorization holder and manufacturer

Holder:

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer:

Atlancic Pharma- Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira.

2710-089 Sintra (Portugal).

Date of the last revision of this package leaflet:April 2022

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