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Prospect: Information for the Patient

Sildenafilo MABO-FARMA 50 mg Film-Coated Tablets

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, 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 and should not be given to others, even if they have the same symptoms, 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

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

Sildenafilois indicated for the treatment of male erectile dysfunction, sometimes referred to as impotence. This occurs when a man cannot obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not takeSildenafilo MABO-FARMA

• If you are allergic (hypersensitive) to sildenafilo or to any of the other components of this medication (listed in section 6)
• If you are taking certain medications called nitrates, as the combination may cause a potentially dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medications called nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a potentially dangerous drop in your 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 clots). PDE5 inhibitors, such as sildenafilo, have shown to 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 a rare inherited eye disorder (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 blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penile deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor must carefully check if your heart can withstand the additional effort of having sex.
• If you have an active 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 is not recommended to be used simultaneously with any other oral or local treatment for erectile dysfunction.

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

Do not take this medication if you do not have erectile dysfunction.

This medication is not indicated for use in women.

Special considerations in patients with renal or hepatic impairment

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

Children and adolescents

This medication is not indicated for use in individuals under 18 years of age.

Other medications and Sildenafilo MABO-FARMA

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

This medication may interact with some medications, especially those used to treat chest pain. In case of a medical emergency, you must inform any healthcare professional that you are taking this medication and when you took it. Do not takesildenafilowith other medications unless your doctor advises you to.

Do not take this medication if you are taking medications called nitrates, as the combination of these products may cause a potentially dangerous drop in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medications, which are often used to relieve chest pain (or "chest pain").

Do not take this medication if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products may also cause a potentially dangerous drop in your 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 to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of this medication

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that may be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when takingsildenafilowith alpha-blockers. This is more likely to occur in the 4 hours following the intake ofthis medication. To reduce 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 this medication.

Care should be taken when starting treatment with sildenafilo in patients treated with medications containing sacubitril/valsartan, used to treat heart failure.

Use of Sildenafilo MABO-FARMA with food and beverages

Sildenafilocan be taken with or without food. However, you may notice thatthis medicationmay take a little longer to take effect if taken with a large meal.

The consumption of alcohol may temporarily impair your ability to obtain an erection. Therefore, to get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before takingthis medication.

Pregnancy and breastfeeding

The use ofsildenafilois not indicated in women.

Driving and operating machinery

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

Sildenafilo MABO-FARMA contains sodium.

This medication containsless than1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.The recommended starting dose is 50 mg.

Do not takethis medicationmore than once a day..

Do not take sildenafilo film-coated tablets with sildenafilo buccal dispersible tablets.

Take this medication approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a little water.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Sildenafilo will only help you achieve an erection if you are sexually stimulated. The time it takes for this medication to take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of this medication may be delayed if taken with a large meal.

If this medication 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 moreSildenafilo 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 doubts 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 Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested).

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The reported side effects associated with the use ofthis medicineare generally mild to moderate in intensity and of short duration.

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

If you suffer from chest pain during or after sexual intercourse:

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

All medicines, includingthis medicinecan cause allergic reactions-this occurs withlow frequency(can affect up to 1 in 100 people). You should contact your doctor immediately if you experience any of the following symptoms after taking this medicine: sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

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

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

There have been reported severe skin reactions - this occurs rarely. Symptoms may include severe peeling and swelling of the skin, vesicular buccal, genital, and around the eyes, as well as fever.

Also, there have been reported seizures or attacks - this occurs rarely.

Other side effects:

Very common side effects(can affect more than1 in 10 patients) include:

headache.

Common side effects(can affect up to1 in 10 people) include: nausea, facial flushing,heat(among the symptoms is a sudden feeling of heat in the upperbody),indigestion, effects on vision (including abnormal color perception, blurred vision, or visual deterioration), nasal congestion, and dizziness.

Uncommon side effects(can affect up to 1 in 100 people) include: vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, irregular or rapid heartbeat,high blood pressure, low blood pressure,muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, nausea, dry mouth,nasal congestion or blockage, inflammation of the nasal mucosa (among the symptoms are sneezing, runny nose, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (among the symptoms is stomach burning),chest pain, feeling of fatigue,arm or leg pain, nosebleed, feeling of heatypresence of blood in the urine.

Rare side effects(between 1 in 1,000 patients) include:

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

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

Also, there have been reported cases of seizures or crises and severe skin reactions that require immediate medical attention, which include blistering, peeling, and pain of the skin.

Reporting of side effects

If you experience any type ofthesideeffects, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from moisture.

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

Do not dispose of medications through drains or trash.Deposit unused packaging and medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Sildenafilo MABO-FARMA 50 mg

The active ingredient of this medication is sildenafilo. Each tablet contains 50 mg of sildenafilo (as citrato).

The other components are:

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

Coating:polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide (E171), talc, and aluminum lake of indigo carmin

Appearance of the product and size of the container

The Sildenafilo MABO-FARMA 50 mg tablets have a coating, are eliptical in shape, and are blue in color.

Sildenafilo MABO-FARMA 50 mg is presented in blisters of 1, 2, 4, 8, and 12 tablets per container.

Only some container sizes may be commercially marketed.

Other presentations:

Sildenafilo MABO-FARMA 100 mg, containers with 4, 8, and 12 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada

Madrid, Spain

Responsible for manufacturing:

Atlancic Pharma- Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira.

2710-089 Sintra (Portugal).

Date of the last review of this prospectus:April 2022

The detailed information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/