Prospect: Information for the Patient

Sildenafilo MABO-FARMA 100 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 doubts, 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 to 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 is unable to 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 severe 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 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 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

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

Other medications and Sildenafilo MABO-FARMA

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

This medication's tablets 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 take sildenafilo with 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 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 sildenafilo with alpha-blockers. This is more likely to occur within 4 hours after taking this 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 sildenafilo.

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

This medication can be taken with or without food. However, you may notice that sildenafilo takes a bit longer to take effect if you ingest it with a large meal.

Consuming alcohol may temporarily impair your ability 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 sildenafilo is not indicated in women.

Driving and operating machinery

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

Follow exactly the administration instructions forsildenafilogiven 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.

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

If you estimate that the effect ofsildenafilois too strong or too weak, inform your doctor or pharmacist.

Sildenafilowill only help you get an erection if you are sexually stimulated. The time it takes for this medication to take effect varies from person to person, usually between 30 minutes and one hour. The effect ofthis medicationmay be delayed if taken with a large meal.

Ifsildenafilodoes not help you get 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 medicinecan cause side effects, although not everyone will experience them. The side effects reported associated with the use ofsildenafilare 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-sitting position and try to relax.
• Do not use nitratesto treat your chest pain.
• Contact your doctor immediately.

All medicines, includingsildenafilcan 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 takingthis medicine: sudden hissing sound while breathing, 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 medicine,which occursrarely(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 taking this medicine - this occurs rarely-and contact your doctor immediately.

There have been reports of 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.

There have also been reports of seizures or attacks - this occurs rarely.

Other side effects:

Frequent side effects(can affect more than 1 in 10 patients) include:

headache.

Frequent side effects(can affect up to 1 in 100) include:

nausea, facial flushing, heat sensation (among the symptoms is a sudden feeling of heat in the upper body), indigestion, effects on vision (including abnormal color perception, blurred vision or visual deterioration), nasal congestion and dizziness.

Infrequent side effects(can affect up to 1 in 100) include:

vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights vision, 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, nasal mucosa inflammation (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 heatand blood in the urine.

Rare side effects(can affect up to 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, visual acuity decrease, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, halos around lights, pupil dilation, change in the color of the white part of the eye, bleeding of the penis, blood in the semen, dry nose, nasal swelling, feeling of irritability, fainting, stroke, heart attack, nosebleed and sudden loss or decrease in hearing.

The side effects reported in post-marketing experience include rarely 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.

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

Reporting of side effects

If you experience any type ofsideeffects, 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 that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at 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.

Composition of Sildenafilo MABO-FARMA 100 mg

The active ingredient of this medication is sildenafilo. Each tablet contains 100 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 carmine.

Appearance of the product and packaging size

The tablets of Sildenafilo MABO-FARMA 100 mg have a coating, are elliptical in shape, and are blue in color. They are engraved with “+” on one face.

Sildenafilo MABO-FARMA 100 mg is presented in blisters of 4, 8, and 12 tablets per package.

Only some packaging sizes may be commercially available.

Other presentations:

Sildenafilo MABO-FARMA 50 mg, packages with 1, 2, 4, 8, and 12 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada

Madrid, Spain

Responsible manufacturer:

Atlancic Pharma- Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, Abrunheira.

2710-089 Sintra (Portugal).

Last review date of this leaflet: April 2022

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