Sildenafil Mabo-Farma 50 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sildenafil MABO-FARMA 50 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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. How to store Sildenafil MABO-FARMA.
6. Contents of the pack and other information.

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

Sildenafil belongs to a group of medicines called phosphodiesterase type 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. You should not take this medicine if you do not have erectile dysfunction. This medicine is not intended for use in women.

Sildenafil is indicated for the treatment of male erectile dysfunction, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection adequate for satisfactory sexual activity.

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

Do not take Sildenafil MABO-FARMA

• 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 cause a potentially 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 nitrate (“poppers”), as the combination may cause a potentially 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 sildenafil, 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 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine.

Inform your doctor:

• 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 should 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 this medicine and contact your doctor immediately.

It is not recommended to use this medicine simultaneously with any other oral or local treatments for erectile dysfunction.

You must not take this medicine with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.

You must not take this medicine if you do not have erectile dysfunction.

This medicine is not intended for use in women.

Special considerations in patients with renal impairment or liver problems

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

Children and adolescents

This medicine is not intended for use in individuals under 18 years of age.

Other medicines and Sildenafil MABO-FARMA

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

This medicine’s 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 this medicine and when you took it. You must not take sildenafil with other medicines unless your doctor advises you to do so.

You must not take this medicine if you are taking medicines 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 medicines, which are often used to relieve angina pain (or “chest pain”).

You must not take this medicine if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products may also lead to a potentially 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 this medicine.

Some patients who are taking 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 down 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 this medicine. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting this medicine. Your doctor may advise you to start treatment with the lowest dose (25 mg) of this medicine.

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

Taking Sildenafil MABO-FARMA with food and drink

Sildenafil can be taken with or without food. However, you may notice that this medicine 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 this medicine, it is advisable not to drink large amounts of alcohol before taking this medicine.

Pregnancy and breastfeeding

The use of sildenafil is not indicated in women.

Driving and using machines

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

Sildenafil MABO-FARMA contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is therefore essentially “sodium-free”.

3. How to TAKE SILDENAFILO MABO-FARMA

Follow exactly the instructions for use of this medicine given 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 medicine**more than once a day .**

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

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

If you feel that the effect of this medicine 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 this medicine takes to work varies from person to person, but usually ranges between half an hour and one hour. The effect of this medicine may be delayed if taken with a heavy meal.

If this medicine 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 SILDENAFILO MABO-FARMA 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.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects reported with this medicine are generally mild to moderate in intensity and short in duration.

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

If you experience chest pain during or after sexual intercourse:

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

All medicines, including this medicine, 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 medicine: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

Cases of prolonged and sometimes painful erections have been reported after taking this medicine; 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.

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

Serious skin reactions have also been reported – this occurs rarely. Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, as well as fever.

Seizures or fits have also been reported – this occurs rarely.

Other adverse effects:

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

headache.

Common adverse effects (may affect up to 1 in 10 people) include: nausea, facial flushing, hot flushes (symptoms include sudden sensation of heat in the upper body), indigestion, visual disturbances (including abnormal colour vision, blurred vision or visual impairment), nasal congestion and dizziness.

Uncommon adverse effects (may affect up to 1 in 100 people) include: vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, perception of flashing lights, visual clarity, light sensitivity, watery eyes, irregular or rapid heartbeat, high blood pressure, low blood pressure, muscle pain, reduced sense of touch, dizziness, tinnitus, nausea, dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (symptoms include heartburn), chest pain, feeling of fatigue, pain in arms or legs, nosebleeds, sensation of warmth, and presence of blood in urine.

Rare adverse effects (in up to 1 in 1,000 patients) include:

irregular heartbeat, transient reduction in blood flow to parts of the brain, sensation of tightness in the throat, numbness of the mouth, bleeding at the back of 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, presence of blood in semen, dry nose, swelling inside the nose, feeling irritable, fainting, stroke, heart attack, nosebleeds, and sudden decrease or loss of hearing.

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

Cases of seizures or fits and serious skin reactions characterized by rash, blisters, skin peeling and pain requiring immediate medical attention have also been reported.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es.

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

5. Storage of Sildenafil MABO-FARMA

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from moisture.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil MABO-FARMA 50 mg

The active substance of this medicine is sildenafil. Each tablet contains 50 mg of sildenafil (as citrate).

The other components are:

Tablet core: microcrystalline cellulose, dibasic calcium phosphate, sodium croscarmellose, and magnesium stearate.

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

Appearance of the product and pack sizes

Sildenafil MABO-FARMA 50 mg tablets are film-coated, elliptical in shape, and blue in colour.

Sildenafil MABO-FARMA 50 mg is available in blister packs containing 1, 2, 4, 8, and 12 tablets per pack.

Only some pack sizes may be marketed.

Other presentations:

Sildenafil MABO-FARMA 100 mg, packs containing 4, 8, and 12 tablets.

Marketing Authorisation 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 most recent review of this leaflet: April 2022

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