SILDENAFIL BEXAL 100 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafilo Bexal 100 mg film-coated tablets EFG

sildenafilo

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

Sildenafilo Bexal contains the active substance sildenafilo, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels in the penis, allowing blood to flow in when you are sexually stimulated. Sildenafilo Bexal will only help you to get an erection if you are sexually stimulated.

Sildenafilo Bexal is indicated for the treatment of erectile dysfunction in adult men, sometimes also called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take Sildenafilo Bexal

Do not takeSildenafilo Bexal

• if you are allergic to sildenafilo or any of the other ingredients of this medicine (listed in section 6),
• if you are taking medicines called nitrates, as the combination can cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are not sure, consult your doctor or pharmacist,
• if you are using any of the medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can 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 sildenafilo, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, 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 disease (such as retinitis pigmentosa),
• if you have previously experienced a loss of vision due to a non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take sildenafilo:

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

Sildenafilo should not be used with other oral or local treatments for erectile dysfunction.

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

You should not take sildenafilo if you do not have erectile dysfunction.

You should not take sildenafilo if you are a woman.

Special considerations in patients with kidney or liver problems

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 sildenafilo is not indicated in children under 18 years of age.

Other medicines and Sildenafilo Bexal

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

Sildenafilo tablets may interfere with some medicines, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor, pharmacist, or nurse that you are taking sildenafilo and when you took it. Do not take sildenafilo with other medicines unless your doctor advises you to.

You should not take sildenafilo if you are taking medicines called nitrates, as the combination of these products can cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

You should not take sildenafilo if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can also cause a dangerous drop in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines 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 sildenafilo.

Some patients who are taking an alpha-blocker, a medicine used to treat high blood pressure or an enlarged prostate, may experience dizziness or lightheadedness that can be 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 happen within the first 4 hours after taking sildenafilo. To minimize the likelihood of these symptoms, you should be taking a regular daily dose of the alpha-blocker before starting sildenafilo. Your doctor may recommend that you start treatment with a lower dose (25 mg) of sildenafilo.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine that contains sacubitril/valsartan, used to treat heart failure.

TakingSildenafilo Bexalwith food, drinks, and alcohol

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

Consuming alcohol can temporarily impair your ability to get an erection. To get the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking Sildenafilo Bexal.

Pregnancy, breast-feeding, and fertility

The use of sildenafilo is not indicated in women.

Driving and using machines

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

Sildenafilo Bexal contains sodium

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

3. How to take Sildenafilo Bexal

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafilo Bexal more than once a day.

Do not take Sildenafilo Bexal tablets with medicines that contain sildenafilo in orodispersible tablets.

You should take sildenafilo about one hour before you plan to have sex. Swallow the tablet with a glass of water.

The tablet can be divided into quarters to facilitate swallowing. The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole and not to divide it into equal parts. If the tablet cannot be swallowed whole, the tablet can be broken and all the pieces should be taken together at the same time (or sequentially).

Dividing the tablet

Place the tablet on a hard and flat surface with the deepest score line facing up. Press with your thumb in the middle of the tablet and the tablet will break into quarters.

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

Sildenafilo will only help you to get an erection if you are sexually stimulated. The time it takes for sildenafilo to work varies from person to person, but it usually takes between half an hour and one hour. You may notice that sildenafilo takes a little longer to work if you take it with a large meal.

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

If you take moreSildenafilo Bexalthan 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 your doctor recommends.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount used.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of sildenafilo are usually mild to moderate and of short duration.

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

• An allergic reaction, which occurs with rare frequency(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, which occurs with rare frequency:

If they occur during or after having sex:

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

• Prolonged and sometimes painful erections, which occur very 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.

• Sudden decrease or loss of vision, which occurs very rarely.

• Severe skin reactions, which occur very rarely. Symptoms can include severe skin peeling and swelling, blisters in the mouth, genitals, and around the eyes, fever.

• Seizures or fits, which occur very rarely.

Other side effects:

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

• headache.

Common(may affect up to 1 in 10 people):

• nausea
• flushing
• hot flushes (among the symptoms is a sudden feeling of heat in the upper body)
• indigestion
• abnormal color perception, blurred vision, visual disturbance,
• nasal congestion
• dizziness

Uncommon(may affect up to 1 in 100 people):

• vomiting
• skin rash
• eye irritation, eye discharge/ red eyes, eye pain, blurred vision, visual clarity, sensitivity to light, watery eyes
• palpitations or rapid heartbeat
• high or low blood pressure
• muscle pain
• feeling of drowsiness
• reduced sense of touch
• vertigo
• ringing in the ears
• dry mouth
• blockage or congestion of the nasal passages
• inflammation of the nasal mucosa (among the symptoms are runny nose, sneezing, and nasal congestion)
• upper abdominal pain
• gastroesophageal reflux disease (among the symptoms is heartburn)
• blood in urine
• arm or leg pain
• nasal bleeding
• feeling of warmth
• feeling of tiredness

Rare(may affect up to 1 in 1,000 people):

• fainting,
• stroke
• heart attack
• irregular heartbeat
• temporary reduction in blood flow to some parts of the brain
• feeling of tightness in the throat
• numbness in the mouth
• bleeding in the back of the eye
• double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye
• penile bleeding
• blood in semen
• dry nose
• swelling inside the nose
• feeling of irritability
• sudden decrease or loss of hearing

During post-marketing experience, cases of unstable angina (heart disease) and sudden death have been reported very rarely. It is noteworthy that most of the men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to sildenafilo.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Bexal

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafilo Bexal

• The active substance is sildenafilo. Each tablet contains 100 mg of sildenafilo (as citrate).
• The other ingredients are: anhydrous calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), crospovidone, sodium croscarmellose (E468), magnesium stearate (E 470b), sodium saccharin (E954), indigo carmine.

Appearance of the product and pack contents

Light blue, round, slightly speckled tablets with a cross-score on both sides and engraved "100" on one side.

Diameter: 12.5 mm.

The tablets are packaged in blisters of polyvinyl chloride-Aclar/Aluminum or PVC/PVDC/Aluminum.

Package sizes:

1, 2, 4, 8, 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bexal Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova, 57

SLO-1526 Ljubljana,

Slovenia

or

Lek S.A.

Domaniewska 50 C

02-672 Varsovia

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu Mures

Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Sempavox 100 mg tablets

Estonia: Sempavox 100 mg tablets

Greece: Sempavox 100 mg δισκ?α

Netherlands: Sempavox 100 mg, tablets

Lithuania: Sempavox 100 mg tablets

Latvia: Sempavox 100 mg tablets

United Kingdom and in the United Kingdom (Northern Ireland): Sempavox 100 mg Tablets

Date of thelast revision of thisleaflet:August 2022

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