Sildenafil Bexal 100 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sildenafil Bexal 100 mg tablets EFG

sildenafil

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Sildenafilo Bexal contains the active substance sildenafil, which 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 the penis when sexually stimulated. Sildenafilo Bexal will only help you achieve an erection if you are sexually stimulated.

Sildenafilo Bexal is indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Bexal

Do not take Sildenafil Bexal

• if you are allergic 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 dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often used to relieve angina (or “chest pain”). If you are unsure, consult your doctor or pharmacist,
• if you are using any nitric oxide donor medicines 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 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 sildenafil:

• if you have sickle cell anemia (a disorder of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of the bone marrow),
• if you have penile deformity or Peyronie’s disease,
• if you have heart problems. In this case, your doctor should carefully assess whether your heart can tolerate the added 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 sildenafil and contact your doctor immediately.

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

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

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

You should not take sildenafil if you are a woman.

Special considerations in patients with kidney or liver problems

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

Children and adolescents

The use of sildenafil is not recommended in individuals under 18 years of age.

Other medicines and Sildenafil Bexal

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

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking sildenafil and when you took it. Do not take sildenafil with other medicines unless advised by your doctor.

Do not take sildenafil if you are taking medicines called nitrates, as the combination may cause a dangerous drop in blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina (or “chest pain”).

Do not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination may also cause a dangerous drop in blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend starting treatment with the lowest dose (25 mg) of sildenafil.

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

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Bexal with food, drinks, and alcohol

Sildenafil Bexal can be taken with or without food. However, you may notice that Sildenafil Bexal takes longer to work if taken with a heavy meal.

Alcohol consumption may temporarily impair your ability to achieve an erection. To get the maximum benefit from the medicine, it is advised not to drink large amounts of alcohol before taking Sildenafil Bexal.

Pregnancy, breastfeeding, and fertility

The use of sildenafil is not indicated in women.

Driving and using machines

Sildenafil may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.

Sildenafil Bexal contains sodium

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

3. How to take Sildenafil Bexal

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafil Bexal more than once a day.

Do not take Sildenafil Bexal tablets together with medicines containing sildenafil in orodispersible tablets.

You should take sildenafil approximately one hour before you plan to have sexual intercourse. Swallow the tablet with a glass of water.

The tablet may be divided into quarters to facilitate swallowing. The score mark is intended solely for ease of breaking the tablet if you find it difficult to swallow it whole, and not for dividing it into equal parts. If the tablet cannot be swallowed whole, it may be divided, and all pieces must be taken together at the same time (or sequentially).

Tablet division

Place the tablet on a hard, flat surface with the deeper groove facing upwards. Press your thumb at the center of the tablet, and it will break into quarters.

If you notice that 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 required for sildenafil to take effect varies from person to person, but generally ranges between half an hour and one hour. You may notice that sildenafil takes slightly longer to work if taken with a heavy meal.

If sildenafil 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 Sildenafil Bexal 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.

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

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

4. Possible adverse effects

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

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

• An allergic reaction, which occurs uncommonly (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 uncommonly:

If chest pain occurs during or after sexual activity:

• Sit in a semi-upright position and try to relax.

• Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections, which occur rarely (may affect up to 1 in 1,000 people). If you have an erection lasting more than 4 hours, you must contact your doctor immediately.

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

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

• Seizures or fits, which occur rarely.

Other adverse effects:

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

• headache.

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

• nausea
• facial flushing
• hot flushes (symptoms include a sudden feeling of warmth in the upper body)
• indigestion
• abnormal colour vision, 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, perception of flashing lights, visual clarity, light sensitivity, watery eyes
• palpitations or rapid heartbeat
• high or low blood pressure
• muscle pain
• drowsiness
• reduced sensation to touch
• vertigo
• tinnitus (ringing in the ears)
• 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)
• presence of blood in urine
• pain in arms or legs
• nosebleeds
• feeling of warmth
• feeling of fatigue

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

• fainting
• stroke
• heart attack
• irregular heartbeat
• transient reduction in blood flow to certain parts of the brain
• throat tightness
• numbness of the mouth
• bleeding behind 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 the colour of the white part 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, rare cases of unstable angina (heart disease) and sudden death have been reported. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to sildenafil.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Bexal

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

Do not use this medicine after the expiry date stated on the carton and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Sildenafil Bexal

• The active substance is sildenafil. Each tablet contains 100 mg of sildenafil (as citrate).
• The other components are: anhydrous calcium hydrogen phosphate (E341), microcrystalline cellulose (E460), crospovidone, sodium croscarmellose (E468), magnesium stearate (E470b), sodium saccharin (E954), indigo carmine.

Appearance of the product and contents of the pack

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

Diameter: 12.5 mm.

The tablets are packed in blisters made of polyvinyl chloride-Aclar/aluminum or PVC/PVDC/aluminum.

Pack sizes:

1, 2, 4, 8, 12 tablets.

Only some pack sizes may be commercially available.

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 Warsaw

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Sempavox 100 mg tabletter

Estonia: Sempavox 100 mg tabletid

Greece: Sempavox 100 mg δισκ?α

Netherlands: Sempavox 100 mg, tabletten

Lithuania: Sempavox 100 mg tabletes

Latvia: Sempavox 100 mg tabletes

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

Date of the most recent revision of this package leaflet: August 2022

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