Package Insert: Information for the Patient

Sildenafilo Bexal 100 mg Tablets EFG

sildenafilo

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Sildenafilo Bexal

4. Possible adverse effects

5. Storage of Sildenafilo Bexal

6. Contents of the package and additional information

Sildenafilo Bexal contains the active ingredient sildenafilo which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels of the penis, allowing blood to flow when sexually stimulated. Sildenafilo Bexal will only help you get 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 cannot obtain or maintain a firm, adequate erection for satisfactory sexual activity.

Do not takeSildenafilo Bexal

• if you are allergic to sildenafilo or any of the other ingredients of this medication (listed in section 6),
• if you are taking certain medications called nitrates, as the combination may cause a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medications, which are often used to relieve angina (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 nitrate ("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). Phosphodiesterase type 5 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 asretinitis 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 sildenafilo:

• if you have sickle cell anemia (a disorder of red blood cells), leukemia (cancer of the blood cells), 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 strain of sexual activity.
• 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 sildenafilo and contact your doctor immediately.

Sildenafilo should not be used with another oral or local treatment for erectile dysfunction.

Do not takesildenafilowith treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other phosphodiesterase type 5 inhibitor.

Do not takesildenafiloif you do not have erectile dysfunction.

Do not takesildenafiloif you are a woman.

Special considerations in patients with kidney or liver problems

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 ofsildenafilois not indicated in patients under 18 years old.

Other medications and Sildenafilo Bexal

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

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

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

Do not take sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may also cause a 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 sildenafilo.

Some patients taking an alpha-blocker, a medication used to treat high blood pressure or prostate enlargement, 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 in the 4 hours following sildenafilo intake. To reduce the likelihood of these symptoms, you should be receiving 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.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication 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 take effect if taken with a large meal.

Consuming alcohol may temporarily impair your ability to achieve an erection. To get the maximum benefit from the medication, it is recommended not to consume large amounts of alcohol before taking Sildenafilo Bexal.

Pregnancy, breastfeeding, and fertility

The use of sildenafilo is not indicated in women.

Driving and operating machinery

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

Sildenafilo Bexal 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 for this medication as indicated 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 medications that contain sildenafil in buccal tablets.

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

The tablet can be divided into quarters to facilitate swallowing.The groove is only for breaking the tablet if it is difficult to swallow it whole and not for dividing it into equal parts.If the tablet cannot be swallowed whole, the tablet can be divided and all the pieces must be taken together at the same time (or sequentially).

Dividing the Tablet

Place the tablet on a hard and smooth surface with the deeper groove facing upwards. Press with your thumb in the middle of the tablet and the tablet will break into quarters.

If you notice that the action of sildenafil is too strong or weak, inform your doctor or pharmacist.

Sildenafil will only help you get an erection if you are sexually stimulated. The time it takes for sildenafil to take effect varies from person to person, but generally ranges from half an hour to one hour. You may notice that sildenafil takes a little longer to take effect if it is taken with a large meal.

If sildenafil does 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 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 recommended by your doctor.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

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

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

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

• An allergic reaction, which occurs withlow frequency(may affect up to 1 in 100 people). Symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain, which occurs withlow frequency:

If they occur during or after sexual intercourse:

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

• Prolonged and sometimes painful erections, which occurrarely(may 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.

• Sudden decrease or loss of vision, which occursrarely.

• Severe skin reactions, which occurrarely. Symptoms may include severe peeling and swelling of the skin, blisters on the mouth, genitals, and around the eyes, fever.

• Seizures or attacks, which occurrarely.
  

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 (including symptoms such as 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, flashing lights, clear vision, light sensitivity, watery eyes
• palpitations or rapid heartbeat
• high or low blood pressure
• muscle pain
• sensation of drowsiness
• reduced sensation to touch
• dizziness
• tinnitus
• dry mouth
• nasal congestion or blockage
• inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion)
• upper abdominal pain
• gastroesophageal reflux disease (including symptoms such as heartburn)
• blood in urine
• arm or leg pain
• nosebleed
• sensation of heat
• sensation of fatigue

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

• syncope,
• stroke
• heart attack
• irregular heartbeat
• transient decrease in blood flow to some parts of the brain
• sensation of throat constriction
• mouth numbness
• 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 vision, halos around lights, pupil dilation, change in color of the white part of the eye
• penile bleeding
• blood in semen
• dry nose
• nasal swelling
• sensation 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 is worth noting that most men who experienced these side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to sildenafil.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blister packafter CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Sildenafilo Bexal Composition

• The active ingredient is sildenafilo.Each tabletcontains 100 mg of sildenafilo (as citrato).
• The other componentsare: calcium hydrogen phosphate anhydrous (E341), microcrystalline cellulose (E460), crospovidona, croscarmelosa sodium (E468), magnesium stearate (E 470b), sodium saccharin (E954), indigo carmin.

Product appearance and packaging contents

Blue-green colored tablets, round in shape, slightly speckled, with a cross-score on both faces and the imprint “100” on one face.

Diameter: 12.5 mm.

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

Packaging sizes:

1, 2, 4, 8, 12 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Bexal Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

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

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

Last review date of thisleaflet:August 2022

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