Leaflet: information for the user

Sildenafil pensa 50 mg chewable tablets EFG

Read 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 yourdoctor, pharmacist or nurse.
• This medicine has been prescribedonlyfor you. Do not pass it on to others even if their symptoms are the same as yours,as it may harm them.
• If you experience any side effects,talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Sildenafil pensa is and what it is used for

2.What you need to know before taking Sildenafil pensa

3. How to take Sildenafil pensa

4. Possible side effects

5. Storage of Sildenafil pensa

6.Contents of the pack and additional information

Sildenafilo Pensa 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 in the penis, allowing blood to flow when sexually stimulated. Sildenafilo Pensa will only help you achieve an erection if you are sexually stimulated.

Sildenafilo Pensa is indicated for the treatment of erectile dysfunction in adult men, 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 take SildenafiloPensaThink

- If you are allergic to sildenafilo or any of the other components of this medication (listed in section 6).

- If you are taking certain medications called nitrates, as the combination may lead to a 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 nitrate ("poppers"), as the combination may lead to a dangerous drop in your blood pressure.- 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 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 Sildenafilo Pensa:

- If you have sickle cell anemia (a blood disorder), leukemia (blood cancer), or multiple myeloma (bone marrow cancer).

- If you have a penile deformity or Peyronie's disease.

- If you have heart problems. Your doctor must carefully check if your heart can handle the additional effort of having sex.

- If you have a current stomach ulcer or bleeding problems (such as hemophilia).

- If you experience sudden vision loss, stop taking Sildenafilo Pensa and contact your doctor immediately.

Do not use Sildenafilo Pensa simultaneously with any other oral or local treatment for erectile dysfunction.

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

Do not take Sildenafilo Pensa if you do not have erectile dysfunction.

Sildenafilo Pensa is not indicated for 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

Sildenafilo Pensa is not indicated for individuals under 18 years old.

Other medications and Sildenafilo Pensa

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

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

Do not take Sildenafilo Pensa if you are taking nitrates, as the combination of these medications may lead to 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 chest pain (or "chest pain").

Do not take Sildenafilo Pensa if you are taking medications called nitric oxide donors, such as amyl nitrate ("poppers"), as the combination may also lead to a dangerous drop in your blood pressure.

If you are taking medications known as protease inhibitors, such as those used to treat HIV, your doctor may recommend starting 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 Pensa with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafilo Pensa. To reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blocker regularly before starting Sildenafilo Pensa. Your doctor may recommend starting treatment with the lower dose (25 mg) of sildenafilo.

Inform your doctor or pharmacist if you are taking medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Pensa with food, drinks, and alcohol

Sildenafilo Pensa can be taken with or without food. However, you may notice that Sildenafilo Pensa takes a bit longer to take effect if you eat 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 Sildenafilo Pensa.

Pregnancy, breastfeeding, and fertility

Sildenafilo Pensa is not indicated for women.

Driving and operating machinery

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

Sildenafilo Pensa contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Sildenafilo Pensa contains aspartame

This medication may be harmful to individuals with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. The recommended starting dose is 50 mg.

Do not take Sildenafilo Pensa more than once a day.

Take Sildenafilo Pensa approximately one hour before planning to have sexual intercourse. The tablet must be chewed and swallowed.

If you notice that the effect of Sildenafilo Pensa is too strong or weak, inform your doctor or pharmacist.

Sildenafilo Pensa will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafilo Pensa to take effect varies from person to person, generally ranging from 30 minutes to one hour. The effect of Sildenafilo Pensa may be delayed if taken with a large meal.

If Sildenafilo Pensa 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 moreSildenafiloPensa than you should

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

Do not take more tablets than indicated by your doctor.

Contact your doctor if you have taken more tablets than advised.

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 Sildenafilo Pensa are generally of mild to moderate intensity and short duration.

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

• Allergic reaction – this occurs withinfrequent frequency(may affect up to 1 in 100 people).

The symptoms include sudden hissing when breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain – this occurs withinfrequent frequency.

If they occur during or after sexual intercourse:

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

2. Prolonged and sometimes painful erections – this occursinfrequently(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 loss or decrease in vision – this occursinfrequently.

• Severe skin reactions – this occursinfrequently.

The symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures – this occursinfrequently.

Other side effects:

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

Common(may affect up to 1 in 10 people): nausea, facial flushing, warmth (including sudden sensation of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual deterioration, nasal congestion, and dizziness.

Infrequent(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, tinnitus, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (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, nasal bleeding, feeling of heat, and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of the brain, sensation 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 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, feeling of irritability, and 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 pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to Sildenafilo.

Reporting 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 the Spanish 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.

• Keep out of the sight and reach of children.
• Store in the original packaging to protect it from light.
• This medication does not require any special storage temperature.
• Do not use Sildenafilo Pensa after the expiration date that appears on the packaging after CAD. Theexpiration date is the last day of the month indicated.

• Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Sildenafilo Pensa 50 mg

• The active ingredient is sildenafilo. Each chewable tablet contains 70.24 mg of

sildenafilo citrate equivalent to 50 mg of sildenafilo.

• The other components are: potassium polacrilex, magnesium stearate, anhydrous colloidal silica,

aspartame (E-951), croscarmellose sodium, peppermint essence, lactose monohydrate, and povidone K-30.

Appearance of the product and content of the packaging

The chewable tablets of Sildenafilo Pensa 50 mg are white, triangular, and biconvex. They are engraved with a “50”on one face.

The chewable tablets are presented in blisters containing 4, 8, and 12 chewable tablets.They may only be commercially marketedin some package sizes.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

Genepharm, S.A

18 kmMarathon Avenue.

153 51 Pallini Attikis (Greece)

This medicine is authorized in the member states of the European Economic Area with

the following names:

PT: Sildenafil toLife, 50 mg, chewable tablets

IT: Sildenafil Pensa Pharma 50 mg, chewable tablets

ES:Sildenafilo Pensa 50 mg chewable tablets EFG

Last review date of this leaflet:December 2023

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