Sildenafil Pensa 50 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sildenafil Pensa 50 mg chewable tablets EFG

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

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. How to store Sildenafil Pensa
6. Contents of the pack and other information

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

Sildenafilo Pensa contains the active substance 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 in when you are 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 achieve or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking Sildenafil Pensa

Do not take Sildenafil Pensa

• 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 lead to a dangerous drop in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often administered 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 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 suffer 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 Sildenafil Pensa:

• If you have sickle cell anemia (an abnormality 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. 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 Sildenafil Pensa and contact your doctor immediately.

The use of Sildenafil Pensa is not recommended simultaneously with any other oral or local treatment for erectile dysfunction.

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

You must not take Sildenafil Pensa if you do not have erectile dysfunction.

The use of Sildenafil Pensa is not indicated in women.

Special considerations in patients with renal impairment or hepatic 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 Pensa is not indicated in individuals under 18 years of age.

Other medicines and Sildenafil Pensa

Consult your doctor or pharmacist about any medicines you are taking, have recently taken, or might need to take.

Sildenafil Pensa 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 Pensa and when you took it. Do not take Sildenafil Pensa with other medicines unless advised by your doctor.

Do not take Sildenafil Pensa if you are taking medicines called nitrates, as the combination of these medicines 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 pain (or "chest pain").

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

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 receiving 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 Pensa with alpha-blockers. This is more likely to occur within 4 hours after taking Sildenafil Pensa. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of your alpha-blocker before starting Sildenafil Pensa. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.

Inform your doctor or pharmacist if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Sildenafil Pensa with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Sildenafil Pensa is not indicated for use in women.

Driving and using machines

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

Sildenafil Pensa contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Sildenafil Pensa contains aspartame

This medicine may be harmful to people with phenylketonuria, as it contains aspartame, a source of phenylalanine.

3. How to take SildenafiloPensa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts. The recommended starting dose is 50 mg.

Sildenafilo Pensa must not be taken more than once a day.

Take Sildenafilo Pensa approximately one hour before you plan to have sexual intercourse. The tablet should be chewed and swallowed.

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

Sildenafilo Pensa will only help you achieve an erection if you are sexually stimulated. The time Sildenafilo Pensa takes to work varies from person to person, usually ranging between half an hour and one hour. The effect of Sildenafilo Pensa may be delayed if taken with a heavy 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 more SildenafiloPensa 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.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91.562.04.20, indicating the medicine and the amount ingested.

Do not take more tablets than indicated by your doctor.

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

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 can cause adverse effects, although not everyone experiences them. The adverse effects reported with Sildenafilo Pensa are generally mild to moderate in intensity and short in duration.

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

• Allergic reaction – this 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 – this 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.

2. Prolonged and sometimes painful erections – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection lasting more than 4 hours, contact your doctor immediately.

• Sudden decrease or loss of vision – this occurs rarely.

• Severe skin reactions – this occurs rarely.

Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – this occurs 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, feeling hot (symptoms include sudden sensation of heat in the upper body), indigestion, abnormal colour vision, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, 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), blood in urine, pain in arms or legs, nosebleeds, feeling hot, and fatigue.

Rare (may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to parts of the brain, tightness in the throat, 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, dilated pupil, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Pensa

• Keep out of sight and reach of children.

• Store in the original packaging to protect from light.

• This medicine does not require any special storage temperature.

• Do not use Sildenafil Pensa after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Sildenafil Pensa 50 mg

• The active substance is sildenafil. Each chewable tablet contains 70.24 mg of

sildenafil citrate equivalent to 50 mg of sildenafil.

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

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

Appearance of the medicine and contents of the pack

Sildenafil Pensa 50 mg chewable tablets are white, triangular and biconvex. They are marked with a "50" on one side.

Chewable tablets are presented in blisters containing 4, 8 and 12 chewable tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Genepharm, S.A

18 km Marathon Avenue.

153 51 Pallini Attikis (Greece)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PT: Sildenafil toLife, 50 mg, chewable tablets

IT: Sildenafil Pensa Pharma 50 mg, chewable tablets

ES: Sildenafil Pensa 50 mg chewable tablets EFG

Date of the most recent revision of this leaflet: December 2023

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