Sildenafil Pensa 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sildenafil Pensa 50 mg film-coated 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 or pharmacist.
• 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 adverse 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 sildenafil, which belongs to a group of medicines known as phosphodiesterase type 5 (PDE5) inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow into the penis when sexually stimulated. Sildenafil 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 starting to take 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 nitrite (“poppers”), as the combination may cause a 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 starting to take Sildenafil Pensa:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of blood cells), or multiple myeloma (cancer of bone marrow).
• If you have a 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.

It is not recommended to take Sildenafil Pensa simultaneously with any other oral or local treatment for erectile dysfunction.

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

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

The use of Sildenafil is not indicated in women.

Special considerations in patients with renal or hepatic impairment

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 indicated in individuals under 18 years of age.

Taking Sildenafil Pensa with other medicines

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

Sildenafil Pensa 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 Pensa and when you took it. You must not take Sildenafil Pensa with other medicines unless your doctor advises you to do so.

You must not take Sildenafil Pensa if you are taking medicines called nitrates, as the combination of these medicines may lead to 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 pain (or “chest pain”).

You must not take Sildenafil Pensa if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination of these products may also lead to a dangerous drop in your 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 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. 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 the lowest dose (25 mg) of Sildenafil.

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.

Drinking alcohol may temporarily impair your ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advised not to consume large amounts of alcohol before taking Sildenafil Pensa.

Pregnancy, breastfeeding, and fertility

The use of Sildenafil Pensa is not indicated 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.

3. How to take Sildenafil Pensa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual starting dose is 50 mg.

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

Take Sildenafil Pensa approximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.

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

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

If Sildenafil 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 Sildenafil Pensa than you should

You may experience an increase in the frequency and severity of adverse 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.

Do not take more tablets than recommended by your doctor.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects reported with Sildenafilo Pensa are generally mild to moderate in intensity and short-lived.

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

• 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, you must contact your doctor immediately.

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

• Severe skin reactions – this occurs rarely,

Symptoms may include severe peeling and swelling of the skin, 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, hot flush (symptoms include sudden feeling of warmth in the upper body), indigestion, colour vision abnormalities, blurred vision, visual disturbance, nasal congestion and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye haemorrhage/red eyes, eye pain, perception of flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus, 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 of warmth 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, throat tightness, mouth numbness, 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 colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, 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 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 effects, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the national reporting system included in 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 the reach and sight of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater 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 unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Pensa

• The active substance is sildenafil.
• The other components are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, hypromellose, titanium dioxide (E 171), polyethylene glycol 6000 (macrogol 6000), talc and indigo carmine lake (E 132).

Appearance of the product and contents of the pack

Each Sildenafil Pensa 50 mg film-coated tablet contains 50 mg of sildenafil (as citrate).

Sildenafil Pensa 50 mg film-coated tablets are blue, elongated and imprinted.

Sildenafil Pensa 50 mg film-coated tablets are available in blisters containing 1, 4 or 8 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid, Spain

or

LABORATORIOS LICONSA, S.A.
Avenida Miralcampo, 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares – Guadalajara, Spain

This leaflet was last reviewed in March 2022

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/