SILDENAFIL PENSA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafil Pensa100 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Sildenafil Pensa contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafil will only help you to get an erection if you are sexually stimulated.

Sildenafil Pensa is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take Sildenafil Pensa

Do not take Sildenafil Pensa

• If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination can cause a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are not sure, consult your doctor or pharmacist.
• If you are using any of the medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a decrease 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 shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.
• If you have a severe 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 a loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Sildenafil Pensa:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow).
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you currently have a stomach ulcer or bleeding problems (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafil Pensa and contact your doctor immediately.

It is not recommended to take Sildenafil Pensa at the same time as any other oral or local treatment for erectile dysfunction.

You must not take Sildenafil with treatments for pulmonary arterial hypertension (PAH) that contain 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 kidney or liver problems

You should 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 persons under 18 years of age.

Use of Sildenafil Pensa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Sildenafil Pensa tablets may interfere with some medicines, especially those used to treat angina pectoris. In case of a medical emergency, you should 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 your doctor advises you to.

You must not take Sildenafil Pensa if you are taking medicines called nitrates, as the combination of these medicines can cause a dangerous decrease 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 pectoris (or "chest pain").

You must not take Sildenafil Pensa if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these products can also cause a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines 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 Sildenafil.

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness that can be caused by a decrease 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 happen within 4 hours of taking Sildenafil. To minimize the likelihood of these symptoms, you should be taking your daily dose of the alpha-blocker regularly before starting Sildenafil. Your doctor may advise you to start treatment with the lower dose (25 mg) of Sildenafil.

Medicines containing sacubitril/valsartan, used to treat heart failure.

Use of Sildenafil Pensa with food, drinks, and alcohol

Sildenafil Pensa can be taken with or without food. However, you may notice that Sildenafil Pensa takes a little longer to work if you take it with a large meal.

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

Pregnancy, breast-feeding, 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 using machines.

3. How to take Sildenafil Pensa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again. The normal starting dose is 50 mg.

Do not take Sildenafil Pensa more than once a day.

You should take Sildenafil Pensa about one hour before you plan to have sex. Swallow the tablet whole with a glass of water.

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

Sildenafil Pensa will only help you to get an erection if you are sexually stimulated. The time Sildenafil Pensa takes to work varies from person to person, but it normally takes between half an hour and one hour. The effect of Sildenafil Pensa may be delayed if you take it with a large meal.

If Sildenafil Pensa does not help you to get 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 side effects and their severity. Doses above 100 mg do not increase efficacy.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

Do not take more tablets than your doctor recommends.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects reported in association with the use of Sildenafil Pensa are usually mild to moderate and of short duration.

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

• Allergic reaction – this occurs with rare frequency(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 with rare frequency

If they occur during or after sex:

• Sit in a semi-upright position and try to relax
• Do not use nitratesto treat chest pain

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

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

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

• Severe skin reactions – this occurs very rarely,

Symptoms can include severe skin peeling and swelling, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits – this occurs very rarely.

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, feeling hot (including a feeling of warmth or heat in the upper body), indigestion, abnormal color perception, 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 flashes of light, increased sensitivity to light, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose (including symptoms such as runny nose, sneezing, and nasal congestion), inflammation of the lining of the nose (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of tightness in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most men who experienced side effects, although not all of them, had heart problems before taking this medicine. It is not possible to determine whether these side effects were directly related to Sildenafil.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafil Pensa

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafil Pensa

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

Appearance of the product and contents of the pack

Each Sildenafil Pensa 100 mg film-coated tablet contains 100 mg of sildenafil (as citrate).

Sildenafil Pensa 100 mg film-coated tablets are blue, elongated, and engraved.

Sildenafil Pensa 100 mg film-coated tablets are presented in blisters containing 4 or 8 tablets.

Marketing authorization holder and manufacturer:

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 revised in March 2022

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