Leaflet: information for the patient

Sildenafil pensa50 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take 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

Pensa Sildenafilcontains the active ingredient sildenafil, whichbelongs 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.Sildenafilwill only help you achieve an erection if you are sexually stimulated.

Pensa Sildenafilis 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 take Sildenafilo Pensa

• 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 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). PDE5 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 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 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 (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow)
• 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 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 Pensa and contact your doctor immediately.

Sildenafilo Pensa is not recommended to be taken simultaneously with any other oral or local treatment for erectile dysfunction.

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

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

The use of Sildenafilo is not indicated in women.

Special considerations in patients with renal or hepatic problems

You must inform your doctor if you have renal or hepatic problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo is not indicated in individuals under 18 years old.

Use of Sildenafilo Pensa with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The Sildenafilo Pensa 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 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 medications called nitrates, as the combination 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 lead to a 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 standing or sitting up quickly. Some patients have experienced these symptoms when taking Sildenafilo Pensa with alpha-blockers. This is more likely to occur in the 4 hours following Sildenafilo Pensa intake. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Sildenafilo Pensa. Your doctor may recommend that you start treatment with the lower dose (25 mg) of Sildenafilo.

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

Use of 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 taken with 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

The use of Sildenafilo Pensa is not indicated in women.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual starting dose is 50 mg.

Do not take Sildenafilo Pensa more than once a day.

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

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 half an hour 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 more Sildenafilo Pensa than you should

You may experience an increase in adverse 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.

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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them. The side effects reported associated with the use ofSildenafilo Pensaare generally mild to moderate in intensity and of 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 sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain – this occurs withinfrequent frequency

If it occurs during or after sexual intercourse:

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

• 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.

• Seizures or attacks – 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 a 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 in the ears, 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 to1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat,transient decrease in blood flow to some partsof 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,ocular or eyelid swelling, small particles or spots in the vision, halos aroundlights, pupil dilation, change in color of the white part of the eye, bleeding of thepene, presence of blood in semen, dry nose, nasal swelling, sensation ofirritability, 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 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 toSildenafilo.

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 national notification system included in the Spanish System of 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 reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. In this way, you will help protect the environment.

Composition of Sildenafilo Pensa

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

Appearance of the product and content of the container

Each film-coated tablet of Sildenafilo Pensa 50 mg film-coated tablets contains 50 mg of sildenafilo (as citrate).

Sildenafilo Pensa 50 mg film-coated tablets are blue, elongated, and printed.

Sildenafilo Pensa 50 mg film-coated tablets are presented in a blister pack containing 1, 4, or 8 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

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 has been reviewed in March 2022

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