SILDENAFIL CINFA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

sildenafilo cinfa 25 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is sildenafilo cinfa and what is it used for
2. What you need to know before taking sildenafilo cinfa
3. How to take sildenafilo cinfa
4. Possible side effects
5. Storage of sildenafilo cinfa
6. Package Contents and Additional Information

1. What is sildenafilo cinfa and what is it used for

sildenafilo cinfa contains the active ingredient sildenafilo, which belongs to a group of medications called phosphodiesterase type 5 inhibitors (PDE5). It works by dilating the blood vessels of the penis, allowing blood flow when sexually stimulated. Sildenafilo will only help you achieve an erection if you are sexually stimulated.

Sildenafilo is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot obtain or maintain a firm erection suitable for satisfactory sexual activity.

2. What you need to know before taking sildenafilo cinfa

Do not take sildenafilo cinfa

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

• If you are taking medications called nitrates, as the combination can lead to a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medications, which are often administered to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.

• If you are using any medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can lead to a dangerous decrease 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 blood clots). PDE5 inhibitors, such as sildenafilo, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

• If you have a serious heart or liver problem.

• If you have recently experienced 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 vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take sildenafilo cinfa.

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

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

• If you have heart problems. Your doctor should carefully check if your heart can withstand the extra effort of having sex.

• If you currently have stomach ulcers or bleeding problems (such as hemophilia).

• If you experience a sudden decrease or loss of vision, stop taking sildenafilo and contact your doctor immediately.

It is not recommended to use sildenafilo simultaneously with any other oral or local treatment for erectile dysfunction.

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

You should not take sildenafilo if you do not have erectile dysfunction. The use of sildenafilo 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

Taking sildenafilo is not indicated in persons under 18 years of age.

Other Medications and sildenafilo cinfa

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

The sildenafilo tablets may interfere with some medications, especially those used to treat chest pain. In case of a medical emergency, you should inform your doctor, pharmacist, or nurse that you are taking this medication and when you took it. Do not take sildenafilo with other medications unless your doctor advises you to do so.

You should not take sildenafilo if you are taking medications called nitrates, as the combination of these medications can lead to a dangerous decrease 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 angina pectoris (or "chest pain").

You should not take sildenafilo if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications can also lead to a dangerous decrease in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

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

If you are taking medications known as protease inhibitors, such as those used in the treatment of HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of sildenafilo.

Some patients who are receiving an alpha-blocker, a medication used to treat high blood pressure or prostatic hyperplasia, 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 sildenafilo cinfa with alpha-blockers. This is more likely to occur within 4 hours of taking sildenafilo.

In order to reduce the likelihood of these symptoms occurring, you should be receiving your daily dose of the alpha-blocker regularly before starting sildenafilo. Your doctor may indicate that you start treatment with the lower dose (25 mg) of sildenafilo.

Taking sildenafilo cinfa with Food, Drinks, and Alcohol

Sildenafilo can be taken with or without food. However, you may notice that this medication takes a little longer to take effect if you take it with a heavy meal.

Consuming alcohol can temporarily make it more difficult 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.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Taking sildenafilo is not indicated in women.

Driving and Using Machines

Sildenafilo can cause dizziness and affect vision. You should know how you react to this medication before driving vehicles or using machinery.

sildenafilo cinfa contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to Take sildenafilo cinfa

Follow the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Do not take sildenafilo more than once a day.

Do not take sildenafilo film-coated tablets with sildenafilo cinfa chewable tablets.

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

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

Sildenafilo will only help you achieve an erection if you are sexually stimulated. The time it takes for sildenafilo to take effect varies from person to person, usually between half an hour and one hour. The effect of sildenafilo can be delayed if you take it with a heavy meal.

In case sildenafilo does not help you achieve an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more sildenafilo cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The side effects reported in association with the use of sildenafilo are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking sildenafilo 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(may affect up to 1 in 100 people).

If they appear during or after having 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 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 rarely(may affect up to 1 in 1,000 people).

• Severe skin reactions - this occurs rarely(may affect up to 1 in 1,000 people).

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 rarely(may affect up to 1 in 1,000 people).

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, hot flushes (including symptoms such as a sudden feeling of heat in the upper body), indigestion, abnormal color perception, blurred vision, visual impairment, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, vision of flashing lights, visual clarity, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced sense of touch, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, inflammation of the nasal mucosa (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 the urine, pain in the arms or legs, nosebleeds, feeling of heat, and feeling of fatigue.

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, feeling of compression in the throat, numbness of the mouth, bleeding in the back of 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, dilation of the pupil of the eye, change in color of the white of the eye, penile bleeding, presence of blood in the semen, dry nose, swelling of the inside of the nose, feeling of irritability, and sudden decrease or loss of hearing.

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of sildenafilo cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions. Do not use this medication after the expiration date shown on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Collection Point in the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of sildenafilo cinfa

• The active ingredient is sildenafilo. Each film-coated tablet contains 25 mg of sildenafilo (in the form of 35.12 mg of sildenafilo citrate).
• The other components are:

Core:Microcrystalline cellulose (E-460), anhydrous calcium hydrogen phosphate (E-341), sodium croscarmellose, hypromellose (E-464), anhydrous colloidal silica, and magnesium stearate.

Coating:Hypromellose/ hypromellose (E-464), polydextrose (E-1200), titanium dioxide (E-171), carmine indigo (E-132), talc (E-553b), maltodextrin, medium-chain triglycerides, yellow iron oxide (E-172), and triacetin.

Appearance of the Product and Package Contents

The sildenafilo cinfa 25 mg film-coated tablets are blue, triangular, biconvex, and marked with "25" on one face.

They are presented in blisters packaged in boxes containing 1, 4, 8, or 12 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

Genepharm S.A.,

18 Km Marathon Avenue,

15351 Pallini, Greece

Date of the Last Revision of this Package Leaflet:May 2022

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80060/P_80060.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80060/P_80060.html