SILDENAFIL CINFA 100 mg CHEWABLE TABLETS

Introduction

Leaflet: information for the patient

sildenafilo cinfa 100 mg chewable tablets EFG

Sildenafil citrate

Read the entire leaflet carefully before starting to take this medication, 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 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 not listed in this leaflet. See section 4.

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

sildenafilo cinfa 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 sildenafil 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 like sildenafil 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 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 a loss of vision 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 penis 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 a stomach ulcer 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 sildenafil 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

The use of 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.

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 sildenafilo 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 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 sildenafilo with alpha-blockers. This is more likely to occur within 4 hours of taking sildenafilo. To reduce the likelihood of these symptoms, you should be taking 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 get 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

The use of sildenafilo is not indicated in women.

Driving and using machines

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

sildenafilo cinfa contains lactose.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

sildenafilo cinfa contains aspartame.

This medication contains 8.6 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

sildenafilo cinfa contains sodium.

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

3. How to take sildenafilo cinfa

Follow the administration instructions for this medication exactly as 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 cinfa more than once a day.

Do not take sildenafilo chewable tablets with film-coated tablets that contain sildenafil, including sildenafil film-coated tablets.

You should take sildenafilo approximately one hour before you plan to have sex.

The tablet should be chewed and swallowed.

Chewable tablets should be taken on an empty stomach, as you will notice that it takes longer to start working if you take it with a heavy meal.

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.

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, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets 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 - rare side effects(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 - rare side effects(may affect up to 1 in 100 people).

If they occur 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 - very rare side effects(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 - very rare side effects(may affect up to 1 in 1,000 people).

• Severe skin reactions - very rare side effects(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 - very rare side effects(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 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, 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, blocked or congested sinuses, 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 warmth, and feeling of fatigue.

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 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 the vision, seeing halos around lights, dilation of the pupil, change in the color of the white of the eye, penile bleeding, presence of blood in the semen, dry nose, swelling inside 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 is noteworthy 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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: 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 any special storage temperature.

Keep it in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears 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 sildenafil. Each tablet contains 100 mg of sildenafil (in the form of 140.48 mg of sildenafil citrate).
• The other components are: potassium polacrylate, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E-951), sodium croscarmellose, peppermint flavor (composed of corn maltodextrin, modified corn starch, and peppermint oil (mentha arvensis)), magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

Appearance of the product and package contents

Triangular, biconvex tablets, white in color, and engraved with "100" on one side.

They are presented in transparent PVC/PCTFE-Aluminum blisters. Each package contains 1, 4, 8, 12 chewable 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.,

18th Marathon Av. 153 51 Pallini Attikis, - Greece

or

PHARMADOX HEALTHCARE Ltd.,

KW20A Kordin Industrial Park, Paola PLA 3000, Malta

Date of the last revision of this leaflet:May 2022

Detailed and updated information on 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 leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/80115/P_80115.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80115/P_80115.html