SILDENAFIL CINFA 50 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Sildenafil Cinfa 50 mg Chewable Tablets EFG

Sildenafil Citrate

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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Sildenafil 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 Sildenafil Cinfa

Do not take Sildenafil Cinfa

• If you are allergic to sildenafil or any of the other ingredients of this medication (listed in section 6).
• If you are taking medicines 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 used 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 Sildenafil 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 Sildenafil and contact your doctor immediately.

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

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

You should 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.

Other medications and Sildenafil Cinfa

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

Sildenafil 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 Sildenafil and when you took it. Do not take Sildenafil with other medications unless your doctor advises you to do so.

You should not take Sildenafil 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 Sildenafil 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 Sildenafil.

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 Sildenafil with alpha-blockers. This is more likely to happen within 4 hours of taking Sildenafil. To reduce the likelihood of these symptoms, you should be receiving your daily dose of the alpha-blocker regularly before starting Sildenafil. Your doctor may indicate that you start treatment with the lower dose (25 mg) of Sildenafil.

Taking Sildenafil Cinfa with food, drinks, and alcohol

Sildenafil can be taken with or without food. However, you may notice that this medication takes a little longer to start working 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 Sildenafil.

Pregnancy, breastfeeding, and fertility

The use of Sildenafil is not indicated in women.

Driving and using machines

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

Sildenafil 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.

Sildenafil 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 disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Sildenafil Cinfa contains sodium.

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

3. How to take Sildenafil Cinfa

Follow the administration instructions of 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 Sildenafil Cinfa more than once a day.

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

You should take Sildenafil 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 Sildenafil is too strong or too weak, inform your doctor or pharmacist.

Sildenafil will only help you achieve an erection if you are sexually stimulated. The time it takes for Sildenafil to work varies from person to person, usually between half an hour and one hour.

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

If you take more Sildenafil 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 further 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 Sildenafil are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking Sildenafil 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 may 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, 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, 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, cases of unstable angina (heart disease) and sudden death have been rarely reported. It is worth noting that most of the 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 Sildenafil.

Reporting side effects

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

5. Storage of Sildenafil Cinfa

Keep this medication out of the 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 any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sildenafil Cinfa

• The active substance is sildenafil. Each tablet contains 50 mg of sildenafil (in the form of 70.24 mg of sildenafil citrate).

• The other ingredients are: potassium polacrilin, 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 pack contents

Triangular, biconvex, white tablets engraved with "50" on one face.

They are presented in transparent PVC/PCTFE-Aluminum blister packs. Each pack contains 1, 2, 4, 8, and 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 package 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 package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/pdfs/es/p/80114/P_80114.pdf

QR code to: https://cima.aemps.es/cima/pdfs/es/p/80114/P_80114.pdf