Leaflet: information for the patient

sildenafilo cinfa 50 mg chewable tablets EFG

Sildenafil citrate

Read this leaflet carefully before you start taking this medicine, because 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.

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

Sildenafilo cinfais indicated for the treatment of erectile dysfunction in adult men, sometimes referred to as impotence. This occurs when a man is unable to obtain or maintain a firm, satisfactory erection for sexual activity.

Do not take sildenafilo cinfa

• If you are allergic to sildenafilo or any of the other ingredients 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 nitrite ("poppers"), as the combination may lead to a dangerous 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 like 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 serious 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 disorder (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 blood disorder), leukemia (blood 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 handle the additional strain of sexual activity.
• If you 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.

Do not use sildenafilo 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 should 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.

Other medications and sildenafilo cinfa

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

Sildenafilo tablets may interact 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 not take sildenafilo if you are taking nitrates, as the combination of these medications 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 if you are taking medications called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medications may also lead to a dangerous drop 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 HIV treatment, 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 with alpha-blockers. This is more likely to occur in the 4 hours following sildenafilo intake. To reduce the likelihood of these symptoms, you should be receiving your regular daily dose of the alpha-blocker before starting sildenafilo. Your doctor may recommend 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 eat 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.

Pregnancy, breastfeeding, and fertility

The use of sildenafilo is not indicated in women.

Driving and operating machinery

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

sildenafilo cinfa contains lactose.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, 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 may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

sildenafilo cinfa contains sodium.

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

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 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 sexual intercourse.

The tablet must be chewed and swallowed.

Chewable tablets should be taken on an empty stomach, as you will notice that it takes longer to start taking effect if taken with a large 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 take effect varies from person to person, usually ranging from 30 minutes to one hour.

If sildenafil 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 sildenafil cinfa than you should

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

You may experience an increase in adverse 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects reported associated with the use ofsildenafilare generally mild to moderate in intensity and of short duration.

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

• Allergic reaction -infrequent side effects(may affect up to 1 in 100 people). Symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain -infrequent side effects (may affect up to 1 in 100 people).

If they occur during or after sexual intercourse:

• Prolonged and sometimes painful erections -rare side effects(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 decrease or loss of vision -rare side effects (may affect up to 1 in 1,000 people).

• Severe skin reactions -rare side effects (may affect up to 1 in 1,000 people). Symptoms may include severe peeling and swelling of the skin, vesiculation of the mouth, genitals, and around the eyes, as well as fever.

• Convulsions or seizures -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, warmth (including symptoms such as sudden heat sensation 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 vision, 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 to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, transient decrease in blood flow to some parts of 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, eye swelling or eyelid swelling, small particles or spots in vision, halos around lights, pupil dilation, change in color of the white part of the eye, bleeding of the penis, blood in semen, dry nose, nasal congestion, swelling of the nasal interior, feeling of irritability, 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 these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related tosildenafil.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require any special temperature for conservation.

Store in the original packaging to protect it from light.

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.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Sildenafil Cinfa Composition

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

• The other components are: potassium polacrilex, anhydrous colloidal silica, lactose monohydrate, povidone K-30, aspartame (E-951), croscarmellose sodium, peppermint flavor (made up of corn maltodextrin, modified cornstarch, and peppermint oil (Mentha arvensis)), magnesium stearate, potassium hydroxide (for pH adjustment) or hydrochloric acid (for pH adjustment).

Appearance of the product and packaging contents

Triangular, biconvex white tablets with “50” engraved on one side.

Presented in transparent PVC/PCTFE-Aluminum blisters. Each package contains 1, 2, 4, 8, and 12 chewable tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Manufacturer responsible

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate 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

Last review date of this leaflet:May 2022

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (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/pdfs/es/p/80114/P_80114.pdf

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