Sildenafil Cinfa 50 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

sildenafilo cinfa 50 mg chewable tablets EFG

Sildenafil citrate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What sildenafilo cinfa is and what it is used for
2. What you need to know before taking sildenafilo cinfa
3. How to take sildenafilo cinfa
4. Possible adverse effects
5. How to store sildenafilo cinfa
6. Contents of the pack and other information

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

sildenafilo cinfa contains the active substance 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 flow into the penis during sexual stimulation. 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 referred to as impotence. This occurs when a man is unable to achieve 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 ingredients of this medicine (listed in section 6).
• If you are taking medicines 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 medicines, which are often used to relieve angina pain (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any medicines known as nitric oxide donors such as amyl nitrite ("poppers"), as the combination may cause a dangerous drop in your blood pressure.
• If you are taking riociguat. This medicine 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 sildenafil have been shown to increase the hypotensive effect of this medicine. 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

Talk to your doctor or pharmacist before taking sildenafilo cinfa:

• If you have sickle cell anemia (an abnormality of red blood cells), leukemia (cancer of 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 should carefully assess whether your heart can tolerate the additional strain of sexual activity.
• If you currently have a stomach ulcer or bleeding disorders (such as hemophilia).
• If you experience 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 must not take sildenafil with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitor.

You must 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

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 individuals under 18 years of age.

Other medicines and sildenafilo cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Sildenafil tablets may interact with certain medicines, especially those used to treat chest pain. In a medical emergency, you must inform your doctor, pharmacist, or nurse that you are taking sildenafil and when you took it. Do not take sildenafil with other medicines unless your doctor advises you to do so.

Do not take sildenafil if you are taking medicines called nitrates, as the combination of these medicines may cause a dangerous drop in your blood pressure. Always inform your doctor, pharmacist, or nurse if you are taking any of these medicines, which are often used to relieve angina pain (or "chest pain").

Do not take sildenafil if you are taking medicines known as nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these medicines may also cause a dangerous drop in your blood pressure.

Inform your doctor or pharmacist if you are taking riociguat.

Inform your doctor if you are taking medicines containing sacubitril/valsartan, used to treat heart failure.

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

Some patients taking an alpha-blocker, a medicine used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness, which may be caused by a drop 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 occur within 4 hours after taking sildenafil. To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafil. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafil.

Taking sildenafilo cinfa with food, drinks, and alcohol

Sildenafil may be taken with or without food. However, you may notice that this medicine takes slightly longer to work if taken with a heavy meal.

Drinking alcohol may temporarily impair your ability to achieve an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink 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 may cause dizziness and affect vision. You should know how you react to sildenafil before driving or operating machinery.

sildenafilo cinfa contains lactose.

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

sildenafilo cinfa contains aspartame.

This medicine contains 8.6 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

sildenafilo cinfa contains sodium.

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

3. How to take sildenafil cinfa

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended starting dose is 50 mg.

Sildenafil cinfa must not be taken more than once a day.

Do not take sildenafil chewable tablets together with film-coated tablets containing sildenafil, including sildenafil film-coated tablets.

You should take sildenafil approximately one hour before planning to have sexual intercourse.

The tablet should be chewed and swallowed.

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

If you find 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 required for sildenafil to take effect varies from person to person, usually ranging between half an hour and 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

You may experience an increase in adverse effects and their severity. Doses higher than 100 mg do not increase efficacy.

You must not take more tablets than those 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 medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects reported with sildenafil use are generally mild to moderate in intensity and short-lived.

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

• Allergic reaction – uncommon adverse 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 – uncommon adverse effects (may affect up to 1 in 100 people).

If chest pain occurs during or after sexual activity:

• Sit in a semi-upright position and try to relax.

• Do not use nitrates to treat chest pain.

• Prolonged and sometimes painful erections – rare adverse effects (may affect up to 1 in 1,000 people).

If you have an erection lasting more than 4 hours, you must contact your doctor immediately.

• Sudden decrease or loss of vision – rare adverse effects (may affect up to 1 in 1,000 people).

• Severe skin reactions – rare adverse effects (may affect up to 1 in 1,000 people). Symptoms may include severe skin peeling and swelling, blistering in the mouth, genital area, and around the eyes, as well as fever.

• Seizures or fits – rare adverse effects (may affect up to 1 in 1,000 people).

Other adverse 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 sudden feeling of warmth in the upper body), indigestion, abnormal colour vision, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon (may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/red eyes, eye pain, seeing flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, dizziness, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, nasal mucosal swelling (including runny nose, sneezing, and nasal congestion), upper abdominal pain, gastroesophageal reflux disease (including heartburn), blood in urine, pain in 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, transient reduction in blood flow to parts of the brain, throat tightness, mouth numbness, bleeding behind 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, pupil dilation, change in colour of the white part of the eye, penile bleeding, blood in semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

In post-marketing experience, cases of unstable angina (heart disease) and sudden death have been reported rarely. It should be noted that most men who experienced these adverse effects, although not all, had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these adverse effects were directly related to sildenafil.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of sildenafil cinfa

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

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of sildenafil cinfa

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

• The other components are: potassium polacrilin, colloidal anhydrous silica, lactose monohydrate, povidone K-30, aspartame (E-951), sodium croscarmellose, mint flavor (composed of maltodextrin (corn), 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 contents of the container

White, triangular, biconvex tablets, engraved with "50" on one side.

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

Only certain 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 most recent review of this leaflet: May 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. 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