Sildenafil Cinfa 50 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

sildenafil cinfa 50 mg film-coated tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 this leaflet

1. What sildenafil cinfa is and what it is used for
2. What you need to know before taking sildenafil cinfa
3. How to take sildenafil cinfa
4. Possible adverse effects
5. How to store sildenafil 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 it 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 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 lead to 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 sudden vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult 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 bone marrow).

• If you have a deformity of the penis 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 sildenafilo and contact your doctor immediately.

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

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

You must 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

Inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

Sildenafilo is not indicated for use 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 this medicine and when you took it. Do not take sildenafilo with other medicines unless your doctor advises you to do so.

You must not take sildenafilo 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”).

You must not take sildenafilo if you are taking medicines known as nitric oxide donors, such as amyl nitrite (“poppers”), as the combination 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 sildenafilo.

Some patients receiving alpha-blockers, medicines used to treat high blood pressure or benign prostatic hyperplasia, may experience dizziness or lightheadedness caused by a drop 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 after taking sildenafilo.

To reduce the likelihood of these symptoms, you should already be on a regular daily dose of the alpha-blocker before starting sildenafilo. Your doctor may advise you to start treatment with the lowest dose (25 mg) of sildenafilo.

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.

Alcohol consumption may temporarily impair your ability to obtain an erection. Therefore, to achieve the maximum benefit from the medicine, it is advisable not to drink large amounts of alcohol before taking sildenafilo.

Pregnancy, breastfeeding, and fertility

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

Sildenafilo is not indicated for use in women.

Driving and using machines

Sildenafil may cause dizziness and affect vision. You should know how you react to this medicine before driving or operating machinery.

sildenafilo cinfa contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take sildenafil cinfa

Follow exactly the instructions for use 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 must not be taken more than once a day.

Do not take sildenafil film-coated tablets together with sildenafil cinfa chewable tablets.

You should take sildenafil approximately one hour before planning to have sexual intercourse. Swallow the tablet whole with a glass of water.

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 required for sildenafil to take effect varies from person to person, usually between half an hour and one hour. The effect of sildenafil may be delayed if taken with a heavy meal.

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 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 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 or pharmacist.

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 in duration.

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

• Allergic reaction – this occurs uncommonly (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 uncommonly (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 – this occurs rarely (may affect up to 1 in 1,000 people).

If you have an erection lasting longer than 4 hours, you must 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 may 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 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, feeling hot (including sudden sensation of warmth in the upper part of the 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, perception of flashing lights, clear vision, sensitivity to light, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, drowsiness, reduced sense of touch, vertigo, tinnitus (ringing in the ears), dry mouth, nasal blockage or congestion, swelling of the nasal mucosa (symptoms include runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (symptoms include 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, sensation of tightness in the throat, numbness of the mouth, 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.

During post-marketing experience, rare cases of unstable angina (heart disease) and sudden death have been reported. 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, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://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 conditions. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of sildenafilo cinfa

• The active substance is sildenafil. Each film-coated tablet contains 50 mg of sildenafil (as 70.24 mg of sildenafil citrate).
• The other components are:

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

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

Appearance of the product and contents of the pack

The sildenafilo cinfa 50 mg film-coated tablets are blue, triangular, biconvex, and marked with "50" on one side.

They are supplied in blister packs contained in cartons with 1, 2, 4, 8, or 12 film-coated tablets.

Only certain pack sizes may be commercially available.

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 most recent revision of this leaflet: May 2022

Detailed 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 up-to-date information about this medicinal product 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/dochtml/p/80061/P_80061.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80061/P_80061.html