Summary of Product Characteristics: Information for the Patient

sildenafilo cinfa 100 mg film-coated tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 widening the blood vessels in the penis, allowing blood to flow when sexually stimulated.Sildenafilowill only help you get an erection if you are sexually stimulated.

Sildenafilois indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain a firm, adequate erection for satisfactory 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, such as 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 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 disorder (such as retinitis pigmentosa).

• If you have experienced previous 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 an active 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.

Sildenafilo is not recommended to be taken 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 of age.

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 this medication 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 medications called nitrates, as the combination 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 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 to treat HIV, 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 that may be 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 be receiving your daily dose of the alpha-blocker regularly 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 ingest it with 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

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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 this medication before driving vehicles or operating machinery.

Sildenafilo cinfa contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) 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 more than once a day.

Do not take Sildenafil film-coated tablets with Sildenafil chewable tablets.

You should takeSildenafilapproximately one hour before you plan to have sexual intercourse. Swallow the tablet whole with a glass of water.

If you notice that the effect ofSildenafilis too strong or weak, inform your doctor or pharmacist.

Sildenafilwill only help you get an erection if you are sexually stimulated. The time it takesSildenafilto take effect varies from person to person, generally ranging from half an hour to one hour. The effect ofSildenafilmay be delayed if taken with a large meal.

IfSildenafildoes not help you get 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 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 or pharmacist.

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 - this occurs withlow frequency(may affect up to 1 in 100 people).

• The symptoms include sudden hissing sound while breathing, difficulty breathing or dizziness, swelling of the eyelids, face, lips, or throat.

• Chest pain - this occurs withlow frequency (may affect up to 1 in 100 people).

If they occur during or after sexual intercourse:

• Position yourself in a semi-sitting position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occursrarely(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 - this occursrarely(may affect up to 1 in 1,000 people).

• Severe skin reactions - this occursrarely(may affect up to 1 in 1,000 people).

The 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 - this occursrarely(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.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, flashing lights, visual clarity, light sensitivity, watery eyes, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling of drowsiness, reduced tactile sensation, vertigo, ringing in the ears, dry mouth, nasal congestion or blockage, nasal mucosa inflammation (including symptoms such as sneezing, runny nose, 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 swelling, 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 heart problems before taking this medicine. It is not possible to determine if these side effects were directly related tosildenafil.

Reporting of 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 Pharmacovigilance of Medicines for Human Use: https://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 special conditions for conservation. 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 disposed of through 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 film-coated tablet contains 100 mg ofsildenafil (in the form of 140.48 mg of sildenafil citrate).
• The other components are:

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

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

Product Appearance and Packaging Contents

Sildenafil Cinfa 100 mg film-coated tablets are blue, triangular, biconvex, and marked with “100” on one side.

They are presented in blisters packaged in boxes containing 1, 4, 8, or 12 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible Manufacturer

Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

or

Genepharm S.A.,

18 Km Marathon Avenue,

15351 Pallini, Greece

Last Review Date of this Leaflet:May 2022

For detailed information about this medicine, 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 medicine 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/80062/P_80062.html

QR code to:https://cima.aemps.es/cima/dochtml/p/80062/P_80062.html