Leaflet: information for the user

vardenafilo cinfa 10 mg bucodispersable tablets EFG

vardenafilo hidrocloruro trihidrato

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.

This medicationcontains vardenafilo, an active ingredient in the group of medications known as phosphodiesterase type 5 inhibitors, which are used to treat erectile dysfunction in adult men, a condition that consists of difficulty in achieving or maintaining an erection.

At least one in ten men has, at some point, problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and vascular alterations result in insufficient blood in the penis to achieve and maintain an erection.

Vardenafilo will only act when sexually stimulated. This medication reduces the action of a natural substance in the body that prevents an erection. Vardenafilo allows for an erection with a sufficient duration to maintain a satisfactory sexual relationship.

Do not take vardenafilo cinfa

• If you are allergic to vardenafilo or any of the other ingredients in this medicine (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing.
• If you are taking medicines that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medicines together with this medicine may severely affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and taking ketoconazol or itraconazol, antifungal medicines.
• If you have a serious heart or liver problem.
• If you are undergoing renal dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure.
• If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had vision loss due to a lack of blood supply to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medicine is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as vardenafilo, have shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking vardenafilo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take vardenafilo cinfa.

Be especially careful with vardenafilo cinfa

• If you have heart problems, as having sex may pose a risk to you.
• If you have irregular heartbeats (arrhythmia cardiaca) or any inherited heart disease that alters your electrocardiogram.
• If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous fibrosis.
• If you have a disease that may cause erections that do not go away (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.
• If you have a stomach ulcer (also known as a gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erectile dysfunction, including vardenafilo tablets coated with a film (see section "Other medicines and vardenafilo cinfa").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with vardenafilo. Stop taking vardenafilo and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.
• If you experience sudden vision loss or your vision becomes distorted or dark while taking vardenafilo, stop taking vardenafilo and contact your doctor immediately.

Children and adolescents

Vardenafilo should not be used in children or adolescents under 18 years old.

Other medicines and vardenafilo cinfa

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

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina or that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafilo may severely affect your blood pressure. Do not take vardenafilo without consulting your doctor first.
• Medicines for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV infections. Do not take vardenafilo without consulting your doctor first.
• Ketoconazol or itraconazol, antifungal medicines.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medicines used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafilo tablets coated with a film in combination with another medicine for erectile dysfunction, including vardenafilo tablets coated with a film.

Taking vardenafilo cinfa with food, drinks, and alcohol

• You can take vardenafilo tablets coated with a film with or without food, but do not take this medicine with a liquid.
• Do not drink grapefruit juice while taking vardenafilo, as it may interfere with the normal effect of the medicine.
• Drinking alcoholic beverages may worsen erectile dysfunction problems.

Pregnancy and breastfeeding

Vardenafilo should not be used in women.

Driving and operating machines

In some people, vardenafilo may cause dizziness or affect vision. Do not drive or operate tools or machines if you feel dizzy or have vision problems after taking vardenafilo.

vardenafilo cinfa contains lactose.

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

vardenafilo cinfa contains aspartame

This medicine contains 1.50 mg of aspartame in each tablet.

Aspartamecontains 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.

vardenafilo cinfa contains benzyl alcohol

This medicine contains 0.182 mg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafilo tablet approximately 25 to 60 minutes before sexual activity. With sexual stimulation, you will be able to obtain an erection from 25 minutes and up to four or five hours after taking vardenafilo.

• Do not remove the buccodispersable tablet from the blister pack until you are ready to take it. With dry hands, press the blister pack gently to release the tablet into your hand. Do not break the tablet.
• Place the buccodispersable tablet whole in your mouth, on the tongue, where it will dissolve in seconds, and then swallow with saliva. The buccodispersable tablet should be taken without any type of liquid.

Do not take vardenafilo cinfa tablets with any other formulation of vardenafilo.

Do not take vardenafilo cinfa more than once a day.

If you estimate that the action of vardenafilo is too strong or too weak, inform your doctor. They may suggest a different dose based on the effect it has on you.

If you take more vardenafilo cinfa than you should

Taking too many vardenafilo tablets can cause more side effects and produce intense back pain. If you have taken more vardenafilo than you should, consult your doctor.

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.

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. Most of these side effects are mild or moderate.

Some patients have experienced a decrease in vision or partial loss of vision, distorted, blurred, or distorted central vision, suddenly, temporarily, or permanently, in one or both eyes.Stop takingvardenafiland contact your doctor immediately.

There have also been reported cases of sudden decrease or loss of hearing.

There have been reported cases of sudden death, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary decrease in blood flow to parts of the brain and cerebral hemorrhage), in men taking vardenafil. Most men who have experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting a side effect is described using the following categories:

Very common side effects(can affect more than 1 in 10 people):

• Headache.

Common side effects(can affect up to 1 in 10 people):

• Dizziness.
• Flushing.
• Nasal congestion or runny nose.
• Indigestion.

Uncommon side effects(can affect up to 1 in 100 people):

• Swelling of the skin and mucous membranes, including facial swelling, lip swelling, or throat swelling.
• Sleep disturbances.
• Numbness and altered sensation of touch.
• Drowsiness.
• Effects on vision; redness of the eyes, effects on color vision, eye pain and discomfort, and photosensitivity.
• Tinnitus, vertigo.
• Palpitations or rapid heartbeat.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort(nausea),dry mouth.
• Elevation of liver enzymes in the blood.
• Skin rashes,redness of theskin.
• Back pain or muscle pain, elevation of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness.
• Prolonged erection.
• General feeling of discomfort.

Rare side effects(can affect up to 1 in 1,000 people):

• Ocular inflammation(conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure(glaucoma), increased tear production.
• Effects on the heart (such as, for example, myocardial infarction,alteration of heart rhythmor angina).
• High or low blood pressure.
• Nasal bleeding.
• Alterations in liver function test results in the blood.
• Sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary decrease in blood flow to parts of the brain.

Very rare or unknown frequency side effects(can affect up to 1 in 10,000 people or the frequency cannot be estimated from the available data):

• Reddish, non-elevated, circular or target-shaped patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions can be preceded by fever and symptoms similar to the flu (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Distorted, blurred, or distorted central vision or sudden decrease in vision.
• Blood in the urine (hematuria).
• Bleeding in the penis (hemorrhage peniana).
• Blood in the semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.

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.

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.

This medication does not require special conditions for conservation.

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 at 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.

Composition of vardenafil cinfa

• The active ingredient isvardenafil. Each buccal dispersible tablet contains 10 mg ofvardenafil (as trihydrate hydrochloride).
• The other components are: lactose monohydrate, calcium silicate, hydroxypropylcellulose, crospovidone, aspartame (E-951), peppermint aroma, anise aroma (contains benzyl alcohol (E-1519)), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

White to off-white, cylindrical, biconvex, non-scored tablets marked with the code “VB” on one of their faces.

They are presented in Alu/Alu blisters.

Each packagecontains 4 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) -Spain

Last review date of this leaflet:February 2025

The detailed and updated information on this medicine is available on 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 with your 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/82684/P_82684.html

QR code to:https://cima.aemps.es/cima/dochtml/p/82684/P_82684.html