VARDENAFIL CINFA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

vardenafil cinfa 10 mg orodispersible tablets EFG

vardenafil hydrochloride trihydrate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is vardenafil cinfa and what is it used for
2. What you need to know before taking vardenafil cinfa
3. How to take vardenafil cinfa
4. Possible side effects
5. Storage of vardenafil cinfa
6. Package contents and additional information

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

This medication contains vardenafil, an active substance from the group of medications known as phosphodiesterase 5 inhibitors, which are used to treat erectile dysfunction in adult men, a condition characterized by difficulty in achieving or maintaining an erection.

At least one in ten men experience problems achieving or maintaining an erection at some point. This can be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel disorders cause insufficient blood flow to the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medication reduces the action of a natural substance in the body that prevents erection. Vardenafil allows you to achieve an erection with sufficient duration to maintain a satisfactory sexual relationship.

2. What you need to know before taking vardenafil cinfa

Do not take vardenafil cinfa

• If you are allergic to vardenafil or any of the other components of this medication (listed in section 6). Signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing.
• If you are taking medications containing nitrates, such as glyceryl trinitrate for angina pectoris, or that release nitric oxide, such as amyl nitrite. Taking these medications together with this medication can seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medications for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and taking ketoconazole or itraconazole, antifungal medications.
• If you have a serious heart or liver problem.
• If you are undergoing renal dialysis.
• If you have recently experienced 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 suffered vision loss due to optic nerve damage caused by insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• 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 blood clots). Phosphodiesterase 5 inhibitors, such as vardenafil, have shown that they increase the hypotensive effect of this medication. 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 sores in the mouth after taking vardenafil.

Warnings and Precautions

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

Be careful with vardenafil cinfa

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

Children and Adolescents

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

Other Medications and Vardenafil Cinfa

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

Some medications can cause problems, especially the following:

• Nitrates, medications for angina pectoris or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil can seriously affect your blood pressure. Do not take vardenafil without consulting your doctor first.
• Medications for the treatment of cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medications for HIV. Do not take vardenafil without consulting your doctor first.
• Ketoconazole or itraconazole, antifungal medications.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medications used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafil orodispersible tablets in combination with any other medication for the treatment of erectile dysfunction, including vardenafil film-coated tablets.

Taking Vardenafil Cinfa with Food, Drinks, and Alcohol

• You can take vardenafil orodispersible tablets with or without food, but do not take this medication with liquid.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medication.
• Consuming alcoholic beverages can worsen erection problems.

Pregnancy and Breastfeeding

Vardenafil should not be used in women.

Driving and Using Machines

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

Vardenafil Cinfa Contains Lactose.

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

Vardenafil Cinfa Contains Aspartame

This medication contains 1.50 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

Vardenafil Cinfa Contains Benzyl Alcohol

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

Benzyl alcohol can cause allergic reactions.

3. How to Take Vardenafil Cinfa

Follow the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take one vardenafil tablet approximately 25 to 60 minutes before sexual activity. With sexual stimulation, you can achieve an erection from 25 minutes to 4-5 hours after taking vardenafil.

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

Do not take vardenafil cinfa orodispersible tabletswith any other formulation of vardenafil.

Do not take vardenafil cinfamore than once a day.

If you think the effect of vardenafil 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 vardenafil cinfa than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology 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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them. Most of these side effects are mild or moderate.

Some patients have experienced sudden vision loss or partial vision loss, distorted, attenuated, or blurred vision, temporarily or permanently, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have also been reports of sudden hearing loss.

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

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

Very Common Side Effects(may affect more than 1 in 10 people):

• Headache.

Common Side Effects(may affect up to 1 in 10 people):

• Dizziness.
• Facial flushing.
• Nasal congestion or runny nose.
• Indigestion.

Uncommon Side Effects(may affect up to 1 in 100 people):

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

Rare Side Effects(may affect up to 1 in 1,000 people):

• Ocular inflammation (conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure (glaucoma), increased tearing.
• Effects on the heart (such as myocardial infarction, altered heart rhythm, or angina).
• High or low blood pressure.
• Nosebleeds.
• Alterations in liver function test results in blood.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary reduction of blood flow to parts of the brain.

Very Rare or Unknown Frequency Side Effects(may affect up to 1 in 10,000 people or the frequency cannot be estimated from the available data):

• Reddish patches, not elevated, in a target or circular shape on the torso, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Distorted, attenuated, or blurred vision or sudden vision loss
• Blood in urine (hematuria).
• Bleeding in the penis (penile hemorrhage).
• Blood in semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vardenafil Cinfa

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

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Vardenafil Cinfa

• The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride trihydrate).
• The other components are: lactose monohydrate, calcium silicate, hydroxypropylcellulose, crospovidone, aspartame (E-951), peppermint flavor, anise flavor (contains benzyl alcohol (E-1519)), colloidal anhydrous silica, and magnesium stearate.

Appearance of the Product and Package Contents

White to off-white, cylindrical, biconvex, uncoated tablets, marked with the code "VB" on one side.

They are presented in Alu/Alu blisters.

Each package contains 4 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet:February 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. 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