VARDENAFIL CINFA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafilo Cinfa 20 mg film-coated tablets EFG

vardenafil hydrochloride trihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Vardenafilo Cinfa and what is it used for
2. What you need to know before you take Vardenafilo Cinfa
3. How to take Vardenafilo Cinfa
4. Possible side effects
5. Storage of Vardenafilo Cinfa
6. Contents of the pack and other information

1. What is Vardenafilo Cinfa and what is it used for

Vardenafilo Cinfa contains vardenafil, which belongs to a group of medicines called phosphodiesterase 5 inhibitors, 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 getting or maintaining an erection. 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 to flow to the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medicine 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 you take Vardenafilo Cinfa

Do not take Vardenafilo Cinfa

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include 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 vardenafil can seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines for the treatment of HIV infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have a serious heart or liver problem.
• If you are undergoing kidney 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 lost your vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).
• 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). Phosphodiesterase 5 inhibitors, such as vardenafil, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking vardenafil.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vardenafilo Cinfa.

Be careful with Vardenafilo 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 affects your electrocardiogram.
• If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernosal fibrosis.
• If you suffer from any condition 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 called gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erection problems, including vardenafil orodispersible tablets (see section "Other medicines and Vardenafilo Cinfa").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop taking 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 of age.

Other medicines and Vardenafilo Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina or that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil can seriously affect your blood pressure. Do not take vardenafil without first consulting your doctor.
• Medicines for the treatment of heart rhythm disorders, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without first consulting your doctor.
• Ketoconazole or itraconazole, 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 vardenafil film-coated tablets in combination with any other medicine for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafilo Cinfa with food, drinks, and alcohol

• You can take vardenafil with or without food, but it is preferable not to do so after a heavy meal or with a high fat content, as the effect may be delayed.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.
• Drinking 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 use tools or machines if you feel dizzy or have vision problems after taking vardenafil.

3. How to take Vardenafilo Cinfa

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

The recommended dose is 10 mg.

Take a vardenafil tablet 25 to 60 minutes, approximately, before sexual activity. With sexual stimulation, you will be able to achieve an erection from 25 minutes to 4 or 5 hours after taking vardenafil.

Swallow the tablet with a glass of water.

Do not take Vardenafilo Cinfa film-coated tabletswith any other formulation of vardenafil.

Do not take vardenafilmore than once a day.

If you think the action of vardenafil is too strong or too weak, inform your doctor. He or she may suggest changing to another formulation of vardenafil with a different dose based on the effect it has on you.

If you take more Vardenafilo Cinfa than you should

Taking too many vardenafil tablets can cause more side effects or produce intense back pain. 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 medicine and the amount ingested.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 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 medicine. 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.
• 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 disorders.
• Numbness and altered touch perception.
• Somnolence.
• Effects on vision; eye redness, effects on color vision, eye pain and discomfort, and photosensitivity.
• Tinnitus; vertigo.
• Accelerated or irregular heartbeat.
• 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

• Eye inflammation (conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure (glaucoma), increased tearing.
• Effects on the heart (such as 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, non-elevated, target-like or circular patches on the trunk, 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 central vision or sudden vision loss
• Blood in urine (hematuria)
• Bleeding in the penis (penile hemorrhage)
• Blood in semen (hematospermia)
• Sudden death.
• Cerebral hemorrhage.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafilo Cinfa

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafilo Cinfa

• The active substance is vardenafil. Each tablet contains 20 mg of vardenafil (as hydrochloride trihydrate).
• The other ingredients are:

In the tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica.

In the film coating: OPADRY Y-1-7000 (macrogol 400, hypromellose, titanium dioxide (E171)), yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and pack contents

Vardenafilo Cinfa 20 mg are orange, film-coated, biconvex, cylindrical tablets, engraved with the logo VR2.

They are presented in aluminum/aluminum blisters. Each pack contains 2, 4, or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) Spain

Date of last revision of this leaflet:February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (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 mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/81751/P_81751.html

QR code to: https://cima.aemps.es/cima/dochtml/p/81751/P_81751.html