VARDENAFIL CINFA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil Cinfa 10 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 Vardenafil Cinfa and what is it used for
2. What you need to know before you take Vardenafil Cinfa
3. How to take Vardenafil Cinfa
4. Possible side effects
5. Storing Vardenafil Cinfa
6. Contents of the pack and other information

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

Vardenafil Cinfa contains vardenafil, which belongs to a group of medicines called phosphodiesterase 5 inhibitors, used to treat erectile dysfunction in adult men. This is a condition where a man cannot achieve or maintain a hard erect penis suitable for sexual activity.

At least one in ten men has trouble getting or keeping an erection at some time. This can be due to physical or psychological causes, or a combination of both.

Regardless of the cause, muscle and blood vessel changes prevent blood from flowing into the penis, making it difficult to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. It works by reducing the effect of a natural chemical in your body called phosphodiesterase type 5, which prevents erections.

2. What you need to know before you take Vardenafil Cinfa

Do not take Vardenafil Cinfa

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include rash, itching, swelling of the face or lips, and difficulty breathing.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with vardenafil can seriously 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 are taking ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are on 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 disorders (such as retinitis pigmentosa).
• If you have ever had loss of vision due to a condition called non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat, a medicine used to treat high blood pressure in the lungs and chronic thromboembolic pulmonary hypertension. PDE5 inhibitors like vardenafil have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have ever developed severe skin rash, blistering of the skin, mouth, and genitals after taking vardenafil.

Warnings and precautions

Consult your doctor or pharmacist before taking Vardenafil Cinfa.

Be cautious with Vardenafil Cinfa

• If you have heart problems, as having sex can be a strain on your heart.
• If you have irregular heartbeats (cardiac arrhythmia) or a heart condition that affects your electrocardiogram.
• If you have a physical condition that affects the shape of your penis, such as angulation, Peyronie's disease, or cavernosal fibrosis.
• If you have a condition that can cause prolonged erections, such as sickle cell anemia, multiple myeloma, or leukemia.
• If you have stomach ulcers (also known as gastric or peptic ulcers).
• 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 Vardenafil 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 of these severe skin reactions, as described in section 4.
• If you experience sudden 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 medicines and Vardenafil 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:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrate. Taking these medicines with vardenafil can seriously affect your blood pressure. Do not take vardenafil without consulting your doctor.
• Medicines for treating irregular heartbeats, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without 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 other medicines for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil Cinfa with food, drinks, and alcohol

• You can take vardenafil with or without food, but it is preferable not to take it after a large or fatty meal, 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 alcohol can make erection problems worse.

Pregnancy and breastfeeding

Vardenafil should not be used in women.

Driving and using machines

Vardenafil may cause dizziness or affect your vision. Do not drive or operate tools or machines if you feel dizzy or have problems with your vision after taking vardenafil.

3. How to take Vardenafil Cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is 10 mg.

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

Swallow the tablet with a glass of water.

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

Do not take vardenafilmore than once a day.

If you think the effect of vardenafil is too strong or too weak, tell your doctor. He or she may suggest changing to another formulation of vardenafil with a different dose, depending on its effect on you.

If you take more Vardenafil Cinfa than you should

Taking too many vardenafil tablets may cause more side effects or produce a severe back pain. If you take more vardenafil than you should, contact your doctor or pharmacist immediately, or call the National Poison Information Service on 91 562 04 20, stating the medicine and the amount taken.

If you have any further questions on 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 the side effects are mild or moderate.

Some patients have experienced sudden loss of vision or partial loss of vision, distorted or blurred vision, of a temporary or permanent nature, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have also been reports of sudden loss of hearing.

There have been reports of sudden death, rapid or irregular 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 of these men had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing a side effect is described in 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.
• 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 or altered sense of touch.
• Somnolence.
• Effects on vision; ocular redness, effects on color vision, eye pain and discomfort, and photosensitivity.
• Tinnitus; vertigo.
• Palpitations or rapid heartbeat.
• Breathing difficulties.
• Nasal stuffiness.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling sick (nausea), dry mouth.
• Increased liver enzymes in the blood.
• Rash; skin redness.
• Back pain or muscle pain; increased muscle enzyme (creatine phosphokinase) in the blood; muscle stiffness.
• Prolonged erections.
• General malaise.

Rare side effects:

may affect up to 1 in 1,000 people

• Ocular inflammation (conjunctivitis).
• Allergic reactions.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure (glaucoma), increased tearing.
• Effects on the heart (such as heart attack, irregular heartbeat, or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results.
• Skin sensitivity to sunlight.
• Painful erections.
• 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 reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Distorted, diminished, or blurred vision
• Blood in urine (hematuria)
• Bleeding from 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vardenafil Cinfa

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

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 shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Cinfa

• The active substance is vardenafil. Each tablet contains 10 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 and packaging

Vardenafil Cinfa 10 mg are orange, film-coated, biconvex, cylindrical tablets, engraved with the logo VR1.

They are available 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 up-to-date 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/81750/P_81750.html

QR code to: https://cima.aemps.es/cima/dochtml/p/81750/P_81750.html