Vardenafil CINFA 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

vardenafil cinfa 10 mg orodispersible tablets EFG

vardenafil hydrochloride trihydrate

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains vardenafil, an active substance belonging to a group of medicines called 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 experiences, at some point, problems in achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, disturbances in the muscles and blood vessels prevent sufficient blood flow into 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 enables you to achieve an erection of sufficient duration to allow satisfactory sexual intercourse.

2. What you need to know before taking vardenafil cinfa

Do not take vardenafil cinfa

• If you are allergic to vardenafil or to 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 pectoris, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with this medicine may seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines used to treat 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 undergoing renal dialysis.
• If you have recently had an ischemic 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 experienced 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 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). PDE5 inhibitors such as vardenafil have been 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 vardenafil.

Warnings and precautions

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

Take special care with vardenafil cinfa

• If you have heart problems, as having sexual intercourse may pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or an inherited heart condition that affects your electrocardiogram.
• If you have a physical condition affecting the shape of your penis, such as curvature, Peyronie's disease, or cavernous fibrosis.
• If you have a condition that may cause prolonged erections (priapism), such as sickle cell anemia, multiple myeloma, or 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 erectile dysfunction, including vardenafil film-coated tablets (see section “Other medicines and vardenafil cinfa”).
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with vardenafil treatment. Stop treatment with vardenafil and seek immediate medical attention if you experience any of the symptoms related to these serious skin reactions described in section 4.
• If you experience sudden decrease or loss of vision, or if your vision becomes distorted or darkened while taking vardenafil, stop taking vardenafil and contact your doctor immediately.

Children and adolescents

Vardenafil must not be used in children or adolescents under 18 years of age.

Other medicines and vardenafil cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina pectoris, or those that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil may seriously affect your blood pressure. Do not take vardenafil without first consulting your doctor.
• Medicines used to treat cardiac arrhythmias, 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 orodispersible tablets in combination with another medicine for the treatment of erectile dysfunction, including vardenafil film-coated tablets.

Taking vardenafil cinfa with food, drinks and alcohol

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

Pregnancy and breastfeeding

Vardenafil must not be used in women.

Driving and using machines

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

vardenafil cinfa contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

vardenafil cinfa contains aspartame

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

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

vardenafil cinfa contains benzyl alcohol

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

Benzyl alcohol may cause allergic reactions.

3. How to take vardenafil cinfa

Follow exactly the instructions for use of this medicine as given 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 may achieve an erection from 25 minutes up to four or five 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 to release the tablet into your hand. Do not break the tablet.
• Place the entire orodispersible tablet in your mouth, on the tongue, where it will dissolve within seconds, then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take vardenafil cinfa orodispersible tablets together with any other formulation of vardenafil.

Do not take vardenafil cinfa more than once a day.

If you feel that the effect of vardenafil is too strong or too weak, inform your doctor. Your doctor may suggest a different dose based on its effect on you.

If you take more vardenafil cinfa than you should

Taking too many vardenafil tablets may cause more side effects and lead to severe back pain. If you have taken more vardenafil than you should, consult your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. Most of these adverse effects are mild or moderate.

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

Sudden decrease or loss of hearing has also been reported.

Cases of sudden death, rapid or irregular heartbeat, heart attacks, chest pain, and cerebrovascular problems (including temporary reduction in blood flow to parts of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Most men who experienced these side effects had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

The likelihood of experiencing an adverse effect is described using the following categories:

Very common adverse effects (may affect more than 1 in 10 people):

• Headache.

Common adverse effects (may affect up to 1 in 10 people):

• Dizziness.
• Facial flushing.
• Runny or stuffy nose.
• Indigestion.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Swelling of the skin and mucous tissue, including facial, lip or throat swelling.
• Sleep disturbances.
• Numbness and altered sense of touch.
• Somnolence.
• Visual disturbances: eye redness, disturbances in colour vision, eye pain and discomfort, and photosensitivity.
• Ringing in the ears (tinnitus), dizziness.
• Fast pulse or palpitations.
• Difficulty breathing.
• Nasal congestion.
• Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting, feeling unwell (nausea), dry mouth.
• Increased liver enzymes in blood.
• Skin rashes, skin redness.
• Back pain or muscle pain, increased muscle enzyme (creatine phosphokinase) in blood, muscle stiffness.
• Prolonged erection.
• General malaise.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Eye inflammation (conjunctivitis).
• Allergic reaction.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure (glaucoma), excessive tearing.
• Effects on the heart (e.g. heart attack, irregular heartbeat, or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results in blood.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary reduction in blood flow to parts of the brain.

Very rare or frequency not known adverse effects (may affect up to 1 in 10,000 people, or frequency cannot be estimated from available data):

• Red, non-elevated, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, dimmed or blurred central vision or sudden vision loss.
• Blood in urine (haematuria).
• Bleeding from the penis (penile haemorrhage).
• Blood in semen (haemospermia).
• Sudden death.
• Cerebral haemorrhage.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of vardenafil cinfa

Keep this medicine out of 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 indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other 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: monohydrate lactose, calcium silicate, hydroxypropylcellulose, crospovidone, aspartame (E-951), peppermint flavour, anise flavour (contains benzyl alcohol (E-1519)), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

White to off-white, cylindrical, biconvex tablets, unmarked and un-scored, marked with the code “VB” on one side.

They are presented in Alu/Alu blisters.

Each pack 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 most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package 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