Vardenafil Pensa 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vardenafilo pensa 10 mg orodispersible tablets EFG

Vardenafil

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 other people, even if they have the same symptoms as you, because it may 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 Vardenafilo Pensa is and what it is used for
2. What you need to know before taking Vardenafilo Pensa
3. How to take Vardenafilo Pensa
4. Possible side effects
5. How to store Vardenafilo Pensa
6. Contents of the pack and other information

1. What Vardenafil Pensa is and what it is 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 will experience problems achieving or maintaining an erection at some point. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, disturbances in muscle function and blood vessels result in insufficient blood 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 enables you to achieve an erection of sufficient duration to allow satisfactory sexual intercourse.

2. What you need to know before taking Vardenafil Pensa

Do not take Vardenafil

• 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 vardenafil may severely 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 a stroke or heart attack.
• If you have low blood pressure, or have had it in the past.
• 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, skin peeling, blisters, and/or mouth sores after taking vardenafil.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Take special care with vardenafil

• If you have heart problems, as having sexual intercourse may pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or a hereditary heart condition affecting 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 disease that may cause erections that do not go away (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 problems, including vardenafil film-coated tablets (see section: “Use of Vardenafil with other medicines”).
• If you suddenly experience a decrease or loss of vision, or your vision becomes distorted or darkened while taking vardenafil, stop taking vardenafil and contact your doctor immediately.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with vardenafil treatment. Discontinue treatment with vardenafil and seek immediate medical attention if you experience any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

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

Other medicines and Vardenafil

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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 severely affect your blood pressure. Do not take vardenafil without first consulting your doctor.
• Medicines for 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 with food, drinks, and alcohol

• You may take vardenafil orodispersible tablets with or without food. 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 Pensa 10 mg orodispersible tablets contain aspartame and lactose

• This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.
• 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.

3. How to take Vardenafil Pensa

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take one vardenafil tablet 25 to 60 minutes, approximately, 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, move it around with your tongue, where it will dissolve within seconds, and then swallow it with saliva. The orodispersible tablet must be taken without any liquid.

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

Do not take vardenafil more than once a day.

If you feel 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 than you should

Taking too many vardenafil tablets may cause an increase in adverse effects and may result in severe back pain.

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, vardenafil may cause adverse effects, although not everyone experiences them. Most of these adverse effects are mild or moderate.

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

Cases of sudden decrease or loss of hearing have also been reported.

Cases of sudden death, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary reduction in blood flow to parts of the brain and cerebral haemorrhage) have been reported in men taking vardenafil. Most of the men who experienced these side effects already had heart problems 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 membranes, including facial, lip or throat swelling.
• Sleep disturbances.
• Numbness and altered sense of touch.
• Drowsiness.
• Vision disturbances; eye discharge, colour vision changes, eye pain, and photosensitivity.
• Ringing in the ears (tinnitus); dizziness.
• Rapid 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, red skin.
• Back pain or muscle pain; increased blood levels of the muscle enzyme creatine phosphokinase; 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.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (such as heart attack, tachycardia or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary reduction in blood flow to parts of the brain.

Very rare or frequency unknown adverse effects: may affect less than 1 in 10,000 people, or frequency cannot be estimated from available data:

• Blood in urine (haematuria).
• Bleeding from the penis (penile haemorrhage).
• Blood in semen (haemospermia).
• Sudden death.
• Cerebral haemorrhage.
• Red, non-raised, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious 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 decrease in vision.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, 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 Pensa

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 unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Vardenafil Pensa

• 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, peppermint flavor, anise flavor, colloidal silicon dioxide, magnesium stearate.

Appearance of the product and contents of the container

Vardenafil Pensa 10 mg are cylindrical, biconvex orodispersible tablets, white to off-white in color, with the logo “VB” on one side.

Each pack contains 4 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 Polígono Industrial Areta

31620 Huarte Pamplona (Navarra)

Spain

Date of the most recent revision of this package leaflet: February 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)