VARDENAFIL PENSA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil Pensa 10 mg Orodispersible Tablets EFG

Vardenafil

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

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

This medicine contains vardenafil, which belongs to a group of medicines called phosphodiesterase 5 inhibitors, used to treat erectile dysfunction in adult men, a condition that means you cannot get or maintain 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 flow to the penis to achieve and maintain an erection.

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

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

Do not take Vardenafil

• 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 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 a severe heart or liver problem.
• If you are on kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure or have had low blood pressure in the past.
• If you have a family history of degenerative eye diseases (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. 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 this medicine.

Be particularly careful with vardenafil

• If you have heart problems, as having sex can be a strain on your heart.
• If you have irregular heartbeats (cardiac arrhythmias) 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 have any condition that may cause prolonged erections (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 film-coated tablets (see section "Using Vardenafil with other medicines").
• 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.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Discontinue vardenafil treatment and seek medical attention immediately if you experience any symptoms related to these severe skin reactions described in section 4.

Children and adolescents

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

Other medicines and Vardenafil

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

Some medicines may cause problems, especially the following:

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

Taking Vardenafil with food, drinks, and alcohol

• You can 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 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 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 told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Vardenafil Pensa

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 can achieve an erection from 25 minutes to 4-5 hours after taking vardenafil.

-

• Do not remove the orodispersible tablet from the blister until you are going to take it. With dry hands, gently press the blister to release the tablet into your hand. Do not break the tablet.
• Place the orodispersible tablet whole in your mouth, under 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 orodispersible 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, inform your doctor. They may suggest a different dose based on the effect it has on you.

If you take more Vardenafil than you should

Taking too many vardenafil tablets can cause more side effects and 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, vardenafil can cause side effects, although not everybody gets them. Most of these side effects are mild or moderate.

Some patients have experienced sudden loss of vision or loss of vision in one eye. 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 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 whether these events were directly related to vardenafil.

The likelihood of experiencing a side effect is described using 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 swelling, lip swelling, or throat swelling.
• Sleep disorders.
• Numbness and altered sensation.
• Somnolence.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Ringing in the ears; vertigo.
• Increased heart rate or palpitations.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth.
• Increased liver enzymes in the blood.
• Skin rash, red skin.
• Back pain or muscle pain; increased muscle enzyme creatine phosphokinase in the 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.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (such as heart attack, rapid or altered heartbeats, or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results.
• 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 less than 1 in 10,000 people or the frequency cannot be estimated from the available data:

• Blood in the urine (hematuria).
• Bleeding in the penis (penile hemorrhage).
• Blood in the semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.
• Red, non-raised, 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.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Pensa

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 is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Pensa

• The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as trihydrate hydrochloride).
• The other ingredients are: lactose monohydrate, calcium silicate, hydroxypropylcellulose, crospovidone, aspartame, peppermint flavor, anise flavor, colloidal silicon dioxide, magnesium stearate.

Appearance of the product and packaging contents

Vardenafil Pensa 10 mg are white to off-white, cylindrical, biconvex orodispersible tablets 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 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/)