VARDENAFIL QUALIGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil Qualigen 20 mg film-coated tablets EFG

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

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

This medication contains vardenafil, an active substance from the group of medications known as phosphodiesterase 5 inhibitors, which are 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 flow to the penis to achieve and maintain an erection.

Vardenafil will only work when you are sexually stimulated. This medication 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 Vardenafil Qualigen

Do not take Vardenafil

• If you are allergic to vardenafil or any of the other ingredients of this medication (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking Vardenafil Qualigen.
• If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafil can seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medications for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medications.
• 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 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 suffered loss of vision due to a nerve damage caused by insufficient blood supply and known as non-arteritic anterior ischemic optic neuropathy (NAION).
• If you are taking riociguat. This medication 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 medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

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

Be careful with vardenafil

• If you have heart problems, as having a sexual relationship can pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or any inherited heart disease that alters your electrocardiogram.
• If you have any physical problem that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous fibrosis.
• If you have a disease 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 film-coated tablets (see the section "Use of Vardenafil with other medications").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Discontinue treatment with Vardenafil Qualigen 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, blurred, or dark while taking Vardenafil Qualigen, 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.

Taking Vardenafil Qualigen with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

Some medications can cause problems, especially the following:

• Nitrates, medications for angina or that release nitric oxide, such as amyl nitrate. Taking these medications together with vardenafil can seriously affect your blood pressure. Do not take vardenafil without consulting your doctor first.
• Medications for the treatment of cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medications for HIV. Do not take vardenafil without consulting your doctor first.
• Ketoconazole or itraconazole, antifungal medications.
• Erythromycin or clarithromycin, macrolide antibiotics.
• Alpha-blockers, a group of medications 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 another medication for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil 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 medication.

• 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.

Information about excipients

This medication can cause allergic reactions because it contains Orange Yellow S (E-110).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Vardenafil Qualigen

Follow the administration instructions of this medication indicated by your doctor. 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 can 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 Vardenafil 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, 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 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 medication and the amount ingested.

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

4. Possible side effects

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

Some patients have experienced a decrease in vision or partial loss of vision, distorted, attenuated, or blurred central vision, suddenly, temporarily, or permanently, 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 altered 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 men who experienced these side effects had pre-existing heart problems before taking this medication. 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 or runny nose.
• 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 disturbances.
• Numbness and altered touch perception.
• Somnolence.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Tinnitus; vertigo.
• Accelerated or irregular heartbeat.
• Breathing difficulties.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth.
• Increased liver enzymes in blood.
• Rash; reddened skin.
• Back pain or muscle pain; increased 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.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (such as infarction, tachycardia, 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 less than 1 in 10,000 people or the frequency cannot be estimated from the available data:

• Blood in urine (hematuria).
• Bleeding in the penis (penile hemorrhage).
• Blood in the semen (hematospermia).
• Sudden death
• Cerebral hemorrhage
• 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, attenuated, or blurred central vision or sudden loss of vision

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Vardenafil Qualigen

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

Do not use this medication after the expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Store this medication below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Vardenafil Qualigen

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

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

In the film coating: macrogol 400, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), orange yellow S (E110).

Appearance of the product and pack contents

Vardenafil Qualigen 20 mg, film-coated tablets, round, biconvex, orange in color. Each pack contains 4 tablets.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Street

83-200 Starogard Gdanski

Poland

Date of the last revision of this leaflet: January 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.