Vardenafil TevaGen 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vardenafilo Tevagen 20 mg film-coated tablets EFG

Vardenafil

Read the entire leaflet carefully before you start taking this medicine, because 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 such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Vardenafil Tevagen 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, at some point, experience problems 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 needed 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 lasting long enough to allow satisfactory sexual intercourse.

2. What you need to know before taking Vardenafil Tevagen

Do not take Vardenafil Tevagen

• 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 have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking vardenafil.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with Vardenafil Tevagen 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 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 sudden 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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vardenafil Tevagen.

Take special care with Vardenafil Tevagen

• 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 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 medical condition that could 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 problems, including vardenafil orodispersible tablets (see section: “Taking Vardenafil Tevagen with other medicines”).
• If you suddenly experience a decrease or loss of vision, or if 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 Tevagen must not be used in children or adolescents under 18 years of age.

Taking Vardenafil Tevagen with other medicines

Inform 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, or those that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil may seriously affect your blood pressure.
• Medicines used to treat cardiac arrhythmias, 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 take Vardenafil Tevagen in combination with another medicine for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil Tevagen with food, drinks, and alcohol

• You may take vardenafil with or without food, but it is preferable not to take it after a heavy or high-fat 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 may worsen erectile problems.

Pregnancy and breastfeeding

Vardenafil Tevagen 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 Tevagen.

Vardenafil Tevagen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; thus, it is essentially “sodium-free”.

3. How to take Vardenafil Tevagen

Follow exactly the instructions for use of this medicine as given by your doctor. 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.

• Swallow the tablet with a glass of water.

Do not take Vardenafil Tevagen with any other formulation of vardenafil.

Do not take vardenafil 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 switching to another formulation of vardenafil with a different dose, depending on its effect on you.

If you take more Vardenafil Tevagen than you should

Taking too many vardenafil tablets may lead to an increased occurrence of adverse effects and cause 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, stating 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 sudden, temporary or permanent decrease or partial loss of vision, or distorted, dimmed or blurred central vision, in one or both eyes. If you experience any of these symptoms, 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 hemorrhage) 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 (may affect more than 1 in 10 people)

• Headache.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Swelling of the skin and mucous tissues, including facial, lip or throat swelling.
• Sleep disturbances.
• Numbness and altered sense of touch.
• Somnolence.
• Visual disturbances; eye discharge, disturbances in color vision, eye pain, and photosensitivity.
• Ringing in the ears (tinnitus); dizziness.
• Rapid pulse or palpitations.
• Difficulty breathing.
• Nasal congestion.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling unwell (nausea), dry mouth.
• Increased liver enzymes in blood.
• Skin rashes, redness of the 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.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Glaucoma (increased intraocular pressure), watery eyes.
• Heart-related effects (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 (may affect fewer than 1 in 10,000 people) or frequency not known (frequency cannot be estimated from available data)

• Blood in urine (haematuria).
• Bleeding from the penis (penile haemorrhage).
• Blood in semen (haematospermia).
• Sudden death.
• Cerebral haemorrhage.
• Red, non-elevated, 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, 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 Tevagen

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 is the last day of the month indicated.

Do not store above 30°C.

Medicines should 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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Tevagen 20 mg film-coated tablets EFG

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

Core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate.

Coating: polyvinyl alcohol (E1203), titanium dioxide (E171), talc (E553b), macrogol/PEG 3350 (E1521), methacrylic acid copolymer type A, yellow iron oxide (E172), sodium bicarbonate (E500 (ii)), red iron oxide (E172).

Appearance of the product and contents of the pack

Vardenafil Tevagen 20 mg film-coated tablets EFG are light yellow, 8.5 mm tablets, marked with “A723” on one side.

The tablets are available in blisters containing 2, 4, 8, 12, 20, 24, 36 or 48 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

Date of the most recent review of this leaflet: October 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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82642/P_82642.html