Vardenafil Teva 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Vardenafil Teva 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 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 effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What is Vardenafil Teva 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 will experience problems achieving or maintaining an erection at some point in their lives. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, changes in 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 of sufficient duration to allow satisfactory sexual intercourse.

2. What you need to know before taking Vardenafil Teva

Do not take Vardenafil Teva

• 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 or peeling skin, 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 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 currently have or have previously had 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 (NA-AION).
• 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 starting this medicine.

• If you have heart problems, as sexual activity 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 cavernosal 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 problems, including vardenafil film-coated tablets (see section: “Use of Vardenafil Teva 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 Teva must not be used in children or adolescents under 18 years of age.

Other medicines and Vardenafil Teva

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 or those that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil may seriously affect your blood pressure.
• Medicines for cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, HIV medicines.
• 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 Teva with food, drinks, and alcohol

• You may take Vardenafil Teva with or without food, but do not take it without liquid.
• 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 Teva 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 Teva contains aspartame and sodium

This medicine contains 1.8 mg of aspartame per orodispersible tablet. Aspartame is 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 properly eliminate it.

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

3. How to take Vardenafil Teva

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 on the blister to release the tablet into your hand. Do not break the tablet.

• Place the entire orodispersible tablet 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 Teva with any other formulation of vardenafil.

Do not take Vardenafil Teva 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 Teva than you should

Taking too many vardenafil tablets may cause more side 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 sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed or blurred central vision, in one or both eyes.

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

Cases of sudden death, rapid or irregular heartbeat, heart attacks, chest pain, and cerebral circulation 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 already 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 stuffy nose.
• Indigestion.

Uncommon (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.
• Visual disturbances; eye haemorrhage, 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, 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 (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 (e.g. heart attack, tachycardia, 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 (haemospermia).
• Sudden death.
• Cerebral haemorrhage.
• Red, flat, non-elevated skin lesions resembling targets or rings, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes 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 Teva

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

6. Contents of the pack and other information

Composition of Vardenafil Teva 10 mg orodispersible tablets

• The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other components are:

microcrystalline cellulose, sodium carboxymethyl starch type A (potato starch), colloidal anhydrous silica, magnesium stearate, aspartame (E951), mint flavour, and sodium stearyl fumarate.

Appearance of the medicinal product and contents of the pack

Vardenafil Teva 10 mg orodispersible tablets are round, flat, white or almost white tablets.

Each pack contains blisters of 4 and 8 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5 Haarlem

2031GA Netherlands

Manufacturer

Chanelle Medical Unlimited Company,

Dublin Road, Loughrea, H62 FH90,

Ireland

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola PLA 3000,

Malta

Local representative

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros B 1st floor

Alcobendas 28108 Madrid

Spain

Date of latest revision of this summary: October 2025

Detailed information about 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 up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83049/P_83049.html