VARDENAFIL TEVA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Vardenafil Teva 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 Teva and what is it used for
2. What you need to know before you take Vardenafil Teva
3. How to take Vardenafil Teva
4. Possible side effects
5. Storage of 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, which belongs to a group of medicines called phosphodiesterase 5 inhibitors, used to treat erectile dysfunction in adult men. This is a condition where a man cannot achieve or maintain a penile erection sufficient for satisfactory sexual performance.

At least one in ten men has, at some time, problems achieving 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 changes prevent sufficient 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 chemical in your body that stops erections. Vardenafil allows an erection to last long enough for you to have satisfactory sex.

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

Do not take Vardenafil Teva

• If you are allergic to vardenafil or 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, or nitric oxide donors, such as amyl nitrite. Taking these medicines with vardenafil can seriously lower 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 taking ketoconazole or itraconazole, antifungal medicines.
• If you have severe heart or liver problems.
• If you are undergoing kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure.
• If you have a family history of degenerative eye disorders (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, used to treat high blood pressure in the lungs (pulmonary hypertension) and chronic thromboembolic pulmonary hypertension. PDE5 inhibitors like vardenafil have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• If you have heart problems, as having sex can be strenuous.
• If you have irregular heartbeats (cardiac arrhythmias) or a hereditary heart condition that affects your electrocardiogram.
• If you have a physical condition that affects the shape of your penis, such as angulation, 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 stomach ulcers (also known as gastric or peptic ulcers).
• 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 Teva with other medicines").
• If you have ever had sudden loss of vision, consult your doctor immediately.

Children and adolescents

Vardenafil Teva should not be used in children or adolescents under 18 years old.

Other medicines and Vardenafil Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may cause problems, especially:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrate. Taking these medicines with vardenafil can seriously lower your blood pressure.
• Medicines for 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 (benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafil orodispersible tablets in combination with other medicines for erectile dysfunction, including vardenafil film-coated tablets.

Taking Vardenafil Teva with food, drinks, and alcohol

• You can take Vardenafil Teva with or without food, but not with any liquid.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.
• Drinking alcohol can worsen erection problems.

Pregnancy and breastfeeding

Vardenafil Teva 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 problems with your vision 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 (a rare genetic disorder in which phenylalanine accumulates in the body because it cannot be eliminated properly).

This medicine contains less than 23 mg of sodium (1 mmol) per orodispersible tablet, which is essentially "sodium-free".

3. How to take Vardenafil Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafil tablet 25 to 60 minutes 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 in your mouth, on 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 Tevawith any other formulation of vardenafil.

Do not take Vardenafil Tevamore than once a day.

If you think the effect of vardenafil is too strong or too weak, tell your doctor. He or she may suggest switching to another formulation of vardenafil with a different dose based on the effect it has on you.

If you take more Vardenafil Teva than you should

Taking too many vardenafil tablets can cause more side effects and 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 taken.

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 partial loss of vision, temporary or permanent, in one or both eyes.

There have also been reports of sudden loss of hearing.

There have been reports of sudden death, rapid or irregular 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 of these men 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(may affect more than 1 in 10 people)

• Headache.

Common(may affect up to 1 in 10 people)

• Dizziness.
• Facial flushing.
• Nasal congestion.
• 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.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Ringing in the ears; vertigo.
• Fast or irregular heartbeat.
• Breathing difficulties.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth.
• Increased liver enzymes in the blood.
• Rash, red skin.
• Back pain or muscle pain; increased muscle enzyme creatine phosphokinase in the blood; 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.
• Heart effects (such as heart attack, rapid or irregular heartbeat, or angina).
• High or low blood pressure.
• Nosebleeds.
• Changes in liver function test results in the blood.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary reduction of blood flow to parts of the brain.

Very rare (may affect less than 1 in 10,000 people) or frequency not known(frequency cannot be estimated from available data)

• Blood in urine (hematuria).
• Bleeding in the penis (penile hemorrhage).
• Blood in semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (https://www.notificaram.es). By reporting side 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 take this medicine after the expiry date stated on the packaging after "EXP" or "CAD". 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. Return the packaging and any unused medicine to a pharmacy for proper disposal. 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 ingredients are:

microcrystalline cellulose, sodium starch glycolate type A (potato starch), colloidal anhydrous silica, magnesium stearate, aspartame (E951), peppermint flavor, and sodium stearyl fumarate.

Appearance of the product and pack contents

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

Each pack contains blisters of 4 and 8 tablets.

Not all 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 1ª planta

Alcobendas 28108 Madrid

Spain

Date of last revision of this leaflet: November 2020

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/)

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83049/P_83049.html