VARDENAFIL TEVAGEN 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Vardenafil Tevagen 10 mg film-coated tablets EFG

Vardenafil

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

1. What is Vardenafil Tevagen 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 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 medicine 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 Tevagen

Do not take Vardenafil Tevagen

• 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 skin 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 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, 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). Phosphodiesterase 5 inhibitors, such as vardenafil, have shown that they increase 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 starting to take Vardenafil Tevagen.

Be careful with Vardenafil Tevagen

• 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 condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernosal fibrosis.
• If you suffer from 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 orodispersible tablets (see the section "Taking Vardenafil Tevagen with other medicines").
• If you have ever suffered a sudden decrease or loss of vision, do not take vardenafil and consult your doctor immediately.

Children and adolescents

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

Taking Vardenafil Tevagen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Some medicines may cause problems, especially the following:

• Nitrates, medicines for angina or that release nitric oxide, such as amyl nitrite. Taking these medicines with Vardenafil Tevagen can seriously affect your blood pressure.
• Medicines for the treatment of 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 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 medicine.
• Drinking alcoholic beverages can worsen erection problems.

Pregnancy and breastfeeding

Vardenafil Tevagen should not be used in women.

Driving and using machines

In some people, vardenafil can cause dizziness or affect vision. Do not drive or use tools or machines 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; this is essentially "sodium-free".

3. How to take Vardenafil Tevagen

Follow the instructions for administration of this medicine indicated by your doctor. If in 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 Tevagen with any other formulation of Vardenafil.

Do not take vardenafil more 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 Tevagen 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 Toxicological Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you have any other questions about 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 a sudden decrease or loss of vision, temporary or permanent, in one or both eyes. If you experience any of this, stop taking vardenafil and contact your doctor immediately.

There have also been reports of sudden hearing loss.

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 of the men who experienced these side effects had pre-existing heart problems before taking this medicine. 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(may affect more than 1 in 10 people)

• Headache.

Common(may affect up to 1 in 10 people)

• Dizziness.
• Facial flushing.
• Nasal congestion or runny nose.
• Indigestion.

Uncommon(may affect up to 1 in 100 people)

• Skin and mucous membrane swelling, including facial, lip, or throat swelling.
• Sleep disorders.
• Numbness and altered touch perception.
• Somnolence.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Tinnitus; vertigo.
• Palpitations or rapid heartbeat.
• Breathing difficulties.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth.
• Elevation of liver enzymes in blood.
• Skin rash, skin flushing.
• Back pain or muscle pain; elevation of muscle enzyme creatine phosphokinase in blood; muscle stiffness.
• Prolonged erection.
• General malaise.

Rare side effects(may affect up to 1 in 1,000 people)

• Ocular 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(may affect less than 1 in 10,000 people) or unknown frequency(frequency cannot be estimated from available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Tevagen

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

Do not take this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the carton and any remaining medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the carton and any remaining medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Tevagen 10 mg film-coated tablets EFG

• The active substance is vardenafil. Each film-coated tablet contains 10 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 10 mg film-coated tablets EFG are light yellow tablets, 7 mm in size, marked with "A721" on one face.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Actavis Ltd.

BLB015-016, Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

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 Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on 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/82641/P_82641.html