VARDENAFIL AUROVITAS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

This medicine contains vardenafil, which is a member of a group of medicines called phosphodiesterase 5 inhibitors, used to treat erectile dysfunction in adult men, a condition which is the inability to achieve or maintain an erection.

At least one in ten men have, at some time, 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 changes 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 chemical in your body that makes it difficult to get an erection. Vardenafil allows you to achieve an erection that is sufficient for satisfactory sexual activity.

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

Do not take Vardenafil Aurovitas

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include rash, itching, swelling of the face, lips or throat and difficulty breathing.
• If you have ever had a severe skin rash or peeling, blisters in your mouth, and/or genital area after taking vardenafil.
• 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 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.
• If you have a family history of degenerative eye diseases (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, a medicine for treating high blood pressure in the lungs or chronic thromboembolic pulmonary hypertension. This medicine has shown an increase in the hypotensive effect of riociguat. If you are taking riociguat or are not sure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be especially cautious with vardenafil

• If you have heart problems, as having sex can put extra strain on your heart.
• If you have irregular heartbeats (arrhythmias) or a family history of heart problems that affect your electrocardiogram.
• If you have any physical condition that may affect the shape of your penis. For example, angulation, Peyronie's disease or cavernosal fibrosis.
• If you have conditions that may cause erections to last longer than normal (priapism). For example, 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 treatments for erection problems, including vardenafil orodispersible tablets (see section: "Other medicines and Vardenafil Aurovitas").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop taking vardenafil and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.
• If you experience sudden loss of vision or your vision becomes distorted or blurred while taking vardenafil, stop taking vardenafil and consult your doctor immediately.

Children and adolescents

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

Other medicines and Vardenafil Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially:

• Nitrates, medicines for angina or that release nitric oxide, such as amyl nitrate. Taking these medicines with vardenafil can seriously lower your blood pressure. Do not take vardenafil without consulting your doctor first.
• Medicines for treating irregular heartbeats, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without consulting your doctor first.
• 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 film-coated tablets in combination with other medicines for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil Aurovitas with food, drinks and alcohol

• You can take vardenafil with or without food, but it is preferable not to take it after a large or fatty 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 erection problems.

Pregnancy and breastfeeding

Vardenafil should not be used in women.

Driving and using machines

In some people, vardenafil may cause dizziness or affect vision. Do not drive or use tools or machines if you feel dizzy or have problems with your vision after taking vardenafil.

Vardenafil Aurovitas contains tartrazine (E102) and orange yellow S (E110)

This medicine may cause allergic reactions because it contains tartrazine (E102) and orange yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Vardenafil Aurovitas

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafil tablet 25-60 minutes before you plan to have sex. With sexual stimulation, you may achieve an erection from 25 minutes up to 4-5 hours after taking vardenafil.

• Swallow the tablet with a glass of water.

Do not take Vardenafil Aurovitas film-coated tabletswith any other formulation of vardenafil.

Do not take vardenafilmore than once a day.

If you feel that the effect of vardenafil is too strong or too weak, tell your doctor. He or she may suggest a switch to another formulation of vardenafil with a different dose, depending on your response to the medicine.

If you take more Vardenafil than you should

Taking too many vardenafil tablets may cause more side effects or produce a severe back pain.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 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 the side effects are mild or moderate.

Some patients have experienced sudden loss of vision or changes in vision, such as blurred vision, or loss of vision 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 irregular heartbeats, heart attacks, chest pain, and stroke (including temporary decreased blood flow to parts of the brain and bleeding in the brain) 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 in 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.
• Flushing.
• Nasal congestion.
• 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 disorders.
• Numbness or altered sense of touch.
• Somnolence.
• Effects on vision, eye redness, effects on color vision, eye pain and discomfort, and photosensitivity.
• Ringing in the ears, vertigo.
• Rapid or irregular heartbeat.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth.
• Increased liver enzymes in the blood.
• Rash, skin redness.
• Back pain or muscle pain; increased muscle enzyme creatine phosphokinase in the 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.
• Increased intraocular pressure (glaucoma), watery eyes, increased tearing.
• Effects on the heart (such as heart attack, irregular heartbeat, or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results in the blood.
• Skin sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary decreased 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, bleeding in the brain.
• Reddish patches, not raised, 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 may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Changes in vision, blurred vision, or loss of vision.

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 via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Vardenafil Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

5 mg (aluminum-aluminum blister):

No special storage conditions are required.

5 mg (aluminum-PVC blister and aluminum-PVC/PVdC blister):

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Vardenafil Aurovitas

• The active substance is vardenafil. Each film-coated tablet contains 5 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other ingredients are:

Core of the tablet:microcrystalline cellulose, hydroxypropylcellulose, crospovidone type B, colloidal anhydrous silica, magnesium stearate.

Coating of the tablet:Opadry beige 03F570025 (hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), tartrazine (E102), orange yellow S (E110), and red iron oxide (E172)).

Appearance and packaging

Light orange or orange, round (5.35 mm in diameter), film-coated tablets with "L" on one face and "05" on the other.

Vardenafil Aurovitas 5 mg film-coated tablets EFG are available in aluminum-aluminum, aluminum-PVC, or aluminum-PVC/PVdC blisters.

Available pack sizes: 4 and 20 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Vardenafil Aurovitas 5 mg film-coated tablets EFG

Date of last revision of this leaflet:January 2025

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/).