VARDENAFIL AUROVITAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil Aurovitas 10 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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. Storage of 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, an active substance from the group of medicines called phosphodiesterase 5 inhibitors, which are 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 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 skin rash, itching, swelling of the face or lips and difficulty breathing.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking vardenafil.
• 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 together 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 serious heart or liver problem.
• 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 diseases (such as retinitis pigmentosa).
• If you have ever suffered loss of vision due to a condition called 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 shown that they increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Be especially careful with vardenafil

• If you have heart problems, as having sex can be a strain for you.
• If you have irregular heartbeats (cardiac arrhythmia) or any inherited heart disease that affects 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 have a condition that can cause prolonged erections (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.
• If you have stomach ulcers (also called gastric or peptic ulcers).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment 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 medical attention immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.
• If you suddenly experience a decrease or 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 of age.

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 the following:

• Nitrates, medicines for angina or that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil can seriously affect your blood pressure. Do not take vardenafil without consulting your doctor first.
• Medicines for the treatment of 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 (as in benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafil film-coated tablets in combination with any other medicine 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 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 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 vision problems 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 can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Vardenafil Aurovitas

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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 will be able to achieve an erection from 25 minutes 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 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 than you should

Taking too many vardenafil tablets can cause more side effects or 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 further 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 sudden decrease or loss of vision, distorted, dimmed, or blurred vision, temporary or permanent, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Sudden loss of hearing has also been reported.

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 side effects:may affect more than 1 in 10 people:

• Headache.

Common side effects:may affect up to 1 in 10 people:

• Dizziness.
• Facial flushing.
• Nasal congestion or runny nose.
• 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 and altered sense of touch.
• Somnolence.
• Effects on vision, eye redness, effects on color vision, eye pain and discomfort, and photosensitivity.
• Tinnitus, vertigo.
• Fast or irregular heartbeat.
• Breathing difficulties.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of nausea, dry mouth.
• Elevation of liver enzymes in blood.
• Skin rashes, skin redness.
• 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:

• 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, altered heartbeat, 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 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, cerebral hemorrhage.
• Reddish patches, not elevated, in a target or circular shape on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, dimmed, or blurred vision or sudden loss of vision.

Reporting of side effects

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

5. Storage of Vardenafil Aurovitas

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

Do not use this medicine after the expiry date that appears on the carton after EXP. The expiry date is the last day of the month indicated.

10 mg (aluminum-aluminum blister):

No special storage conditions are required.

10 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. Place the empty packaging and any unused medicinal products in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and medicinal products you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Aurovitas

• The active substance is vardenafil. Each film-coated tablet contains 10 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 of the product and packaging contents

Light orange or orange, round (6.10 mm in diameter), film-coated tablets with "480" marked on one side and smooth on the other.

Vardenafil Aurovitas 10 mg film-coated tablets EFG are available in aluminum-aluminum, aluminum-PVC, or aluminum-PVC/PVdC blisters.

Package sizes: 2, 4, and 8 film-coated tablets.

Not all package 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 10 mg film-coated tablets EFG

Date of the last revision of this package 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/).