Vardenafil Aurovitas 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Vardenafil Aurovitas 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Vardenafil Aurovitas is and what it is 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 the 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 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). 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 skin peeling, 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 have 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 damage to the optic nerve 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). 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 to take this medicine.

Take special care with vardenafil

• 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 that affects your electrocardiogram.
• If you have a physical condition affecting the shape of your penis, for example, curvature, Peyronie’s disease, or cavernosal fibrosis.
• If you have a disease 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 orodispersible tablets (see section: “Other medicines and Vardenafil Aurovitas”).
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Stop treatment with vardenafil and seek immediate medical attention if you experience any symptoms related to these serious skin reactions described in section 4.
• If you experience sudden decrease or loss of vision, or if your vision becomes distorted or darkened while taking vardenafil, stop taking vardenafil and consult your doctor immediately.

Children and adolescents

Vardenafil must 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 need to take any other medicines, including those obtained without a prescription.

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. Do not take vardenafil without first consulting your doctor.
• Medicines for cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without first consulting your doctor.
• 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 another medicine for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil Aurovitas with food, drinks, and alcohol

• You may take vardenafil with or without food, but it is preferable not to take it after a heavy or high-fat meal, as this may delay its effect.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.
• Drinking alcoholic beverages may worsen erectile problems.

Pregnancy and breastfeeding

Vardenafil must not be used in women.

Driving and use of 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 Aurovitas contains tartrazine (E102) and sunset yellow FCF (E110)

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

3. How to take Vardenafil Aurovitas

Follow exactly the instructions for use of this medicine provided by your doctor. 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.

• Swallow the tablet with a glass of water.

Do not take vardenafil film-coated tablets together with any other formulation of vardenafil.

Do not take vardenafil 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 than you should

Taking too many vardenafil tablets may cause more adverse effects or cause 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 partial reduction or loss of vision, distorted, dimmed or blurred central vision, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Sudden reduction or loss of hearing has also been reported.

Cases of sudden death, rapid or irregular heartbeat, heart attack, 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 of the men who experienced these side effects 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 adverse effects: may affect more than 1 in 10 people:

• Headache.

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

• Dizziness.
• Facial flushing.
• Runny or congested nose.
• Indigestion.

Uncommon adverse effects: 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.
• Somnolence.
• Visual disturbances, eye redness, disturbances in color vision, eye pain and discomfort, and photosensitivity.
• Ringing in the ears (tinnitus), dizziness.
• Rapid pulse or palpitations.
• Difficulty breathing.
• Nasal congestion.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling unwell (nausea), dry mouth.
• Increased liver enzymes in blood.
• Skin rashes, skin redness.
• Back pain or muscle pain; increased blood levels of the muscle enzyme creatine phosphokinase; muscle stiffness.
• Prolonged erection.
• General malaise.

Rare adverse 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 (e.g., heart attack, irregular heartbeat, or 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 or frequency unknown adverse effects: may affect fewer than 1 in 10,000 people, or frequency cannot be estimated from available data:

• Blood in urine (hematuria).
• Bleeding from the penis (penile hemorrhage).
• Blood in semen (hematospermia).
• Sudden death, cerebral hemorrhage.
• Red, non-elevated, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, dimmed, or blurred central vision or sudden reduction in vision.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

20 mg (aluminium-aluminium blister):

No special storage conditions required.

20 mg (aluminium-PVC blister and aluminium-PVC/PVdC blister):

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Package contents and other information

Composition of Vardenafil Aurovitas

• The active substance is vardenafil. Each film-coated tablet contains 20 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other components are:

Tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone type B, colloidal anhydrous silica, magnesium stearate.

Tablet coating: Opadry beige 03F570025 (hypromellose, titanium dioxide (E171), polyethylene glycol, iron oxide yellow (E172), tartrazine (E102), sunset yellow FCF (E110) and iron oxide red (E172)).

Appearance of the medicinal product and contents of the pack

Film-coated tablets, light orange or orange in colour, round (8.10 mm in diameter), marked “481” on one side and plain on the other.

Vardenafil Aurovitas 20 mg film-coated tablets EFG are available in aluminum-aluminum, aluminum-PVC or aluminum-PVC/PVdC blister packs.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Vardenafil Aurovitas 20 mg film-coated tablets EFG

Date of the most recent revision of this leaflet: January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).