Prospect: Information for the User

Vardenafilo Aurovitas 10 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Vardenafilo Aurovitas

3.How to take Vardenafilo Aurovitas

4.Possible adverse effects

5.Storage of Vardenafilo Aurovitas

6.Contents of the package and additional information

This medicationcontains vardenafilo, an active ingredient from the group of medications known as phosphodiesterase type 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 every ten men has, at some point, problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel alterations result in insufficient blood in the penis to achieve and maintain an erection.

Vardenafilo will only act when sexually stimulated. This medication reduces the action of a natural substance in the body that prevents an erection. Vardenafilo allows for an erection with a sufficient duration to maintain a satisfactory sexual relationship.

Do not take VardenafiloAurovitas

•If you are allergic to vardenafilo or any of the other components of this medication (listed in section 6). 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 mouth sores after taking vardenafilo.

•If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafilo may severely affect your blood pressure.

•If you are taking ritonavir or indinavir, medications for the treatment of human immunodeficiency virus (HIV) infections.

•If you are over 75 years old and taking ketoconazol or itraconazol, antifungal medications.

•If you have a severe heart or liver problem.

•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 suffered vision loss due to a lack of blood supply to the optic nerve, known as non-arteritic anterior ischemic optic neuropathy (NAION).

•If you are taking riociguat. This medication is used to treat pulmonary hypertension (high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as vardenafilo, have shown to increase the effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

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

Be especially careful with vardenafilo

•If you have heart problems, as having sex may pose a risk to you.

•If you have irregular heartbeats (arrhythmia cardiaca) 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 cavernous fibrosis.

•If you have a disease that may cause erections that do not subside (priapismo). For example, sickle cell anemia, multiple myeloma, and leukemia.

•If you have a stomach ulcer (also known as a gastric or peptic ulcer).

•If you have bleeding disorders (such as hemophilia).

•If you are using any other treatment for erectile dysfunction, including vardenafilo bucodispersable tablets (see section: “Other medications and Vardenafilo Aurovitas”).

•Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafilo treatment. Discontinue vardenafilo treatment and seek immediate medical attention if you experience any symptoms related to these severe skin reactions described in section 4.

•If you experience sudden vision loss or distortion, or if your vision becomes cloudy while taking vardenafilo, stop taking vardenafilo and consult your doctor immediately.

Children and adolescents

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

Other medications and Vardenafilo Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may cause problems, especially the following:

•Nitrates, medications for angina or that release nitric oxide, such as amyl nitrite. Taking these medications together with vardenafilo may severely affect your blood pressure. Do not take vardenafilo without consulting your doctor first.

•Medications for the treatment of cardiac arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.

•Ritonavir or indinavir, medications for HIV. Do not take vardenafilo without consulting your doctor first.

•Ketoconazol or itraconazol, antifungal medications.

•Erythromycin or clarithromycin, macrolide antibiotics.

•Alpha-blockers, a group of medications used to treat high blood pressure and enlarged prostate (such as in benign prostatic hyperplasia).

•Riociguat.

Do not use vardenafilo bucodispersable tablets in combination with another medication for the treatment of erectile dysfunction, including vardenafilo bucodispersable tablets.

Taking Vardenafilo Aurovitas with food, drinks, and alcohol

•You can take vardenafilo with or without food, but it is recommended not to do so after a large or high-fat meal, as the effect may be delayed.

•Do not drink grapefruit juice while taking vardenafilo, as it may interfere with the normal effect of the medication.

•Drinking alcoholic beverages may worsen erectile dysfunction.

Pregnancy and breastfeeding

Vardenafilo should not be used in women.

Driving and operating machinery

In some people, vardenafilo may cause dizziness or affect vision. Do not drive or operate tools or machinery if you feel dizzy or have vision problems after taking vardenafilo.

Vardenafilo Aurovitascontains tartrazine (E102) and sunset yellow FCF (E110)

This medication 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take a vardenafilo tablet 25 to 60 minutes before sexual activity. With sexual stimulation, you will be able to obtain an erection from 25 minutes and up to four or five hours after taking vardenafilo.

- Swallow the tablet with a glass of water.

Do not take vardenafilo film-coated tablets with any other vardenafilo formulation.

Do not take vardenafilo more than once a day.

If you estimate that the action of vardenafilo is too strong or weak, inform your doctor. They may suggest changing to another vardenafilo formulation with a different dose based on the effect it has on you.

If you take more Vardenafilo than you should

Taking too many vardenafilo tablets may 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 medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, vardenafil may cause side effects, although not everyone will experience them. Most of these side effects are mild or moderate.

Some patients have experienced a decrease or partial loss of vision, distorted, blurred, or dim central vision, suddenly, temporarily, or permanently, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have also been reported cases of sudden hearing loss.

There have been reported cases 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 men who have experienced these side effects had pre-existing heart problems before taking this medication. It is not possible to determine if these events were directly related to vardenafil.

The possibility of presenting a side effect is described using 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 or rhinorrhea.

•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 disturbances.

•Numbness and altered tactile perception.

•Drowsiness.

•Effects on vision, eye redness, effects on color vision, eye pain and discomfort, and photosensitivity.

•Tinnitus, vertigo.

•Palpitations or rapid heartbeat.

•Dyspnea.

•Blocked nose.

•Reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth.

•Elevation of liver enzymes in blood.

•Skin eruptions, skin redness.

•Back pain or muscle pain; elevated 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.

•Syncope.

•Amnesia (memory loss).

•Seizures.

•Increased intraocular pressure (glaucoma), watery eyes, increased tear production.

•Effects on the heart (such as myocardial infarction, arrhythmia, or angina).

•Hypertension or hypotension.

•Nasal bleeding.

•Alterations in liver function test results in blood.

•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 fewer than 1 in 10,000 people or the frequency cannot be estimated from available data:

•Blood in urine (hematuria).

•Bleeding in the penis (hemorrhagic penile).

•Blood in semen (hematospermia).

•Sudden death, cerebral hemorrhage.

•Reddish, non-elevated, target-like or circular patches on the trunk, often with central vesicles, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

•Distorted, blurred, or dim central vision or sudden loss of vision.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration 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.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofVardenafilo Aurovitas

-The active ingredient is vardenafil. Each film-coated tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).

-The other components are:

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

Tablet coating:Opadry beige 03F570025 (hypromellose, titanium dioxide (E171), macrogol, yellow iron oxide (E172), tartrazine (E102), yellow-orange S (E110) and red iron oxide (E172)).

Appearance of the product and content of the container

Film-coated tablets of a light orange or orange color, round (6.10 mm in diameter), with the mark “480” on one side and smooth on the other.

Vardenafilo Aurovitas 10 mg film-coated tablets are available in aluminum-aluminum blister packs, aluminum-PVC or aluminum-PVC/PVdC.

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

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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 with the following names:

Spain:Vardenafilo Aurovitas 10 mg film-coated tablets EFG

Last review date of this leaflet: January 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).