Leaflet: information for the user

Vardenafilo Flas Stada 10 mg buccal tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

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

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

1. What Vardenafilo Flas Stada is and what it is used for

2. What you need to know before taking Vardenafilo Flas Stada

3. How to take Vardenafilo Flas Stada

4. Possible side effects

5. Storage of Vardenafilo Flas Stada

6. Contents of the pack 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 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 vascular 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 Vardenafilo Flas Stada

-If you are allergic to vardenafil 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 vardenafil.

-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 vardenafil 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 ketoconazole or itraconazole, antifungal medications.

-If you have a severe heart or liver problem.

-If you are undergoing renal dialysis.

-If you have recently experienced a stroke or heart attack.

-If you have low blood pressure, or if you 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 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 arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PDE5 inhibitors, such as vardenafil, have shown to increase the hypotensive 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.

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

-If you have irregular heartbeats (arrhythmia) or a hereditary heart disease that alters your electrocardiogram.

-If you have a physical condition that affects the shape of your penis, such as angulation, Peyronie's disease, or cavernous fibrosis.

-If you have a disease that may cause erections that do not subside (priapism), such as sickle cell anemia, multiple myeloma, or 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 vardenafil film-coated tablets (see the section: “Using Vardenafil with other medications”).

• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Discontinue vardenafil 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 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 Medications and Vardenafilo Flas Stada

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 vardenafil may severely affect your blood pressure. Do not take vardenafil without consulting your doctor first.

-Medications for arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.

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

-Ketoconazole or itraconazole, antifungal medications.

-Erythromycin or clarithromycin, macrolide antibiotics.

-Alpha-blockers, a group of medications 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 medication for erectile dysfunction, including vardenafil buccal dissolvable tablets.

Taking Vardenafilo Flas Stada with Food, Drinks, and Alcohol

-You can take vardenafil with or without food, but do not take this medication with a liquid.

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

-Drinking alcoholic beverages may worsen erectile dysfunction problems.

Pregnancy, Breastfeeding, and Fertility

Vardenafil should not be used in women.

Driving and Operating Machinery

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

Vardenafilo Flas Stada contains aspartame and sodium

This medication contains 1.80 mg of aspartame per tablet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 can obtain an erection from 25 minutes to four or five hours after taking vardenafilo.

- Do not remove the buccodispersable tablet from the blister until you are ready to take it. With dry hands, press the blister gently to release the tablet into your hand. Do not break the tablet.

- Place the buccodispersable tablet whole in your mouth, on the tongue, where it will dissolve in seconds, and then swallow with saliva. The buccodispersable tablet should be taken without any type of liquid.

Do not take vardenafilo buccodispersable 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 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 medication and the amount ingested.

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

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

There have been reports 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 already had heart problems before taking this medication. It is not possible to determine if these events were directly related to vardenafil.

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

There have also been reports of sudden hearing loss.

The possibility of presenting a side effect is described using the following categories:

Very common side effects:can affect more than 1 in 10 people:

-Headache.

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

-Dizziness.

-Facial flushing.

-Nasal congestion or runny nose.

-Indigestion.

Uncommon side effects:can 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 sensation.

-Drowsiness.

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

-Tinnitus; vertigo.

-Palpitations or rapid heartbeat.

-Difficulty breathing.

-Stuffy nose.

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

-Elevation of liver enzymes in the blood.

-Skin rash, red skin.

-Back pain or muscle pain; elevated muscle enzyme creatine phosphokinase in the blood; muscle stiffness.

-Prolonged erection.

-General malaise.

Rare side effects:can 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 myocardial infarction, tachycardia, or angina).

-High or low blood pressure.

-Nasal bleeding.

-Alterations in liver function test results in the 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:can affect fewer than 1 in 10,000 people or the frequency cannot be estimated from the available data:

-Blood in urine (hematuria).

-Bleeding in the penis (hemorrhagic penile).

-Blood in semen (hematospermia).

-Sudden death.

• Cerebral hemorrhage.
• Flat, non-elevated, circular or target-like spots on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, blurred, or distorted 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 Medicines for Human Use https://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.

This medication does not require special storage conditions.

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.

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

Composition of Vardenafilo Flas Stada 10 mg

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

-The other components are:

Microcrystalline cellulose, sodium carboxymethylcellulose type A (potato starch), anhydrous colloidal silica, magnesium stearate, aspartame (E951), peppermint aroma, and sodium stearoyl fumarate.

Appearance of the product and content of the packaging

Vardenafilo Flas Stada 10 mg buccal dispersible tablets EFG are round white to off-white tablets.

Each package contains 2, 4, or 8 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing

Chanelle Medical Unlimited Company

Dublin Road, Loughrea,

County Galway H62 FH90

Ireland

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

Last review date of thisleaflet:February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/