VARDENAFIL STADA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil Flas Stada 10 mg Orodispersible 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 Flas Stada and what is it used for
2. What you need to know before you take Vardenafil Flas Stada
3. How to take Vardenafil Flas Stada
4. Possible side effects
5. Storage of Vardenafil Flas Stada
6. Contents of the pack and other information

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

This medicinal product contains vardenafil, which is a member of a class of medicines called phosphodiesterase type 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 has, 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 sufficient for satisfactory sexual activity.

2. What you need to know before you take Vardenafil Flas Stada

Do not take Vardenafil Flas Stada

• 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, swollen face or lips and difficulty breathing.
• If you have ever had a severe skin rash or peeling of the skin, blisters in the 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. When taken together with vardenafil, these medicines can cause your blood pressure to drop to an unsafe level.
• 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 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 had 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 due to blood clots). PDE5 inhibitors, such as vardenafil, have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

• 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 occur without sexual stimulation, such as 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 film-coated tablets (see section "Using Vardenafil with other medicines").
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with vardenafil treatment. Discontinue vardenafil treatment and seek medical attention immediately if you experience any 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 of age.

Other medicines and Vardenafil Flas Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with vardenafil can cause your blood pressure to drop to an unsafe level. Do not take vardenafil without consulting your doctor.
• 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.
• 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 Flas Stada with food, drinks, and alcohol

• You can take vardenafil with or without food, but do not take this medicine with liquid.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.
• Drinking alcohol can make erection problems worse.

Pregnancy, breastfeeding, and fertility

Vardenafil should not be used in women.

Driving and using machines

Vardenafil may cause dizziness or affect your vision. Do not drive or operate tools or machines if you feel dizzy or have problems with your vision after taking vardenafil.

Vardenafil Flas Stada contains aspartame and sodium

This medicine contains 1.80 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (a rare, genetic disorder in which phenylalanine builds up because the body cannot remove it properly).

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

3. How to take Vardenafil Flas Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is 10 mg.

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

• Do not remove the orodispersible tablet from the blister until you are ready to take it. With dry hands, gently press the blister to release the tablet into your hand. Do not break the tablet.
• Place the entire orodispersible tablet on the tongue, where it will dissolve in seconds, and then swallow with saliva. The orodispersible tablet should be taken without any liquid.

Do not take Vardenafil Flas Stada orodispersible 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, inform your doctor. He or she may suggest switching to another formulation of vardenafil with a different dose based on its effect on you.

If you take more vardenafil than you should

Taking too many vardenafil tablets may cause more side effects and may produce intense back pain.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you have any further questions on the use of this product, 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.

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 experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

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

There have also been reports of sudden loss of hearing.

The likelihood of experiencing 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.
• 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 sense of touch.
• Somnolence.
• Effects on vision; eye redness, effects on color vision, eye pain and discomfort, and photosensitivity.
• Tinnitus; vertigo.
• Rapid or irregular heartbeat.
• Difficulty breathing.
• Nasal stuffiness.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling sick (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.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (such as heart attack, rapid or 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 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 from the penis (penile hemorrhage).
• Blood in the semen (hematospermia).
• Sudden death.
  • Cerebral hemorrhage.
  • Red, non-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 can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Distorted, diminished, or blurred vision or sudden loss of vision.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Flas Stada

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

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Flas Stada 10 mg

• The active substance is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).
• The other ingredients are:

Microcrystalline cellulose, sodium starch glycolate type A (potato starch), colloidal anhydrous silica, magnesium stearate, aspartame (E951), peppermint flavor, and sodium stearyl fumarate.

Appearance and packaging of the product

Vardenafil Flas Stada 10 mg orodispersible tablets EFG are white to off-white round tablets.

Each pack contains 2, 4, or 8 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

Chanelle Medical Unlimited Company

Dublin Road, Loughrea,

County Galway H62 FH90

Ireland

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000,

Malta

Date of last revision of this leaflet:February 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/