Vardenafil Flas Stada 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vardenafil Flas Stada 10 mg orodispersible 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Vardenafil Flas Stada 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, at some point, experience problems achieving or maintaining an erection. This may be due to physical or psychological causes, or a combination of both. Regardless of the cause, disturbances 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 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). 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, peeling skin, blisters, and/or mouth sores after taking vardenafil.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or medicines 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 currently have or have previously had low blood pressure.
• If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever experienced sudden vision loss due to optic nerve damage caused by insufficient blood supply, known as non-arteritic anterior ischemic optic neuropathy (NA-AION).
• 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 taking this medicine.

• 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, such as curvature, Peyronie’s disease, or cavernosal fibrosis.

• If you have a medical condition 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 film-coated tablets (see section: “Use of Vardenafil with other medicines”).

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

• If you suddenly experience a 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 Flas Stada

Inform 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 Flas Stada with food, drinks, and alcohol

• You may 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 alcoholic beverages may worsen erectile problems.

Pregnancy, breast-feeding, and fertility

Vardenafil must not be used in women.

Driving and using 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 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 (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

3. How to take Vardenafil Flas Stada

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 25 to 60 minutes approximately before sexual activity. With sexual stimulation, you may achieve an erection from 25 minutes up to four or five 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 in your mouth, on the tongue, where it will dissolve within seconds, then swallow with saliva. The orodispersible tablet must be taken without any liquid.

Do not take vardenafil orodispersible tablets with any other formulation of vardenafil.

Do not take vardenafil more than once a day.

If you feel 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 an increase in adverse effects and may result in 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.

Cases of sudden death, rapid or irregular heartbeat, heart attacks, 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 men who experienced these side effects already had pre-existing heart conditions before taking this medicine. It is not possible to determine whether these events were directly related to vardenafil.

Some patients have experienced sudden, temporary or permanent partial or complete vision loss, or sudden distorted, dimmed, or blurred central vision, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Sudden decrease or loss of hearing has also been reported.

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 stuffy 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.
• Drowsiness.
• Visual disturbances: eye redness, color vision changes, eye pain and discomfort, and photosensitivity.
• Ringing in the ears (tinnitus); dizziness.
• Fast 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, red skin.
• 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.
• Memory loss (amnesia).
• Seizures.
• Glaucoma (increased intraocular pressure), watery eyes.
• Heart-related effects (such as heart attack, tachycardia, 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 adverse effects or frequency unknown: 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-like or circular skin rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Sudden distorted, dimmed, or blurred central vision or sudden vision loss.

Reporting of adverse effects

If you experience any 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Vardenafil Flas Stada Storage

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 stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are:

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

Appearance of the medicinal product and contents of the pack

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

Each pack contains 2, 4, or 8 tablets.

Only certain 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

Date of the most recent revision of this product information: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/