LEVATIK 10 mg ORALLY DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Levatik® 10 mg Orodispersible Tablets EFG

Vardenafil

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Levatik and what is it used for
2. What you need to know before taking Levatik
3. How to take Levatik
4. Possible side effects
5. Storage of Levatik
6. Package Contents and Additional Information

1. What is Levatik and what is it used for

This medication contains vardenafil, an active ingredient in the group of medications called phosphodiesterase 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 can be due to physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel disorders cause insufficient blood flow to the penis to achieve and maintain an erection.

Levatik will only work when you are sexually stimulated. This medication reduces the action of a natural substance in the body that prevents erection. Levatik allows you to achieve an erection with sufficient duration to maintain a satisfactory sexual relationship.

2. What you need to know before taking Levatik

Do not take Levatik:

• If you are allergic to vardenafil or any of the other components of this medication (listed in section 6). The signs of an allergic reaction include skin rash, itching, swelling of the face or lips, and difficulty breathing.
• If you are taking medications that contain nitrates, such as glyceryl trinitrate for angina pectoris, or that release nitric oxide, such as amyl nitrite. Taking these medications together with Levatik can seriously 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 serious 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 or 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 loss of vision 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 medication 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). Phosphodiesterase 5 inhibitors, such as vardenafil, have shown that they increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or ulcers in the mouth after taking vardenafil.

Warnings and Precautions

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

Be careful with Levatik

• If you have heart problems, as having sexual intercourse can pose a risk to you.
• If you have irregular heartbeats (cardiac arrhythmia) or any inherited heart disease that alters your electrocardiogram.
• If you have any physical problem that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous fibrosis.
• If you have a disease that can cause erections that do not disappear (priapism). For example, sickle cell anemia, multiple myeloma, and leukemia.
• If you have a stomach ulcer (also called gastric or peptic ulcer).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erection problems, including vardenafil film-coated tablets (see the section "Other medications and Levatik").
• 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 suddenly experience a decrease or loss of vision or your vision becomes distorted or blurred while taking vardenafil, stop taking Levatik and consult your doctor immediately.

Children and Adolescents

Levatik should not be used in children or adolescents under 18 years of age.

Other medications and Levatik

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

Some medications can cause problems, especially the following:

• Nitrates, medications for angina pectoris or that release nitric oxide, such as amyl nitrite. Taking these medications together with Levatik can seriously affect your blood pressure. Do not take this medication 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 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 Levatik orodispersible tablets in combination with another medication for the treatment of erectile dysfunction, including vardenafil film-coated tablets.

Taking Levatik with food, drinks, and alcohol

• You can take Levatik tablets with or without food, but do not take this medication with liquid.
• Do not drink grapefruit juice when taking this medication, as it may interfere with the normal effect of the medication.
• Drinking alcoholic beverages can worsen erection problems.

Pregnancy and Breastfeeding

Levatik should not be used in women.

Driving and Using Machines

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

Levatik 10 mg Orodispersible Tablets contain aspartame and sodium

• Aspartame: This medication contains 1.80 mg of aspartame in each 10 mg orodispersible tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.
• Sodium: This medication contains less than 23 mg of sodium (1 mmol) per 10 mg orodispersible tablet; that is, it is essentially "sodium-free".

3. How to take Levatik

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

The recommended dose is 10 mg.

Take a Levatik tablet 25 to 60 minutes, approximately, before sexual activity. With sexual stimulation, you will be able to achieve an erection from 25 minutes to 4 or 5 hours after taking this medication.

• Do not remove the orodispersible tablet from the blister pack until you are ready to take it. With dry hands, pull the edge of the blister pack from the support and press gently on the top to release the tablet into your hand. Do not break the tablet.

• Place the entire orodispersible tablet in your mouth, on your tongue, where it will dissolve in seconds, and then swallow with your saliva. The orodispersible tablet should be taken without any liquid.

Do not take Levatik orodispersible tabletswith any other formulation of vardenafil.

Do not take Levatikmore than once a day.

If you think the effect of vardenafil is too strong or too weak, inform your doctor. He or she may suggest changing to another formulation of vardenafil with a different dose based on the effect it has on you.

If you take more Levatik than you should

Taking too many Levatik 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 Toxicology 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.

4. Possible side effects

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

Some patients have experienced sudden vision loss or partial vision loss, distorted, attenuated, or blurred vision, temporary or permanent, in one or both eyes. If any of this occurs, stop taking this medication and consult your doctor immediately.

There have also been reports of sudden hearing loss.

There have been reports of sudden death, rapid or altered 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 of the men who 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 through 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.
• Facial flushing.
• Nasal congestion or runny nose.
• 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 disorders.
• Numbness and altered sensation of touch.
• Somnolence.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Tinnitus; vertigo.
• Rapid or irregular heartbeat.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (nausea), dry mouth.
• Elevation of liver enzymes in blood.
• Skin rashes, reddened skin.
• Back pain or muscle pain; elevation of muscle enzyme creatine phosphokinase in blood; muscle stiffness.
• Prolonged erection.
• General discomfort.

Rare side effects(may 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 infarction, tachycardia, or angina).
• High or low blood pressure.
• Nosebleeds.
• 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 less than 1 in 10,000 people or the frequency cannot be estimated from the available data):

• Blood in urine (hematuria).
• Bleeding in the penis (penile hemorrhage).
• Blood in the semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.
• Reddish, 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 rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, attenuated, or blurred central vision or sudden vision loss.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Levatik

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 shown on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Levatik

• The active ingredient is vardenafil. Each orodispersible tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate).

• The other ingredients are:

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

Appearance of the product and package contents

Levatik 10 mg orodispersible tablets are round, flat, white or almost white tablets.

The tablets are available in blister packs of 1, 2, 4, or 8 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, Co. Galway

Ireland

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park,

Paola PLA 3000

Malta

or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany Vardenaristo 10 mg Schmelztabletten

Italy Vardenafil Aristo Pharma 10 mg

Ireland Vardenadil Chanelle 10 mg Orodispersible Tablets

United Kingdom Vardenafil Chanelle 10 mg Orodispersible Tablets

Date of the last revision of this package leaflet: February 2025

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