Prospect: Information for the User

Levatik® 10 mg Bucodispersable Tablets EFG

Vardenafilo

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

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

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

-This medication has been prescribed only to 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 Levatik is and for what it is used

2. What you need to know before starting to take Levatik

3. How to take Levatik

4. Possible adverse effects

5. Storage of Levatik

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 characterized by difficulty achieving or maintaining an erection.

At least one in ten men experience, at some point, difficulty 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 flow to the penis to achieve and maintain an erection.

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

Do not take Levatik:

-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 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 Levatik can 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 have had it in the past.

-If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).

-If you have ever experienced 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 vardenafil, have shown to 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 peeling, blisters, or mouth sores after taking vardenafil.

Warnings and precautions

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

Take special care with Levatik

-If you have heart problems, as having sex can 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 can 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 tablets (see 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 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 partial vision loss, or if your vision becomes distorted or dark 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 old.

Other medications and Levatik

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those obtained 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 Levatik can severely affect your blood pressure. Do not take this medication without consulting your doctor first.

-Medications for treating 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 tablets in combination with another medication for erectile dysfunction, including vardenafil tablets coated with a film.

Levatik with food, drinks, and alcohol

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

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

-Drinking alcoholic beverages may worsen erectile dysfunction problems.

Pregnancy and breastfeeding

Levatik should not be used in women.

Driving and operating machinery

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

Levatik 10 mg tablets contain aspartame and sodium

• Aspartame: This medication contains 1.80 mg of aspartame in each 10 mg 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.
• Sodium: This medication contains less than 23 mg of sodium (1 mmol) per 10 mg tablets; that is, it is essentially “sodium-free”.

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

The recommended dose is 10 mg.

Take one Levatik 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 this medication.

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

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

Do not take Levatik buccal tablets with any other vardenafil formulation.

Do not take Levatik more than once a day.

If you estimate that the vardenafil effect is too strong or too weak, inform your doctor. They may suggest switching to another vardenafil formulation 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 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, Levatik can cause side effects, although not everyone will experience them. Most of these side effects are mild or moderate.

Some patients have experienced a decrease in vision or partial loss of vision, distorted, blurred, or sudden, temporary, or permanent vision in one or both eyes. If this happens, stop taking this medicine and consult your doctor immediately.

There have also been reported cases of sudden hearing loss or 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 already had heart problems before taking this medicine. 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.

-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 swelling, lip swelling, or throat swelling.

-Sleep disturbances.

-Numbness and altered sensation of touch.

-Drowsiness.

-Effects on vision; eye bleeding, effects on color vision, eye pain, 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 blood.

-Skin rash, red skin.

-Back pain or muscle pain; elevated muscle enzyme 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.

-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 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.

-Flat, non-elevated, circular or target-like spots on the trunk, often with central blisters, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

- Distorted, blurred, or reduced central vision or sudden vision loss.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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 medicine.

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 the 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 Levatik

• 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 carboxymethyl starch (potato starch), anhydrous colloidal silica, magnesium stearate, aspartame (E951), peppermint flavor, and stearoyl fumarate and sodium.

Appearance of the product and contents of the package

Levatik 10 mg buccal dispersible tablets are round, flat, white or off-white tablets.

The tablets are presented in blisters of 1, 2, 4, or 8 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible 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 medicine is authorized in the member states of the European Economic Area with the following names:

GermanyVardenaristo 10 mg Schmelztabletten

ItalyVardenafil Aristo Pharma 10 mg

IrelandVardenadil Chanelle 10 mg Orodispersible Tablets

United KingdomVardenafil Chanelle 10 mg Orodispersible Tablets

Last review date of this leaflet: February 2025

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