Levatik 10 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levatik® 10 mg orodispersible tablets EFG

Vardenafil

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Levatik 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 result in insufficient blood flow to the penis to achieve and maintain an erection.

Levatik will only work when you are sexually stimulated. This medicine reduces the action of a natural substance in the body that prevents erection. Levatik enables you to achieve an erection of sufficient duration to allow satisfactory sexual intercourse.

2. What you need to know before taking Levatik

Do not take Levatik:

• If you are allergic to vardenafil or to 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 are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with Levatik may severely 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 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 optic nerve damage caused by insufficient blood supply, known as 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 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.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking vardenafil.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Take special care with Levatik

• 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 affecting your electrocardiogram.
• If you have a physical condition affecting the shape of your penis, such as curvature, Peyronie’s disease, or cavernous fibrosis.
• If you have a 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 orodispersible tablets (see section: “Other medicines and Levatik”).
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with vardenafil treatment. Stop treatment with vardenafil and seek immediate medical attention if you experience any symptoms related to these serious skin reactions described in section 4.
• If you suddenly experience a decrease or partial loss of vision, or if your vision becomes distorted or darkened while taking vardenafil, stop taking Levatik and consult your doctor immediately.

Children and adolescents

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

Other medicines and Levatik

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 Levatik may severely affect your blood pressure. Do not take this medicine 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 Levatik orodispersible tablets in combination with another medicine for the treatment of erectile dysfunction, including vardenafil film-coated tablets.

Taking Levatik with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Levatik must not be used in women.

Driving and using machines

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 medicine.

Levatik 10 mg orodispersible tablets contain aspartame and sodium

• Aspartame: This medicine contains 1.80 mg of aspartame per 10 mg orodispersible 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.
• Sodium: This medicine contains less than 23 mg of sodium (1 mmol) per 10 mg orodispersible tablet; this is essentially “sodium-free.”

3. How to take Levatik

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

Take one Levatik tablet approximately 25 to 60 minutes before sexual activity. With sexual stimulation, you may achieve an erection from 25 minutes up to four or five hours after taking this medicine.

• Do not remove the orodispersible tablet from the blister until you are ready to take it. With dry hands, pull the edge of the blister from its backing and gently press the top 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 it with saliva. The orodispersible tablet must be taken without any liquid.

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

Do not take Levatik 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 vardenafil formulation with a different dose, depending on the effect it has on you.

If you take more Levatik than you should

Taking too many Levatik tablets may cause more side effects and lead to severe back pain.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating 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, Levatik may cause adverse effects, although not everyone experiences them. Most of these adverse effects are mild or moderate.

Some patients have experienced sudden, temporary or permanent decrease or loss of vision, or distorted, dimmed or blurred central vision, in one or both eyes. If any of these occur, stop taking this medicine and consult your doctor immediately.

Sudden decrease or loss of hearing has also been reported.

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.

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 congested 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.
• Somnolence.
• Visual disturbances; eye discharge, disturbances in color vision, eye pain, and photosensitivity.
• Ringing in the ears (tinnitus); dizziness.
• Rapid pulse or palpitations.
• Difficulty breathing.
• Nasal congestion.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling of discomfort (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.
• Amnesia (memory loss).
• Seizures.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (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 or frequency unknown adverse effects (may affect less than 1 in 10,000 people or frequency cannot be estimated from available data):

• Blood in urine (hematuria).
• Bleeding in the penis (penile hemorrhage).
• Blood in semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.
• Red, non-elevated, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, dimmed or blurred central vision or sudden decrease in vision.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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. Storage of Levatik

Keep this medicine out of 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 in household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levatik

• 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 flavour, and sodium stearyl fumarate.

Appearance of the medicinal product and contents of the pack

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

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

Only certain 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 medicinal product 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 most recent revision of this leaflet: February 2025

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