Leaflet: information for the user

Levatik 5 mg film-coated tablets EFG

Vardenafilo

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.,

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Levatik is and what it is used for

2. What you need to know before you start taking Levatik

3. How to take Levatik

4. Possible side effects

5. Storage of Levatik

6. Contents of the pack and additional information

This medication contains vardenafilo, an active ingredient from the group of medications known as phosphodiesterase 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 vascular alterations result in insufficient blood flow to the penis to achieve and maintain an erection.

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

Do not take vardenafil

-If you are allergic to vardenafil or any of the other ingredients in 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 vardenafil may 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 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 had 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 been 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 skin peeling, blisters, and/or mouth sores after taking vardenafil.

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

Be especially careful with vardenafil

-If you have heart problems, as having sex may 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 may cause erections that do not subside (priapism), such as sickle cell anemia, multiple myeloma, and 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 film-coated tablets (see section: "Use of Vardenafil with other medications").

- 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 darkens 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 old.

Other medications and vardenafil

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 vardenafil may severely affect your blood pressure. Do not take vardenafil without consulting your doctor.

-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.

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

Taking vardenafil with food, drinks, and alcohol

-You can take vardenafil with or without food, but it is recommended not to do so after a large or high-fat meal, as the effect may be delayed.

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

-Drinking alcoholic beverages may worsen erectile dysfunction problems.

Pregnancy and breastfeeding

Vardenafil should not be used in women.

Driving and operating machinery

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.

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

The recommended dose is 10 mg.

Take a vardenafil tablet 25 to 60 minutes before sexual activity. With sexual stimulation, you can obtain an erection from 25 minutes to four or five hours after taking vardenafil.

-Swallow the tablet with a glass of water.

Do not take vardenafil film-coated tablets with any other vardenafil formulation.

Do not take vardenafil more than once a day.

If you estimate that the effect of vardenafil is too strong or 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 Vardenafilo than you should

Taking too many vardenafil 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 medications, vardenafil may 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 central vision, suddenly, temporarily, or permanently, in one or both eyes.

Cases of sudden decrease or loss of hearing have also been reported.

Cases of sudden death, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary decrease in blood flow to parts of the brain and cerebral hemorrhage) have been reported in men taking vardenafil. Most men who have 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 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 or rhinorrhea.

-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.

-Drowsiness.

-Effects on vision; eye hemorrhage, effects on color vision, eye pain, and photosensitivity.

-Tinnitus; vertigo.

-Palpitations or rapid heartbeat.

-Dyspnea.

-Blocked nose.

-Reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth.

-Elevation of liver enzymes in the blood.

-Skin rash, red skin.

-Back pain or muscle pain; elevated 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.
• Syncope.
• Amnesia (memory loss).
• Seizures.
• Glaucoma (increased intraocular pressure), watery eyes.
• Effects on the heart (such as, for example, myocardial infarction, tachycardia, or angina).
• Hypertension or hypotension.
• Nasal bleeding.
• Alterations in liver function test results in the blood.
• Sensitivity to sunlight. Painful erection. Chest pain.
• Temporary decrease in 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 the available data:

• Blood in urine (hematuria).
• Penile bleeding (hemorrhage).
• Blood in semen (hematospermia).
• Sudden death; Cerebral hemorrhage.
• Flat, non-elevated, circular or target-shaped patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, blurred, or central vision or sudden decrease in vision.

Reporting of side effects

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

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

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.

Store this medication at a temperature below 30°C.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your 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 principle is vardenafil. Each tablet contains 5 mg of vardenafil (as hydrochloride).
• The other components are:

In the tablet core: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, and magnesium stearate.

On the film coating: polyvinyl alcohol, titanium dioxide (E171), talc, macrogol/PEG 3350, copolymer of methacrylic acid type C, yellow iron oxide (E172), sodium bicarbonate, and red iron oxide (E172).

Appearance of the product and content of the packaging

Levatik 5 mg are film-coated tablets of a light yellow color, round, and marked with “A719” on one side.

Each package contains 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Actavis Ltd.

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Last review date of this leaflet: January 2025

The 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/