VARDENAFIL KRKA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Vardenafil Krka

Do not take Vardenafil

• 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 had a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking vardenafil.

• If you are taking medicines that contain nitrates, such as glyceryl trinitrate for angina, or that release nitric oxide, such as amyl nitrite. Taking these medicines with vardenafil can seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines for the treatment of human immunodeficiency virus (HIV) infections.
• If you are over 75 years old and are taking ketoconazole or itraconazole, antifungal medicines.
• If you have a severe heart or liver problem.
• If you are on kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure or have ever had low blood pressure.
• If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).
• If you have ever had loss of vision due to a condition called 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). Phosphodiesterase type 5 inhibitors like vardenafil have shown an increase in the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be cautious with vardenafil

• If you have heart problems, as having sex can be a strain on your heart.
• If you have irregular heartbeats (cardiac arrhythmias) or a family history of heart problems that affect your electrocardiogram.
• If you have a physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernosal fibrosis.
• If you have a condition that may cause prolonged erections (such as sickle cell anemia, multiple myeloma, or leukemia).
• If you have stomach ulcers (also known as gastric or peptic ulcers).
• If you have bleeding disorders (such as hemophilia).
• If you are using any other treatment for erection problems, including vardenafil orodispersible tablets (see section "Other medicines and Vardenafil Krka").

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

• If you have ever had a decrease or loss of vision or your vision is distorted or blurred while taking vardenafil, suddenly, temporarily, or permanently in one eye, do not take vardenafil and consult your doctor immediately.

Children and adolescents

Vardenafil should not be used in children or adolescents under 18 years old.

Other medicines and Vardenafil Krka

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially:

• Nitrates, medicines for angina, or medicines that release nitric oxide, such as amyl nitrate. Taking these medicines with vardenafil can seriously affect your blood pressure. Do not take vardenafil without consulting your doctor.
• Medicines for treating irregular heartbeats, such as quinidine, procainamide, amiodarone, or sotalol.
• Ritonavir or indinavir, medicines for HIV. Do not take vardenafil without 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 (as in benign prostatic hyperplasia).
• Riociguat.

Do not use vardenafil film-coated tablets in combination with other medicines for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil with food, drinks, and alcohol

• You can take vardenafil with or without food, but it is preferable not to take it after a large or fatty meal, as the effect may be delayed.
• Do not drink grapefruit juice when taking vardenafil, as it may interfere with the normal effect of the medicine.
• Drinking alcohol can worsen erection problems.

Pregnancy and breastfeeding

Vardenafil should not be used in women.

Driving and using machines

In some people, vardenafil can cause dizziness or affect vision. Do not drive or use tools or machines if you feel dizzy or have problems with your vision after taking vardenafil.

3. How to take Vardenafil Krka

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is 10 mg.

Take a vardenafil tablet 25 to 60 minutes before you plan to have sex. With sexual stimulation, you may achieve an erection from 25 minutes up to 4-5 hours after taking vardenafil.

Swallow the tablet with a glass of water.

Do not take Vardenafil film-coated tabletswith any other formulation of vardenafil.

Do not take Vardenafilmore than once a day.

If you feel that the effect of vardenafil is too strong or too weak, tell your doctor. He or she may suggest a change 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 more side effects and may produce a severe backache.

If you have taken more vardenafil than you should, tell a doctor or go to a hospital casualty department immediately. Take the medicine pack with you. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild or moderate.

Some patients have experienced a sudden decrease or loss of vision, distorted or blurred vision, of sudden onset, temporary or permanent, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have been reports of sudden death, fast or irregular heartbeats, heart attacks, chest pain, and stroke (including temporary decreased blood flow to parts of the brain and bleeding in the brain) in men taking vardenafil. Most of these men had pre-existing heart problems. It is not possible to determine whether these events were directly related to vardenafil.

There have also been reports of sudden decrease or loss of hearing.

The likelihood of experiencing a side effect is described in 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.
• 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 or altered sense of touch.
• Somnolence.
• Effects on vision; eye discharge, effects on color vision, eye pain, and photosensitivity.
• Ringing in the ears; vertigo.
• Fast or irregular heartbeat.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling sick (nausea), dry mouth.
• Elevated liver enzymes in the blood.
• Rash, red skin.
• Back pain or muscle pain; elevated muscle enzyme creatine phosphokinase in the blood; muscle stiffness.
• Prolonged erections.
• General malaise.

Rare side effects:may affect up to 1 in 1,000 people:

• Eye inflammation (conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased pressure in the eye (glaucoma), watery eyes.
• Effects on the heart (such as heart attack, fast or irregular heartbeat, or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function test results.
• Skin sensitivity to sunlight.
• Painful erections.
• Chest pain.
• Temporary decreased 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 from the penis (penile hemorrhage).
• Blood in semen (hematospermia).
• Sudden death.
• Brain hemorrhage.
• Red, non-raised, target-like or circular patches on the trunk, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, diminished, or blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Krka

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Krka

• The active substance is vardenafil. Each tablet contains 10 mg of vardenafil (as hydrochloride trihydrate).
• The other ingredients are: microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, magnesium stearate (E470b) in the tablet core, and hypromellose, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172) in the film coating.

Appearance of the product and pack contents

10 mg film-coated tablets: the film-coated tablets are orange-brown, oval, slightly biconvex, scored on one side, and engraved with a "10" on the other side, dimensions 10.5mm x 5.5mm. The tablet can be divided into equal doses.

Vardenafil Krka is available in packs containing:

• 2, 4, 8, 12, and 20 film-coated tablets in blisters,
• 2 x 1, 4 x 1, 8 x 1, 12 x 1, and 20 x 1 film-coated tablets in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Date of last revision of this leaflet:May 2025

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