Vardenafil Krka 10 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Vardenafil Krka 10 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What is Vardenafil Krka and what is it 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.

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

2. What you need to know before taking Vardenafil Krka

Do not take Vardenafil

• 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 have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking vardenafil.

• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina pectoris, or those that release nitric oxide, such as amyl nitrite. Taking these medicines together with vardenafil may seriously 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

Take special care with vardenafil

• 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 medical condition that may cause erections that do not go away (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 film-coated 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 treatment with vardenafil and seek immediate medical attention if you experience any symptoms related to these severe skin reactions described in section 4.

• If you have ever experienced a decrease or loss of vision, or your vision becomes distorted or darkened suddenly, temporarily or permanently in one eye, do not take vardenafil and consult your doctor immediately.

Children and adolescents

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

Other medicines and Vardenafil Krka

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 pectoris or those that release nitric oxide, such as amyl nitrate. Taking these medicines together with vardenafil may seriously affect your blood pressure. Do not take vardenafil without first consulting your doctor.
• Medicines used to treat 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 vardenafil film-coated tablets in combination with another medicine for the treatment of erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil with food, drinks, and alcohol

• You may take vardenafil with or without food, but it is preferable not to take it after a heavy or high-fat 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 may worsen erectile problems.

Pregnancy and breastfeeding

Vardenafil must not be used in women.

Driving and using machines

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.

3. How to take Vardenafil Krka

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

The recommended dose is 10 mg.

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

Swallow the tablet with a glass of water.

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

Do not take vardenafil more than once a day.

If you feel that the effect of vardenafil is too strong or too weak, inform your doctor. Your doctor may suggest switching to another formulation of vardenafil with a different dose, depending on how it affects you.

If you take more vardenafil than you should

Taking too many vardenafil tablets may cause more adverse 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 telephone number 91 562 04 20, indicating 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, this medicine may cause adverse effects, although not everyone will experience them. Most of these adverse effects are mild or moderate.

Some patients have experienced partial or complete loss of vision, or sudden, temporary or permanent blurred, dimmed or distorted central vision, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and cerebrovascular events (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.

Sudden decrease or loss of hearing has also been reported.

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 (drowsiness).
• 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 unwell (nausea), dry mouth.
• Increased liver enzymes in blood.
• Skin rashes, redness of the 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:

• Inflammation of the eye (conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure (glaucoma), 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 adverse effects or those with unknown frequency: may affect less than 1 in 10,000 people, or frequency cannot be estimated from available data:

• Blood in urine (hematuria).
• Bleeding from the penis (penile hemorrhage).
• Blood in semen (hematospermia).
• Sudden death.
• Cerebral hemorrhage.
• Red, non-elevated target-shaped or circular skin 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).
• Sudden blurred, dimmed or distorted central vision, or sudden decrease in vision.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, 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 at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vardenafil Krka

Keep this medicine out of sight and reach of children.

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at a pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Vardenafil Krka

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

Appearance of the product and contents of the pack

10 mg film-coated tablets: the film-coated tablets (tablets) are orange-brown in colour, oval, slightly biconvex, with a score line on one side and engraved with "10" on the other side, dimensions 10.5 mm x 5.5 mm. 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 × 1, 4 × 1, 8 × 1, 12 × 1 and 20 × 1 film-coated tablets in unit-dose blisters.

Only some pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

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

Date of the most recent review of this leaflet: May 2025

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