VARDENAFIL KRKA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Vardenafil Krka 20 mg Film-Coated Tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Vardenafil Krka and what is it used for
2. What you need to know before you take Vardenafil Krka
3. How to take Vardenafil Krka
4. Possible side effects
5. Storage of 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, which belongs to a group of medicines called phosphodiesterase 5 inhibitors, used to treat erectile dysfunction in adult men, a condition which means that the man cannot achieve or maintain an erection.

At least one in ten men has, at some time, problems achieving or maintaining an erection. This can be due to either physical or psychological causes, or a combination of both. Regardless of the cause, muscle and blood vessel changes result in not enough blood entering 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 chemical in your body which is stopping an erection. Vardenafil allows an erection to last long enough for you to have successful sex.

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

Do not take Vardenafil Krka

• If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include rash, itching, swollen face or lips and shortness of breath.
• If you have ever had a severe skin reaction to vardenafil.
• If you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with vardenafil may seriously affect your blood pressure.
• If you are taking ritonavir or indinavir, medicines for HIV.
• 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 on kidney dialysis.
• If you have recently had a stroke or heart attack.
• If you have low blood pressure.
• If you have a family history of degenerative eye diseases.
• 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, a medicine for high blood pressure in the lungs.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine.

Be cautious when taking Vardenafil Krka

• If you have heart problems, as having sex can put extra strain on your heart.
• If you have an irregular heartbeat (arrhythmia) or a family history of heart problems which affect your electrocardiogram.
• If you have any physical condition affecting the shape of your penis, such as angulation, Peyronie's disease or cavernosal fibrosis.
• If you have sickle cell anaemia, multiple myeloma or leukaemia.
• If you have stomach ulcers.
• If you have bleeding problems.
• If you are using any other treatments for erection problems.
• There have been reports of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, in association with vardenafil treatment. Stop taking vardenafil and seek medical attention immediately if you experience any of the symptoms described in section 4.
• If you experience any sudden loss of vision, distortion or loss of vision in one or both eyes, do not take vardenafil and consult your doctor immediately.

Children and adolescents

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

Other medicines and Vardenafil Krka

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Some medicines may cause problems, especially:

• Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these medicines with vardenafil may seriously affect your blood pressure.
• Medicines for arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
• Ritonavir or indinavir, medicines for HIV.
• 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.
• Riociguat.

Do not take vardenafil film-coated tablets in combination with other medicines for erectile dysfunction, including vardenafil orodispersible tablets.

Taking Vardenafil Krka with food, drinks and alcohol

You can take vardenafil with or without food, but it is best not to take it after a large or high-fat meal, as this may delay the effect.

Do not drink grapefruit juice when taking vardenafil, as it may affect the efficacy of the medicine.

Drinking alcohol may impair your ability to get an erection.

Pregnancy and breastfeeding

Vardenafil Krka should not be used in women.

Driving and using machines

Vardenafil may cause dizziness or affect your vision. Do not drive or operate machinery if you feel dizzy or have any problems with your vision after taking vardenafil.

3. How to take Vardenafil Krka

Always 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 25-60 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 Krka film-coated tabletswith any other formulation of vardenafil.

Do not take Vardenafil Krkamore than once a day.

If you think that the effect of vardenafil is too strong or too weak, talk to your doctor.

If you take more Vardenafil Krka than you should

Taking too many vardenafil tablets may cause more side effects. In case of overdose or accidental intake, consult your doctor or pharmacist immediately or call the National Poison Centre, phone 91 562 04 20, indicating the medicine and the amount taken.

If you have any further questions on the use of this medicine, 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 loss of vision in one or both eyes, distorted vision, blurred vision, or loss of vision, temporary or permanent, in one or both eyes. Stop taking vardenafil and contact your doctor immediately.

There have been reports of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and stroke in men taking vardenafil. Most of these men had pre-existing heart problems.

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 colour vision, eye pain, and photosensitivity.
• Ringing in the ears; vertigo.
• Rapid or irregular heartbeat.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, feeling sick (nausea), dry mouth.
• Increased liver enzymes in the blood.
• Rash, red skin.
• Back pain or muscle pain; increased muscle enzyme 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.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased pressure in the eye (glaucoma), watery eyes.
• Effects on the heart (such as heart attack, rapid or irregular heartbeat, or angina).
• High or low blood pressure.
• Nosebleeds.
• Abnormal liver function tests.
• Skin 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 less than 1 in 10,000 people or the frequency cannot be estimated from the available data:

• Blood in urine (hematuria).
• Bleeding in 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, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Distorted, blurred, or decreased vision.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines 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 packaging after "EXP". The expiry date refers to the last day of the 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. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Vardenafil Krka

• The active substance is vardenafil. Each tablet contains 20 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 and packaging of the product

20 mg film-coated tablets: the film-coated tablets are orange-brown, round, biconvex, with beveled edges, scored on one side and engraved with a "20" on the other side, diameter 10 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 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 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 medicine, 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 last revision of this leaflet:May 2025

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