Leaflet: information for the user

Vardenafilo Krka 10 mg film-coated tablets EFG

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, ask 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 Vardenafilo Krka is and what it is used for

2.What you need to know before you start taking Vardenafilo Krka

3.How to take Vardenafilo Krka

4.Possible side effects

5.Storage of Vardenafilo Krka

6.Contents of the pack and additional information

This medicationcontains vardenafilo, an active ingredient belonging to the group of medications known as phosphodiesterase type 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, difficulties 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 a sufficient duration to maintain a satisfactory sexual relationship.

Do not take Vardenafilo

-If you are allergic to vardenafilo or any of the other components of 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 vardenafilo 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 ketoconazol or itraconazol, antifungal medications.

-If you have a severe 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 if you have had it in the past.

-If you have a family history of degenerative eye diseases (such as retinitis pigmentosa).

-If you have ever suffered 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 vardenafilo, have shown to increase the hypotensive effect of this medication. If you are taking riociguat or are unsure, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Be especially careful with vardenafilo

-If you have heart problems, as having sex may pose a risk to you.

-If you have irregular heartbeats (arrhythmia) or any inherited heart disease that alters your electrocardiogram.

-If you have any physical condition that affects the shape of your penis. For example, angulation, Peyronie's disease, or cavernous fibrosis.

-If you have a disease that may cause erections that do not go away (priapism). For example, 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 vardenafilo film-coated tablets (see section: “Other medications and Vardenafilo Krka”).

-If you have ever had a sudden, temporary, or permanent loss of vision in one eye, do not take vardenafilo and consult your doctor immediately.

Children and adolescents

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

Other medications and Vardenafilo Krka

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased 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 vardenafilo may severely affect your blood pressure. Do not take vardenafilo without consulting your doctor first.

-Medications for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone, or sotalol.

-Ritonavir or indinavir, medications for HIV. Do not take vardenafilo without consulting your doctor first.

-Ketoconazol or itraconazol, 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 vardenafilo film-coated tablets in combination with another medication for erectile dysfunction, including vardenafilo buccal dispersible tablets.

Taking Vardenafilo with food, drinks, and alcohol

-You can take vardenafilo 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 vardenafilo, as it may interfere with the normal effect of the medication.

-Drinking alcoholic beverages may worsen erectile dysfunction.

Pregnancy and breastfeeding

Vardenafilo should not be used in women.

Driving and operating machinery

In some people, vardenafilo may cause dizziness or affect vision. Do not drive or operate tools or machinery if you feel dizzy or have vision problems after taking vardenafilo.

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

The recommended dose is 10 mg.

Take a vardenafilo tablet 25 to 60 minutes before sexual activity. With sexual stimulation, you will be able to obtain an erection from 25 minutes and up to four or five hours after taking vardenafilo.

Swallow the tablet with a glass of water.

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

Do not take vardenafilo more than once a day.

If you estimate that the action of vardenafilo is too strong or weak, inform your doctor. They may suggest changing to another vardenafilo formulation with a different dose based on the effect it has on you.

If you take more Vardenafilo than you should

Taking too many vardenafilo tablets may 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 medicines, this medicine can 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, sudden, temporary, or permanent, in one or both eyes.

There have been reports of sudden death, rapid or irregular heartbeats, heart attacks, chest pain, and cerebral circulation problems (including temporary reduction of blood flow to parts of the brain and cerebral hemorrhage) in men taking vardenafil. Most men who have experienced these side effects had pre-existing heart problems before taking this medicine. It is not possible to determine if these events were directly related to vardenafil.

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

The possibility of presenting a side effect is described using the following categories:

Very common side effects:can affect more than 1 in 10 people:

• Headache.

Common side effects:can affect up to 1 in 10 people:

• Dizziness.
• Flushing of the face.
• Runny or congested nose.
• Indigestion.

Uncommon side effects:can 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 of touch.
• Drowsiness.
• Effects on vision; eye bleeding, effects on color vision, eye pain, and photosensitivity.
• Tinnitus; vertigo.
• Fast or irregular heartbeat.
• Difficulty breathing.
• Stuffy nose.
• Acid reflux, gastritis, abdominal pain, diarrhea, vomiting, nausea, dry mouth.
• Elevation of liver enzymes in the blood.
• Rash; red skin.
• Back pain or muscle pain; elevated muscle enzyme creatine phosphokinase in the blood; muscle stiffness.
• Prolonged erection.
• General feeling of discomfort.

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

• Eye inflammation (conjunctivitis).
• Allergic reaction.
• Anxiety.
• Fainting.
• Amnesia (memory loss).
• Seizures.
• Increased intraocular pressure (glaucoma), watery eyes.
• Effects on the heart (such as myocardial infarction, tachycardia, or angina).
• High or low blood pressure.
• Nasal bleeding.
• Alterations in liver function test results in the blood.
• Sensitivity to sunlight.
• Painful erection.
• Chest pain.
• Temporary reduction of blood flow to parts of the brain.

Very rare side effects or unknown frequency:can affect fewer 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.
• Cerebral hemorrhage.

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 Pharmacovigilance of Medicines for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

This medication does not require special conservation conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. 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 Vardenafilo Krka

- The active ingredient is vardenafil. Each tablet contains 10 mg of vardenafil (as trihydrate hydrochloride).

- The other components are: microcrystalline cellulose, crospovidone (type A), anhydrous colloidal silica, magnesium stearate (E470b) in the core of the tablet 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 contents of the package

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

Vardenafilo Krka is available in packages 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 single-dose blisters.

Only some package 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 request more information about this medicine by contacting 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 EEA under the following names:

Last review date of this leaflet: October 2021

The detailed information about this medicine is available on the website of the

Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .