Viavardis

Leaflet attached to the packaging: patient information

Viavardis, 5 mg, film-coated tablets

Viavardis, 10 mg, film-coated tablets

Viavardis, 20 mg, film-coated tablets

Vardenafil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Viavardis and what is it used for
• 2. Important information before taking Viavardis
• 3. How to take Viavardis
• 4. Possible side effects
• 5. How to store Viavardis
• 6. Contents of the pack and other information

1. What is Viavardis and what is it used for

Viavardis contains vardenafil, a substance belonging to a group of medicines called phosphodiesterase type 5 inhibitors. These medicines are used to treat erectile dysfunction in adult men, i.e., a condition in which there are difficulties in achieving or maintaining an erection.
At least one in ten men has problems with achieving or maintaining an erection. Their cause may be physical or psychological factors, or a combination of both. However, regardless of the cause, the effect is the same: due to changes in the muscles and blood vessels, too little blood flows to the penis to ensure and maintain its proper stiffness.
Viavardis only works when a man is sexually aroused. The medicine reduces the activity of a chemical substance that occurs in the body, causing the erection to subside. Viavardis allows for an erection that is long enough for the patient to achieve full satisfaction from sexual intercourse.

2. Important information before taking Viavardis

When not to take Viavardis

• if the patient is allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include: rash, itching, swelling of the face or lips, difficulty breathing.
• if the patient has ever experienced a severe skin rash or peeling of the skin, blisters, and/or ulcers of the mouth after taking Viavardis.
• if the patient is taking medicines containing nitrates (nitroglycerin used in angina pectoris) or medicines that release nitric oxide (such as amyl nitrite). Taking these medicines at the same time as Viavardis can seriously affect blood pressure.
• if the patient is taking ritonavir or indinavir, medicines used to treat HIV infection;
• if the patient is over 75 years old and is taking antifungal medicines - ketoconazole or itraconazole;
• if the patient has severe heart or liver disease;
• if the patient is undergoing dialysis;
• if the patient has recently had a stroke or heart attack;
• if the patient has currently or has had low blood pressure;
• if there is a history of degenerative eye diseases in the patient's family (e.g., pigmentary retinal degeneration);
• if the patient has ever had a condition characterized by loss of vision due to damage to the optic nerve due to insufficient blood supply, called non-arteritic anterior ischemic optic neuropathy;
• if the patient is taking riociguat. This is a medicine used to treat pulmonary 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). It has been shown that PDE5 inhibitors, such as Viavardis, enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions

Before starting to take Viavardis, the patient should consult a doctor or pharmacist.

When to be particularly careful when taking Viavardis

• if the patient has heart problems. In such a situation, sex may be dangerous.
• if the patient has an irregular heart rhythm (arrhythmia) or any congenital heart disease that affects the ECG recording;
• if the patient has conditions that affect the shape of the penis (penile curvature, Peyronie's disease, fibrosis of the cavernous bodies);
• if the patient has diseases that can cause persistent erections (priapism), such as sickle cell anemia, multiple myeloma, leukemia;
• if the patient has a stomach ulcer (also called a peptic ulcer);
• if the patient has blood clotting disorders (such as hemophilia);
• if the patient has used any other treatment for erectile dysfunction (see "Viavardis and other medicines");
• severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported in association with vardenafil treatment. If the patient experiences any symptoms associated with severe skin reactions described in section 4, they should stop taking Viavardis and seek medical attention immediately.
• if the patient experiences sudden vision loss or vision loss, or distorted or blurred vision while taking Viavardis, they should stop taking Viavardis and contact their doctor immediately.

Children and adolescents

Viavardis is not intended for use in children and adolescents under 18 years of age.

Viavardis and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may cause problems, and in particular:

• medicines used to treat angina pectoris: nitrates or nitric oxide-releasing medicines (such as amyl nitrite). Taking these medicines at the same time as Viavardis can have a very unfavorable effect on blood pressure. The patient should consult their doctor before taking Viavardis.
• medicines used to treat heart rhythm disorders, such as quinidine, procainamide, amiodarone, or sotalol;
• medicines used to treat HIV infection, such as ritonavir or indinavir. The patient should consult their doctor before taking Viavardis.
• ketoconazole or itraconazole, antifungal medicines;
• erythromycin or clarithromycin, macrolide antibiotics;
• medicines that block alpha-adrenergic receptors used to treat high blood pressure and prostate enlargement (benign prostatic hyperplasia);
• riociguat. The patient should not take Viavardis with any other medicines used to treat erectile dysfunction.

Viavardis with food and alcohol

• Viavardis can be taken with or without food, but if taken with food, it is better to avoid fatty meals, as they may delay the effect of the medicine.
• Viavardis should not be taken with grapefruit juice, as it may have an unfavorable effect on the medicine.
• Alcoholic beverages may increase erection problems.

Pregnancy and breastfeeding

Viavardis is not a medicine intended for use in women.

Driving and using machines

In some people, taking Viavardis may cause dizziness or vision disturbances. If dizziness or vision disturbances occur after taking Viavardis, the patient should not drive vehicles or operate tools and machines.

3. How to take Viavardis

This medicine should always be taken according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose is 10 mg.
The Viavardis tablet should be taken about 25 minutes to 60 minutes before starting sexual activity. After sexual stimulation, the patient can achieve an erection at any time between 25 minutes and 4-5 hours after taking the medicine.

• The tablet should be swallowed and washed down with a glass of water.

Viavardis should not be takenmore than once a day.
If the patient feels that the effect of Viavardis is too strong or too weak, they should tell their doctor.

Taking a higher dose of Viavardis than recommended

In men who have taken too high a dose of Viavardis, more side effects may occur, and severe back pain may occur. If a higher dose of Viavardis than recommended is taken, the patient should contact their doctor.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Viavardis can cause side effects, although not everybody gets them.
These effects are usually mild or moderate.
In some patients, partial, sudden, transient, or permanent vision loss, or distorted, blurred, or unclear vision in one or both eyes has occurred. The patient should stop taking Viavardis and contact their doctor immediately.
In men taking vardenafil, cases of sudden death, accelerated or disturbed heart rhythm, heart attack, chest pain, and cerebral circulation problems (including transient reduction of blood flow to part of the brain and cerebral hemorrhage) have been reported.
Most men who experienced these side effects had heart problems before taking this medicine. It cannot be determined whether these events were directly related to taking vardenafil.
There have been reports of sudden hearing loss.
The risk of a side effect is described according to the following frequency of occurrence:
Very common(may occur in more than 1 in 10 patients):

• headache

Common(may occur in up to 1 in 10 patients):

• dizziness
• sudden reddening, especially of the face
• runny nose or feeling of a blocked nose
• indigestion

Uncommon(may occur in up to 1 in 100 patients):

• swelling of the skin and mucous membranes, tissues, including swelling of the face, lips, or throat
• sleep disturbances
• numbness and disturbances of touch
• drowsiness
• effects on vision; redness of the eyes, effects on color vision, eye pain, and discomfort in the eye, sensitivity to light
• ringing in the ears, dizziness with balance disturbances
• rapid heartbeat or palpitations
• shortness of breath
• feeling of a blocked nose
• acid reflux, stomach inflammation, abdominal pain, diarrhea, vomiting, nausea, dryness in the mouth
• increased activity of liver enzymes in the blood
• rash, redness of the skin
• back pain or muscle pain, increased activity in the blood of the enzyme found in muscles (creatine phosphokinase), muscle stiffness
• prolonged erections
• malaise

Rare(may occur in up to 1 in 1,000 patients):

• inflammation of the eye (conjunctivitis)
• allergic reaction
• anxiety
• fainting
• memory loss (amnesia)
• seizure
• increased pressure in the eyeball (glaucoma), increased tearing
• effects on the heart (e.g., heart attack, changed heart rhythm, or angina)
• increased or decreased blood pressure
• nosebleeds
• effects on liver function test results
• sensitivity of the skin to sunlight
• painful erections
• chest pain
• transient reduction of blood flow to part of the brain

Very rare or unknown frequency(may occur in up to 1 in 10,000 patients or the frequency cannot be estimated from the available data):

• blood in the urine (hematuria)
• bleeding from the penis
• presence of blood in the semen (hematospermia)
• sudden death
• cerebral hemorrhage
• red, unraised, patchy, or circular spots on the torso, often with central blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes. These severe skin changes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• distorted, blurred, or unclear central vision, or sudden vision loss.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Viavardis

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after the abbreviation "Lot".
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Viavardis contains

• The active substance of Viavardis is vardenafil. Each film-coated tablet contains 5 mg, 10 mg, or 20 mg of vardenafil (as trihydrate hydrochloride).
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone type A, colloidal anhydrous silica, and magnesium stearate in the tablet core, and hypromellose 6cP, macrogol 4000, titanium dioxide (E 171), yellow iron oxide (E 172), and red iron oxide (E 172) in the tablet coating.

What Viavardis looks like and what the pack contains

5 mg: orange-brown, round, slightly convex film-coated tablet with a beveled edge and marked with "5" on one side; tablet diameter: 5.5 mm.
10 mg: orange-brown, oval, slightly convex film-coated tablet with a beveled edge and a score line on one side and marked with "10" on the other side; tablet dimensions: 10.5 mm x 5.5 mm; the tablet can be divided into equal doses.
20 mg: orange-brown, round, convex film-coated tablet with a beveled edge and a score line on one side and marked with "20" on the other side; tablet diameter: 10 mm; the tablet can be divided into equal doses.

Packaging:

• 2 (only for 5 mg and 10 mg doses), 4, 8, 12, and 20 film-coated tablets in blisters in a cardboard box
• 2 x 1 (only for 5 mg and 10 mg doses), 4 x 1, 8 x 1, 12 x 1, and 20 x 1 film-coated tablet in single-dose blisters in a cardboard box 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
To obtain more detailed information on the names of medicinal products in other EU member states, the patient should contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500.
Date of last revision of the leaflet:02.05.2025