Viavardis

Package leaflet: Information for the patient

Viavardis, 5 mg, coated tablets
Viavardis, 10 mg, coated tablets
Viavardis, 20 mg, coated tablets
vardenafil
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Viavardis is and what it is 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 Viavardis is and what it is 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, a condition in which a man has difficulty achieving or maintaining an erection.
At least one in ten men experiences problems achieving or maintaining an erection. These problems may be caused by 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, insufficient blood flows into the penis to produce and maintain adequate rigidity.
Viavardis works only when a man is sexually stimulated. The medicine reduces the activity of a chemical substance in the body that causes the end of an erection. Viavardis enables the achievement of an erection sufficiently long-lasting for the patient to achieve full satisfaction from sexual intercourse.

2. Important information before using Viavardis

When not to use Viavardis

• if the patient is allergic to wardenafil or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, itching, facial or lip swelling, difficulty breathing.
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulceration after taking Viavardis.
• if the patient is taking medicines containing nitrates (e.g. nitroglycerin used for angina) or medicines that release nitric oxide (e.g. amyl nitrite). Taking these medicines together with Viavardis may seriously affect blood pressure.
• if the patient is taking ritonavir or indinavir, medicines used in the treatment of human immunodeficiency virus (HIV) infection;
• if the patient is over 75 years of age 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 currently has or has previously had low blood pressure;
• if degenerative eye diseases (e.g. retinitis pigmentosa) have been diagnosed in the patient's family;
• if the patient has ever experienced sudden vision loss due to optic nerve damage caused by poor blood flow, known as non-arteritic anterior ischemic optic neuropathy;
• if the patient is taking riociguat. This medicine is 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). PDE5 inhibitors, such as Viavardis, have been shown to 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 Viavardis, consult a doctor or pharmacist.
When to exercise special caution with Viavardis

• if the patient has heart problems. In such cases, sexual activity may be dangerous.
• if the patient has an irregular heartbeat (arrhythmia) or any congenital heart disease affecting the ECG pattern;
• if the patient has conditions affecting the shape of the penis (penile curvature, Peyronie's disease, fibrosis of the corpora cavernosa);
• if the patient has conditions that may cause prolonged erection (priapism), such as sickle cell anemia, multiple myeloma, leukemia;
• if the patient has a stomach ulcer (also known as peptic ulcer);
• if the patient has blood clotting disorders (such as hemophilia);
• if the patient has used any other treatment for erectile dysfunction (see section "Viavardis with other medicines");
• severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with wardenafil treatment. If the patient experiences any symptoms related to severe skin reactions described in section 4, treatment with Viavardis should be stopped immediately and medical help sought without delay.
• if the patient experiences sudden vision deterioration or vision loss, or distorted or blurred vision during treatment with Viavardis, treatment with Viavardis should be stopped and the patient should contact a doctor immediately.

Children and adolescents
Viavardis is not intended for use in children and adolescents under 18 years of age.
Viavardis with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Some medicines may cause problems, particularly:

• medicines used to treat angina: nitrates or nitric oxide-releasing agents (such as amyl nitrite). Taking these medicines together with Viavardis may severely affect blood pressure. Consult your 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. Consult your doctor before taking Viavardis.
• ketoconazole or itraconazole, antifungal medicines;
• erythromycin or clarithromycin, macrolide antibiotics;
• alpha-adrenergic receptor blockers used to treat hypertension and benign prostatic hyperplasia (enlarged prostate);
• riociguat. Viavardis should not be taken with any other medicines used to treat erectile dysfunction.

Viavardis, food and alcohol

• Viavardis can be taken with or without food, but when taken with food, it is advisable to avoid large, fatty meals, as they may delay the medicine's effect.
• Viavardis should not be taken with grapefruit juice, as it may adversely affect the medicine's action.
• Alcoholic beverages may worsen difficulties in achieving an erection. Pregnancy and breastfeeding Viavardis is not a medicine intended for use in women.

Driving and operating machinery
In some individuals, taking Viavardis may cause dizziness or visual disturbances. If dizziness or visual disturbances occur after taking Viavardis, the patient should not drive or operate tools and machinery.

3. How to use Viavardis

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The recommended dose is 10 mg.
A Viavardis tablet should be taken approximately 25 to 60 minutes before planned sexual
activity. After sexual stimulation, the patient can achieve an erection at any time within
25 minutes to 4-5 hours after taking the medicine.

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

Do not take Viavardis more than once a day.
If you feel that the effect of Viavardis is too strong or too weak, inform your doctor.
Taking more than the recommended dose of Viavardis
In men who have taken an excessive dose of Viavardis, more side effects may occur and severe back pain may develop. If a dose higher than recommended is taken, contact your doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These effects are usually mild or moderate.
In some patients, partial, sudden, transient or permanent loss of vision, or distorted, blurred or unclear central vision in one or both eyes has occurred. Treatment with Viavardis should be discontinued immediately and medical advice should be sought without delay.
Cases of sudden death, rapid or irregular heartbeat, heart attack, chest pain, and cerebral circulation problems (including transient ischaemic attack and intracranial haemorrhage) have been reported in men taking wardenafil.
Most of these men had pre-existing heart problems before taking this medicine. It is not possible to determine whether these events were directly related to the use of wardenafil.
Cases of sudden worsening or loss of hearing have been reported.

The risk of adverse effects is described according to the following frequency of occurrence:

Very common (may affect more than 1 in 10 people):

• headache

Common (may affect up to 1 in 10 people):

• dizziness
• sudden flushing, especially of the face
• nasal congestion or stuffy nose
• indigestion

Uncommon (may affect up to 1 in 100 people):

• swelling of the skin and mucous membranes, tissues, including swelling of the face, lips or throat
• sleep disorders
• numbness and disturbances in touch sensation
• drowsiness
• visual disturbances; eye redness, colour vision disturbances, eye pain and eye discomfort, light sensitivity
• ringing in the ears, dizziness with balance disturbances
• rapid heartbeat or palpitations
• shortness of breath
• stuffy nose
• acid regurgitation, gastritis, abdominal pain, diarrhoea, vomiting, nausea, dry mouth
• increased liver enzyme activity in blood
• rash, skin redness
• back or muscle pain, increased blood levels of an enzyme found in muscles (creatine phosphokinase), muscle stiffness
• prolonged erections
• malaise

Rare (may affect up to 1 in 1,000 people):

• inflammation of the eye (conjunctivitis)
• allergic reaction
• anxiety
• fainting
• memory loss (amnesia)
• seizure
• increased intraocular pressure (glaucoma), excessive tearing
• effects on the heart (e.g. heart attack, irregular heartbeat or angina)
• increased or decreased blood pressure
• nosebleeds
• abnormal liver function test results
• skin sensitivity to sunlight
• painful erections
• chest pain
• transient ischaemic attack

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

• blood in the urine (haematuria)
• bleeding from the penis
• blood in the semen (haemospermia)
• sudden death
• intracranial haemorrhage
• red, non-blanching, flat or circular spots on the trunk, often with central blisters, skin peeling, and ulcers of the mouth, throat, nose, genital organs and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• distorted, blurred or unclear central vision, or sudden worsening of vision.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Viavardis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Viavardis contains

• The active substance is wardenafil. Each coated tablet contains 5 mg, 10 mg, or 20 mg of wardenafil (as hydrochloride trihydrate).
• The other ingredients (excipients) are: microcrystalline cellulose, crospovidone type A, anhydrous colloidal silicon dioxide, and magnesium stearate in the tablet core; hypromellose 6 cP, 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 contents of the pack
5 mg: orange-brown, round, slightly biconvex coated tablet with bevelled edges and marked "5" on one side; tablet diameter: 5.5 mm.
10 mg: orange-brown, oval, slightly biconvex coated tablet with bevelled edges, a break line on one side and marked "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, biconvex coated tablet with bevelled edges, a break line on one side and marked "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 strengths), 4, 8, 12 and 20 coated tablets in blisters packed in a cardboard box
• 2 x 1 (only for 5 mg and 10 mg strengths), 4 x 1, 8 x 1, 12 x 1 and 20 x 1 coated tablet in unit-dose blisters packed in a cardboard box

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 product names in other European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw, Poland
Tel. 22 57 37 500