Vardenafil Krka

PACKAGE LEAFLET

Package leaflet: information for the patient

Vardenafil Krka 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

Vardenafil
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 Vardenafil Krka is and what it is used for

Vardenafil Krka contains vardenafil, which belongs to a class of medicines called phosphodiesterase type 5 inhibitors. These are used for the treatment of erectile dysfunction in adult men, a condition involving difficulty in achieving or maintaining an erection.
At least one man in ten occasionally experiences difficulty in achieving or maintaining an erection.
This may be due to physical or psychological causes, or a combination of both. Whatever the cause, an insufficient amount of blood is retained in the penis to allow and maintain an erection, due to changes in the muscles and blood vessels.
Vardenafil Krka works only in the presence of sexual stimulation. The medicine reduces the action of a chemical substance in the body that causes the erection to subside. Vardenafil Krka enables the achievement and maintenance of an erection long enough to complete sexual intercourse satisfactorily.

2. What you need to know before taking Vardenafil Krka

Do not take Vardenafil Krka:

• 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 and lips, and shortness of breath.
• if you are taking medicines containing nitrates, such as glyceryl trinitrate for angina, or sources of nitric oxide, such as amyl nitrite. Taking these medicines together with Vardenafil Krka could dangerously lower 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 on renal dialysis.
• if you have recently had a stroke or heart attack.
• if you have, or have had, low blood pressure.
• if there is a family history of degenerative eye diseases (such as retinitis pigmentosa).
• if you have ever had a condition characterized by sudden vision loss due to damage of the optic nerve from insufficient blood flow, known as non-arteritic anterior ischemic optic neuropathy (NAION).
• if you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (e.g., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (e.g., high blood pressure in the lungs due to blood clots). PDE5 inhibitors such as Vardenafil Krka have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vardenafil Krka.
Take special care with Vardenafil Krka
if you have heart problems. Sexual activity may be risky for you.
if you suffer from irregular heartbeat (cardiac arrhythmia) or inherited heart diseases that alter the electrocardiogram.
if you have a physical condition causing changes in the shape of the penis. These include conditions known as curvature, Peyronie’s disease, or cavernosal fibrosis.
if you have a disease that may cause prolonged erections (priapism). These include sickle cell anemia, multiple myeloma, or leukemia.
if you have stomach ulcers (also known as gastric or peptic ulcers).
if you have a bleeding disorder (such as hemophilia).
if you are using other medicines to treat erection difficulties (see section: Other medicines and Vardenafil Krka).
if you experience a sudden decrease or loss of vision, stop taking Vardenafil Krka and contact your doctor immediately.

Children and adolescents
Vardenafil Krka is not intended for use in children and 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 take any other medicines.
Some medicines may cause problems, particularly the following:
nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking these together with Vardenafil Krka could dangerously lower your blood pressure. Do not take Vardenafil Krka and consult a doctor.
medicines for the treatment of arrhythmia, such as quinidine, procainamide, amiodarone, or sotalol.
ritonavir or indinavir, HIV medicines. Do not take Vardenafil Krka and consult a doctor.
ketoconazole or itraconazolo, antifungal medicines.
erythromycin or clarithromycin, macrolide antibiotics.
alpha-blockers, a type of medicine used to treat high blood pressure and enlarged prostate (such as benign prostatic hyperplasia).
riociguat.
Do not use Vardenafil Krka film-coated tablets in combination with other treatments for erectile dysfunction.

Vardenafil Krka with food, drinks, and alcohol
You may take Vardenafil Krka with or without food – but preferably not after a heavy or high-fat meal, as this may delay its effect.
Do not drink grapefruit juice when using Vardenafil Krka. It may interfere with the medicine’s effect.
Alcoholic beverages may worsen erection difficulties.

Pregnancy and breastfeeding
Vardenafil Krka is not indicated for use in women.

Driving and using machines
In some people, Vardenafil Krka may cause dizziness or vision disturbances. If you feel dizzy or notice vision problems after taking Vardenafil Krka, do not drive or operate tools or machinery.

3. How to take Vardenafil Krka

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of Vardenafil Krka approximately 25 to 60 minutes before sexual activity.
If you are sexually stimulated, you may achieve an erection as early as 25 minutes after taking Vardenafil Krka and lasting up to four to five hours.
Swallow the tablet with a glass of water.
Do not take Vardenafil Krka more than once a day.
If you feel the effect of Vardenafil Krka is too strong or too weak, talk to your doctor.
If you take more Vardenafil Krka than you should
Men who take an excessive amount of Vardenafil Krka may experience more side effects or severe back pain. If you take more Vardenafil Krka than you should, consult your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The effects are mostly mild or moderate.
Some patients have reported partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. Stop taking Vardenafil Krka and contact your doctor immediately.
Sudden decrease or loss of hearing has also been reported.
The likelihood of experiencing a side effect is described in the following categories:
Very common (may affect more than 1 in 10 people)
Headache
Common (may affect up to 1 in 10 people)
Dizziness
Flushing
Stuffy or runny nose
Indigestion
Uncommon (may affect up to 1 in 100 people)
Swelling of the skin and mucous membranes including swelling of the face, lips or throat
Sleep disturbances
Numbness and impaired tactile sensation
Drowsiness
Vision disturbances; red eyes, changes in colour vision, eye pain and discomfort, light sensitivity
Ringing in the ears, dizziness
Fast heartbeat or pounding sensation in the chest
Shortness of breath
Stuffy nose
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling unwell ( nausea ), dry mouth
Increased levels of liver enzymes in the blood
Skin rash, red skin
Back or muscle pain, increased levels of a muscle enzyme (creatine phosphokinase) in the blood, muscle stiffness
Prolonged erections
Malaise
Rare (may affect up to 1 in 1,000 people)
Inflammation of the eyes ( conjunctivitis )
Allergic reaction
Anxiety
Fainting
Amnesia
Seizure
Increased eye pressure ( glaucoma ), increased tear production
Effects on the heart (such as heart attack, irregular heartbeat or angina)
High or low blood pressure
Nosebleed
Effect on liver function test results
Skin sensitivity to sunlight
Painful erections
Chest pain
Not known (frequency cannot be estimated from the available data)
Blood in the urine (haematuria)
Bleeding from the penis (penile haemorrhage)
Blood in the semen (haematospermia)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vardenafil Krka

Keep this medicine out of the 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 that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vardenafil Krka contains

• The active substance is vardenafil. Each film-coated tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as vardenafil hydrochloride trihydrate). The other components (excipients) are microcrystalline cellulose, crospovidone Type A, anhydrous colloidal silica, magnesium stearate (E470b) in the tablet core, and hypromellose, macrogol 4000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) in the tablet coating.

Description of the appearance of Vardenafil Krka and package contents

5 mg film-coated tablets: Orange-brown, round, slightly biconvex, film-coated tablets (tablets) with bevelled edges, engraved with "5" on one side, diameter 5.5 mm.

10 mg film-coated tablets: Orange-brown, oval, slightly biconvex, film-coated tablets (tablets) engraved with "10" on one side, size 10.5 mm x 5.5 mm. The tablet can be divided into two equal doses.

20 mg film-coated tablets: Orange-brown, round, biconvex, film-coated tablets (tablets) with bevelled edges, scored on one side and engraved with "20" on the other side, diameter 10 mm. The tablet can be divided into two equal doses.

Vardenafil Krka is available in packages containing:

• 2, 4, 8, 12 and 20 film-coated tablets in a box,
• 2 x 1, 4 x 1, 8 x 1, 12 x 1 and 20 x 1 film-coated tablet in single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:

This leaflet was last reviewed on: