VARDENAFIL 5 mg Film-Coated Tablets

Зміст інструкції

1. Vardenafil Krka 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets
   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. Package Contents and Other Information

PACKAGE LEAFLET

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

Vardenafil

Generic medicine

Read this leaflet carefully before taking this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 that involves difficulty achieving or maintaining an erection.
At least one in ten men occasionally have difficulty achieving or maintaining an erection.
This may be due to physical or psychological causes or a combination of both. Whatever the cause, not enough blood is retained in the penis to allow and maintain
an erection, due to changes in the muscles and blood vessels.
Vardenafil Krka only works in the presence of sexual stimulation. The medicine reduces the action of the
chemical substance present in the body, which stops the erection. Vardenafil Krka allows you to
achieve and maintain an erection long enough to satisfactorily complete the
sexual intercourse.

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). The signs of an allergic reaction include skin rash, itching, swelling of the face and lips and shortness of breath.
• if you are taking medicines that contain 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 alter 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 of age and are taking ketoconazole or itraconazole, antifungal medicines.
• if you have serious heart or liver problems.
• if you are undergoing renal dialysis.
• if you have recently had a stroke or a heart attack.
• if you have, or have had, low blood pressure.
• if your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
• if you have previously had a condition characterised by loss of vision due to damage to the optic nerve due to insufficient blood supply, known as non-arteritic anterior ischaemic 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 following 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 hereditary heart disease that
modifies the electrocardiogram.
if you have a physical condition that causes alterations in the shape of the penis. These include
conditions called curvature, Peyronie's disease and fibrosis of the cavernous bodies.
if you have a disease that can cause persistent erections (priapism). These include
sickle cell anaemia, multiple myeloma or leukaemia.
if you have stomach ulcers (also called gastric or peptic ulcers).
if you have a bleeding disorder (such as haemophilia).
if you are using other medicines for the treatment of erectile dysfunction (see section:
Other medicines and Vardenafil Krka)
if you notice 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines can cause problems, particularly the following:
nitrates, medicines for angina, or sources of nitric oxide such as amyl nitrite. Taking
these medicines together with Vardenafil Krka could dangerously alter 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, medicines for HIV. Do not take Vardenafil Krka and consult a doctor.
ketoconazole or itraconazole, antifungal medicines.
erythromycin or clarithromycin, macrolide antibiotics.
alpha-blockers, a type of medicine used to treat high blood pressure and
enlargement of the prostate (such as benign prostatic hyperplasia).
riociguat.
Do not use Vardenafil Krka film-coated tablets in association with other treatments for the
treatment of erectile dysfunction.

Vardenafil Krka with food, drinks and alcohol
you can take Vardenafil Krka with or without food – but preferably not after a
heavy or fatty meal as this may delay the effect.
do not drink grapefruit juice when using Vardenafil Krka. It may interfere with the effect of the
medicine.
alcoholic beverages can worsen erectile difficulties.

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

Driving and operating machinery
In some people Vardenafil Krka may cause dizziness or alter vision. 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 following the doctor's instructions exactly. If you have any doubts, consult
your doctor or pharmacist.
The recommended dose is 10 mg.
Take one tablet of Vardenafil Krka approximately 25-60 minutes before sexual activity.
If you are sexually stimulated, you may be able to achieve an erection within 25 minutes and up to four to five hours
after taking Vardenafil Krka.
Swallow one tablet with a glass of water.

Do not take Vardenafil Krkamore than once a day.
If you feel that the effect of Vardenafil Krka is too strong or too weak, consult
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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 been reported.
The likelihood of an adverse effect occurring 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
Hot flushes
Nasal congestion 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 disorder
Numbness and impaired tactile perception
Drowsiness
Effects on vision; red eyes, effects on colour perception, eye pain and discomfort,
sensitivity to light
Tinnitus, vertigo
Fast heartbeat or heart with pounding sensation
Shortness of breath
Nasal congestion
Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling unwell ( nausea),
dry mouth
Increased levels of liver enzymes in the blood
Skin rash, reddened skin
Back or muscle pain, increased levels of a muscle enzyme
(creatine phosphokinase) in the blood, muscle stiffness
Prolonged erections
Feeling unwell

Rare(may affect up to 1 in 1,000 people)
Eye inflammation ( conjunctivitis)
Allergic reaction
Anxiety
Fainting
Amnesia
Convulsion
Increased eye pressure ( glaucoma), increased tearing
Effects on the heart (such as heart attack, altered heartbeat or angina)
High or low blood pressure
Nosebleed
Effect on liver function tests
Skin sensitivity to sunlight
Painful erections
Chest pain

Not known(frequency cannot be estimated from the available data)
Blood in the urine (hematuria)
Bleeding of the penis (penile hemorrhage)
Presence of blood in the semen (hematospermia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through
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 which is stated on the pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is vardenafil. Each film-coated tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as vardenafil trihydrate hydrochloride). The other ingredients (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 contents5 mg film-coated tablets: Orange-brown, round, slightly biconvex, film-coated tablets (tablets) with bevelled edges, with 5 inscribed on one side, diameter 5.5 mm. 10 mg film-coated tablets: Orange-brown, oval, slightly biconvex, film-coated tablets (tablets) with 10 inscribed on one side, dimensions 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, marked on one side and with 20 inscribed on the other side, diameter 10 mm. The tablet can be divided into two equal doses.

Vardenafil Krka is available in packs 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 Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for 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 authorised in the Member States of the European Economic Area under the
following denominations: