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VARDENAFIL ZENTIVA 20 MG FILM-COATED TABLETS

Active substance(s): VARDENAFIL HYDROCHLORIDE TRIHYDRATE

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EPAR from eMC Report dated Jan 2016 – March 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
Vardenafil Zentiva 5 mg film-coated tablets
Vardenafil Zentiva 10 mg film-coated tablets
Vardenafil Zentiva 20 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What vardenafil is and what it is used for
2. What you need to know before you take vardenafil
3. How to take vardenafil
4. Possible side effects
5. How to store vardenafil
6. Contents of the pack and other information

1. What vardenafil is and what it is used for
The name of your medicine is Vardenafil Zentiva 5mg, 10mg and 20mg film-coated tablets
(called vardenafil throughout this leaflet). It contains vardenafil, a member of a class of
medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile
dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection.
At least one in ten men has trouble getting or keeping an erection at some time. There may
be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle
and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.
Vardenafil will only work when you are sexually stimulated. It reduces the action of the natural
chemical in your body which makes erections go away. Vardenafil allows an erection to last long
enough for you to satisfactorily complete sexual activity.

2. What you need to know before you take vardenafil

EPAR from eMC Report dated Jan 2016 – March 2016

Do not take vardenafil if
– you are allergic to vardenafil or any of the other ingredients of this medicine (listed
in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and
shortness of breath.
– you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric
oxide donors, such as amyl nitrite. Taking these medicines with vardenafil could seriously
affect your blood pressure.
– you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus
(HIV) infections.
– you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal
medicines.
– you have a severe heart or liver problem.
– you are having kidney dialysis.
– you have recently had a stroke or heart attack.
– you have or have had low blood pressure.
– your family has a history of degenerative eye diseases (such as retinitis pigmentosa).
– you have ever had a condition involving loss of vision due to damage to the optic nerve from
insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
– you are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e. high
blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high
blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as vardenafil
have been shown to increase the hypotensive effects of this medicine. If you are taking
riociguat or are unsure tell your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking vardenafil if you
– have heart trouble. It may be risky for you to have sex.
– suffer from irregular heart beat (cardiac arrythmia) or inherited heart diseases affecting your
electrocardiogram.
– have a physical condition affecting the shape of the penis. This includes conditions called
angulation, Peyronie’s disease and cavernosal fibrosis.
– have an illness that can cause erections which won’t go away (priapism). These include
sickle cell disease, multiple myeloma and leukaemia.
– have stomach ulcers (also called gastric or peptic ulcers).
– have a bleeding disorder (such as haemophilia).
– are using any other treatments for erection difficulties, including vardenafil- containing
orodispersible tablets (see section “Other medicines and vardenafil”).
– experience sudden decrease or loss of vision, stop taking vardenafil and contact your doctor
immediately.

EPAR from eMC Report dated Jan 2016 – March 2016
Children and adolescents
Vardenafil is not intended for use by children or adolescents under 18.
Other medicines and vardenafil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines may cause problems, especially these:
– Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite. Taking these
medicines with vardenafil could seriously affect your blood pressure. Talk to a doctor
without taking vardenafil
– Medicine for the treatment of arrythmias, such as quinidine, procainamide, amiodarone
or sotalol.
– Ritonavir or indinavir, medicines for HIV. Talk to a doctor without taking vardenafil.
– Ketoconazole or itraconazole, anti-fungal medicines.
– Erythromycin, or clarithromycin, macrolide antibiotics.
– α-blockers, a type of medicine used to treat high blood pressure and enlargement
of the prostate (as benign prostatic hyperplasia).
– Riociguat.
– Do not use vardenafil film-coated tablets combined with any other treatment for erectile
dysfunction, including vardenafil-containing orodispersible tablets.
Vardenafil with food, drink and alcohol
You can take vardenafil with or without food, but preferably not after a heavy or high-fat meal as
this may delay the effect.
Don’t drink grapefruit juice when you use vardenafil. It can interfere with the usual effect of the
medicine.
Alcoholic drink can make erection difficulties worse.
Pregnancy, breast-feeding and fertility
Vardenafil is not for use by women.
Driving and using machines
Vardenafil might make some people feel dizzy or affect their vision. If you feel dizzy or if your
vision is affected after taking vardenafil don’t drive or operate any tools or machines.

3. How to take vardenafil
Always take this medicinal product exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.

EPAR from eMC Report dated Jan 2016 – March 2016

The recommended dose is 10 mg.
Take a vardenafil tablet about 25 to 60 minutes before sexual activity. With sexual stimulation
you may achieve an erection anywhere from 25 minutes up to four to five hours after taking
vardenafil.
Swallow one tablet with a glass of water.
Do not take vardenafil film-coated tablets with any other forms of vardenafil.
Do not take vardenafil more than once a day.
Tell your doctor if you think vardenafil is too strong or too weak. He or she may suggest a switch
to an alternative vardenafil formulation with a different dose, depending on how well it works for
you.
If you take more vardenafil than you should
Men who take too much vardenafil may experience more side effects or may get severe back
pain. If you take more vardenafil than you should, tell your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. Most
of the effects are mild or moderate.
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been
experienced by patients. Stop taking vardenafil and contact your doctor immediately. Sudden
decrease or loss of hearing has been reported.
The chance of having a side effect is described by 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.
– Blocked or runny nose.
– Indigestion.
Uncommon (may affect up to 1 in 100 people):
– Swelling of skin and mucous tissue including swollen face, lips or throat.
– Sleep disorder.

EPAR from eMC Report dated Jan 2016 – March 2016
– Numbness and impaired perception of touch.
– Sleepiness.
– Effects on vision; redness of the eye, effects on colour vision, eye pain and discomfort, light
sensitivity.
– Ringing in the ears, vertigo.
– Fast heart beat or pounding heart.
– Breathlessness.
– Stuffy nose.
– Acid reflux, gastritis, abdominal pain, diarrhoea, vomiting; feeling sick (nausea), dry mouth.
– Raised levels of liver enzymes in your blood.
– Rash, reddened skin.
– Back or muscle pain; increase in blood of a muscle enzyme (creatine phosphokinase), 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.
– Increase pressure in the eye (glaucoma), lacrimation increased.
– Effects on the heart (such as heart attack, altered heart beat or angina).
– High or low blood pressure.
– Nose bleed.
– Effect on results of blood tests to check liver function.
– Sensitivity of the skin to sun light.
– Painful erections.
– Chest pain.
Not known (frequency cannot be estimated from the available data):
– Blood in the urine (haematuria).
– Penile bleeding (penile haemorrhage).
– Presence of blood in the semen (haematospermia).
Reporting of side effects

EPAR from eMC Report dated Jan 2016 – March 2016
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store vardenafil
Keep this medicine out of the sight and reach of children.
Do not use your medicine after the expiry date which is stated on the carton and on the blister
after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What vardenafil 5mg, 10mg and 20mg film-coated tablets contains
The active substance is: vardenafil (as hydrochloride trihydrate) 5 mg, 10 mg or 20 mg.
The other ingredients are: Tablet core: Cellulose, microcrystalline; Silica colloidal anhydrous;
Crospovidone (type A); Stearic acid.
Tablet coating: Hypromellose; Macrogol 400; Titanium dioxide (E171);
Iron oxide yellow (E172); Iron oxide red (E172).
What vardenafil 5mg, 10mg and 20mg film-coated tablets looks like and contents of the
pack
Vardenafil 5 mg film-coated tablets are slightly yellow to slightly brown round tablets of size
approx. 6 mm, embossed with “5” on one side.
Vardenafil 10 mg film-coated tablets are yellow-orange round tablets of size approx. 6 mm,
embossed with “10” on one side and with decorative line on the other side. The score line is only
to facilitate for ease of swallowing and not to divide into equal doses.
Vardenafil 20 mg film-coated tablets are orange round tablets of size approx. 8 mm, embossed
with “20” on one side and with decorative line on the other side. The score line is only to
facilitate for ease of swallowing and not to divide into equal doses.
Blisters in packages of 2, 4, 8, 12 and 24 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer

EPAR from eMC Report dated Jan 2016 – March 2016
ZENTIVA, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, 102 37, Czech Republic
This leaflet was last revised in 03/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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