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VARDENAFIL KRKA 10MG FILM-COATED TABLETS

Active substance(s): VARDENAFIL HYDROCHLORIDE TRIHYDRATE / VARDENAFIL HYDROCHLORIDE TRIHYDRATE

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Package leaflet: Information for the patient

Vardenafil 5 mg film-coated tablets
Vardenafil 10 mg film-coated tablets
Vardenafil 20 mg film-coated tablets
vardenafil

Read all of this leaflet carefully before you
start using 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 nurse.
• If you get any side effects talk to your doctor or
nurse. 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
Vardenafil 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
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.
• If 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.
• 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, anti-fungal
medicines.
• If you have a severe heart or liver problem.
• If you are having kidney dialysis.
• If you have recently had a stroke or 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 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).
• If 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.
Take special care with Vardenafil
• If you have heart trouble. It may be risky for you
to have sex.

If you suffer from irregular heart beat (cardiac
arrythmia) or inherited heart diseases affecting
your electrocardiogram.
If you have a physical condition affecting the
shape of the penis. This includes conditions
called angulation, Peyronie’s disease and
cavernosal fibrosis.
If you have an illness that can cause erections
which won’t go away (priapism). These include
sickle cell disease, multiple myeloma and
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 any other treatments for erection
difficulties (see section: Other medicines and
Vardenafil).
If you experience sudden decrease or loss of
vision, stop taking Vardenafil and contact your
doctor immediately.

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.
• Alpha-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.
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 and breast-feeding
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 medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
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 more than once a day.

Tell your doctor if you think Vardenafil is too strong
or too weak.
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

5. How to store Vardenafil
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 packaging 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 contains
The active substance is vardenafil.
Each film-coated tablet contains 5 mg, 10 mg or
20 mg vardenafil (as vardenafil hydrochloride
trihydrate).
• The other ingredients (excipients) are
microcrystalline cellulose, crospovidone (Type A),
colloidal anhydrous 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
film coating.



Common (may affect up to 1 in 10 people)
• Dizziness
• Flushing
• Blocked or runny nose
• Indigestion

What Vardenafil looks like and contents of the pack

Uncommon (may affect up to 1 in 100 people)
• Swelling of skin and mucous tissue including
swollen face, lips or throat
• Sleep disorder
• 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

Film-coated tablets (tablets) are orange-brown, oval,
slightly biconvex, scored on one side and engraved
with 10 on the other side, dimensions 10.5 mm x
5.5 mm. The tablet can be divided into equal doses.

Rare (may affect up to 1 in 1,000 people)
• Inflammation of the eyes (conjunctivitis)
• Allergic reaction
• Anxiety
• Fainting
• Amnesia
• Seizure
• Increased pressure in the eye (glaucoma),
increased tearing of the eyes
• 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

5 mg film-coated tablets:

Film-coated tablets (tablets) are orange-brown,
round, slightly biconvex, with bevelled edges,
engraved with 5 on one side, 5.5 mm in diameter.
10 mg film-coated tablets:

20 mg film-coated tablets:

Film-coated tablets (tablets) are orange-brown,
round, biconvex, with bevelled edges, scored on
one side and engraved with 20 on the other side,
10 mm in diameter. The tablet can be divided into
equal doses.
Vardenafil is available in boxes containing:
• 2, 4, 8, 12 and 20 film-coated tablets in blisters,
• 2 x 1, 4 x 1, 8 x 1, 12 x 1 and 20 x 1 film-coated
tablet in unit-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Krka, d.d., Novo mesto,
Šmarješka cesta 6,8501 Novo mesto,
Slovenia
Distributed by:
Consilient Health (UK) Ltd.
No. 1 Church Road,
Richmond upon Thames, Surrey,
TW9 2QE
This leaflet was last revised in 02/2017

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
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 Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.

P0599

Expand Transcript

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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