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VARDENAFIL ACCORD 5 MG FILM-COATED TABLETS

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

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Package leaflet: Information for the user

Vardenafil Accord 5 mg
film-coated tablets
Vardenafil Accord 10 mg
film-coated tablets
Vardenafil Accord 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 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 Accord is and what it is used
for
2. What you need to know before you take
Vardenafil Accord
3. How to take Vardenafil Accord
4. Possible side effects
5. How to store Vardenafil Accord
6. Contents of the pack and other information

1. What Vardenafil Accord is and
what it is used for
Vardenafil Accord 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.

Other medicines and Vardenafil Accord
Please tell your doctor or pharmacist if you are
using, have recently used or might use any other
medicines, including medicines obtained without
a prescription.
Some medicines may cause problems, especially
these:
- Nitrates, medicines for angina, or nitric oxide
donors, such as amyl nitrite. Taking these
medicines with Vardenafil Accord could
seriously affect your blood pressure. Talk to a
doctor without taking Vardenafil Accord.
- 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 Accord.
- 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 Accord film-coated tablets
combined with any other treatment for erectile
dysfunction, including vardenafil orodispersible
tablets.
Vardenafil Accord with food, drink and
alcohol
- You can take Vardenafil Accord 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 take this
medicine. It can interfere with the usual effect of
the medicine.
- Alcoholic drink can make erection difficulties
worse.
Pregnancy and breast-feeding
This medicine is not for use by women.
Driving and using machines
Vardenafil Accord might make some people feel
dizzy, or affect their vision. If you feel dizzy or if
your vision is affected after taking this medicine
don’t drive or operate any tools or machines.

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.

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure. The
recommended dose is 10 mg.

Vardenafil Accord 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 Accord allows an
erection to last long enough for you to
satisfactorily complete sexual activity.

Take a Vardenafil Accord 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 Accord.
- Swallow one tablet with a glass of water

2. What you need to know before
you take Vardenafil Accord
Do not take Vardenafil Accord
- 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 Accord 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 Levitra
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 Accord.
Take special care with Vardenafil Accord
- 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, including vardenafil
orodispersible tablets (see section: Other
medicines and Vardenafil Accord).
- If you experience sudden decrease or loss of
vision, stop taking Vardenafil Accord and
contact your doctor immediately.
Children and adolescents
Vardenafil Accord is not intended for use by
children or adolescents under 18.

3. How to take Vardenafil Accord

Do not take Vardenafil Accord film-coated
tablets with any other forms of vardenafil.
Do not take Vardenafil Accord more than once
a day.
Tell your doctor if you think Vardenafil Accord 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 Accord than you
should
Men who take too much Vardenafil Accord may
experience more side effects or may get severe
back pain. If you take more Vardenafil Accord
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 this
medicine 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 users
- Headache
Common:
may affect up to 1 in 10 users
- Dizziness
- Flushing
- Blocked or runny nose
- Indigestion
Uncommon:
may affect up to 1 in 100 users
- 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
Rare:
may affect up to 1 in 1,000 users
- 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
Very rare or not known:
may affect less than 1 in 10,000 users or
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.
This includes any possible side effects not listed
in this leaflet. You can also report side effects
directly via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Laboratori Fundació DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona,
Spain
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Member
States
Austria

Invented Names

Vardenafil Accord
5 mg/10 mg/20 mg Filmtabletten
Denmark
Vardenafil Accord
5 mg/10 mg/20 mg
Finland
Vardenafil Accord
5 mg/10 mg/20 mg
kalvopäällysteiset tabletit
Ireland
Vardenafil Accord
5 mg/10 mg/20 mg film-coated
tablets
Italy
Vardenafil Accord
Malta
Vardenafil Accord
5 mg/10 mg/20 mg film-coated
tablets
Netherland Vardenafil Accord
5 mg/10 mg/20 mg filmomhulde
tabletten
Poland
Vardenafil Accord
Sweden
Vardenafil Accord
5 mg/10 mg/20 mg filmdragerad
tabletter
United
Vardenafil Accord
Kingdom
5 mg/10 mg/20 mg film-coated
tablets
Spain
Vardenafil Accord
5 mg/10 mg/20 mg comprimidos
recubiertos con película
France
VARDENAFIL ACCORD
5 mg/ 10 mg/ 20 mg, comprimé
pelliculé
This leaflet was last revised in 05/2017.

Malta
ADR Reporting,
Website: ww.medicinesauthority.gov.mt/adrportal.
By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Vardenafil
Accord
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 carton 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 Accord contains
- The active substance is vardenafil.
- Vardenafil Accord 5 mg film-coated tablets:
Each tablet contains 5 mg vardenafil (as
hydrochloride trihydrate).
Vardenafil Accord 10 mg film-coated tablets:
Each tablet contains 10 mg vardenafil (as
hydrochloride trihydrate).
Vardenafil Accord 20 mg film-coated tablets:
Each tablet contains 20 mg vardenafil (as
hydrochloride trihydrate).
- The other ingredients of the tablets are:
Tablet core: crospovidone (type B), magnesium
stearate, cellulose microcrystalline and silica
colloidal anhydrous.
Film-coat: macrogol 400, hypromellose (E464),
titanium dioxide (E171), iron oxide red (E172)
and iron oxide yellow (E172).
What Vardenafil Accord looks like and
contents of the pack
Vardenafil Accord 5 mg film-coated tablets are
beige coloured, round shaped, approximately
5.5 mm in diameter, biconvex, film-coated tablets
debossed with 'FA1' on one side and plain on
other side.
Vardenafil Accord 10 mg film-coated tablets are
beige coloured, round shaped, approximately
6.8 mm in diameter, biconvex, film-coated tablets
debossed with 'FA2' on one side and plain on
other side.
Vardenafil Accord 20 mg film-coated tablets are
beige coloured, round shaped, approximately
8.9 mm in diameter, biconvex, film-coated tablets
debossed with 'FA3' on one side and plain on
other side.
The tablets are provided in PVC/PVdC
-Aluminium blister packs containing 2, 4, 8, 12 or
20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage house, 319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom
Wessling Hungary Kft
Fòti ùt 56., Budapest 1047,
Hungary

INP001
10 00000 0 000000

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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