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SILDENAFIL TEVA 20 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE / SILDENAFIL CITRATE / SILDENAFIL CITRATE

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TEVA UK Ref:

231-30-12345-A LEA SILDENAFIL (HYPERTENSION) CITRATE 20mg FC TABS TUK Dimensions:

Length:
Width:

Depth:

Colours Used:

540 mm
160 mm
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Foil Width:

Perforated:

Shelf Ready Pack:

SILDENAFIL 20 mg
FILM-COATED TABLETS
Package leaflet:
Information for the patient

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.
2.
3.
4.
5.
6.

Version: 1 06 October 2016

What Sildenafil is and what it is used
for
What you need to know before you
take Sildenafil
How to take Sildenafil
Possible side effects
How to store Sildenafil
Contents of the pack and other
information

1 What Sildenafil is and what it is
used for





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blood cells (leukaemia), cancer of
bone marrow (multiple myeloma), or
any disease or deformity of the penis
currently have a stomach ulcer, a
bleeding disorder (such as
haemophilia) or problems with nose
bleeds
take medicines for erectile
dysfunction.

When used to treat male erectile
dysfunction (ED), the following visual
side effects have been reported with
PDE5 inhibitors, including sildenafil at an
unknown frequency; partial, sudden,
temporary, or permanent decrease or
loss of vision in one or both eyes.
If you experience sudden decrease or
loss of vision, stop taking Sildenafil and
contact your doctor immediately (see
also section 4).
Prolonged and sometimes painful
erections have been reported in men
after taking sildenafil. If you have an
erection, which lasts continuously for
more than 4 hours, stop taking Sildenafil
and contact your doctor immediately
(see also section 4).
Special considerations for patients with
kidney or liver problems
You should tell your doctor if you have
kidney or liver problems, as your dose
may need to be adjusted.

Sildenafil contains the active substance Children
sildenafil which belongs to a group of
Sildenafil should not be given to children
medicines called phosphodiesterase type below 1 year of age.
5 (PDE5) inhibitors.
Other medicines and Sildenafil
Sildenafil brings down blood pressure in Tell your doctor or pharmacist if you are
the lungs by widening the blood vessels taking, have recently taken or might take
in the lungs. Sildenafil is used to treat
any other medicines.
adults and children and adolescents from
• medicines containing nitrates, or
1 to 17 years old with high blood
nitric oxide donors such as amyl
pressure in the blood vessels in the
nitrate (“poppers”). These medicines
lungs (pulmonary arterial hypertension).
are often given for relief of angina
pectoris or “chest pain” (see section
2 What you need to know before
2. Before you take Sildenafil)
you take Sildenafil
• tell your doctor or pharmacist if you
Do not take Sildenafil if you:
are already taking riociguat
• are allergic to sildenafil or any of the • therapies for pulmonary
other ingredients of this medicine
hypertension (e.g. bosentan, iloprost)
(listed in section 6)
• medicines containing St. John’s Wort
• are taking medicines containing
(herbal medicinal product),
nitrates, or nitric oxide donors such
rifampicin (used to treat bacterial
as amyl nitrate (“poppers”). These
infections), carbamazepine,
medicines are often given for relief of
phenytoin and phenobarbital (used,
chest pain (or “angina pectoris”).
among others, to treat epilepsy)
Sildenafil can cause a serious
• blood thinning medicines (for
increase in the effects of these
example warfarin) although these did
medicines. Tell your doctor if you are
not result in any side effect
taking any of these medicines. If you • medicines containing erythromycin,
are not certain, ask your doctor or
clarithromycin, telithromycin (these
pharmacist
are antibiotics used to treat certain
• are taking riociguat. This drug is used
bacterial infections), saquinavir (for
to treat pulmonary arterial
HIV) or nefazodone (for mental
hypertension (i.e., high blood
depression), as your dose may need
pressure in the lungs) and chronic
to be adjusted
thromboembolic pulmonary
• alpha-blocker therapy (e.g.
hypertension (i.e., high blood
doxazosin) for the treatment of high
pressure in the lungs secondary to
blood pressure or prostate problems,
blood clots). PDE5 inhibitors, such as
as the combination of the two
Sildenafil have been shown to
medicines may cause symptoms
increase the hypotensive effects of
resulting in the lowering of your
this medicine. If you are taking
blood pressure (e.g. dizziness, light
riociguat or are unsure tell your
headedness).
doctor
Sildenafil with food and drink
• have recently had a stroke, a heart
You should not drink grapefruit juice
attack or if you have severe liver
while you are being treated with
disease or very low blood pressure
Sildenafil.
(<90/50 mmHg)




are taking a medicine to treat fungal
infections such as ketoconazole or
itraconazole or medicines containing
ritonavir (for HIV)
have ever had loss of vision because
of a problem with blood flow to the
nerve in the eye called non-arteritic
anterior ischaemic optic neuropathy
(NAION).

Warnings and precautions
Talk to your doctor before taking
Sildenafil if you:
• have a disease due to a blocked or
narrow vein in the lungs rather than
a blocked or narrow artery
• have a severe heart problem
• have a problem with the pumping
chambers of your heart
• have high blood pressure in the
blood vessels in the lungs
• have low blood pressure at rest
• lose a large amount of body fluids
(dehydration) which can occur when
you sweat a lot or do not drink
enough liquids. This can happen if
you are sick with a fever, vomiting, or
diarrhoea
• have a rare inherited eye disease
(retinitis pigmentosa)
• have an abnormality of red blood
cells (sickle cell anaemia), cancer of

Pregnancy and breast-feeding
If you are pregnant, or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine. Sildenafil should not be
used during pregnancy unless strictly
necessary.
Sildenafil should not be given to women
of child bearing potential unless using
appropriate contraceptive methods.
Stop breast-feeding when you start
Sildenafil treatment. Sildenafil should
not be given to women who are
breast-feeding since it is not known if the
medicine passes into the breast milk.
Driving and using machines
Sildenafil can cause dizziness and can
affect vision. You should be aware of how
you react to the medicine before you
drive or use machines.

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

TEVA UK Ref:

231-30-12345-A LEA SILDENAFIL (HYPERTENSION) CITRATE 20mg FC TABS TUK Dimensions:

Length:
Width:

Version: 1 06 October 2016

Colours Used:

540 mm
160 mm

Depth:

-

Foil Width:

Perforated:

Shelf Ready Pack:

For adults, the recommended dose is
20 mg three times a day (taken 6 to 8
hours apart) taken with or without food.
Use in children and adolescents
For children and adolescents aged 1 year
to 17 years old, the recommended dose
is either 10 mg three times a day for
children and adolescents ≤ 20 kg or
20 mg three times a day for children and
adolescents > 20 kg, taken with or
without food. Higher doses should not
be used in children. This medicine should
be used only in case of administration of
20 mg three times a day. Other
pharmaceutical forms may be more
appropriate for administration to patients
≤ 20 kg and other younger patients who
are not able to swallow tablets.

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lungs, chest pain, fainting, respiratory
infection, bronchitis, viral infection in the
stomach and intestines, urinary tract
infections and tooth cavities.
The following serious adverse events
were considered to be treatment related
and were reported uncommonly (may
affect up to 1 in 100 people), allergic
reaction (such as skin rash, swelling of
the face, lips and tongue, wheezing,
difficulty breathing or swallowing),
convulsion, irregular heart-beat, hearing
impairment, shortness of breath,
inflammation of the digestive tract,
wheezing due to disrupted airflow.
Side effects reported very commonly
(may affect more than 1 in 10 people)
were headache, vomiting, infection of the
throat, fever, diarrhoea, flu and
nosebleed.

If you take more Sildenafil than you
should
You should not take more medicine than
Side effects reported commonly (may
your doctor tells you to.
affect up to 1 in 10 people) were nausea,
If you take more medicine than you have increased erections, pneumonia and
runny nose.
been told to take contact your doctor
immediately. Taking more Sildenafil than
Reporting of side effects
you should may increase the risk of
If you get any side effects, talk to your
known side effects.
doctor or pharmacist. This includes any
possible side effects not listed in this
If you forget to take Sildenafil
leaflet. You can also report side effects
If you forget to take Sildenafil, take a
directly via the Yellow Card Scheme at:
dose as soon as you remember, then
www.mhra.gov.uk/yellowcard
continue to take your medicine at the
By reporting side effects you can help
usual times. Do not take a double dose
provide more information on the safety
to make up for a forgotten dose.
of this medicine.
If you stop taking Sildenafil
Suddenly stopping your treatment with
5 How to store Sildenafil
Sildenafil may lead to your symptoms
getting worse. Do not stop taking
Keep this medicine out of the sight and
Sildenafil unless your doctor tells you to.
reach of children.
Your doctor may tell you to reduce the
dose over a few days before stopping
Do not use this medicine after the expiry
completely.
date which is stated on the carton after
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4 Possible side effects

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
Like all medicines, Sildenafil can cause
your pharmacist how to throw away
side effects, although not everybody gets
medicines you no longer use. These
them.
measures will help to protect the
environment.
If you experience any of the following
side effects you should stop taking
Sildenafil and contact a doctor
6 Contents of the pack and other
information
immediately (see also section 2):
• if you experience sudden decrease or
What Sildenafil contains
loss of vision (frequency not known)
• The active substance is sildenafil.
• if you have an erection, which lasts
Each tablet contains 20 mg of
continuously for more than 4 hours.
sildenafil (as the citrate).
Prolonged and sometimes painful
• The other ingredients are:
erections have been reported in men
Tablet core: cellulose
after taking sildenafil (frequency not
microcrystalline, calcium hydrogen
known).
phosphate (anhydrous),
croscarmellose sodium, magnesium
Adults
stearate.
Side effects reported very commonly
Film-coat: hypromellose, macrogol
(may affect more than 1 in 10 people)
6000, talc, titanium dioxide (E171).
were headache, facial flushing,
indigestion, diarrhoea and pain in the
What Sildenafil looks like and contents
arms or legs.
of the pack
Sildenafil Film-coated Tablets are white
Side effects reported commonly (may
to off white, approx. 6.5 mm, biconvex
affect up to 1 in 10 people) included:
circular, embossed with “20” on one side
infection under the skin, flu-like
symptoms, inflammation of the sinuses, and plain on the other side.
reduced number of red blood cells
Sildenafil Film-coated Tablets are packed
(anaemia), fluid retention, difficulty
in PVC/PVdC-Aluminium blisters or
sleeping, anxiety, migraine, shaking,
perforated unit dose blisters of 30, 90,
“pins and needles”-like sensation,
90x1 or 300 film-coated tablets.
burning sensation, reduced sense of
touch, bleeding at the back of the eye,
Not all pack sizes may be marketed.
effects on vision, blurred vision and light
Marketing Authorisation Holder
sensitivity, effects on colour vision, eye
TEVA UK Limited, Eastbourne,
irritation, bloodshot eyes/red eyes,
BN22 9AG, UK
vertigo, bronchitis, nosebleed, runny
nose, cough, stuffy nose, stomach
Manufacturer
inflammation, gastroenteritis, heartburn, Teva Operations Poland Sp. z.o.o, ul.
piles, abdominal distension, dry mouth, Mogilska 80, Kraków, 31-546, Poland
hair loss, redness of the skin, night
This leaflet was last revised in 10/2016
sweats, muscle aches, back pain and
increased body temperature.
PL 00289/2051
Side effects reported uncommonly (may
affect 1 in 100 people) included: reduced
sharpness of vision, double vision,
abnormal sensation in the eye, penile
bleeding, presence of blood in semen
and/or urine, and breast enlargement in
men.
Skin rash and sudden decrease or loss of
hearing and decreased blood pressure
have also been reported at an unknown
frequency (frequency cannot be
estimated from the available data).
Children and adolescents
The following serious adverse events
have been reported commonly (may
affect up to 1 in 10 people); pneumonia,
heart failure, right heart failure, heart
related shock, high blood pressure in the

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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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