SILDENAFIL ZENTIVA 50MG FILM-COATED TABLETS

Active substance: SILDENAFIL CITRATE

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Package leaflet: Information for the user

SILDENAFIL 25MG
FILM-COATED TABLETS
SILDENAFIL 50MG
FILM-COATED TABLETS
SILDENAFIL 100MG
FILM-COATED TABLETS

Special considerations for patients with
kidney or liver problems
You should tell your doctor if you have
kidney or liver problems. Your doctor may
decide on a lower dose for you.
Children and adolescents
Sildenafil should not be given to individuals
under the age of 18.

Other medicines and sildenafil
Tell your doctor or pharmacist if you are
Read all of this leaflet carefully before you taking, have recently taken or might take any
other medicines.
start taking this medicine because it
contains important information for you.
Sildenafil film-coated tablets may interfere
with some medicines, especially those used
• Keep this leaflet. You may need to read it
to treat chest pain. In the event of a medical
again.
emergency, you should tell any health care
• If you have any further questions, please
professional treating your condition that you
ask your doctor pharmacist or nurse.
• This medicine has been prescribed for you have taken sildenafil and when you did. Do
not take sildenafil with other medicines
only. Do not pass it on to others. It may
unless your doctor tells you that you can.
harm them, even if their signs of illness
You should not take sildenafil if you are
are the same as yours.
taking medicines called nitrates as the
• If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes combination of these products may cause a
potentially dangerous decrease in your
any possible side effects not listed in this
blood pressure. Always tell your doctor or
leaflet.
pharmacist if you are taking any of these
What is in this leaflet:
medicines that are often used for the relief of
1. What sildenafil is and what it is used for
angina pectoris (or “chest pain”).
2. What you need to know before you take
You should not take sildenafil if you are using
sildenafil
any of the drugs known as nitric oxide donors
3. How to take sildenafil
such as amyl nitrite (“poppers”) as the
4. Possible side effects
combination may also lead to a potentially
5. How to store sildenafil
dangerous decrease in your blood pressure.
6. Contents of the pack and other information If you are taking medicines known as protease
inhibitors, such as for the treatment of HIV,
your doctor may start you on the lowest dose
The name of your medicine is Sildenafil 25mg, (25mg) of sildenafil.
50mg or 100mg film-coated tablets (referred
Some patients who take alpha-blocker
to as sildenafil throughout this leaflet).
therapy for the treatment of high blood
Sildenafil belongs to a group of medicines
pressure or prostate enlargement may
experience dizziness or light-headedness
called phosphodiesterase type 5 (PDE 5)
which may be caused by low blood pressure
inhibitors. It works by helping to relax the
upon sitting or standing up quickly. Certain
blood vessels in your penis, allowing blood
to flow into your penis when you get sexually patients have experienced these symptoms
excited. Sildenafil will only help you to get an when taking sildenafil with alpha-blockers.
This is most likely to occur within 4 hours
erection if you are sexually stimulated. You
after taking sildenafil. In order to reduce the
should not take sildenafil if you do not have
likelihood that these symptoms occur, you
erectile dysfunction. You should not take
should be on a regular daily dose of your
sildenafil if you are a woman.
alpha-blocker before you start sildenafil.

Zentiva
PIL SILDENAFIL CITRATE 25MG, 50MG & 100MG FILM-COATED TABLETS UK

LEAFLET
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366931
19-FEB-13
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1. What sildenafil is and what it is used for

Sildenafil is a treatment for men with erectile
dysfunction, sometimes known as impotence.
This is when a man cannot get, or keep a
hard, erect penis suitable for sexual activity.
2. What you need to know before you take
sildenafil
Do not take sildenafil
- If you are taking medicines called nitrates,
as the combination may cause a potentially
dangerous decrease in your blood pressure.
Tell your doctor if you are taking any of
these medicines which are often given for
relief of angina pectoris (or “chest pain”).
If you are not certain, ask your doctor or
pharmacist.
- If you are using any of the drugs known as
nitric oxide donors such as amyl nitrite
(“poppers”) as the combination may also
lead to a potentially dangerous decrease
in your blood pressure.
- If you are allergic to sildenafil or any of the
other ingredients of this medicine (listed in
section 6).
- If you have a severe heart or liver problem.
- If you have recently had a stroke or a heart
attack, or if you have low blood pressure.
- If you have certain rare inherited eye
diseases (such as retinitis pigmentosa).
- If you have ever had loss of vision because
of non-arteritic anterior ischaemic optic
neuropathy (NAION)
Warning and precautions
Talk to your doctor, pharmacist or nurse
before taking sildenafil
- If you have sickle cell anaemia (an
abnormality of red blood cells), leukaemia
(cancer of blood cells), multiple myeloma
(cancer of bone marrow).
- If you have a deformity of your penis or
Peyronie’s Disease.
- If you have problems with your heart. Your
doctor should in that case carefully check
whether your heart can take the additional
strain of having sex.
- If you currently have a stomach ulcer, or a
bleeding problem (such as haemophilia).
- If you experience sudden decrease or loss
of vision, stop taking sildenafil and
contact your doctor immediately.

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148 x 420mm
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Your doctor may start you on a lower dose
(25mg) of sildenafil.
Sildenafil with food, drink and alcohol
Sildenafil may be taken with or without food.
However, you may find that sildenafil takes
longer to start working if you take it with a
heavy meal.
Drinking alcohol can temporarily impair your
ability to get an erection. To get the
maximum benefit from your medicine, you
are advised not to drink excessive amounts
of alcohol before taking sildenafil.
Pregnancy and breast feeding
Sildenafil is not indicated for use by women.
Driving and using machines
Sildenafil may cause dizziness and can affect
vision. You should be aware of how you react
to sildenafil before you drive or use machinery.
Sildenafil contains lactose
If you have been told by your doctor that
you have an intolerance to some sugars,
such as lactose, contact your doctor before
taking sildenafil.
3. How to take sildenafil
Always take sildenafil exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure. The
usual starting dose is 50mg.
You should not take sildenafil more than
once a day.
You should take sildenafil about one hour
before you plan to have sex. Swallow the
tablet whole with a glass of water.
If you have the impression that the effect of
sildenafil is too strong or too weak, talk to
your doctor or pharmacist.
Sildenafil will only help you to get an
erection if you are sexually stimulated. The
amount of time sildenafil takes to work
varies from person to person, but it normally
takes between half an hour and one hour.
You may find that sildenafil takes longer to
work if you take it with a heavy meal.
If sildenafil does not help you to get an
erection, or if your erection does not last
long enough for you to complete sexual
intercourse you should tell your doctor.
The tablet can be divided into equal halves.

If you take more sildenafil than you should:
You may experience an increase in side
You should not use sildenafil with any other
effects and their severity. Doses above
oral or local treatments for erectile dysfunction. 100 mg do not increase the efficacy.

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:
Signature:

00000000
00000000

You should not take more tablets than
your doctor tells you to.
Contact your doctor if you take more tablets
than you should.
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. The side effects reported in association
with the use of sildenafil are usually mild to
moderate and of a short duration.
If you have chest pains during or after
intercourse:
- Get in a semi-sitting position and try to relax
- Do not use nitrates to treat your chest pain
- Contact your doctor immediately
All medicines including sildenafil can cause
allergic reactions. You should contact your
doctor immediately if you experience any of
the following symptoms after taking sildenafil:
sudden wheeziness, difficulty in breathing or
dizziness, swelling of the eyelids, face, lips or
throat.
Prolonged and sometimes painful erections
have been reported after taking sildenafil.
If you have an erection which lasts for more
than 4 hours, you should contact a doctor
immediately.
If you experience a sudden decrease or loss
of vision, stop taking sildenafil and contact
your doctor immediately.

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 sildenafil contains
The active substance is sildenafil. Each
film-coated tablet contains 25/50/100mg of
sildenafil (as citrate salt).
The other ingredients are:
• Tablet core : microcrystalline cellulose,
calcium hydrogen phosphate
(anhydrous), croscarmellose sodium,
magnesium stearate
• Tablet coating: lactose monohydrate,
hypromellose, titanium dioxide (E171),
triacetin, indigo carmine aluminium lake
(E132)

Zentiva
PIL SILDENAFIL CITRATE 25MG, 50MG & 100MG FILM-COATED TABLETS UK

What sildenafil looks like and contents of
the pack

LEAFLET
3100
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Sildenafil 25mg film-coated tablet
Blue coloured round, biconvex, film-coated
tablets debossed with 124 on one side and
J on the other side

00000
366931
19-FEB-13

Sildenafil 50mg film-coated tablet
Blue coloured round, scored biconvex,
film-coated tablets debossed with 125 on
one side and J on the other side with the
score line

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Sildenafil 100mg film-coated tablet
Blue coloured round, biconvex, scored
film-coated tablets debossed with 126 on
one side and J on the other side with the
Common side effects (likely to occur in 1 to score line
10 patients in 100) include:
Sildenafil is supplied in the following pack
• facial flushing
sizes:
• indigestion

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148 x 420mm
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A very common side effect (likely to occur
in more than 1 in 10 patients) is headache.

• effects on vision (including colour tinge
to vision, light sensitivity, blurred vision
or reduced sharpness of vision)
• stuffy nose
• dizziness
Uncommon side effects (likely to occur in
1 to 10 patients in 1000) include:
• vomiting
• skin rash
• bleeding at the back of the eye
• eye irritation
• bloodshot eyes/red eyes
• eye pain
• double vision
• abnormal sensation in the eye
• irregular or rapid heartbeat
• muscle pain
• feeling sleepy
• reduced sense of touch
• vertigo
• ringing in the ears
• nausea
• dry mouth
• chest pain
• feeling tired

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PVC/Aluminium foil blisters in cartons of 1,
2, 4 or 8 tablets.

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Not all pack sizes may be marketed.
1

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK.

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Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola,
PLA 3000, Malta
Or
S.C. Zentiva S.A.
50, Theodor Pallady Blvd., 032266,
Bucharest, Romania.
This leaflet was last revised in February 2013.
‘Zentiva’ is a registered trademark. © 2013
Zentiva.

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva - Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD OFFICE USE
Other - as required
Approved: Yes
No
ONLY
Date:

Rare side effects (likely to occur in 1 to
10 patients in 10000) include:
• high blood pressure
• low blood pressure
• fainting
• stroke
• nosebleed
• sudden decrease or loss of hearing

Signature:

Additional side effects reported from
post-marketing experience include:
• pounding heartbeat
• chest pain
• sudden death
• heart attack or temporary decreased
blood flow to parts of the brain

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Most, but not all, of these men had heart
problems before taking this medicine. It is not
possible to determine whether these events
were directly related to sildenafil. Cases of
convulsions or seizures and serious skin
reactions characterised by rash, blisters,
peeling skin and pain which require immediate
medical attention have also been reported.
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any side effects not listed in this leaflet.
5. How to store sildenafil
Keep this medicine out of the sight and
reach of children.
This medicinal product does not require any
special storage conditions.
Do not use sildenafil after the expiry date
which is stated on the carton. The expiry date
refers to the last day of the month.
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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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