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SILDENAFIL 50MG FILM-COATED TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
(Sildenafil citrate)

Read all of this leaflet carefully before you start taking this medicine
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 Sildenafil is and what it is used for
2. What you need to know before you take Sildenafil
3. How to take Sildenafil
4. Possible side effects
5. How to store Sildenafil
6. Contents of the pack and other information
1. What Sildenafil is and what it is used for
Sildenafil belongs to a group of medicines called phosphodiesterase type 5
(PDE5) inhibitors. It works by helping to relax the blood vessels in your penis,
allowing blood to flow into your penis when you get sexually excited. Sildenafil
will only help you to get an erection if you are sexually stimulated. You should
not take Sildenafil if you do not have erectile dysfunction. You should not take
Sildenafil if you are a woman.
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

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Do not take Sildenafil
• If you are allergic to sildenafil or any of the other ingredients of this
medicine (listed in section 6).
• 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 (hypersensitive) to Sildenafil or any of the other
ingredients of Sildenafil .
• 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 due to non-arteritic anterior ischaemic
optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor 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.
You should not use Sildenafil with any other oral or local treatment for erectile
dysfunction.
Children and adolescents
Sildenafil should not be given to individuals under the age of 18.
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.
Other medicines and Sildenafil
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Sildenafil tablets may interfere with some medicines, especially those used to
treat chest pain. In the event of a medical emergency, you should tell any
health care professional treating your condition that you have taken Sildenafil
and when you did. Do not take Sildenafil with other medicines unless your
doctor tells you that you can.
You should not take Sildenafil if you are taking medicines called nitrates, as
the combination of these products may cause a potentially dangerous
decrease in your blood pressure. Always tell your doctor or pharmacist if you
are taking any of these medicines that are often used for the relief of angina
pectoris (or “chest pain”).
You should not take Sildenafil if you are using any of the drugs known as nitric
oxide donors such as amyl nitrite (“poppers”), as the combination may lead to
a potentially dangerous decrease in your blood pressure.
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 (25 mg) of
Sildenafil.
Some patients who take alpha-blocker therapy for the treatment of high blood
pressure or prostate enlargement may experience dizziness or
light-headedness, which may be caused by low blood pressure upon sitting or
standing up quickly. Certain patients have experienced these symptoms when
taking Sildenafil with alpha-blockers. This is most likely to occur within 4 hours
after taking Sildenafil . In order to reduce the likelihood that these symptoms
occur, you should be on a regular daily dose of your alpha-blocker before you
start Sildenafil . Your doctor may start you on a lower dose (25 mg) of
Sildenafil .
Sildenafil with food, drink and alcohol
Sildenafil can 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 can cause dizziness and can affect vision. You should be aware of
how you react to Sildenafil before you drive or use machinery.
Sildenafil contains tartrazine
May cause allergic reactions as it contains Tartrazine (E-102). It can worsen
asthma.
continued overleaf

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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.
The usual starting dose is 50 mg.
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.
If you take more Sildenafil than you should:
You may experience an increase in side effects and their severity. Doses
above 100 mg do not increase the efficacy.
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 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.
A very common side effect (may affect more than 1 in 10 people) is
headache.

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Common side effects (may affect up to 1 in 10 people) include: facial
flushing, indigestion, effects on vision (including colour tinge to vision, light
sensitivity, blurred vision or reduced sharpness of vision) stuffy nose and
dizziness.
Uncommon side effects (may affect up to 1 in 100 people) 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, watery eyes,
irregular or rapid heartbeat, muscle pain, feeling sleepy, reduced sense of
touch, vertigo, ringing in the ears, nausea, dry mouth, penile bleeding,
presence of blood in semen and/or urine, chest pain and feeling tired.
Rare side effects (may affect up to 1 in 1,000 people) include: high blood
pressure, low blood pressure, fainting, stroke, heart attack, nosebleed,
sudden decrease or loss of hearing and non�arteritic anterior ischaemic optic
neuropathy.
Additional side effects reported from post-marketing experience include:
pounding heartbeat, chest pain, sudden death, or temporary decreased blood
flow to parts of the brain. 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, blister, peeling skin and pain
which require immediate medical attention have also been reported.
Reporting of side effects
If you get any side effects, talk to you doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the
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.
5. How to store Sildenafil
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage
conditions.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
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 to 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 mg of sildenafil, as the citrate.
Each film-coated tablet contains 50 mg of sildenafil, as the citrate.
Each film-coated tablet contains 100 mg of sildenafil, as the citrate.
The other ingredients are:
• Tablet core: cellulose powder, colloidal silicon (anhydrous), calcium
phosphate dibasic (anhydrous), croscarmellose sodium, magnesium
stearate,
• Film coat: hypromellose, titanium dioxide (E171), triacetin, indigotine
aluminium lake (E132), brilliant blue aluminium lake (E133), tartrazine
aluminium lake (E102)
What Sildenafil looks like and contents of the pack
Sildenafil film-coated tablets are blue, circular and biconvex tablets. The
tablets are provided in blister packs containing 2, 4, 8 or 12 tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Strandhaven Ltd t/a Somex Pharma
600 High Road, Seven Kings, Ilford,
Essex, IG3 8BS, United Kingdom
Manufacturer
Lácer S.A.
C/ Boters 5,
R-08290 Cerdanyola del Vallès, Spain
This medicinal product is authorised in the Member State of the EEA
under the following names:
Name of the Member State
Sildenafil 25 mg film-coated tablets
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
This leaflet was last revised in 09/2013

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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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