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SILDENAFIL 50MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL / SILDENAFIL CITRATE

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APPROVED FOR MANUFACTURE AT RISK - M. HERRITY 20/08/2014

Service Développement Pfizer Amboise
Produit
Code
Remplace le
Type
Format

SILDENAFIL UK

NOIR

8818434
Couleur:
8818433
bobine
Minimum font size: 9 pts
135 x 315 mm
Version: 1
Recto: 4a + spot / Verso: 4b
Préparé par : Christophe GASSELIN
Date: 18/08/2014



Package leaflet: Information for the patient

Sildenafil

25 mg, 50 mg and 100 mg film-coated tablets

Sildenafil

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, pharmacist or nurse.
- 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, pharmacist or nurse. 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

You should not use this medicine with treatments
for pulmonary arterial hypertension (PAH) containing
sildenafil or any other PDE5 inhibitors.
You should not take Sildenafil if you do not have
erectile dysfunction.
You should not take Sildenafil if you are a woman.
Special considerations for patients with kidney or
liver problems
You should tell your doctor if you have kidney or liver
1. What Sildenafil is and what it is used for
problems. Your doctor may decide on a lower dose
Sildenafil contains the active substance sildenafil
for you.
(as citrate), which belongs to a group of medicines
Children and adolescents
called phosphodiesterase type 5 (PDE5) inhibitors.
It works by helping to relax the blood vessels in
This medicine should not be given to individuals
your penis, allowing blood to flow into your penis
under the age of 18.
when you get sexually excited. This medicine will
Other medicines and Sildenafil:
only help you to get an erection if you are sexually
Tell your doctor or pharmacist if you are taking, have
stimulated.
recently taken or might take any other medicines.
This medicine is a treatment for adult men with
Sildenafil tablets may interfere with some
erectile dysfunction, sometimes known as
medicines, especially those used to treat chest pain.
impotence. This is when a man cannot get, or keep In the event of a medical emergency, you should
a hard, erect penis suitable for sexual activity.
tell your doctor, pharmacist or nurse that you have
taken this medicine and when you did. Do not take
2. What you need to know before you take
this medicine with other medicines unless your
Sildenafil
doctor tells you that you can.
Do not take Sildenafil
You should not take this medicine if you are taking
- If you are allergic to sildenafil or any of the other
medicines called nitrates, as the combination of
ingredients of this medicine (listed in section 6).
these medicines may lead to a dangerous fall in your
- If you are taking medicines called nitrates, as the blood pressure. Always tell your doctor, pharmacist
combination may lead to a dangerous fall in your or nurse if you are taking any of these medicines
blood pressure. Tell your doctor if you are taking
that are often used for the relief of angina pectoris
any of these medicines which are often given for (or “chest pain”).
relief of angina pectoris (or “chest pain”). If you
You should not take this medicine if you are using
are not certain, ask your doctor or pharmacist.
any of the medicines known as nitric oxide donors
- If you are using any of the medicines known
such as amyl nitrite (“poppers”) as the combination
as nitric oxide donors such as amyl nitrite
may also lead to a dangerous fall in your blood
(“poppers”), as the combination may also lead to pressure.
a dangerous fall in your blood pressure.
If you are taking medicines known as protease
- If you have a severe heart or liver problem.
inhibitors, such as for the treatment of HIV, your
- If you have recently had a stroke or a heart attack, doctor may start you on the lowest dose (25 mg) of
this medicine.
or if you have low blood pressure.
Some patients who take alpha-blocker therapy
- If you have certain rare inherited eye diseases
for the treatment of high blood pressure or
(such as retinitis pigmentosa).
prostate enlargement may experience dizziness
- If you have ever had loss of vision due to
non-arteritic anterior ischaemic optic neuropathy or light-headedness, which may be caused by low
blood pressure upon sitting or standing up quickly.
(NAION).
Certain patients have experienced these symptoms
Warnings and precautions
when taking Sildenafil with alpha-blockers. This
Talk to your doctor, pharmacist or nurse before
is most likely to happen within 4 hours after taking
taking Sildenafil
this medicine. To reduce the chance that these
- If you have sickle cell anaemia (an abnormality of symptoms might happen, you should be on a regular
red blood cells), leukaemia (cancer of blood cells), daily dose of your alpha-blocker before you start this
multiple myeloma (cancer of bone marrow).
medicine. Your doctor may start you on a lower dose
- If you have a deformity of your penis or Peyronie’s (25 mg) of this medicine.
Disease.
Sildenafil with food, drink and alcohol
- If you have problems with your heart. Your doctor This medicine can be taken with or without food.
should carefully check whether your heart can
However, you may find that this medicine takes
take the additional strain of having sex.
longer to start working if you take it with a heavy
- If you currently have a stomach ulcer, or a
meal.
bleeding problem (such as haemophilia).
Drinking alcohol can temporarily impair your ability
- If you experience sudden decrease or loss of
to get an erection. To get the maximum benefit
vision, stop taking this medicine and contact your from your medicine, you are advised not to drink
doctor immediately.
excessive amounts of alcohol before taking this
You should not use this medicine with any other oral medicine.
or local treatments for erectile dysfunction.

Pregnancy, breast-feeding and fertility
This medicine is not indicated for use by women.
Driving and using machines
This medicine can cause dizziness and can affect vision.
You should be aware of how you react to this medicine
before you drive or use machinery.
Sildenafil tablets contain 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 this medicine.

ringing in the ears, nausea, dry mouth, penile bleeding,
presence of blood in semen and/or urine, chest pain and
feeling tired.
Rare (may affect up to 1 in 1,000 people): high blood
pressure, low blood pressure, fainting, stroke, heart
attack, irregular heartbeat, nosebleed and sudden
decrease or loss of hearing.
Not known (frequency cannot be estimated from the
available data):
Additional side effects reported from post-marketing
experience:
3. How to take Sildenafil
Unstable angina (a heart condition), sudden death,
temporary decreased blood flow to parts of the brain.
Always take this medicine exactly as your doctor or
Most, but not all, of the men who experienced these side
pharmacist has told you. Check with your doctor or
effects had heart problems before taking this medicine.
pharmacist if you are not sure. The recommended
It is not possible to determine whether these events
starting dose is 50 mg.
You should not take Sildenafil more than once a day. were directly related to this medicine.
Reporting of side effects
You should take this medicine about one hour before
If you get any side effects, talk to your doctor,
you plan to have sex. Swallow the tablet whole with a
pharmacist or nurse. This includes any possible side
glass of water.
If you feel that the effect of this medicine is too strong or effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
too weak, talk to your doctor or pharmacist.
www.mhra.gov.uk/yellowcard. By reporting side
This medicine will only help you to get an erection if
effects you can help provide more information on
you are sexually stimulated. The amount of time this
the safety of this medicine.
medicine takes to work varies from person to person,
but it normally takes between half an hour and one hour. 5. How to store Sildenafil
You may find that this medicine takes longer to work if
Keep this medicine out of the sight and reach of
you take it with a heavy meal.
children.
If this medicine does not help you to get an erection,
Do not store above 30°C.
or if your erection does not last long enough for you to
Do not use this medicine after the expiry date which is
complete sexual intercourse you should tell your doctor. stated on the carton and the blister after EXP. The expiry
If you take more Sildenafil than you should:
date refers to the last day of that month.
You may experience an increase in side effects and
Store in the original package, in order to protect from
their severity. Doses above 100 mg do not increase the
moisture.
efficacy.
Do not throw away any medicines via wastewater or
You should not take more tablets than your doctor
household waste. Ask your pharmacist how to throw
tells you to.
away medicines you no longer use. These measures will
help protect the environment.
Contact your doctor if you take more tablets than you
should.
6. Contents of the pack and other information
If you have any further questions on the use of this
What Sildenafil tablets contain
medicine, ask your doctor, pharmacist or nurse.
- The active substance is sildenafil. Each tablet
4. Possible side effects
contains 25 mg, 50 mg or 100 mg of sildenafil (as the
Like all medicines, this medicine can cause side effects
citrate salt).
although not everybody gets them. The side effects
reported in association with the use of this medicine are - The other ingredients are:
- Tablet core: microcrystalline cellulose, calcium
usually mild to moderate and of a short duration.
hydrogen phosphate (anhydrous), croscarmellose
If you experience any of the following serious side
sodium, magnesium stearate.
effects stop taking Sildenafil and seek medical help
-
Film coat: hypromellose, lactose (see section
immediately:
2 ‘sildenafil tablets contain lactose’), triacetin,
• An allergic reaction (this occurs rarely)
titanium dioxide (E171).
Symptoms include sudden wheeziness, difficulty in
What
Sildenafil tablets look like and contents of the
breathing or dizziness, swelling of the eyelids, face,
pack
lips or throat.
Sildenafil 25 mg film-coated tablets are white to
• Chest pains (this occurs uncommonly)
off-white, with a rounded-diamond shape and they are
If this occurs during or after intercourse
marked “25” on one side.
- Get in a semi-sitting position and try to relax.
Sildenafil 50 mg film-coated tablets are white to
- Do not use nitrates to treat your chest pain.
off-white, with a rounded-diamond shape and they are
• Prolonged and sometimes painful erections
marked “50” on one side.
(frequency unknown)
Sildenafil 100 mg film-coated tablets are white to
If you have an erection which lasts for more than 4
off-white, with a rounded-diamond shape and they are
hours, you should contact a doctor immediately.
marked “100” on one side.
• A sudden decrease or loss of vision (frequency
The tablets are provided in blister packs containing 2, 4,
unknown)
8, 12 or 24 tablets in a carton. Some pack sizes may not
be marketed in your country.
• Serious skin reactions (frequency unknown)
Symptoms may include severe peeling and swelling
Marketing Authorisation Holder and Manufacturer
of the skin, blistering of the mouth, genitals and
The marketing authorisation holder is Pfizer Limited,
around the eyes, fever.
Ramsgate Road, Sandwich, Kent, CT13 9NJ. United
• Seizures or fits (frequency unknown)
Kingdom.
Other side effects:
The manufacturer of this medicine is Fareva Amboise,
Zone Industrielle, 29 route des Industries,
Very common (may affect more than 1 in 10 people):
37530 Pocé-sur-Cisse, France.
headache.
Common (may affect up to 1 in 10 people): facial
This leaflet was last revised in 10/2014
flushing, indigestion, effects on vision (including colour
tinge to vision, light sensitivity, blurred vision or reduced
Ref: dVI 8_0
sharpness of vision), stuffy nose and dizziness.
Uncommon (may affect up to 1 in 100 people):
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, pounding heartbeat, rapid heartbeat, muscle
pain, feeling sleepy, reduced sense of touch, vertigo,

8818434

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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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