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SILDENAFIL-HAMELN 100 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

hameln

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 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 your 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.
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 (PDE 5) 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
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.
• 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.
• are allergic to sildenafil or any of the other ingredients
of this medicine (listed in section 6).
• have a severe heart or liver problem.
• have recently had a stroke or a heart attack, or if
you have low blood pressure.
• have certain rare inherited eye diseases (such as
retinitis pigmentosa).
• have ever had loss of vision because of non-arteritic
anterior ischaemic optic neuropathy (NAION).
Warnings and precautions
Tell 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)
• have a deformity of your penis or Peyronie’s
Disease.
• have problems with your heart. Your doctor should in
that case carefully check whether your heart can take
the additional strain of having sex.
• currently have a stomach ulcer, or a bleeding
problem (such as haemophilia).

• 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
treatments 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 other medicines or might take any other medicines,
including medicines obtained without prescription.
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 healthcare
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
medicines 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 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 and drink
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.

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 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.

Rare side effects (likely to occur in 1 to 10 patients
in 10000) include: high blood pressure, low blood
pressure, fainting, stroke, nosebleed and sudden
decrease or loss of hearing.
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.
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.
This includes any possible side effects not listed in this leaflet.

5. How to store Sildenafil
Keep this medicine out of the sight and reach of children.
Store in the outer carton in order to protect from light.
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.

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.

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.

You should not take more tablets than your doctor
tells you to.

6. Contents of the pack and other information

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.
A very common side effect (likely to occur in more than
1 in 10 patients) is headache.
Common side effects (likely to occur in 1 to 10 patients
in 100) 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 (likely to occur in 1 to 10 patients
in 1000) include: vomiting, skin rash, bleeding at the
back of the eye, 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 and feeling tired.

What Sildenafil contains
• Sildenafil 25 mg: Each tablet contains 35.12 mg of
sildenafil citrate quantitatively equivalent to 25 mg sildenafil.
• Sildenafil 50 mg: Each tablet contains 70.24 mg of sildenafil
citrate quantitatively equivalent to 50 mg of sildenafil.
• Sildenafil 100 mg: Each tablet contains 140.48 mg of
sildenafil citrate quantitatively equivalent to 100 mg of
sildenafil.
The other ingredients are:
• Tablet core:
microcrystalline cellulose, calcium hydrogen phosphate
(anhydrous), povidone 25, croscarmellose sodium,
magnesium stearate, macrogol 6000.
• Film-coat:
Hypromellose, microcrystalline cellulose titanium
dioxide (E171), brilliant blue FCF aluminium lake
(E133), macrogol stearate.
What Sildenafil looks like and contents of the pack
• Sildenafil 25 mg film-coated tablets are blue, oval and
biconvex.
• Sildenafil 50 mg film-coated tablets are blue, oval and
biconvex with break-marks on both sides to facilitate
ease of dosing.
• Sildenafil 100 mg film-coated tablets are blue, oval
and biconvex with break-marks on both sides to
facilitate ease of dosing.
The tablets are provided in blister packs containing 4, 10,
12 or 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, United Kingdom
Manufacturer
hameln rds a.s.
Horná 36, 900 01 Modra, Slovak Republic
This leaflet was last revised in July 2013.
57029/27/13

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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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