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SILDENAFIL ASPEN 100 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Sildenafil 50mg
Film-coated Tablets
Sildenafil 100mg
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.
 f you have any further questions, please ask your
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doctor or pharmacist.
  his medicine has been prescribed for you only. Do not
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pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
 f you get any side effects, talk to your doctor or
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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 (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
Do not take Sildenafil
 f you are taking medicines called nitrates, as the
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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.
 f you are using any of the drugs known as nitric oxide
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donors such as amyl nitrite (‘poppers’), as the
combination may also lead to a potentially dangerous
decrease in your blood pressure.
 f you are allergic to sildenafil or any of the other
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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.
 If you have low blood pressure.
 f you have certain rare inherited eye diseases
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(such as retinitis pigmentosa).
 f you have ever had loss of vision due to non-arteritic
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anterior ischaemic optic neuropathy (NAION).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sildenafil
 f you have sickle cell anaemia (an abnormality of red
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blood cells), leukaemia (cancer of blood cells), multiple
myeloma (cancer of bone marrow).
 f you have a deformity of your penis or
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Peyronie’s Disease.
 f you have problems with your heart. Your doctor
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should in that case carefully check whether your heart
can take the additional strain of having sex.
 f you currently have a stomach ulcer, or bleeding
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problems (such as haemophilia).
 f you experience sudden decrease or loss of vision,
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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 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 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 (25mg) 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 (25mg) of Sildenafil.

3. How to take 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.

4. Possible side effects

Pregnancy, breast-feeding and fertility
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.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended 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.
If you take more Sildenafil than you should
You may experience an increase in side effects and their
severity. Doses above 100mg 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.

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,
  ffects on vision (including colour tinge to vision,
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light sensitivity, blurred vision or reduced sharpness
of vision),
 stuffy nose,
 dizziness.
Uncommon side effects
(likely to occur in 1 to 10 patients in 1,000) 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.
Rare side effects
(likely to occur in 1 to 10 patients in 10,000) include:
 high blood pressure,
 low blood pressure,
 fainting,
 stroke,
 nosebleed,
 sudden decrease or loss of hearing,
 hypersensitivity reactions.

Additional side effects reported from post-marketing
experience include:
 sudden death,
 pounding heartbeat,
 chest pain,
  eart attack or temporary decreased blood flow to
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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 or
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.
Do not use this medicine after the expiry date which is
stated on the carton after 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 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.
Sildenafil 50mg: Each tablet contains 50mg of
sildenafil (as the citrate salt).
Sildenafil 100mg: Each tablet contains 100mg of
sildenafil (as the citrate salt).
The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose
sodium, dibasic calcium phosphate anhydrous,
hypromellose, sodium stearyl fumarate.
Film coat: hypromellose, titanium dioxide (E171),
triacetin, indigo carmine aluminium lake (E132).

What Sildenafil looks like and contents
of the pack
Sildenafil 50mg Film-coated tablets are blue, round
(diameter approx. 9.6 m), biconvex, film coated tablets,
debossed with ‘8’ Bisect ‘7’ on one side and plain on the
other side. The tablet can be divided into equal doses.
Sildenafil 100mg Film-coated tablets are blue, round
(diameter approx. 12.3 mm), biconvex, film coated
tablets, debossed with ‘8’ Bisect ‘8’ on one side and
plain on the other side. The tablet can be divided into
equal doses.
Pack size: 2, 4, 8 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aspen Pharma Trading Limited
12/13 Exchange Place
Custom House Dock
IFSC, Dublin 1
Ireland
Manufacturer
CEMELOG BRS Kft.
2040 Budaörs, Vasút u. 13
Hungary
For more information about this medicine contact:
Navamedic ASA,
Fornebuveien 42-44,
1325 Lysaker,
Norway.

This medicinal product is authorised in the
Member States of the EEA under the
following names:
Austria 
Sildenafil Aspen 50/100 mg
Filmtabletten
Belgium 
Sildenafil Aspen 50/100 mg
filmomhulde tabletten
Denmark
Sildenafil Aspen
Finland 
Sildenafil Aspen 50/100 mg tabletti,
kalvopäällysteinen
Luxembourg 
Sildenafil Aspen 50/100 mg comprimés
pelliculés
Ireland Sildenafil Aspen 50/100mg
film-coated tablets
Iceland 
Sildenafil Aspen 50/100 mg
filmuhúðaðar töflur
The Netherlands 
Sildenafil Aspen 50/100 mg
filmomhulde tabletten
Norway
Sildenafil Aspen
Poland
Sildenafil Aspen
SE 
Sildenafil Aspen 50/100 mg
filmdragerade tabletter
UK 
Sildenafil 50/100mg Film-coated Tablets
This leaflet was last revised in 06/2012.

Expand Transcript

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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