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SILDENAFIL MYLAN 25 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Sildenafil 25 mg
Film-Coated Tablets
Sildenafil 50 mg
Film-Coated Tablets
Sildenafil 100 mg
Film-Coated Tablets
sildenafil

FPO

Read all of this leaflet carefully before
you start taking this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Sildenafil is and what it is used for
2. Before you take Sildenafil
3. How to take Sildenafil
4. Possible side effects
5. How to store Sildenafil
6. Further 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. 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 (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 because
of non-arteritic anterior ischaemic optic
neuropathy (NAION)
Take special care with Sildenafil
Tell your doctor
• 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 treatments for erectile dysfunction.
Special considerations for children and
adolescents
Sildenafil should not be given to individuals
under the age of 18.

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.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken 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 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 (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.
Taking 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.
You should not use Sildenafil more than
once a day.

FPO

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

If any of the following happen, do not
take more Sildenafil. Tell your doctor
immediately or go to the casualty
department at your nearest hospital:
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.
If you experience a stroke, stop taking
Sildenafil and seek medical attention
immediately.
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
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.

5. HOW TO STORE SILDENAFIL
• Keep out of the reach and sight of
children.
• This medicine does not require any special
storage conditions.
• Do not use Sildenafil after the expiry date
which is stated on the carton and blister
foil. The expiry date refers to the last day
of the month.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Sildenafil contains
• The active substance is sildenafil. Each
tablet contain 25 mg, 50 mg or 100 mg of
sildenafil (as sildenafil citrate)
• The other ingredients are:
- Tablet Core - Cellulose
Microcrystalline, Calcium Hydrogen
Phosphate Anhydrous, Croscarmellose
Sodium, Magnesium Stearate
- Film Coating - Hypromellose (E464),
Titanium Dioxide (E171), Indigo
Carmine Aluminium Lake (E132),
Triacetin
What Sildenafil looks like and contents of
the pack
The 25 mg tablets are blue film-coated,
round biconvex tablets marked 'M' on one
side and 'SL over 25' on the other side.
The 50 mg tablets are blue film-coated,
round biconvex tablets marked 'M' on one
side and 'SL over 50' on the other side.

If you experience a sudden decrease or loss
of vision, stop taking Sildenafil and contact
your doctor immediately.

The 100 mg tablets are blue film-coated,
round biconvex tablets marked 'M' on one
side and 'SL over 100' on the other side.

Additional side effects reported from
post-marketing experience include:
Sudden death, temporary decreased blood
flow to parts of the brain or heart attack.
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.

The tablets are provided in blister packs
containing 1, 2, 4, 8 or 12 tablets. Some pack
sizes may not be marketed.

Other side effects reported:
Very common side effects (likely to occur
in more than 1 in 10 patients):
• headache
Common side effects (likely to occur in 1 to
10 patients in 100):
• facial flushing, indigestion, effects on
vision (including colour tinge to vision,
light sensitivity, blurred vision or reduced
sharpness of vision) stuffy nose and
dizziness.

Marketing Authorisation Holder
Mylan S.A.S.
117 Allée des Parcs,
69 800 Saint-Priest,
France
Manufacturers
McDermott Laboratories Limited t/a Gerard
Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13
Ireland
Mylan Hungary Kft.,
H‑2900 Komárom, Mylan utca 1,
Hungary

Uncommon side effects (likely to occur in
1 to 10 patients in 1000):
• 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.

FPO

FPO

Like all medicines, Sildenafil 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.

Also you can help to make sure that
medicines remain as safe as possible by
reporting any unwanted side effects via the
internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone
0808 100 3352 (available from 10 a.m. to
2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

Rare side effects (likely to occur in 1 to
10 patients in 10000):
• high blood pressure, low blood pressure,
fainting, nosebleed and sudden decrease
or loss of hearing.
Not known (frequency cannot be estimated
from the available data):
• pounding heartbeat.
If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet please tell your doctor.

This leaflet was last revised
in September 2013.

10005368

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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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