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SILDENAFIL MYLAN 25 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Package leaflet: Information for the patient

Sildenafil Mylan 25 mg
Film‑coated Tablets
Sildenafil Mylan 50 mg
Film‑coated Tablets
Sildenafil Mylan 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 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 Mylan is and what it is used
for
2. What you need to know before you take
Sildenafil Mylan
3. How to take Sildenafil Mylan
4. Possible side effects
5. How to store Sildenafil Mylan
6. Contents of the pack and other information

1. What Sildenafil Mylan is and
what it is used for
Sildenafil Mylan 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 Mylan
will only help you to get an erection if you
are sexually stimulated. You should not take
Sildenafil Mylan if you do not have erectile
dysfunction.
You should not take Sildenafil Mylan if you
are a woman.
Sildenafil Mylan is a treatment for adult 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 Mylan
Do not take Sildenafil Mylan

• 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 lead to
a dangerous fall 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 medicines
known as nitric oxide donors such as amyl
nitrite (“poppers”) as the combination may
also lead to a dangerous fall in your blood
pressure
• if you are taking riociguat. This medicine
is used to treat pulmonary arterial
hypertension (i.e. high blood pressure in
the lungs) and chronic thromboembolic
pulmonary hypertension (i.e. high
blood pressure in the lungs secondary
to blood clots). PDE5 inhibitors, such as
sildenafil have been shown to increase the
hypotensive effects of this medicine. If you
are taking riociguat or are unsure tell your
doctor.
• 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).

Warnings and precautions

Talk to your doctor or pharmacist before
taking Sildenafil Mylan:
• 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 Mylan and
contact your doctor immediately.

You should not use Sildenafil Mylan
with treatments for pulmonary arterial
hypertension (PAH) containing sildenafil or
any other PDE5 inhibitors.
You should not take Sildenafil Mylan if you
do not have erectile dysfunction.
You should not take Sildenafil Mylan if you
are a woman.

Children and adolescents

Sildenafil Mylan 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.

Other medicines and Sildenafil Mylan

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Sildenafil Mylan 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 Mylan and when you
did. Do not take Sildenafil Mylan with other
medicines unless your doctor tells you that
you can.
You should not take Sildenafil Mylan if
you are taking medicines called nitrates or
nicorandil (a nitrate like medicine) as the
combination of these products may lead
to a dangerous fall 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 Mylan 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 dangerous fall in your blood
pressure.
Tell your doctor or pharmacist if you are
already taking riociguat.
Some medicines such as ketoconazole,
itraconazole, erythromycin and cimetidine
may increase the effect of sildenafil.
Sildenafil may increase the effect of some
medicines such as bosentan (used to treat
increased blood pressure) whereas some
medicines such as rifampicin (an antibiotic)
may reduce the effect of sildenafil.
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 Mylan.
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 happen within 4 hours
after taking Sildenafil Mylan. To reduce the
chance that these symptoms might happen,
you should be on a regular daily dose of
your alpha-blocker before you start Sildenafil
Mylan. Your doctor may start you on a lower
dose (25 mg) of Sildenafil Mylan.
You should not use Sildenafil Mylan with
any other oral or local treatments for erectile
dysfunction, including those known as
PDE5 inhibitors (such as tadalafil).

Sildenafil Mylan with food and alcohol
Sildenafil Mylan can be taken with or
without food (see section 3 “How to take
Sildenafil Mylan”). However, you may find
that Sildenafil Mylan 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 Mylan.

Pregnancy, breast-feeding and fertility
Sildenafil Mylan is not indicated for use by
women.

Driving and using machines

Sildenafil Mylan can cause dizziness and can
affect vision. You should be aware of how
you react to Sildenafil Mylan before you
drive or use machinery.

3. How to take Sildenafil Mylan
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 50 mg.
You should not take Sildenafil Mylan more
than once a day.
You should take Sildenafil Mylan about one
hour before you plan to have sex. Swallow
the tablet whole with a glass of water.
If you feel that the effect of Sildenafil Mylan
is too strong or too weak, talk to your doctor
or pharmacist. Sildenafil Mylan will only help
you to get an erection if you are sexually

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stimulated. The amount of time Sildenafil
Mylan takes to work varies from person to
person, but it normally takes between half
an hour and one hour. You may find that
Sildenafil Mylan takes longer to work if you
take it with a heavy meal.
If Sildenafil Mylan 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 Mylan than
you should

You may experience an increase in side
effects and their severity such as headache,
facial flushing, dizziness, indigestion,
stuffy nose and effects on vision (including
light sensitivity, blurred vision or reduced
sharpness of vision). 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 a short
duration.

If you experience any of the following
serious side effects stop taking
Sildenafil Mylan and seek medical help
immediately:
Uncommon (may affect up to 1 in
100 people):
• An allergic reaction
Symptoms include sudden wheeziness,
difficulty in breathing or dizziness, swelling
of the eyelids, face, lips or throat.
• Chest pains
If this occurs during or after intercourse, get
in a semi-sitting position and try to relax.
Do not use nitrates to treat your chest pain.
Rare (may affect up to 1 in 1,000 people):
• Stroke or “mini‑stroke” (transient ischaemic
attack)
Symptoms include numbness or weakness
of the arms or legs, headache, dizziness
and confusion, visual disturbance, difficulty
swallowing, slurred speech and loss of
speech.
• Heart attack
Symptoms include crushing feeling in the
chest, chest pain that spreads to the jaw,
neck, arms and back, shortness of breath,
feeling weak and/or lightheaded, sweating,
weakness.
• A very fast or unusual heart beat.
• Prolonged and sometimes painful
erections
If you have an erection which lasts for more
than 4 hours, you should contact a doctor
immediately.
• Penile bleeding.
• A sudden decrease or loss of vision, which
may be due to bleeding at the back of the
eye, blockage of blood vessels in the eye
or increased pressure in the eye which
may lead to gradual loss of vision.
• Serious skin reactions
Symptoms may include severe peeling and
swelling of the skin, blistering of the mouth,
genitals and around the eyes, fever.
• Seizures or fits.
• Unstable angina (a heart condition) with
chest pain when resting.
Additional side effects reported from
post-marketing experience include sudden
death. Most, but not all, of the men who
experienced this side effect had heart
problems before taking this medicine. It is
not possible to determine whether these
events were directly related to sildenafil.

Other side effects reported:
Very common (may affect more than 1 in
10 people):
• headache.
Common (may affect up to 1 in 10 people):
• nausea (feeling sick), facial flushing, hot
flush (symptoms include a sudden feeling
of heat in your upper body), indigestion,
effects on vision (including colour tinge to
vision like blue vision, blurred vision, visual
disturbance) stuffy nose and dizziness.
Uncommon (may affect up to 1 in
100 people):
• vomiting, skin rash, bloodshot eyes/red
eyes, eye pain, seeing flashes of light,
visual brightness, light sensitivity, watery
eyes, itching of the eye and crusty
eyelids, dry eyes, pounding heartbeat,
rapid heartbeat, high blood pressure,
low blood pressure, muscle pain, feeling
sleepy, reduced sense of touch, vertigo,
ringing in the ears, dry mouth, blocked or
stuffy sinuses, inflammation of the lining
of the nose (symptoms include runny
nose, sneezing and stuffy nose), upper

abdominal pain, gastro-oesophageal
reflux disease (symptoms include
heartburn), pain in the arms or legs,
nosebleed, presence of blood in urine,
feeling hot and feeling tired.
Rare (may affect up to 1 in 1,000 people):
• fainting, temporary decreased blood flow
to parts of the brain, feeling of tightening
of the throat, numb mouth, bleeding at
the back of the eye, double vision, reduced
sharpness of vision, abnormal sensation in
the eye, swelling of the eye or eyelid, small
particles or spots in your vision, seeing
halos around lights, dilation of the pupil
of the eye, discolouration of the white of
the eye, eye irritation, presence of blood
in semen, dry nose, swelling of the inside
of the nose, feeling irritable and loss of
hearing.

Reporting of side effects

If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the national reporting system (see details
below). By reporting side effects you can
help provide more information on the safety
of this medicine.
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 16764971;
Fax: +353 16762517.
Website: www.hpra.ie;
e‑mail: medsafety@hpra.ie
United Kingdom:
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard

5. How to store Sildenafil Mylan
• 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 and
blister foil after EXP. The expiry date refers
to the last day of that month.
• This medicine 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 to protect the environment.

6. Contents of the pack and other
information
What Sildenafil Mylan contains

• The active substance is sildenafil. Each
tablet contains 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 Mylan 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.
The 100 mg tablets are blue film‑coated,
round biconvex tablets marked “M” on one
side and “SL over 100” on the other side.
Sildenafil Mylan 25 mg Film‑Coated Tablets
are available in blister packs containing 1, 2,
4, 8 or 12 tablets. Some pack sizes may not
be marketed.
Sildenafil Mylan 50 mg and 100 mg
Film‑Coated Tablets are available in
blister packs containing 1, 2, 4, 8, 12, 24 or
36 tablets.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Mylan S.A.S.
117 allee des Parcs,
69 800 Saint Priest,
France

Manufacturers

Gerard Laboratories
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13
Ireland
Mylan Hungary Kft.,
H‑2900 Komárom,
Mylan utca 1,
Hungary
This leaflet was last revised in July 2017.

1257032
4665.2001

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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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