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SILDENAFIL MYLAN 100 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Package leaflet: Information for the patient

Children and adolescents

Sildenafil 25 mg
Film-coated Tablets
Sildenafil 50 mg
Film-coated Tablets
Sildenafil 100 mg
Film-coated Tablets

Sildenafil should not be given to individuals
under the age of 18.

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.

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.

FPO

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 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
Do not take Sildenafil

• 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 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:
• 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).
You should not take Sildenafil if you do not
have erectile dysfunction.
You should not take Sildenafil if you are
a woman.

Description Sildenafil Citrate 25/50/100mg 4

Other medicines and Sildenafil

Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

You should not take Sildenafil 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 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 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 medicines such as ketoconazole,
itraconazole, erythromycin and cimetidine
may increase the effect of sildenafil whereas
medicines such as rifampicin may reduce
its effect.
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. 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.
Your doctor may start you on a lower dose
(25 mg) of Sildenafil.
You should not use Sildenafil with any
other oral or local treatments for erectile
dysfunction including those known as
PDE5 inhibitors (such as tadalafil).
You should not use Sildenafil with
treatments for pulmonary arterial
hypertension (PAH) containing sildenafil
or bosentan.

Sildenafil with food, drink and alcohol

Sildenafil can be taken with or without food
(see section 3 “How to take Sildenafil”).
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.
You are advised not to drink grapefruit juice
while taking Sildenafil as it may increase the
effect of this medicine.

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.

3. How to take Sildenafil
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 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.

Date: 23 Mar 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 493497

SAP No. N/A

Colours

Superceded Affiliate Item Code 365711
TrackWise PR No. 493497
MA No.

33302/0019,
0020 & 0021

Vendor Job No. 236230
Trackwise Proof No. 2
Glams Proof No. UK

Packing Site/Printer N/A

Client Market N/A

Supplier Code TBC

Keyline/Drawing No. N/A
Barcode Info

FPO

(sildenafil)

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.

1

Time: 12:52
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 160 x 480 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

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.
FPO

If you take more Sildenafil 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
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 heartbeat.
• 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 had heart problems before
taking this medicine. It is not possible to
determine whether this was 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, 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 eyes 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),
presence of blood in urine, pain in the arms or
legs, nosebleed, feeling hot and feeling tired.
Rare (may affect up to 1 in 1,000 people):
• fainting, feeling of tightening of the throat,
numb mouth, double vision, swelling of
the eye or eyelid, reduced sharpness of
vision, abnormal sensation in the eye, 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, sudden decrease or 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 internet at
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.

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 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 protect the environment.

6. Contents of the pack and other
information
What Sildenafil 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 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 25 mg Film-Coated Tablets are
available in blister packs containing 1, 2, 4,
8 or 12 tablets.
Sildenafil 50 mg and 100 mg Film-Coated
Tablets are available in blister packs
containing 1, 2, 4, 8, 12, 24 or 36 tablets.
Some pack sizes may not be marketed.

Marketing Authorisation Holder
Mylan S.A.S.
117 Allée 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
March 2016

Description Sildenafil Citrate 25/50/100mg 4

Date: 23 Mar 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 493497

SAP No. N/A

Colours

Superceded Affiliate Item Code 365711
TrackWise PR No. 493497
MA No.

33302/0019,
0020 & 0021

Vendor Job No. 236230
Trackwise Proof No. 2
Glams Proof No. UK

Packing Site/Printer N/A

Client Market N/A

Supplier Code TBC

Keyline/Drawing No. N/A
Barcode Info

FPO

If you feel 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.

1

493497

Time: 12:52
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 160 x 480 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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