Skip to Content

UK Edition. Click here for US version.

SILDENAFIL 25 MG FILM-COATED TABLETS

Active substance(s): SILDENAFIL CITRATE / SILDENAFIL CITRATE / SILDENAFIL CITRATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet:
Information for the user

Sildenafil 25 mg
film-coated tablets
Sildenafil 50 mg
film-coated tablets
Sildenafil 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 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 contains the
active substance sildenafil
which 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.
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 due to
non-arteritic anterior
ischaemic optic
neuropathy (NAION)

P151XXXXX

Warnings and
precautions
Talk to your doctor or
pharmacist before taking
Sildenafil.

Black

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.
You should not use Sildenafil with
treatments for pulmonary arterial
hypertension (PAH) containing
sildenafil or any other PDE5
inhibitors.
You should not take Sildenafil
if you do not have erectile
dysfunction.
You should not take Sildenafil if
you are a woman.
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.
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 your
doctor or pharmacist 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 medicines 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 patients who take alphablocker 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 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.
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.
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.
Sildenafil contains lactose
Sildenafil film-coated tablets
contain lactose monohydrate.
If you have been told by
your doctor that you have an
intolerance to some sugars, such
as lactose, contact your doctor
before taking this medicinal
product.
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.
Do not take Sildenafil film-coated
tablets in combination with
Sildenafil orodispersible tablets.
You should take Sildenafil about
one hour before you plan to have
sex. Swallow the tablet whole
with a glass of water.

If you feel 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 100 mg do not
increase the efficacy.

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, penile
bleeding, presence of blood in
semen,dry nose, swelling of the
inside of the nose, feeling irritable
and sudden decrease or loss of
hearing.
From post-marketing experience
cases of unstable angina (a heart
condition) and sudden death
have been reported rarely. Of
note, most, but not all, of the
men who experienced these side
effects had heart problems before
taking this medicine. It is not
possible to determine whether
these events were directly related
to Sildenafil.

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

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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can
help provide more information on
the safety of this medicine.

If you have any further
questions on the use of
this medicine, ask your
doctor or pharmacist.

Keep this medicine out of the
sight and reach of children.

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:

An allergic reaction
this occurs
uncommonly (may
affect up to 1 in 100
people)
Symptoms include
sudden wheeziness,
difficulty in breathing
or dizziness, swelling
of the   
eyelids,
face, lips or throat.

Chest pains
(this occurs
uncommonly)
If this occurs during
or after intercourse::
Get in a semisitting position
and try to relax
Do not use
nitrates to treat
your chest pain

Prolonged and
sometimes painful
erections -this occurs
rarely (may affect up
to 1 in 1,000 people)
If you have an
erection which lasts
for more than 4
hours, you should
contact a doctor
immediately.

A sudden decrease
or loss of vision - this
occurs rarely

Serious skin
reactions -this occurs
rarely
Symptoms may
include severe
peeling and swelling
of the skin, blistering
of the mouth, genitals
and around the eyes,
fever.

Seizures or fits- this
occurs rarely
Other side effects:
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, colour tinge
to vision, blurred vision,
visual disturbance, stuffy
nose and dizziness.
Uncommon (may affect
up to 1 in 100 people):
vomiting, skin rash,
eye irritation, bloodshot
eyes/red eyes, eye
pain,seeing flashes of
light, visual brightness,
light sensitivity, watery
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 1000 people):
fainting, stroke, heart
attack, irregular heartbeat,

How to store Sildenafil

This medicinal product does
not require any special storage
conditions
Do not use this medicine after
the expiry date which is stated on
the label, carton and blister after
EXP. The expiry date refers to
the last day of that month.
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 film-coated tablet contains
25 mg Sildenafil (as sildenafil
citrate).
Each film-coated tablet contains
50 mg Sildenafil (as sildenafil
citrate).
Each film-coated tablet contains
100 mg Sildenafil (as sildenafil
citrate).
The other ingredients are
Tablet core: Calcium hydrogen
phosphate anhydrous, cellulose
microcrystalline, croscarmellose
sodium, silica colloidal
anhydrous, magnesium stearate.
Tablet coat: Lactose
monohydrate, hypromellose
15cP, titanium dioxide (E171),
triacetin
What Sildenafil looks like and
contents of the pack
Film-coated tablet
Sildenafil 25 mg film-coated
tablets
White to off-white, round (7.1 mm
diameter), biconvex film-coated
tablets debossed with “SL” on
one side and 25 on the other
side.
Sildenafil 50 mg film-coated
tablets
White to off-white, round (9.6 mm
diameter), biconvex film-coated
tablets debossed with “SL” on
one side and 50 on the other
side.
Sildenafil 100 mg film-coated
tablets
White to off-white, round
(11.2 mm diameter), biconvex
film-coated tablets debossed with
“SL” on one side and 100 on the
other side.
Sildenafil film-coated tablets are
available in clear PVC/PVdCAluminium foil blisters and HDPE
bottle packs.
Blister pack:
25 mg: 2, 4, 8 & 12 film-coated
tablets
50 mg & 100 mg: 1, 2, 4, 8 & 12
film-coated tablets
HDPE pack:
50 mg: 30, 1000 film-coated
tablets
100 mg: 30, 500 film-coated
tablets
Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business
Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta)
Limited
HF26, Hal Far Industrial Estate,
Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business
Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in
11/2016.

P151XXXXX

4.

5.

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.

Hide