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SILDENAFIL DR REDDYS 100 MG FILM-COATED TABLET

Active substance(s): SILDENAFIL CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Sildenafil 25 mg, 50 mg, 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, pharmacist or nurse.
- 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, pharmacist or nurse. 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 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 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
decrease 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).

Warnings and precautions

Talk to your doctor, pharmacist or
nurse 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
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.

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.

Children and adolescents

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

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, pharmacist or nurse
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, pharmacist or nurse
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 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.

Sildenafil with food and 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

If you have been told by your doctor
that you have an intolerance to
some sugars, such as lactose,
contact your doctor before taking
Sildenafil.

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 usual starting dose is 50 mg.
1. Swallow the tablet whole with a
glass of water.
2. You should not take Sildenafil
more than once a day
3. You should take Sildenafil
about one hour before you
plan to have sex.
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.
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.

Rare (may affect up to 1 in 1,000
people): fainting, stroke, heart
attack, irregular heartbeat,
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.

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

Reporting of side effects
If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. You
can also report side effects directly
via the Yellow Card Scheme
website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can
help provide more information on the
safety of this medicine.

4. Possible side effects

5. How to store Sildenafil

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:

Keep this medicine out of the sight
and reach of children.
This medicinal product does not
require any special storage
conditions.

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

Do not use this medicine after
the expiry date which is stated
on the carton and blister after
EXP. The expiry date refers to
the last day of that month.



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.

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.



Chest pains - this occurs
uncommonly. 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.

6. Contents of the pack
and other information



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) is 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,
bloodshot eyes/red eyes, eye
irritation, 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.

What Sildenafil contains

The active substance is Sildenafil
citrate.
Each 25 mg tablet contains 35.12
mg Sildenafil citrate equivalent to 25
mg Sildenafil.
Each 50 mg tablet contains 70.24
mg Sildenafil citrate equivalent to 50
mg Sildenafil.
Each 100 mg tablet contains
140.48mg Sildenafil citrate
equivalent to 100 mg Sildenafil.
The other ingredients are:
Tablet core: microcrystalline
cellulose, calcium hydrogen
phosphate dihydrate,
croscarmellose sodium, hydroxy
propyl cellulose, magnesium
stearate.
Tablet coating: hypromellose
(E464), lactose monohydrate,
triacetin (E1518), titanium dioxide
(E171), lake indigo carmine (E132).

What Sildenafil looks like and
contents of the pack

Each 25 mg tablet is a blue
coloured, round film-coated tablet
debossed with ‘SC’ on one side and
‘25’ on other side.
Each 50 mg tablet is a blue
coloured, round film-coated tablet
debossed with ‘SC’ on one side and
‘50’ on other side.
Each 100 mg tablet is a blue
coloured, round film-coated tablet
debossed with ‘SC’ on one side and
‘100’ on other side.
Tablets are packed in boxes of 2, 4,
8, 12 or 24 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley,
East Yorkshire, HU17 0LD,
United Kingdom.
This leaflet was last revised in
02/2015

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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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