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SILDENAFIL DR REDDYS 25 MG FILM-COATED TABLET

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

You should not use Sildenafil with
treatments for pulmonary arterial
hypertension (PAH) containing sildenafil or
any other PDE5 inhibitors.

1. What Sildenafil is and what it
is used for

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.

Sildenafil contains the active substance
sildenafil which belongs to a group of
medicines called phosphodiesterase type 5
(PDE5) 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 setion 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 drug 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 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 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.

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.
Tell your doctor or pharmacist if you are
already taking riociguat.
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 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 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 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.
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, pharmacist
or nurse.

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:


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 semi-sitting 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 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.

Reporting of side effects

If you get any side effects, talk to your
doctor or 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.

5. How to store Sildenafil
Keep this medicine out of the sight and
reach of children.
This medicinal product does not require any
special storage conditions.
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.
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 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 09/2016

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.

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