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SILDENAFIL ACCORD 100MG FILM COATED TABLETS

Active substance(s): SILDENAFIL CITRATE

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Sildenafil 25 / 50 / 100 mg

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

8 (Page 1 of 2) (IB005)

Date

31/07/14 (Sildenafil (ACC-UK)IB005-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

tablets with other medicines unless your doctor
tells you that you can.
PACKAGE LEAFLET: INFORMATION FOR THE
USER

Sildenafil Accord 25mg
Film coated Tablets
Sildenafil Accord 50 mg
Film coated Tablets
Sildenafil Accord 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, please 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 are Sildenafil tablets and what are they
used for
2. What you need to know before you take
Sildenafil tablets
3. How to take Sildenafil tablets
4. Possible side effects
5. How to store Sildenafil tablets
6. Contents of the pack and other information

1. What are Sildenafil Tablets
and what are they used for
Sildenafil tablets 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 tablets will only help you to get an
erection if you are sexually stimulated.
Sildenafil tablets are used to treat 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
Tablets
Do not take Sildenafil tablets
− If you are taking medicines called nitrates, as
the combination may cause a potentially
dangerous decrease 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 drugs known as
nitric oxide donors such as amyl nitrite
(“poppers”), as the combination may also lead
to a potentially dangerous decrease in your
blood pressure.
− If you are allergic (hypersensitive) to sildenafil
or any of the other ingredients of Sildenafil
tablets (see section 6).
− 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
Tell your doctor
− If you suffer from sickle cell anaemia (an
abnormality of red blood cells), leukaemia
(cancer of blood cells) and multiple myeloma
(cancer of bone marrow).
− If you suffer from deformity of your penis or
Peyronie’s Disease.
− If you suffer from heart problems. Your doctor
should in that case carefully check whether
your heart can take the additional strain of
having sex.
− If you are suffering from stomach ulcer, or a
bleeding problems (such as haemophilia).
− If you experience sudden decrease or loss of
vision, stop taking Sildenafil tablets and contact
your doctor immediately.
You should not use Sildenafil tablets 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
women.
Special considerations for patients with kidney or
liver problems
If you suffer from kidney or liver problems. Your
doctor may decide on a lower dose for you.
Children and adolescents
Sildenafil tablets should not be given to
individuals under the age of 18.
Other medicines and Sildenafil tablets:
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
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 health care professional treating
your condition that you have taken Sildenafil
tablets and when you did. Do not take Sildenafil

You should not take Sildenafil tablets if you are
taking medicines called nitrates, as the
combination of these products may cause a
potentially dangerous decrease 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 tablets if you are
using any of the drugs known as nitric oxide
donors such as amyl nitrite (“poppers”) as the
combination may also lead to a potentially
dangerous decrease 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 tablets.
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 tablets with
alpha-blockers. This is most likely to occur within
4 hours after taking Sildenafil tablets. In order to
reduce the likelihood that these symptoms occur,
you should be on a regular daily dose of your
alpha-blocker before you start Sildenafil tablets.
Your doctor may start you on a lower dose (25
mg) of Sildenafil tablets.
Taking Sildenafil tablets with food and drink
Sildenafil tablets can be taken with or without
food. However, you may find that Sildenafil
tablets 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 tablets.
Pregnancy, Breast feeding and fertility
Sildenafil tablets are not indicated for use by
women.
Driving and using machines
Sildenafil tablets can cause dizziness and can
affect vision. You should be aware of how you
react to Sildenafil tablets before you drive or use
machinery.
Important information about some of the
ingredients of Sildenafil tablets
Sildenafil tablets contain lactose monohydrate.
If you have been told by your doctor that you
have intolerance to some sugars, then contact
your doctor before taking Sildenafil tablets.

3. How to take Sildenafil Tablets
Always take Sildenafil tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure. The
usual starting dose is 50 mg.
You should not take Sildenafil tablets more
than once a day.
You should take Sildenafil tablets about one hour
before you plan to have sex Swallow the tablet
whole with a glass of water.
If you have the impression that the effect of
Sildenafil tablets is too strong or too weak, talk to
your doctor or pharmacist.
Sildenafil tablets will only help you to get an
erection if you are sexually stimulated. The
amount of time Sildenafil tablets takes to work
varies from person to person, but it normally
takes between half an hour to one hour. You may
find that Sildenafil tablets takes longer to work if
you take it with a heavy meal.
If Sildenafil tablets do 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 tablets than you
should
If you or someone else swallows several of these
tablets all together, or you think a child has
swallowed any of these tablets, contact your
doctor or pharmacist or hospital emergency
department immediately. Always take any tablets
left over with you, also the box and leaflet as this
will allow easier identification of the tablets.
You may experience an increase in side effects
and their severity. Doses above 100 mg do not
increase the efficacy.
If you have any further questions on the use
of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Sildenafil tablets can cause
side effects although not everybody gets them.
The side effects reported in association with the
use of Sildenafil tablets are usually mild to
moderate and of a short duration.
If you have chest pains during or after
intercourse:
- Get in a semi-sitting position and try to relax
- Do not use nitrates to treat your chest pain
- Contact your doctor immediately
All medicines including Sildenafil tablets can
cause allergic reactions. You should contact your
doctor immediately if you experience any of the
following symptoms after taking Sildenafil tablets:

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Sildenafil 25 / 50 / 100 mg

Market

UK

Language

English

Size

170 x 550 mm (PIL)

Min. Font Size

9

Version No.

8 (Page 2 of 2) (IB005)

Date

31/07/14 (Sildenafil (ACC-UK)IB005-PIL)

Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

• sudden wheeziness,
• difficulty in breathing or dizziness,
• swelling of the eyelids,face, lips or throat.
Prolonged and sometimes painful erections have
been reported after taking Sildenafil tablets. If
you have an erection which lasts for more than 4
hours, you should contact a doctor immediately.
Cases of convulsions or seizures and serious
skin reactions characterised by rash, blisters,
peeling skin and pain which require immediate
medical attention have also been reported.
If you experience a sudden decrease or loss of
vision, stop taking Sildenafil tablets and contact
your doctor immediately.
The frequency of possible side effects listed
below is defined using the following convention:
very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from
the available data).
Very common side effect
• headache
Common side effects include:
• facial flushing
• Hot flush (symptoms include a sudden feeling
of heat in your upper body)
• Nausea
• indigestion
• visual disturbances (includes colour tinge to
vision, light sensitivity, blurred vision or
reduced sharpness of vision)
• stuffy nose
• dizziness
Uncommon side effects include:




























vomiting
skin rash
eye irritation
bloodshot eyes /red eyes
eye pain
seeing flashes of light
visual brightness
light sensitivity
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 linning of the nose
upper abdominal pain
gastro-oesophageal reflux disease
feeling tired
feeling hot
pain in arms or legs
nose bleed
presence of blood in urine
watery eyes

Rare side effects include:























heart attack
irregular heartbeat
fainting
stroke
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
sudden decrease or loss of hearing

Additional side effects reported from
post-marketing experience include:
• unstable angina (a heart condition)
• sudden death
Most, but not all, of these men had heart
problems before taking this medicine. It is not
possible to determine whether these events were
directly related to Sildenafil tablets.
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 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
Tablets
Keep this medicine out of the sight and reach of
children.
This medicinal product does not require any
special storage conditions.
Do not use Sildenafil tablets after the expiry date
which is stated on the carton label and blister foil
after ‘EXP’. The expiry date refers to the last day
of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Approved By
Quality Assurance

6. Contents of the pack and
other information
What Sildenafil Tablet contains
The active substance is Sildenafil. Each tablet
contains 25mg, 50mg or 100mg of sildenafil as
sildenafil citrate
The Other ingredients are:
- Tablet core: cellulose microcrystalline, calcium
hydrogen phosphate anhydrous,
croscarmellose sodium, hypromellose 5cp
(E464), magnesium stearate
- Film coat hypromellose 15cp (E464), titanium
dioxide(E171), lactose monohydrate, triacetin,
indigo carmine aluminium lake (E132) (see
section 2 for Important information about some
of the ingredients Sildenafil Tablets)
What Sildenafil Tablets look like and contents
of the pack
Sildenafil Tablets 25 mg are Blue, almond
shaped, biconvex, film coated, debossed with ‘25’
on one side and plain on other side.
Sildenafil Tablets 50 mg are Blue, almond
shaped, biconvex, film coated, debossed with ‘50’
on one side and plain on other side.
Sildenafil Tablets 100 mg are Blue, almond
shaped, biconvex, film coated, debossed with
‘100’ on one side and plain on other side.
Sildenafil Tablets are available in blister packs of
2, 4, 8 or 12 tablets.
(Not all pack sizes may be marketed).
Marketing Authorisation Holder
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
or
Cemelog-BRS Ltd., H-2040 Budaors, Vasut u.
13, Hungary
This leaflet was last revised in 07/2014

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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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