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SULINDAC TABLETS BP 200MG

Active substance(s): SULINDAC

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Sulindac
#200 mg
Tablets

Sulindac
#200 mg
Tablets

22

200 Sulindac 200 mg
mg Tablets (sulindac)

200 Sulindac 200 mg
mg Tablets (sulindac)

56 tablets

56 tablets

Each tablet contains: 200 mg sulindac
Contains: lactose. See leaflet for further
information. For oral use as directed by the doctor.
Read the package leaflet before use. Keep out of
the sight and reach of children. Store below
25ºC. Store in the original package in
order to protect from light and moisture.
PL 04569/0188  POM
318596
Mylan, Potters Bar, Herts, EN6 1TL, UK.

Each tablet contains: 200 mg sulindac
Contains: lactose. See leaflet for further
information. For oral use as directed by the doctor.
Read the package leaflet before use. Keep out of
the sight and reach of children. Store below
25ºC. Store in the original package in
order to protect from light and moisture.
PL 04569/0188  POM
318596
Mylan, Potters Bar, Herts, EN6 1TL, UK.

TBC

• 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 Sulindac is and what it is used for
2. What you need to know before you take Sulindac
3. How to take Sulindac
4. Possible side effects
5. How to store Sulindac
6. Contents of the pack and other information
1. What Sulindac is and what it is used for
Sulindac belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs). It is
a painkiller and antipyretic (reduces fever). Sulindac
works by reducing inflammation and relieving pain,
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Other less common side effects are:
• liver problems which may cause dark urine, pale stools
• severe stomach upset (gastritis)
• change in urinary function such as difficulty or pain
in passing urine, blood, protein or crystals forming
in the urine, change in urine colour
• swollen ankles and breathlessness, a racing or
irregular heart beat
• vaginal bleeding, swollen breasts (in men)
• vertigo, feeling drowsy or tired, sleeplessness
• tingling or numbness in the arms and legs
• headache, fainting,
• feeling dizzy, nervous, confused, depressed, weak or
generally unwell
• hallucinating, ringing in the ears
• aggressive or abnormal behaviour, mood changes,

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6. Contents of the pack and other
information
What Sulindac contains
The active substance is sulindac. Each tablet contains
100 mg or 200 mg of sulindac.
The other ingredients are lactose (see section 2,
‘Sulindac contains lactose’), microcrystalline cellulose,
povidone, sodium starch glycolate, magnesium
stearate, talc and quinoline yellow (E104).
What Sulindac looks like and contents of the pack
Your medicine comes as orange-yellow tablets. The
100 mg tablets are marked ‘SD/100’ on one side and ‘α’
on the other. The 200 mg tablets are marked ‘SD/200’
on one side and ‘α’ on the other.
Sulindac is available in plastic bottles or blister packs
of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50 (bottles only),

• have any problems with your stomach or bowel e.g.
ulcerative colitis, Crohn’s disease
• have had bleeding problems
• have a history of high blood pressure and/or
shortness of breath and swelling of the feet or legs
due to fluid build up
• have problems with your heart, liver or kidneys;
your doctor will monitor your kidney function
regularly
• have a collagen vascular disease e.g. lupus (SLE).
Please note:
Medicines such as Sulindac may be associated with
a small increased risk of heart attack (“myocardial
infarction”) or stroke. Any risk is more likely with high
doses and prolonged treatment. Do not exceed the
recommended dose or duration of treatment.

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TBC

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 Sulindac
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which
is shown on the label or carton. The expiry date refers
to the last day of that month.
Store below 25°C. Store in the original package in
order to protect from light and moisture.
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.

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If you have heart problems, previous stroke or think
that you might be at risk of these conditions (for
example if you have high blood pressure, diabetes or
high cholesterol or are a smoker) you should discuss
your treatment with your doctor or pharmacist.
Discuss your treatment with the doctor before
taking Sulindac:
• if you have heart problems including heart failure,
angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease
(poor circulation in the legs or feet due to narrow
or blocked arteries), or any kind of stroke (including
‘mini-stroke’ or transient ischaemic attack 'TIA')
• if you have high blood pressure, diabetes, high
cholesterol, have a family history of heart disease or
stroke, or if you are a smoker.

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• medicines to treat depression called selective
serotonin reuptake inhibitors (SSRIs) such as
fluoxetine, citalopram
• probenecid, for gout, as the dose of Sulindac you
will need will be lower than usual
• 
antibiotics to treat infection e.g. ofloxacin, as side effects
may occur if some antibiotics are taken with Sulindac
• corticosteroids such as prednisolone
• immunosuppressants such as ciclosporin, tacrolimus
• mifepristone (taken in the last 12 days)
• dimethyl sulfoxide, which may also be an ingredient
in some medicines
• zidovudine to treat HIV infection
Pregnancy, breast-feeding and fertility
Sulindac should not be taken in the last three months
of pregnancy as it can affect the growth of your
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56, 60, 84, 90, 100, 112, 120, 168, 180, 200 (bottles
only) and 500 (bottles only) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire EN6 1TL, United
Kingdom
Manufacturers:
Generics (UK) Limited, Potters Bar, Hertfordshire
EN6 1TL, United Kingdom
Gerard Laboratories, 35-36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
This leaflet was last revised in 09/2014.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Side
effects are more likely in older patients.
If any of the following happen, stop taking Sulindac
and tell your doctor immediately or go to your
nearest hospital emergency department:
• if you have severe stomach pain
• if you pass blood in your faeces (stools/motions)
• if you pass black, tarry stools
• if you vomit any blood or dark particles that look
like coffee grounds
• if you have an allergic reaction causing difficulty in
breathing, tightness of the chest, swelling of the
face, throat or tongue, nose bleeds, sore, dry or itchy
skin

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feeling and being sick, diarrhoea, feeling disorientated
or highly excited, ringing in the ear, fits, fainting and a
reduction in urine output.
If you forget to take Sulindac
Take it as soon as you remember unless it is almost
time for your next dose. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Sulindac
Do not stop taking Sulindac without talking to your
doctor, even if you feel better. It is important that you
take the full course of your treatment prescribed by
your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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swelling and stiffness in the joints and muscles. There
are a number of painful conditions that can affect
your joints and muscles, which can be helped by
taking Sulindac. These conditions include:
• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis (arthritis in the spine)
• Gout
• Musculo-skeletal disorders such as sprains, strains
and other injuries.
2. What you need to know before you take
Sulindac
Do not take Sulindac if you
• are allergic to sulindac or any of the other
ingredients of this medicine (listed in section 6)
• have taken an NSAID in the past (e.g. ibuprofen,

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SAP No. N/A

Superceded Affiliate Item Code 10004854
TrackWise PR No. N/A
MA No. 04569/0188
Packing Site/Printer TBC
Supplier Code TBC
Sign-offs

sweating
• loss of hearing, hair loss
• bitter or metallic taste in the mouth
• raised blood pressure
• high levels of potassium or glucose in the blood
• rarely, swollen red sore skin (vasculitis)
• changes in your eye sight; Tell your doctor if you
suffer from loss of vision or blurred vision. You may
need an eye examination.
Patients on medicine to thin the blood e.g. warfarin,
may need their dose adjusted.
Reporting of side effects.
If you get any side effects, talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.

• if you have severe skin reactions causing rash, red
patches or blistering of the skin, mouth, eyes or
genitals
• if you notice sensitivity of the skin to sunlight, red
spots or rash on the skin or unusual bruising or
bleeding of the skin
• if your skin or the whites of your eyes become yellow
• if you have severe upper stomach pain often with
feeling or being sick (signs of inflammation of the
pancreas)
• if you have fits
• if you are feeling unusually tired and pale, feverish, have
a sore throat, suffer from more infections than usual
Stop taking the medicine and tell your doctor if you
experience:
• indigestion or heartburn

Your doctor will want to ensure that you take the
lowest necessary dose of Sulindac for the shortest
period necessary.
Other medicines and Sulindac
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines:
• anticoagulants to thin your blood, such as warfarin;
as the level of all the medicine in your blood may
increase when you start taking Sulindac
• diuretics (water tablets), as these may not work as
well when you start taking Sulindac
• medicines to lower your blood pressure or to treat a
heart condition e.g. digoxin
• lithium to treat mental illness or methotrexate, for
psoriasis, as your body may not be able to clear
these as quickly when you start taking Sulindac

Sulindac 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 this medicine.
3. How to take Sulindac
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the tablets with a glass of water, with or after
food.
The tablet can be divided into equal doses.
Adults
The recommended dose is up to 400 mg a day,
divided into two doses. The length of treatment for
gout is usually 7 days and for joint swelling and pain,

treatment should be no longer than 10 days.
Older people
If you are an older person the dose you take will be
similar to other adults but should be the lowest dose
that is effective. If you notice any signs of bleeding in
your stomach or gut (e.g. black, tarry stools or if you
vomit blood) stop taking Sulindac and tell your doctor
straight away.
Use in children
Sulindac should not be given to children.
If you take more Sulindac than you should
Contact your doctor or nearest hospital emergency
department immediately. Take the container and any
remaining tablets with you. Symptoms of overdose
include drowsiness, dizziness, heartburn, indigestion,

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Vendor Job No. 218554
Proof No. 3
Client Market UK
Keyline/Drawing No. N/A
Barcode Info 5016695710082

Colours
Non-Print
Colours

Time: 08:55

1

Page Count
Black

PMS
306

Keyline

Braille

PMS
486

1/1

PMS
Reflex Blue

Equate CMYK
with
Main Font Myriad Pro
Dimensions 101 x 52mm

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8

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unborn baby and may also affect your labour. If you
are trying to get pregnant, Sulindac may make it more
difficult to become pregnant. You should inform your
doctor if you are planning to become pregnant or if
you have problems becoming pregnant.
Do not breast-feed your baby, as small amounts of
sulindac can pass into breast milk.
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby ask your
doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Do not drive or use machinery if you suffer from side
effects such as dizziness, drowsiness, fatigue and
visual disturbances.

No. of colours

Affiliate Item Code 318596

(sulindac)

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.

5

• abdominal pain (pains in your stomach) or other
abnormal stomach symptoms.
Medicines such as Sulindac may be associated with
a small increased risk of heart attack ('myocardial
infarction') or stroke.
There have been reports of patients suffering from
a mild form of meningitis (causing headache, a stiff
neck, fever, confusion, feeling or being sick). This
is more likely in patients with a collagen vascular
disease such as lupus (SLE).
The most commonly seen side effects affect the stomach
or gut and they include feeling or being sick, loss of
appetite, diarrhoea, wind, constipation, stomach cramps
or pain, indigestion, mouth ulcers, a sore swollen mouth
and worsening of symptoms in patients with ulcerative
colitis, Crohn’s disease or other gut disorder.

Date: 10 Sep 2014
Pharma Code TBC

Sulindac 100 mg and 200 mg
Tablets

aspirin) and suffered an allergic reaction or had
problems such as bleeding or ulcers
• have a stomach or gut ulcer, bleeding in your
stomach or know that you have suffered with ulcers,
stomach bleeding or perforation in the past
• have severe heart failure
• have severe liver or kidney problems
• are already taking an NSAID eg. celecoxib,
etoricoxib, naproxen
• are in the last three months of pregnancy (please
read the ‘Pregnancy and breast-feeding’ section of
this leaflet).
Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you:
• suffer from or have a history of asthma

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Component Type Leaflet

Package leaflet: Information for the patient

21

13

Description Sulindac 200mg 56

2

Body Text Size 7pt

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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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