SULINDAC 200 MG TABLETS

Active substance: SULINDAC

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Sulindac 100 mg and 200 mg Tablets

If you take more than you should
If you take too many tablets by mistake, talk to your doctor
straight away.

Sulindac

F684

120-121/L/e/1

Read all of this leaflet carefully before you start using this medicine.

iKeep this leaflet. You may need to read it again.
iIf you have any further questions, ask your doctor or pharmacist.
iThis medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
iIf any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1 What this medicine is and what it is
used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1. What this medicine is and what it is
used for
Sulindac tablets contain a medicine called sulindac. This
belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). NSAIDs work by stopping the
production of chemicals found naturally in the body called
'prostaglandins'. Prostaglandins cause swelling, redness and
pain in some illnesses.
Sulindac is used for:
irheumatoid arthritis, caused by your immune system
attacking your joints
iosteoarthritis, caused by wear and tear of your joints
iacute gouty arthritis, caused by gout
iarthritis of the spine
ibursitis, swelling near one of your joints due to a build up
of fluid
itendinitis or tenosynovitis, pain and swelling of your
tendons.
Ask your doctor to explain why you have been given Sulindac
tablets if you are unsure.

2. Before you take
Do not take Sulindac tablets if:
iyou are allergic (hypersensitive) to sulindac or any of the
other ingredients of this medicine (listed in Section 6)
iyou are in the last three months of pregnancy (see
'Pregnancy and breast-feeding' for further information)
iyou have ever had a bad reaction to other non-steroidal
anti-inflammatory drugs (NSAIDs), such as ibuprofen or
aspirin
iyou have ever had an ulcer in your stomach or intestine
iyou have ever had bleeding from your intestine. Signs of
this may have included pain in or around your stomach
area (abdominal pain), vomiting blood, and black tarry
stools or blood in your stools
iyou have liver problems
iyou have severe heart problems or severe kidney
problems.
Do not take Sulindac tablets if any of the above apply to you.
If you are not sure talk to your doctor or pharmacist before
taking the tablets.
Sulindac should not be given to children.
Take special care with Sulindac tablets
Check with your doctor or pharmacist before taking the
tablets if:
iyou already take other medicines called NSAIDs or
cyclooxygenase (COX II) inhibitors
iyou have a history of ulcers, bleeding from your stomach
or intestine, or other stomach disorders, Crohn's disease
or ulcerative colitis (inflammation of the colon), although
at this time you are not ill with any of these
iyou have ever had liver or kidney problems, including
kidney stones. Your doctor may check your kidney or
liver function before and during treatment
iyou have ever had blood-clotting problems
iyou are being treated for an infection
iyou are elderly or have a heart problem
iyou have high blood pressure or have ever had fluid
retention
iyou have diabetes
iyou have any allergies
iyou have ever had asthma, as taking NSAIDs can make
your asthma worse
iyou have Systemic Lupus Erythematosus (Lupus) or
something called a 'mixed connective tissue disorder'.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Sulindac.
You should stop taking Sulindac immediately and tell your
doctor if you notice any serious side effects (see Section 4)
including:
isigns of an allergic reaction such as fever, rash, blistering
or peeling of the skin, mouth, eyes or genitals, swelling of
the face, wheezing or difficulty breathing
istomach pain or any sign of bleeding in the stomach or
intestines such as passing blood or black tarry stools, or
vomiting blood.
Sulindac and your risk of stroke or heart attack
Medicines such as Sulindac may cause a small increase in
your risk of heart attack (myocardial infarction) or stroke. This
is more likely with high doses and/or if you take the medicine
for a long time. Do not exceed the recommended dose or
length of treatment.

If you forget to take
iIf you miss a dose, skip the missed dose.
iTake the next dose at the usual time.
iDo not take an extra dose to make up for a forgotten dose.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects

If you have heart problems, have ever had a stroke or think
that you might be at risk of these (for example if you have
high blood pressure, diabetes or high cholesterol or are a
smoker) you should talk to your doctor or pharmacist.

Like all medicines, Sulindac tablets may cause side effects,
although not everybody gets them. The following side effects
may happen with this medicine. These may disappear if your
dose is reduced.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines.
Do not take Sulindac if you have ever had a bad reaction to
other non-steroidal anti-inflammatory drugs (NSAIDs), such
as ibuprofen or aspirin. Signs of this may have been
breathing problems, swelling, skin rashes (which looked like
nettle-rash), or a runny nose.
Also tell your doctor or pharmacist if you are taking any of the
following medicines:
iother NSAIDs including diflunisal and cyclooxygenase
(COX 2) inhibitors (such as etoricoxib or celecoxib)
idimethyl sulphoxide, used to treat cold sores, genital
herpes, shingles, chicken pox, and inflammation of the
bladder
imedicines such as anti-platelet agents and
anticoagulants, used to thin the blood (e.g. warfarin,
aspirin, clopidogrel)
imedicines for diabetes that decrease blood sugar levels
(e.g. glipizide and glibenclamide)
iaspirin or medicines that contain aspirin
iprobenecid used for gout
idiuretics (water tablets), e.g. furosemide, spironolactone
or medicines used for high blood pressure
(antihypertensives), e.g. atenolol, ramipril, valsartan
imethotrexate, used for some types of cancer, severe skin
problems, and rheumatoid arthritis
iciclosporin, used after organ or bone marrow transplants
and for severe skin disease, or rheumatoid arthritis
ilithium, used for mental disorders
imedicines like digoxin, used to treat heart failure and
irregular heart beat
icorticosteroids used for anti-inflammatory and
replacement therapies (such as prednisolone or
dexamethasone)
imifepristone, used in emergency for termination of
pregnancy
iantibiotics called 'quinolones', such as ciprofloxacin and
norfloxacin
iantidepressants called selective serotonin re-uptake
inhibitors (SSRIs), (e.g. paroxetine)
itacrolimus, used after skin or organ transplants
izidovudine, a medicine used for HIV.
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before taking Sulindac tablets.

Stop taking the tablets and see a doctor straight away, if
you notice any of the following serious side effects:
iallergic reaction - the signs may include:
- high temperature
- fever, chills, sudden difficulty in breathing and
swallowing, swollen lips, face, tongue and throat
- rash, serious skin reactions, including blistering or
peeling of the skin, mouth, eyes or genitals, giant
wheals, itching, a serious skin reaction called
'Stevens-Johnson syndrome' and swollen glands
ipassing blood in your stools (faeces) or passing black
tarry stools
ivomiting any blood or dark particles that look like coffee
grounds
ipains in or around your stomach (stomach or abdominal
pain)
iheartburn or indigestion
iinflammation of membranes of your brain and spine.
Signs of this may be stiff neck, headache, nausea, being
sick, high temperature (fever) or feeling confused.

Pregnancy and breast-feeding
Do not take Sulindac if you are in the last three months of
pregnancy. Talk to your doctor or pharmacist before taking
Sulindac if you are breast-feeding, or if you are pregnant and
in the first six months of pregnancy.
Sulindac may make it more difficult to become pregnant. Talk
to your doctor if you are planning to become pregnant or if
you have any problems becoming pregnant.
Driving and using machines
Sulindac can make you feel dizzy, tired, or sleepy and cause
changes in your eyesight. If any of these things happen to
you, do not drive or use tools or machines.
Eye checks while you are taking Sulindac
Your doctor may want to examine your eyes from time to time
during your treatment with Sulindac. Talk to your doctor if you
notice any change in your vision.

3. How to take
Always take Sulindac tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you
are not sure.
Taking this medicine
iTake Sulindac by mouth. It is best to take it with or just after
food.
Swallow the tablets whole with a full glass of water.
iThe number of tablets you take each day will depend upon
your condition.
Adults
iThe usual dose is 200 mg twice a day.
iThe dosage may be reduced, depending on your
response.
iDoses above 400 mg a day are not recommended.
iFor arthritis caused by gout (gouty arthritis) Sulindac is
usually taken for 7 days.
iFor inflammation of your tendons (tendinitis,
tenosynovitis) Sulindac should not be taken for longer
than 10 days.
Children
Children should not take Sulindac tablets.
Continued over page

Other side effects
Frequently reported side effects
istomach or abdominal pain, indigestion, feeling sick
(nausea), being sick (vomiting)
idiarrhoea, constipation, wind
iloss of your appetite, stomach cramps
ifeeling dizzy, feeling nervous, headache
iringing in your ears
ifluid retention.
Less frequent side effects are
Digestive system:
isore mouth, pain and swelling (inflammation) of your
stomach
iulcers of your stomach or intestine, inflammation of your
colon, Crohn's disease
ibleeding from your intestine, perforated ulcers (which
have been very rarely linked with death, especially in the
elderly)
iinflammation of your pancreas (an organ which lies
below and behind the stomach)
iloss of your sense of taste, metallic or bitter taste
iinflammation of your tongue
iliver problems, including jaundice. Signs of this may be
yellowing of your skin and eyes, sometimes with a high
temperature (fever)
ilower flow of bile from your gall bladder. Signs may be
pale stools and dark urine.
Skin and hair:
isore or dry mucous membranes, such as the inside of
your nose or mouth
ibaldness
iincreased sensitivity of your skin to sunlight.
Heart and circulation:
iheart failure, palpitations
ihigh blood pressure
imedicines like Sulindac may be associated with a small
increased risk of heart attack (myocardial infarction) or
stroke.
Blood:
ieffects on the components of your blood such as
anaemia (usually found by blood tests). Signs of this
may be pale skin, feeling tired, sore throat, bruising or
bleeding for long time after a cut
ihigh levels of potassium in your blood
iabnormally high sugar levels (usually found by a
laboratory blood test)
inose bleeds.
Urinary:
idiscolouring of your urine, difficulty or pain when passing
urine
iblood in your urine
iprotein in your urine, crystals in the urine (both usually
found by a test)
ipain and swelling (inflammation) of your kidneys, kidney
failure.

120-121/L/e/1

F684

Nervous system:
ifeeling giddy, problems sleeping, sweating, feeling weak
or tired, pins and needles
ifits, feeling faint or depressed, mental disorders.
Joints and muscles:
iweak muscles.
Eyes or ears:
ichanges in your eyesight
iblurred vision
idifficulty hearing.
Sexual:
ibreast swelling in men
ivaginal bleeding in women.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store
iKeep out of the reach and sight of children.
iDo not store above 25ÂșC. Store in the original package.
iKeep in the outer carton to protect from light.
iDo not put the tablets in another container as they might
get mixed up.
iIf you have any tablets left over when your doctor tells you
to stop taking them, return them to the pharmacist.
iDo not use the tablets past the expiry date which is clearly
marked on the pack.
iMedicines 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.

6. Further information
What Sulindac Tablets contain
iThe active substance in Sulindac Tablets is sulindac
(100 mg or 200 mg).
iThe other ingredients are: microcrystalline cellulose
(E460), maize starch, magnesium stearate (E572).
What Sulindac Tablets look like and contents of the pack
Sulindac 100 mg Tablets are brilliant yellow, scored and
hexagonal shaped, marked '943', and are available in blister
packs of 56 or 60 tablets, or bottles of 100 tablets.*
Sulindac 200 mg Tablets are brilliant yellow, scored and
hexagonal shaped, marked '942', and are available in blister
packs of 56 or 60 tablets, or bottles of 100 tablets.*
*Not all packs may be marketed.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as Essential Generics,
7 Egham Business Village, Crabtree Road, Egham, Surrey
TW20 8RB.
Manufacturer
Dales Pharmaceuticals Ltd, Snaygill Industrial Estate,
Keighley Road, Skipton BD23 2RW.
This leaflet was last revised in
April 2010

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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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