SULINDAC 200 MG TABLETS - patient leaflet, side effects, dosage

Sulindac 100 mg and 200 mg Tablets

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

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.

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 anti-inflammatory 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:

• rheumatoid arthritis, caused by your immune system attacking your joints
• osteoarthritis, caused by wear and tear of your joints
• acute gouty arthritis, caused by gout
• arthritis of the spine
• bursitis, swelling near one of your joints due to a build up of fluid
• tendinitis 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

• you are allergic (hypersensitive) to sulindac or any of the other ingredients of this medicine (listed in Section 6)
• you are in the last three months of pregnancy (see ‚Pregnancy and breast-feeding‘ for further information)
• you have ever had a bad reaction to other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin
• you have ever had an ulcer in your stomach or intestine
• you 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
• you have liver problems
• you 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:

• you already take other medicines called NSAIDs or cyclooxygenase (COX II) inhibitors
• you 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
• you have ever had liver or kidney problems, including kidney stones. Your doctor may check your kidney or liver function before and during treatment
• you have ever had blood-clotting problems
• you are being treated for an infection
• you are elderly or have a heart problem
• you have high blood pressure or have ever had fluid retention
• you have diabetes
• you have any allergies
• you have ever had asthma, as taking NSAIDs can make your asthma worse
• you 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:

• signs 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
• stomach 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 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.

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:

• other NSAIDs including diflunisal and cyclooxygenase (COX 2) inhibitors (such as etoricoxib or celecoxib)
• dimethyl sulphoxide, used to treat cold sores, genital herpes, shingles, chicken pox, and inflammation of the bladder
• medicines such as anti-platelet agents and anticoagulants, used to thin the blood (e.g. warfarin, aspirin, clopidogrel)
• medicines for diabetes that decrease blood sugar levels (e.g. glipizide and glibenclamide)
• aspirin or medicines that contain aspirin
• probenecid used for gout
• diuretics (water tablets), e.g. furosemide, spironolactone or medicines used for high blood pressure (antihyperten­sives), e.g. atenolol, ramipril, valsartan
• methotrexate, used for some types of cancer, severe skin problems, and rheumatoid arthritis
• ciclosporin, used after organ or bone marrow transplants and for severe skin disease, or rheumatoid arthritis
• lithium, used for mental disorders
• medicines like digoxin, used to treat heart failure and irregular heart beat
• corticosteroids used for anti-inflammatory and replacement therapies (such as prednisolone or dexamethasone)
• mifepristone, used in emergency for termination of pregnancy
• antibiotics called ‚quinolones‘, such as ciprofloxacin and norfloxacin
• antidepressants called selective serotonin re-uptake inhibitors (SSRIs), (e.g. paroxetine)
• tacrolimus, used after skin or organ transplants
• zidovudine, 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.

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

• Take Sulindac by mouth. It is best to take it with or just after food.

Swallow the tablets whole with a full glass of water.

• The number of tablets you take each day will depend upon your condition.
• The usual dose is 200 mg twice a day.
• The dosage may be reduced, depending on your response.
• Doses above 400 mg a day are not recommended.
• For arthritis caused by gout (gouty arthritis) Sulindac is usually taken for 7 days.
• For 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

If you take more than you should

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

If you forget to take

• If you miss a dose, skip the missed dose.
• Take the next dose at the usual time.
• Do 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

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.

Stop taking the tablets and see a doctor straight away, if you notice any of the following serious side effects:

• allergic 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

• passing blood in your stools (faeces) or passing black tarry stools
• vomiting any blood or dark particles that look like coffee grounds
• pains in or around your stomach (stomach or abdominal pain)
• heartburn or indigestion
• inflammation of membranes of your brain and spine.

Signs of this may be stiff neck, headache, nausea, being sick, high temperature (fever) or feeling confused.

Other side effects

Frequently reported side effects

• stomach or abdominal pain, indigestion, feeling sick (nausea), being sick (vomiting)
• diarrhoea, constipation, wind
• loss of your appetite, stomach cramps
• feeling dizzy, feeling nervous, headache
• ringing in your ears
• fluid retention.

Less frequent side effects are

Digestive system:

• sore mouth, pain and swelling (inflammation) of your stomach
• ulcers of your stomach or intestine, inflammation of your colon, Crohn's disease
• bleeding from your intestine, perforated ulcers (which have been very rarely linked with death, especially in the elderly)
• inflammation of your pancreas (an organ which lies below and behind the stomach)
• loss of your sense of taste, metallic or bitter taste
• inflammation of your tongue
• liver problems, including jaundice. Signs of this may be yellowing of your skin and eyes, sometimes with a high temperature (fever)
• lower flow of bile from your gall bladder. Signs may be pale stools and dark urine.

Skin and hair:

• sore or dry mucous membranes, such as the inside of your nose or mouth
• baldness
• increased sensitivity of your skin to sunlight.

Heart and circulation:

• heart failure, palpitations
• high blood pressure
• medicines like Sulindac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Blood:

• effects 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
• high levels of potassium in your blood
• abnormally high sugar levels (usually found by a laboratory blood test)
• nose bleeds.

Urinary:

• discolouring of your urine, difficulty or pain when passing urine
• blood in your urine
• protein in your urine, crystals in the urine (both usually found by a test)
• pain and swelling (inflammation) of your kidneys, kidney failure.

Nervous system:

• feeling giddy, problems sleeping, sweating, feeling weak or tired, pins and needles
• fits, feeling faint or depressed, mental disorders.

Joints and muscles:

• weak muscles.

Eyes or ears:

• changes in your eyesight
• blurred vision
• difficulty hearing.

Sexual:

• breast swelling in men
• vaginal bleeding in women.

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:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store

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

• 6. Further information

• The active substance in Sulindac Tablets is sulindac (100 mg or 200 mg).
• The 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

June 2015

ESSENTIAL GENERICS