patient information leaflet clinoril

PATIENT INFORMATION LEAFLET

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR TABLETS EVEN IF YOU HAVE JUST HAD A REPEAT PRESCRIPTION. SOME OF THE INFORMATION IN YOUR PREVIOUS LEAFLET MAY HAVE CHANGED.

Keep this leaflet. You may want to read it again.

Clinoril ® 100 mg Tablets

(sulindac)

Clinoril ® 200 mg Tablets

(sulindac)

WHAT IS IN YOUR TABLETS?

Active ingredients

The active ingredient in ‘Clinoril’ Tablets is sulindac. ‘Clinoril’ Tablets are brilliant yellow, scored and hexagonal shaped, and are available in two strengths: one marked ‘MSD 943’ containing 100 mg sulindac, the other marked ‘MSD 942’ containing 200 mg sulindac.

Other ingredients

Microcrystalline cellulose E460, pregelatinised maize starch, magnesium stearate E572.

‘Clinoril’ Tablets are supplied in blister packs of 60 tablets.

HOW DO YOUR TABLETS WORK?

Sulindac is a medicine known as a non-steroidal anti-inflammatory drug, which is commonly known as ‘NSAID’. Aspirin is a well-known member of this group of medicines. NSAIDs work by blocking the production of natural chemicals called prostaglandins. In many patients, sulindac relieves inflammation (swelling, redness) and pain.

WHY DO YOU NEED TO TAKE THESE TABLETS?

Your doctor has probably prescribed ‘Clinoril’ for you because you are suffering from one of the following, which he will have explained to you:

rheumatoid arthritis
osteoarthritis
acute gouty arthritis
arthritis of the spine
swelling near a joint due to a build-up of fluid (bursitis)
inflammation of tendons (tendinitis, tenosynovitis).

ARE THERE PATIENTS WHO SHOULD NOT TAKE THESE TABLETS?

Yes, do not take the tablets if:

you are in the last three months of your pregnancy
you have had a bad or allergic reaction to this or similar medicines, or to any of the ingredients in the past; for example, if you have experienced breathing difficulties, localised swelling, skin rashes which look like nettle-rash, or a runny nose after taking aspirin or other non-steroidal anti-inflammatory medicines
you have, or have ever had an ulcer in your stomach or intestine
you have, or have ever had bleeding from your intestine, symptoms of which may be abdominal pain, vomiting blood, black or blood-containing faeces
you have liver disease
you suffer from severe heart failure or severe kidney failure.

‘Clinoril’ Tablets should not be given to children.

If you think any of these apply to you, do not take the tablets, go and talk to your doctor first and follow the advice given.

WHAT ELSE SHOULD YOU KNOW BEFORE TAKING YOUR TABLETS?

You should check with your doctor before taking ‘Clinoril’ Tablets if:

you are breast-feeding
you are already taking other medicines called NSAIDs or cyclooxygenase (COX II) inhibitors.
you have a history of ulcers, bleeding from your stomach or intestine, other stomach disorders, Crohn’s disease or ulcerative colitis (inflammation of the colon), although you may not currently be ill with this
you have or have had kidney disease
you have had kidney stones
you have or have had blood-clotting problems
you are being treated for infection
you are elderly or have a heart condition, high blood pressure, diabetes, allergies, or have a tendency for fluid retention
you suffer from, or have a history of bronchial asthma
you are pregnant and in the first six months of pregnancy
you suffer from Systemic Lupus Erythematosus – SLE (Lupus) or mixed connective tissue disorder.

‘Clinoril’ may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have any problems becoming pregnant.

Medicines such as ‘Clinoril’ 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.

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.

In addition your doctor may want to examine your eyes at intervals during your treatment with ‘Clinoril’ Tablets. You should see your doctor if you notice any change in your vision.

WHAT ABOUT DRIVING AND OPERATING MACHINERY?

‘Clinoril’ Tablets can cause dizziness, tiredness, drowsiness or visual disturbances in some people. If this happens to you, avoid activities which require alertness, such as driving a car or operating machinery.

CAN YOU TAKE ‘CLINORIL’ TABLETS WITH OTHER MEDICINES?

There are a few other medicines which may not mix with ‘Clinoril’ Tablets. Your doctor knows about these and will alter your treatment as needed. It is important that you tell your doctor about all the medicines you are taking, including any drugs you are taking without a doctor’s prescription.

If you are taking any of the following medicines, you should talk to your doctor before taking ‘Clinoril’ Tablets:

Dimethyl sulphoxide, used to treat cold sores, genital herpes, shingles, chicken pox, and inflammation of the bladder.
Anticoagulant medicines which thin the blood.
Antidiabetic medicines for decreasing blood-sugar levels.
Aspirin or aspirin-containing medicines.
Other NSAIDs including diflunisal and cyclooxygenase-2-inhibitors.
A medicine for gout called probenecid.
Diuretics, or antihypertensive medicines for the treatment of high blood pressure.
Methotrexate, a drug used in the treatment of cancer, severe skin disease, and rheumatoid arthritis.
Ciclosporin, a drug used to prevent the body from rejecting an organ or bone-marrow transplant, to treat severe skin disease and rheumatoid arthritis.
Lithium for treatment of mental disorders.
Cardiac glycosides such as digoxin, a medicine used to treat heart failure and alterations of heart rhythm.
Corticosteroid drugs, including anti-inflammatory and replacement therapies.
Mifepristone, a treatment used in emergency for termination of pregnancy.
Antibiotics from the quinolone group of antibiotics.
Tacrolimus, used in treatment of immunosuppression.

HOW SHOULD YOU TAKE ‘CLINORIL’ TABLETS?

It is important that you take ‘Clinoril’ Tablets by mouth preferably with food or fluids. You must take your tablets exactly as advised by your doctor or pharmacist. The number of tablets you take each day will depend upon your condition. For many people this is usually 400 mg a day taken in two doses. However, the dosage may be lowered, depending on the response.

For acute gouty arthritis, the medication is usually taken for seven days.

For the treatment of bursitis, tendinitis, and tenosynovitis, ‘Clinoril’ Tablets should be taken for no longer than ten days.

Doses above 400 mg per day are not recommended.

WHAT IF YOU FORGET TO TAKE A TABLET OR TAKE TOO MANY?

If you miss a dose, just carry on with the next one as normal. Do not take an extra one to make up.

If you take too many tablets by mistake, contact your doctor as soon as possible.

The most common symptoms observed following an overdose include nausea, vomiting and stomach pains, reduced responsiveness (stupor), coma, decreased amount of urine passed, and low blood pressure.

WHAT UNWANTED EFFECTS COULD YOUR TABLETS HAVE?

Like all medicines, ‘Clinoril’ Tablets may occasionally cause side effects in some patients. These may disappear if your dose of tablets is reduced. Most side effects involve the stomach and intestines, such as stomach or abdominal pain, indigestion, nausea with or without vomiting, diarrhoea, constipation, wind, loss of appetite, stomach cramps.

Serious allergic reactions to ‘Clinoril’ Tablets have been reported. If you notice any of following effects, STOP TAKING the tablets at once and seek medical help immediately:

Fever; chills; sudden difficulty in breathing and swallowing; swollen lips, face, tongue and throat; rash; serious skin reactions, including blistering of the skin; giant wheals; itchiness, including Stevens-Johnson syndrome and swollen glands. This may also include problems with liver, kidneys, or blood cells (see below for symptoms of each).

Frequently reported side effects are:,

dizziness, headache, nervousness, ringing in the ears, and fluid retention.

Less frequent side effects are:

Disorders of the digestive system: sore mouth, inflammation of the stomach, ulcers of the stomach or intestine, inflammation of the colon, Crohn’s disease, bleeding from the intestine, perforated ulcers (which have been very rarely linked with death, especially in the elderly), inflammation of the pancreas (an organ which lies below and behind the stomach), loss of the sense of taste, inflammation of the tongue.

If you suffer from any of the following at any time during your treatment, STOP TAKING the medicine and seek immediate medical help:

pass blood in your faeces (stools/motions)
pass, black tarry stools
vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience pains in your stomach or other abnormal stomach symptoms, heartburn or indigestion.

Disorders of the liver and gallbladder: liver disorders, including jaundice, symptoms of which may be yellowing of the skin and eyes, sometimes with a fever, reduction of the flow of bile, symptoms of which may be pale stools and dark urine.

Skin disorders: sore or dry mucous membranes, baldness, increased sensitivity to sunlight.

Heart disorders: heart failure, palpitations, high blood pressure.

Blood disorders: effects on the components of the blood such as anaemia and are usually diagnosed by blood tests. Some symptoms may be paleness of skin, tiredness, sore throat, bruising or prolonged bleeding.

Disorders of the kidneys, urinary tract and gentials: discolouring of urine, difficulty or pain when passing urine, vaginal bleeding in women, blood in the urine, protein in the urine, excretion of crystals in the urine (may only be diagnosed from laboratory tests), inflammation of the kidneys, kidney failure.

Nervous system disorders: giddiness; sleeping disorders; sweating; weakness; tiredness; pins and needles; fits; faintness; depression; mental disorders; inflammation of the surrounding membranes of the brain and spine (symptoms of this may be stiff neck, headache, nausea, vomiting, fever or confusion).

Others: high levels of potassium in the blood, abnormally high sugar levels (these are usually diagnosed by a blood test); muscle weakness; visual disturbances; blurred vision; decreased hearing; metallic or bitter taste; nose bleeds; breast swelling in men.

Medicines such as ‘Clinoril’ may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

If you notice any of the above effects, or you have any other unusual symptoms or feelings, contact your doctor.

HOW SHOULD YOUR TABLETS BE KEPT?

Keep your tablets 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 into another container as they might get mixed up. If you have any tablets left over when your doctor tells you to stop taking them, then return them to the pharmacist.

Do not take the tablets past the expiry date which is clearly marked on the pack.

REMEMBER, this medicine is for you. Do not share it with anyone else. It may not suit them.

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘CLINORIL’ TABLETS?

This leaflet gives you some important patient information about ‘Clinoril’ Tablets. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.

ARTHRITIS CARE

Patients requiring further independent information or advice should contact Arthritis Care, the UK’s largest voluntary organisation working with people with arthritis. Arthritis Care works with and for all people with arthritis to promote their health, well-being and independence, through services, support, self-help, influence, and information.

Medicine: clinoril