Indometacin Capsules 25mg and 50mg
Please read this leaflet carefully before you start to take your medicine.
It tells you some of the more important things you should know.
If you want to know more, or you are not sure about anything, ask your doctor or pharmacist.
Keep the leaflet until you have finished the medicine.
What’S In Your Medicine
The active ingredient in this medicine is Indometacin. This is the new name for Indomethacin. The ingredient itself has not changed.
Indometacin Capsules are ivory, hard gelatin capsules which come in two strengths. Each capsule contains either 25mg or
50mg of the active ingredient Indometacin.
The capsules also contain: Starch 1500, Powdered Cellulose, Colloidal Silicon Dioxide, Magnesium Stearate. The capsule shell contains: Yellow Iron Oxide (E172), Titanium Dioxide (E171), Gelatin.
The printing ink contains: Shellac glaze and iron oxide black (E172).
Indometacin capsules are available in a pack size of 28.
Your capsules are made by
who are also the Marketing Authorisation holder.
About Your Medicine
Indometacin is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), these drugs are painkillers which reduce swelling.
Indometacin Capsules may be used for:
- inflammatory diseases of the joint or surrounding tissue such as rheumatoid arthritis, osteoarthritis, degenerative hip disease, bursitis, tendinitis, synovitis, tenosynovitis and capsulitis
- deformity and stiffening of the backbone (ankylosing spondylitis)
- muscular pain, low back pain and pain following bone or joint surgery
- period pain
- gout
Before Taking Your Medicine
Do not take Indometacin Capsules if you:
- have ever had an allergic reaction to Indometacin Capsules or any of the ingredients in the capsule. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
- have experienced asthma attacks, allergic skin reactions swelling, especially of the throat, or rashes, or a runny nose while taking aspirin or any other NSAIDs or COX II inhibitors (e.g. celecoxib)
- have now or have previously had stomach ulcers or bleeding in the digestive system
- have severe liver, kidney or heart disease
- suffer with nasal polyps
- are in the last three months of pregnancy
- are giving the medicine to a child under 12 years old.
Check with your doctor or pharmacist before taking Indometacin capsules if you:
- have bleeding disorders or blood clotting problems
- suffer from a psychiatric disorder, epilepsy or parkinsonism
- have kidney problems
- currently have an infection (treated or not) or are receiving treatment with live vaccines
- suffer from any conditions of the liver or heart that causes fluid retention, or high blood pressure
- suffer from asthma
- suffer from any diseases of the bowel such as Crohn’s disease or ulcerative colitis
- suffer with systemic lupus erythematosus (SLE) or any other connective tissue disorder
- are due to have an operation
Medicines such as indometacin 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 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
pharmicist.
Check with your doctor or pharmacist if you are taking any of the following:
- aspirin or related medicines (salicylates)
- other NSAIDs including diflunisal
- quinolone antibiotics (such as ciprofloxacin)
- SSRI antidepressants (eg paroxetine)
- sulphonylureas (used to treat diabetes)
- medicines used to treat high blood pressure ( such as atenolol, captopril, doxazosin, hydralazine, losartan, nifedipine, propranolol or quinipril)
- anti-platelet medicine or drugs to stop the blood clotting
- lithium or haloperidol (psychiatric medicines)
- anti-viral medicines (such as zidovudine or ritonivir)
- cardiac glycosides (used to treat heart conditions e.g. digoxin)
- ciclosporin or tacrolimus (immune system medicine)
- corticosteroids (anti-inflammatories)
- methotrexate (used to treat some cancers, severe psoriasis and severe rheumatoid arthritis)
- desmopressin (hormone preparation used for night-time bed wetting)
- thiazides, furosemide and triamterene (control fluid levels in the body)
- mifepristone (used to induce abortion)
- baclofen (muscle relaxant)
- pentoxifylline (used to treat vascular disease)
- probenecid (a treatment for gout)
- tiludronic acid (used to treat bone diseases)
Pregnancy and Breast-feeding:
Indometacin Capsules 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. If you ARE pregnant, or are breast feeding speak to your doctor
or pharmacist before taking this medicine.
Driving and using machines:
Indometacin Capsules may make you feel drowsy, dizzy, tired or affect your vision. Make sure you are not affected before you drive or operate machinery.
Other precautions you should take:
Indometacin Capsules may alter the results of some blood or urine tests. If you see another doctor or go into hospital, let them know what medicines you are taking.
Taking Your Medicine
Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions exactly, and those on the pharmacy label. If you do not understand anything, ask your doctor or pharmacist. The usual dosage(s) are described below:
- Adults: 50-200mg daily.
- Acute joint disease: Initially 25mg two or three times a day.
- Long term joint disease: 25mg two or three times daily increasing by 25mg up to 150mg daily, rarely more than 200mg daily is necessary.
- Sudden flare up of long term condition: Up to 150-200mg daily.
- Severe muscular aches and pains: Initially 50mg two or three times daily, according to severity for 10-14 days. Normally 150mg daily, rarely 200mg daily.
- Lumbago: 50mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.
- Gout: 50mg three or four times daily until symptoms subside.
- Following orthopaedic procedures: 100-150mg daily in divided doses.
- Elderly: Your doctor may prescribe you a different dose and monitor your progress more closely.
- Children: Not recommended.
These capsules should be swallowed whole preferably with meals, milk or an indigestion remedy (antacid)
If you forget to take Indometacin Capsules:
If you forget to take a capsule take one as soon as you remember unless it is nearly time to take the next one. NEVER
take two doses together. Take the remaining doses at the correct time.
If you take more Indometacin Capsules than you should:
If you (or someone else) swallow a lot of the capsules at the same time, or if you think a child has swallowed any of the
capsules, contact your nearest hospital casualty department or your doctor immediately. If an overdose has been taken there
may be signs such as headache, feeling or being sick, stomach pain or bleeding, drowsiness, dizziness, ringing in the ears or fainting.
After Taking Your Medicine
Like many medicines, indometacin may occasionally cause side-effects in some patients, particularly when you first start
taking them. The most common side effects are headache, dizziness and indigestion. If you get a prolonged headache tell
your doctor.
If you develop a rash or become jaundiced (yellow skin or eyes) stop taking indometacin and talk to your doctor immediately.
Aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as headache, fever, stiff
neck, tiredness, feeling ill and your eyes become very sensitive to bright light. If you experience any of these symptoms seek medical attention immediately.
Medicines such as indometacin may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
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, pass black tarry stools or vomit blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience: indigestion or heartburn, abdominal pains (pains in your stomach) or other abdominal symptoms.
Other side effects are:
Effects on the blood – changes in the numbers and types of blood cells. If you develop bruising, sore throats, nose bleeds or infections tell your doctor who may wish to test your blood.
Allergic reactions - skin rash which may be itchy, itching, redness, swelling especially of the throat, difficulty breathing, asthma and fluid in the lungs.
Effects on the nervous system - fatigue, drowsiness, dizziness, headaches, problems with speech, fainting, nervousness, coma, lightheadedness, vertigo, tiredness, hallucinations (seeing things that are not there), difficulty sleeping, depression, confusion, anxiety, mental disturbances, involuntary movements, loss of co-ordination, numbness and
tingling, fits or worsening of fits and Parkinson’s syndrome.
Effects on the eye - pain in and around the eye, blurred or double vision, inflammation of the optic nerve, deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina).
Effects on the ears - ringing or buzzing or other hearing disturbances (rarely deafness).
Effects on the heart - swelling especially of ankles, high or low blood pressure, chest pain, fast or irregular heart beats and heart failure.
Effects on the stomach - feeling or being sick, abdominal pain or discomfort, loss of appetite, constipation or diarrhoea, flatulence, inflammation of the mouth or guts or worsening of these conditions and ulceration of the intestines which can cause bleeding, obstruction or can perforate (burst), worsening of Crohn’s disease or ulcerative colitis.
Effects on the liver - inflammation, jaundice (yellow skin or eyes see above).
Effects on the skin – sensitivity to light, worsening of psoriasis.
Effects on the kidney - inflammation, disease or failure, blood or protein in the urine and increase in blood urea.
Other effects - increase in blood sugar, sugar in the urine, high blood potassium, bleeding from the vagina, breast changes (enlargement, tenderness, breast development in men), flushing, sweating, mouth ulcers, muscle weakness and worsening of cartilage damage.
Tell your doctor if you notice or are worried by any of the side effects listed or notice any other effects not listed.
If you get any other unusual effects, tell your doctor or pharmacist immediately and seek advice.
Storing Your Medicine
- Do not use the capsules after the expiry date shown on the product packaging.
- Keep the capsules in a dry place below 25°C and protected from light, and in the original packaging.
KEEP INDOMETACIN CAPSULES OUT OF THE REACH AND SIGHT OF CHILDREN IN A SECURE PLACE
REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours.- Return all unused medicines back to your pharmacist for safe disposal.
Date of last revision: March 2007
If you would like a leaflet with larger text, please contact 01271 311257.
50108870
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