Indometacin Capsules Bp 50mg
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? INDOMETACIN Capsules 25mg & 50mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Indometacin Capsules are and what they are used for
2. Before you take Indometacin Capsules
3. How to take Indometacin Capsules
4. Possible side effects
5. How to store Indometacin Capsules
6. Further information
1. What Indometacin Capsules are and what they are used for
Indometacin Capsules are available in two strengths. Each capsule contains either 25mg or 50mg of the active ingredient Indometacin.
The medicine belongs to a group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs) which are used for pain relief and reducing inflammation.
This medicine is used to relieve pain, swelling and redness in a number of conditions affecting the joints and muscles, including rheumatism. It may also be used for other conditions such as acute gout and period pain.
2. Before you take Indometacin Capsules
Do not take these capsules if:
• you are allergic to Indometacin or other non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, aspirin, cyclooxygenase (COX-2) NSAIDs such as celecoxib or rofecoxib or any of the ingredients (see section 6) in the capsules. (An allergic reaction may be recognised as shortness of breath, skin rash, itching, blocked nose or swollen face or lips)
• you have redness and soreness of the nasal cavity
• you have a peptic ulcer (ulcer in your stomach or duodenum), or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
• you have had stomach bleeding or perforation ever caused by taking NSAIDs
• you have severe liver, kidney or heart failure
• you are in the last 3 months of pregnancy.
Check with your doctor before taking these capsules if:
• you are already taking another non-steroidal anti-inflammatory drug (NSAID), including aspirin as taking more than one NSAID at the same time may increase the possibility of developing the unwanted gastrointestinal effects (e.g. sickness, heartburn, abdominal pain etc)
• you are elderly
• you suffer from mental illness
• you suffer from liver, kidney, heart problems, diabetes mellitus, Parkinson’s disease, epilepsy, blood clot disorder, high blood levels of potassium, high blood pressure, asthma or have a history of bronchial asthma, gastrointestinal problems or heart failure
• you have ever suffered from a stomach or intestinal disorder (e.g. ulcerative colitis or Crohn’s disease)
• you suffer from systemic lupus erythematosus (SLE - an allergic condition which causes joint pain, skin rashes and fever) or a connective tissue disorder
• you are on antibiotic therapy, i.e. if you have an infection or if you have recently been vaccinated, or are due to be vaccinated
• you are in the first 6 months of pregnancy, planning to become pregnant or breast-feeding. Indometacin 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.
Taking other medicines:
Check with your doctor or pharmacist before taking these capsules if you are taking other medicines, especially:
• aspirin or other salicylates e.g. diflunisal
• medicines to treat blood clotting e.g. warfarin or anti-platelet drugs e.g. clopidogrel
• medicines to treat high blood pressure e.g. diuretics such as furosemide and triamterene, beta blockers such as atenolol and propranolol, or ACE inhibitors (e.g. captopril) or the drugs diazoxide, hydralazine or nifedipine
• probenecid (for gout)
• lithium or haloperidol (for mental illness) or medicine to treat anxiety, sleeping difficulty e.g. diazepam
• corticosteroids (for replacement therapy or inflammatory disorders) e.g. hydrocortisone or prednisolone
• treatment to prevent rejection following an organ transplant e.g ciclosporin, tacrolimus or muromonab-CD3
• methotrexate (used in the treatment of leukaemias, tumours and rheumatoid arthritis) or cyclophosphamide (to treat cancer)
■ quinolone antibiotics to treat infections e.g. ciprofloxacin
• cardiac glycosides e.g. digoxin and cymarin (used to slow the heart rate and which are also given in chronic heart failure)
• mifepristone (used for the termination of pregnancies “the morning after pill”)
• drospirenone (a contraceptive pill), baclofen (a treatment for muscle spasm), sibutramine (an appetite suppressant), or phenytoin (to treat epilepsy)
■ antidepressant medicines e.g. amitriptyline, fluoxetine, venlafaxine
• pentoxifylline (used to treat problems with peripheral blood-vessels), phenylpropanolamine (a nasal decongestant), desmopressin (used in the treatment of diabetes insipidus and bed wetting), tiludronic acid (used to treat Paget’s disease)
• anti-diabetic treatments e.g. chlorpropamide, metformin
■ antiviral medications e.g. zidovudine, ritonavir, zalcitabine.
Other special warnings:
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 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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose. If you are taking this medicine for a long time, eye examinations, liver and kidney function tests, abdominal tests and blood tests should be done periodically. Indometacin can cause increased values in liver function tests. If you need to have liver function tests tell your doctor you are taking indometacin. Indometacin can cause false-negative results in the dexamethasone suppression test (DST). If you need to take this test tell the doctor you are taking indometacin.
You could encounter headache, dizziness and light-headedness when you start taking this medicine. If it continues for a long period, stop taking the medicine and see your doctor immediately.
Driving or any activity requiring alertness:
Do not drive or operate machinery if you experience dizziness, drowsiness, fatigue or visual disturbances when you start taking this medicine.
3. How to take Indometacin Capsules
The capsules should be swallowed whole with a drink of water, milk or an antacid after a meal or a snack as directed.
The doctor will decide the dose that Is best for you. The pharmacist’s label will tell you how many capsules to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
Adults: 50 to 200mg per day In divided doses.
Elderly: Caution should be exercised and therapy should only start at the lowest recommended dose.
Children: Not recommended.
If you have taken too many capsules:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining capsules and the pack so that the medicine can be identified.
If you forget to take a dose:
If you miss a dose of this medicine, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. There will be fewer side effects if you take the lowest effective dose for the shortest time necessary.
If any of the following occur STOP TAKING the capsules IMMEDIATELY and contact your doctor:
* pass blood in your faeces (stools/motions)
* pass black tarry stools
* vomit any blood or dark particles that look like coffee grounds. These may be signs of a stomach ulcer or bleeding in your stomach.
STOP TAKING the capsules and tell your doctor if you experience any of the following:
* stomach pain or other abnormal stomach symptoms, indigestion or heartburn
* allergic reactions which can include skin rash, itching, bruising, painful red areas, red tender nodules on the shins, flaking, peeling or blistering, dizziness, wheezing or shortness of breath, difficulty in breathing, coughing up blood, excessive sweating, anxiety and pale skin, swollen face, throat, lips, hands or fingers or sores around the nose, mouth, ears, genitals or anus, shock and in severe cases collapse
* yellowing of your skin or the whites of your eyes and/or pale stools, dark urine, loss of appetite as these may be signs of liver problems
■ passing more or less urine than normal, difficult or painful urination, cloudy or foamy urine, blood in urine, pain in the back, fever, rash,swelling (particularly of the ankles), high blood pressure, as these may be signs of kidney problems.
Very rare effects (that may happen to less than 1 in 10,000 people):
* inflammation of the pancreas causing severe pain in the abdomen and back
* Stevens-Johnson syndrome (serious illness causing blistering of the skin, mouth, eyes and genitals)
* toxic epidermal necrolysis (serious illness causing blistering of the skin).
If you get any of these, STOP TAKING the capsules and tell your doctor as soon as possible.
Other effects which have been reported are:
* high blood pressure (symptoms may include headache, dizziness or blurred vision), oedema (water retention), heart failure (which can cause shortness of breath or swollen ankles)
■ feeling or being sick, loss of appetite, diarrhoea, constipation, flatulence (wind) or sore mouth
* worsening of the symptoms of colitis and Crohn’s disease.
Uncommon effects (that may happen to less than 1 in 100 people):
* blood disorders including severe reduction in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising or make infections more likely, or increased levels of urea (a waste product) in the blood
* increased sensitivity to sunlight, hair loss or worsening of a skin condition called psoriasis
* headache, feeling of dizziness or “spinning”, light-headedness, ringing in the ears or other hearing disturbances (rarely deafness), tiredness, lack of energy, drowsiness, confusion, “pins and needles” in the hands and feet, depression or hallucinations or nervousness
■ eyesight problems (such as blurred or double vision, partial or complete loss of vision, pain in or around the eye, blind spots, halos around lights), deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina)
* fast or irregular heartbeat, feeling your heartbeat, chest pain, low blood pressure (symptoms may include light-headedness, dizziness or fainting)
* aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck and back, feeling or being sick, skin rash, eyes being very sensitive to bright light, disorientation and muscle pain
* inflammation of the stomach lining or the ileum (small intestine). Symptoms include stomach pain or discomfort, feeling or being sick, diarrhoea, loss of appetite, weight loss, fever, bad taste in the mouth, belching and indigestion
■ bleeding from the vagina, increase in blood sugar level, sugar in the urine, high levels of blood potassium which can cause abnormal heart rhythm
* flushing, sweating, nosebleed, changes in the breast (enlargement or tenderness), breast development in males
* worsening of cartilage damage
* medicines such as indometacin may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
Rare effects (that may happen to less than 1 in 1,000 people):
* difficulty in sleeping, difficulty speaking, confusion, anxiety, psychiatric problems, fainting, coma
* weakness, tingling or numbness, muscle weakness, involuntary jerky movements, fits, worsening of epilepsy, tremor, stiffness and shuffling. 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: 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 Indometacin Capsules
Keep the capsules in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN
Do not take the capsules if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients:
Indometacin Capsules are available in two strengths. Each capsule contains either 25mg or 50mg of indometacin as the active ingredient.
The capsules also contain the following ingredients: talc, magnesium stearate, sodium starch glycolate, sodium lauryl sulphate, lactose, quinoline yellow (E104), titanium dioxide (E171) and gelatin. The capsules are printed with an ink containing shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide.
What the medicine looks like:
Indometacin Capsules 25mg are ivory coloured shells printed with ‘IND 25’ and company logo. Indometacin Capsules 50mg are ivory coloured shells printed with ‘IND 50’ and company logo. Indometacin Capsules are available in pack sizes of 28,42, 50,56, 84100,112,250,500, and 1000 capsules (not all pack sizes may be marketed).
Who makes this medicine and holds the product licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Date leaflet revised: May 2015
If you would like this leaflet in a different format please contact the licence holder at the above address.