Indometacin Capsules Bp 50mg
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KEEP THIS LEAFLET AND READ IT BEFORE YOU TAKE YOUR
MEDICINE
YOUR MEDICINE:
These capsules are called Indometacin Capsules BP 25mg or 50mg. Each capsule contains the active ingredient Indometacin BP 25.0mg or 50.0mg. Each capsule also contains Lactose, Maize Starch, Silicon Dioxide (E551), Magnesium Stearate (E572) , Erythrosin (E127), Quinoline Yellow (E104) and Titanium Dioxide (E171).
The product is available in two strengths.
The 25mg product is available in containers of
1000, 500, 100, 84, 70, 56, 42, 28, 21, 15 and 14 capsules and in blister of 14, 15, 21, 28, 42, 56, 70 and 84 capsules.
The 50mg product is available in containers of 1000, 500, 250, 100,
84, 70, 56, 42, 28, 21, 15 and 14 capsules and in blisters of 14, 15, 21, 28, 42, 56, 70 and 84 capsules.
WHO MAKES IT?
The product licence is held by the manufacturer by
Mercury Pharmaceuticals Ltd
Capital House, 85 King William Street,
London EC4N 7BL, UK
WHAT IS IT FOR?
Indometacin is a non-steroidal anti-inflammatory agent. Indometacin Capsules BP 25mg or 50mg are used to relieve the symptoms of the following: rheumatoid arthritis, rheumatism and inflammation of the spine, pain and stiffening of the joints (osteoarthritis), gout (a form of arthritis), muscular pain, hip pain, lower back pain, inflammation pain and oedema (fluid retention in tissues) following orthopaedic procedures, and pain and other symptoms associated with painful periods.
WARNING:
This product may cause dizziness. If affected, do not drive or operate machinery.
Do not use this medicine if:
1. You have, or have ever had, peptic ulceration (ulcer in your stomach or duodenum) or bleeding in your digestive tract.
2. You are allergic to Indometacin, Aspirin, or other non-steroidal anti-inflammatory drugs, or to any of the above listed ingredients.
3. You are pregnant or breast feeding or suffer from kidney disease.
4. You have mental illness, epilepsy or Parkinsons disease.
5. You get symptoms of asthma, inflammation of the nose or blotches on the skin after taking aspirin or other non-steroidal anti-inflammatory agents.
6. You suffer from serious liver, kidney or heart problems.
7. You are taking any other non-steroidal anti-inflammatory agents.
8. You have ever suffered bleeding in your digestive tract while taking any non-steroidal anti-inflammatory agents.
9. You are pregnant or breast-feeding.
SPECIAL WARNINGS
Indometacin should be used with caution in patients with existing but controlled infection. Indometacin may cause an interaction with certain laboratory tests (the dexamethasone suppression test).
Taking 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.
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.
Tell your doctor or pharmacist before taking this medicine if:
1. You suffer from any of the following: blood abnormalities, bleeding conditions, Crohn’s disease, inflammation of the colon.
2. You have a history of any of the following: Gastro intestinal ulcers, haematemesis, melena.
3. You have kidney, liver or heart problems.
4. You are pregnant or breast feeding.
5. You have a history of high blood pressure and/or heart failure.
6. You suffer from or have previously suffered from asthma.
7. You suffer from systemic lupus erythematous or mixed connective tissue disorders.
ARE YOU TAKING ANY OTHER MEDICINES?
You should consult your doctor BEFORE taking any other medicines, including any of the following:
• Medicines used to treat high blood pressure.
• Diuretics (drugs which increase urine production).
• Medicines used for heart conditions e.g. digoxin
• Medicines used to treat depression e.g. lithium
• Methotrexate
• Ciclosporin or tacrolimus (immunosuppressive drugs used to prevent rejection after transplant surgery).
• Mifepristone (used in abortions)
• Other non-steroidal anti-inflammatory drugs.
• Corticosteroids (steroidal medicines)
• Medicines used to thin the blood (anticoagulants)
• Quinolone antibiotics (drugs used to treat infections)
• Probenecid (used to treat gout, a form of arthritis).
• Diflunisal (used to treat rheumatic pain and inflammation, and painful periods).
TAKING YOUR MEDICINE:
To be taken orally.
Adults: 50 to 100mg, increasing to 150 to 200mg daily in divided doses. (Your doctor will decide upon a suitable dose for you).
Elderly patients: Your doctor may decide to give you a reduced dose.
Children: Not recommended for children.
NOTE:
If you forget to take a dose or take too many capsules, contact your doctor or pharmacist at once for advice.
IMPORTANT:
Keep taking these capsules for as long as your doctor or pharmacist advises.
SIDE EFFECTS:
Some people may suffer from stomach ulcers, nausea, vomiting, diarrhoea, wind, constipation, indigestion and abdominal pain.
Patients may also experience hypersensitivity reactions, the symptoms of which may include wheezing or shortness of breath, skin rash, itching, bruising or painful red areas. Other possible side effects include fluid retention, kidney failure and related problems, liver function disorders including hepatitis and jaundice, visual disturbances, headaches, tingling sensation, aseptic meningitis (the symptoms of which include stiff neck, headache, nausea, vomiting, fever or disorientation).
Other possible side effects are depression, confusion, hallucinations, ringing in the ears, vertigo, dizziness, weakness, tiredness and drowsiness, blood disorders (including anaemia) and sensitivity to light.
Allergic reactions may occur in Aspirin sensitive patients.
Indometacin may provoke or worsen asthma.
Other side effects include light headedness, insomnia, psychiatric disturbances, fainting, convulsions, coma, blurred vision and other effects on the eye, oedema (fluid retention in tissues) weight gain, high blood pressure, blood in the urine, skin rashes and other skin reactions, reversible hair loss, nose bleeds, blood disorders and vaginal bleeding may occur. 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 above or have any other side effects these should be reported to your doctor or pharmacist immediately.
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek 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:
Indigestion or heartburn.
Abdominal pain (pain in your stomach) or other abnormal stomach symptoms).
STORING YOUR MEDICINE:
Keep container tightly closed and store in a dry place at or below 25°C. Keep them in the pack they came in, do not transfer them to another container. Keep all medicines out of reach of children. Do not take these capsules after the expiry date shown on the label.
REMEMBER:
These capsules are only for you. Only a doctor or pharmacist can give them to you. Never give them to anyone else, even if they have the same symptoms as you have.
Revised on: March 2014.
This leaflet is a summary of information about your medicine. It does not contain all the information, if you have any questions, ask your doctor or pharmacist.