INDOMETHACIN CAPSULES BP 25 MG - Patient leaflet, side effects, dosage

What Indometacin is and what it is used for

Indometacin belongs to a group of medicines known as Non -Steroidal Anti-Inflammatory Drugs (NSAIDs). Indometacin is a pain-reliever and antipyretic (reduces fever).

Indometacin works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles.

Indometacin is used to treat the following conditions:

• ■ Rheumatoid arthritis

• ■ Osteoarthritis

• ■ Lower back pain

• ■ Gout

• ■ Muscular pain

• ■ Period pain

• ■ Disease of the hip joint

• ■ Ankylosing spondylitis (arthritis in the spine)

• ■ Inflammation, pain and swelling following bone and joint operations

• ■ Musculo-skeletal disorders such as sprains, strains and other injuries

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What you need to know before you take Indometacin

Do not take Indometacin:

• ■ If you are allergic (hypersensitive) to Indometacin, other NSAIDs or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”)

• ■ If you have taken other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) before (including aspirin and ibuprofen) and had an allergic reaction, such as asthma, skin rashes, swelling, runny nose (see section 4 “Possible side effects”)

• ■ If you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of proven ulcers or bleeding

• ■ If you have severe liver, kidney or heart failure

• ■ If you are in the last trimester (3 months) of pregnancy or are breast-feeding (see ‚Pregnancy and breast-feeding‘, section)

• ■ If you have a history of stomach lesions, bleeding or perforation, which is related to taking NSAIDs

• ■ If you have a growth in your nose (nasal polyps)

• ■ If you are giving this medicine to a child

Warnings and precautions

Talk to your doctor before taking Indometacin:

• ■ If you are taking other NSAIDs such as aspirin (see “Other medicines and Indometacin” section)

• ■ If you suffer from or have ever suffered from bronchial asthma

• ■ If you have problems with your kidneys, as you should be closely monitored and a lower daily dose should be used

• ■ If you suffer from liver problems

• ■ If you suffer from heart problems including high blood pressure, heart failure and heart disease or are at risk of heart disease (high cholesterol levels, diabetic, smoker)

• ■ If you suffer from conditions prone to fluid retention, as the use of NSAIDs may result in deterioration of kidney function and may cause fluid retention and swelling which may further aggravate these conditions. Your dose of Indometacin should be kept as low as possible and kidney function should be monitored

• ■ If you currently have an infection (treated or not) or you are receiving treatment with live vaccines as Indometacin may mask the signs and symptoms of an infection, so antibiotic therapy should be started promptly if an infection occurs during treatment with Indometacin

• ■ If you suffer from a mental disorder, epilepsy or parkinsonism (tremor, stiffness and shuffling) as Indometacin may aggravate these disorders

• ■ If you have problems with your blood clotting

• ■ If you have a history of inflammatory bowel or intestine disease such as ulcerative colitis or Crohn’s disease, as these conditions may become worse whilst taking Indometacin. Treatment should commence on the lowest dose possible. Combination treatment with protective medicines should be considered and also if you require a low dose of aspirin, or other medicines likely to increase risk of stomach problems

• ■ If you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disorders

• ■ If you are a woman trying to conceive a baby (see ’Pregnancy and breast-feeding and fertility’ section)

• ■ If you are older, as you are more at risk of having side effects, especially stomach bleeding and perforation

• ■ If you have rheumatoid arthritis as eye changes may occur and periodic eye examinations are recommended

• ■ If you are taking corticosteroids, Selective Serotonin-Reuptake Inhibitors (SSRI’s) or anticoagulants such as warfarin (see “Other medicines and Indometacin” section)

Other medicines and Indometacin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Indometacin should not be taken with the following:

• ■ Other NSAIDs, such as aspirin, diflunisal, ibuprofen

• ■ Ritonavir, used to treat HIV and AIDS

• ■ Triamterene, used to treat high blood pressure and water retention (diuretic)

Other medicines which may interact with Indometacin:

• ■ Medicines to thin the blood, such as warfarin (anticoagulants)

• ■ Methotrexate, used to treat some cancers, psoriasis and rheumatoid arthritis

• ■ Ciclosporin or tacrolimus, used to suppress the body's immune system after an organ transplant. Kidney function should be monitored carefully

• ■ Mifepristone, used in the termination of pregnancy. Indometacin should not be used for 8–12 days after mifepristone as it can reduce the effect of mifepristone

• ■ Corticosteroids, used to reduce inflammation, such as betamethasone

• ■ Quinolone antibiotics, used to treat bacterial infections, such as ciprofloxacin. You may have an increased risk of developing fits (convulsions)

• ■ Lithium and haloperidol, used to treat mental illness

• ■ Medicines used to treat high blood pressure, such as atenolol (beta-blockers), doxazosin (alpha blockers), losartan (angiotensin II antagonists), hydralazine (vasodilator), nifedipine (calcium channel blocker) and captopril (ACE inhibitor)

• ■ Probenecid, used for gout

• ■ Diuretics (water tablets), such as furosemide and thiazides or other diuretics

• ■ Cardiac glycosides, used to treat heart conditions, such as digoxin

• ■ Selective Serotonin Reuptake Inhibitors (SSRIs), such as paroxetine, used to treat depression

• ■ Oral medicines for diabetes, such as glimepiride (sulphonylureas)

• ■ Zidovudine, used to treat viral infections

• ■ Desmopressin, used for night time bed wetting (hormone preparation)

• ■ Baclofen, used to relax muscles

• ■ Pentoxifylline, used to treat poor circulation and leg ulcers

• ■ Phenylpropanolamine used to treat nasal congestion associated with colds, allergies, hay fever, or other respiratory illnesses

• ■ Tiludronic acid, used to treat bone diseases

Effects on laboratory tests

Indometacin may cause a false-negative result in the Dexamethasone Suppression Test (DST).

Indometacin with food and drink

You should take Indometacin with food, milk or an indigestion remedy (antacid) in order to reduce the risk of stomach problems.

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Indometacin.

Pregnancy

• ■ Indometacin must not be taken during the last 3 months of pregnancy.

• ■ It should also not be taken during the first 2 trimesters of pregnancy unless necessary.

• ■ If indometacin is used during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

Breast-feeding

Small amounts of Indometacin pass into breast milk, therefore, it should be avoided whilst breast-feeding.

Fertility

• ■ 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.

• ■ If indometacin is used when attempting to conceive, the dose should be kept as low and duration of treatment as short as possible.

Driving and using machines

Indometacin may make you feel dizzy, sleepy, tired, cause headaches or affect your vision. If affected, do not drive or operate machinery or pursuing any activity in which full attention is required.

Indometacin contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Indometacin

Always take Indometacin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• ■ These capsules are to be taken orally

• ■ You should swallow the capsules whole, with food, milk or an indigestion remedy (antacid) to reduce the risk of stomach problems

• ■ Side effects may be minimised by using the lowest effective dose for the shortest length of time necessary to control your symptoms

• ■ For chronic (long-lasting) conditions, your treatment should be started on a low dose and gradually increased to give the best result

Adults:

The usual dose is 50 – 200mg a day given in divided doses.

Acute gouty arthritis

• ■ The usual dose is 150 – 200mg a day given in divided doses.

• ■ Treatment should continue until all symptoms disappear.