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PATIENT INFORMATION LEAFLET

INDOMETACIN 25mg AND 50mg CAPSULES

Read all of this leaflet carefully before you start taking this medicine as it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Indometacin belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Indometacin works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. Indometacin is used to relieve some symptoms caused by:

•    gout (pain and inflammation of the joints)

•    rheumatoid arthritis

•    osteoarthritis

•    acute musculoskeletal disorders (e.g. sprains, strains and other injuries, such as backache and neck ache)

•    lower back pain

•    ankylosing spondylitis (arthritis of the spine)

•    degenerative hip disease

•    pain following bone and joint surgery

•    period pain

DO NOT take Indometacin Capsules if you:

•    are allergic (hypersensitive) to indometacin or any other ingredients in these capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

•    suffer from severe heart failure, a disease of the heart that causes shortness of breath and swelling of the feet or legs due to fluid build up

•    suffer from porphyria (disorder in which an important part of blood, haem, is not made properly)

•    have previously taken another NSAID (including aspirin) and suffered an allergic reaction including skin rashes, swelling (especially of the throat) or a runny nose

•    have a stomach ulcer or bleeding in your stomach, or have had more than one episode of stomach ulcers, stomach bleeding or perforation

•    suffer from severe liver or kidney disease

•    suffer from nasal polyps (growths within the nose)

•    are in the last three months of pregnancy or breast-feeding

Indometacin capsules must NOT be used in children.

If any of the above applies to you, you should NOT take indometacin. Tell your doctor IMMEDIATELY.

Take special care with Indometacin Capsules if you:

•    are taking other anti-inflammatory agents, including aspirin

•    suffer from asthma

•    have kidney problems, especially if you are also elderly, have diabetes, have liver problems, have an infection or are taking other medicines which can affect the kidney

•    are elderly (See “Other warnings”)

•    have a bleeding or blood clotting disorder, or are taking any medicine which thins the blood or prevents blood clotting, such as warfarin or clopidogrel

•    suffer from any diseases of the bowel such as Crohn’s disease or ulcerative colitis, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/ pockets in the colon)

•    suffer from any conditions of the liver or heart that cause fluid retention, or high blood pressure

•    suffer from a psychiatric disorder, epilepsy or parkinsonism (may be made worse if taking indometacin)

•    suffer with systemic lupus erythematosus (SLE) or any other connective tissue disorder

•    develop an infection during treatment as indometacin may mask the signs of infection. Your doctor will prescribe antibiotics immediately if this occurs during your treatment

•    are receiving treatment with live vaccines

•    notice changes to your eyes - you may need to have eye checks if you are taking this medicine for a long period of time

•    are due to have an operation

Other warnings:

If you are elderly or you have previously had stomach ulcers, you have a higher risk of getting side effects, especially from the stomach. Your doctor should therefore prescribe the lowest dose that gives you sufficient relief. If you experience any unusual symptoms from the stomach, you must tell your doctor about it.

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, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking pain killers for headaches too often or for too long can make them worse.

Tell your doctor if any of the above apply to you.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription, herbal and homeopathic remedies.

It is especially important to mention if you are taking:

•    other non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, naproxen or COX II inhibitors (e.g. celecoxib) or diflunisal (for pain and inflammation)

•    antidepressants (e.g. selective serotonin reuptake inhibitors (SSRIs) e.g. citalopram, fluoxetine)

•    corticosteroids (e.g. cortisone, prednisone)

•    medicines to stop the blood clotting (e.g. warfarin)

•    medicines to treat diabetes (e.g. tolbutamide, chlorpropamide, glipizide)

•    medicines to treat high blood pressure (e.g. furosemide, thiazide, triamterene, atenolol, bisoprolol, propranolol, captopril, quinapril, hydralazine, losartan, nifedipine)

•    diuretics (water tablets) such as triamterene, thiazides (e.g. bendroflumethiazide) or furosemide

•    lithium or haloperidol (medicines to treat mental illness)

•    antiviral medicines (e.g. zidovudine or ritonavir)

•    medicines to treat heart conditions (e.g. digoxin)

•    immunosuppressive drugs e.g. ciclosporin or tacrolimus (used after an organ transplant operation in order to reduce the risk of organ rejection)

•    methotrexate (used to treat some cancers, severe psoriasis and severe rheumatoid arthritis)

•    desmopressin (hormone preparation used for night-time bed wetting)

•    mifepristone (used to induce abortion)

•    baclofen (muscle relaxant)

•    pentoxifylline (used to improve blood flow through the blood vessels)

•    probenecid (used to treat gout)

•    antacids (used to relieve heartburn, upset stomach or acid indigestion)

•    tiludronic acid (used to treat bone diseases)

•    quinolone antibiotics (e.g. ciprofloxacin) to treat infection

Pregnancy and breast-feeding

DO NOT take Indometacin Capsules if you are in the last three months of pregnancy or breast feeding. You may only take indometacin capsules in the first six months of pregnancy under medical supervision. Tell your doctor if you are planning to become pregnant or if you are having problems becoming pregnant. Always speak to your doctor or pharmacist before taking any medicine.

WARNING: Indometacin belongs to a group of medicines which may affect fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Indometacin will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Driving or using machines

This medicine may make you feel drowsy, dizzy, tired or affect your vision. If affected, do not drive or operate machinery.

Tests

Your doctor may want to carry out tests to monitor your kidney and liver function, the levels of blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have or have had a history of high blood pressure or heart failure your doctor may also want to monitor you. If you have rheumatoid arthritis you may be advised to have regular eye tests to check your sight.

Effects on laboratory tests

If you need to have any tests such as blood or urine tests, tell the doctor that you are taking Indometacin Capsules. You may need to stop taking this medicine before you have the test.

You should swallow the capsules whole with a glass of water. The capsules should be taken with milk, food or immediately after meals, or with an antacid (a substance that neutralises stomach acid and helps relieve symptoms of some stomach problems).Always take Indometacin Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

In long term conditions, your doctor may start you on a lower dose and increase it as required.

DOSAGE

Adults

The usual adult dose is 50mg - 200mg daily.

Acute rheumatoid arthritis:

Initially 25mg two or three times a day.

Long term rheumatic disorders:

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, usually for 10 - 14 days. Normally 150mg daily, rarely 200mg daily.

Lower back pain:

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 bone or joint surgery:

100 - 150mg daily in divided doses until symptoms subside.

Period pain:

Up to 75mg daily, continuing for as long as symptoms last.

Elderly

If you are elderly your doctor may prescribe a lower daily dose and reduce the duration of treatment. Your doctor will see you more often while you are taking this medicine.

Children

Indometacin is not recommended for use in children.

Your doctor may advise you to take your medicine in a different way. You should always follow your doctor’s advice about when and how to take your medicine and always read the label.

If you take more of your medicine than you should

If you take more of your medicine than you should, contact your doctor or go to the nearest hospital accident and emergency department immediately. If an overdose has been taken there may be signs such as headache, feeling sick or being sick, stomach pain or bleeding, drowsiness, dizziness, ringing in the ears or fainting.

If you forget to take your medicine

If you forget to take your medicine, take it as soon as you remember, unless it is almost time for your next dose. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking your medicine

Indometacin should only be used for the shortest period of time to control your symptoms. If you feel that you do not require this medicine anymore please talk to your doctor before you stop your treatment.

Like all medicines Indometacin Capsules can cause side effects in some patients, particularly when you first start taking it.

STOP taking Indometacin Capsules and talk to your doctor IMMEDIATELY or go to your nearest hospital emergency department if you:

•    suffer any allergic reaction such as skin rash, swelling of the face, lips or throat, wheezing or difficulty breathing

•    experience severe abdominal pains (pain in your stomach) or other abnormal stomach symptoms including inflammation of the mouth, indigestion, ulceration of the intestines which can cause bleeding, obstruction or perforation, worsening of Crohn’s disease or ulcerative colitis

•    pass blood in your faeces (stools/ motions), pass black tarry stools

•    vomit blood or dark particles that look like coffee grounds

•    suffer inflammation of the liver - symptoms include fever, fatigue, nausea, stomach pain, loss of appetite, dark coloured urine, light coloured stools andabnormal liver function tests.

•    become jaundiced (yellowing of the skin and whites of the eyes)

•    develop aseptic meningitis - symptoms include headache, fever, stiff neck, tiredness, feeling ill, eyes being sensitive to bright light

•    develop blistering or peeling of the skin

•    develop irregular red patches on the skin of the hands and arms

WARNING: Medicines such as Indometacin may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke (see Section 2 ‘Other warnings’).

Other possible side effects

•    Effects on the blood: changes in the numbers and types of blood cells (this will be seen in the results of blood tests), bruising, sore throat, nose bleeds, infections

•    Effects on the nervous system: fatigue, drowsiness, dizziness, headaches, problems with speech, fainting, nervousness, coma, light-headedness, 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 (symptoms include tremor, stiffness and shuffling of the body)

•    Effects on the eye: pain in and around the eye, blurred or double vision, deposits on the front surface of the eye (cornea), poor vision and bright flashes of light or floating black spots

•    Effects on the ear: ringing or buzzing or other hearing disturbances (rarely deafness)

•    Effects on the heart: high or low blood pressure (symptoms include dizziness, fainting, lightheadedness, nausea, heart attack), chest pains, fast or irregular heartbeats and heart failure (symptoms include shortness of breath, tiredness, increased heart rate, flushing, swelling -especially of the ankles). Medicines such as indometacin may be associated with a small increased risk of heart attack or stroke.

•    Effects on the stomach: feeling or being sick, anorexia, constipation or diarrhoea, flatulence

•    Effects on the skin: rash, itching, hives, sensitivity to light, worsening of psoriasis, hair loss, sweating, skin reactions such as, blisters or skin that is red, flaky or peeling such as severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome)

•    Effects on the kidneys: may be manifested by lower back pain, fever, pain while urinating, blood in urine or kidney failure, cloudy or light red urine, urinating more often, swelling in the ankles, legs, arms or hands, weakness, muscle cramps

•    Other effects: worsening of asthma, increase in blood sugar, sugar in the urine, bleeding from the vagina, breast enlargement and tenderness, breast development in men, mouth ulcers, muscle/cartilage weakness

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.

Do not use your medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

Keep the capsules in the original container.

Protect your medicine from light, heat (store below 25^oC) and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

What Indometacin Capsules contain

The name of your medicine is Indometacin Capsules. Each capsule contains 25mg or 50mg of the active ingredient indometacin. Each capsule also contains starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, gelatin, yellow iron oxide (E172), and titanium dioxide (E171).

What Indometacin Capsules look like and contents of the pack

The 25mg strength capsule is ivory coloured and printed in black on the capsule is “INDO 25”.

The 50mg strength capsule is ivory coloured and printed in black on the capsule is “INDO 50”. Indometacin 25mg Capsules are available in packs of 28, 84, 100, 500 and 1000 capsules.

Indometacin 50mg Capsules are available in packs of 28, 84, 100, 250 and 500 capsules.

Not all pack sizes may be marketed.

Indometacin Capsules are available only on prescription from your doctor. Marketing authorisation holder

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland. Manufacturer responsible for release of this medicine

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K. Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 06453/0013 and PL 06453/0014 This leaflet was last revised July 2014.