PATIENT INFORMATION LEAFLET

Indometacin Capsules 25mg and 50mg

What Indometacin is and what it is used for

Indometacin belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is a painkiller and antipyretic (reduces fever). Indometacin works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles.

There are a number of painful conditions that can affect your joints and muscles, which can be helped by taking Indometacin. These conditions include:

■    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, such as backache or neckache

|2 Before you take Indometacin

Do not take Indometacin:

■    if you are allergic (hypersensitive) to Indometacin or any of the other ingredients in these tablets (these are listed in section 6)

■    if you have taken other non-steroidal anti-inflammatory drugs (NSAIDs) before (including aspirin and ibuprofen) and had an allergic reaction, such as asthma, redness and itching of the skin, swelling of the face or throat, itchy, running nose

■    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 peptic ulcers, stomach bleeding or perforation

■    if you have severe liver, kidney or heart disease

■    if you are in the last trimester (3 months) of pregnancy (see 'Pregnancy and breast-feeding', Section 2)

■    if you have a history of stomach 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

Take special care with Indometacin:

■    if you suffer or have ever suffered from bronchial asthma

■    if you have problems with your kidneys, liver or heart (including congestive heart failure), you are taking diuretics ('water tablets'), have diabetes or you are elderly

■    if you currently have an infection (treated or not) or you are receiving treatment with live vaccines

■    if you suffer from a mental disorder, epilepsy or Parkinsonism (tremor, stiffness and shuffling)

■    if you have problems with your blood clotting

■    if you have a history of high blood pressure or ever suffered heart failure, as these conditions may cause fluid retention

■    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

■    if you have systemic lupus erythematosus (SLE) or mixed connective tissue disorders with symptoms such as joint pain, skin rash or fever

■    if you are elderly, 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

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

Please note: 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.

Indometacin may mask the signs and symptoms of an infection, so antibiotic therapy should be started promptly if an infection occurs during treatment.

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, or any of the following:

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

■    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

■    Mifepristone, used in the termination of pregnancy

■    Corticosteroids, used to reduce inflammation, such as betamethasone

■    Quinolone antibiotics, used to treat bacterial infections, such as ciprofloxacin

■    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

■    Tiludronic acid, used to treat bone diseases

Taking 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

If you are pregnant you should not take Indometacin, unless

told to do so by your doctor.

During the first and second trimester of pregnancy, Indometacin should not be given unless clearly necessary. If Indometacin is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

Indometacin must not be taken during the third trimester (last 3 months) of pregnancy. It should also not be taken during labour, unless told to do so by your doctor.

Small amounts of Indometacin pass into breast milk. Therefore, it should be avoided whilst 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Indometacin may make you feel dizzy, sleepy, tired or affect your vision. If affected, do not drive or operate machinery.

Effects on laboratory tests

Indometacin 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.

Important information about some of the ingredients

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 medicine.

How to take Indometacin

Always take Indometacin exactly as your doctor has told you

to. You should check with your doctor or pharmacist if you

are not sure.

Dosage

■    These capsules are for oral administration

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

■    The dose you should take will depend on what you are taking Indometacin for

■    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 in divided doses.

Acute gout (gouty arthritis)

The usual dose is 150 - 200mg a day in divided doses. Treatment should continue until all symptoms and signs disappear.

Period pains

The usual dose is up to 75mg a day. Treatment should start with the onset of cramps or bleeding and continue for as long as the symptoms last.

Elderly:

If you are elderly you are more likely to have side-effects when you take your capsules.The dose you take will be similar to other adults but should be the lowest dose that is effective.

continued....

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Your doctor will monitor you regularly for signs of gastrointestinal bleeding but if you notice any signs of bleeding in your stomach or gut (e.g. black, tarry stools or if you vomit blood) stop taking Indometacin and tell your doctor straight away.

Children:

Children should not take this medicine.

If you take more Indometacin than you should

If you take more capsules than you should, contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose include feeling or being sick, headache, stomach pain or bleeding, diarrhoea, dizziness, feeling disorientated, ringing in the ears, fits, feeling excited, sleepy, lethargic, fainting, mental confusion or coma. Take this leaflet and any remaining capsules with you.

If you forget to take Indometacin

If you forget to take Indometacin, 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 Indometacin

Do not stop taking Indometacin without talking to your doctor, even if you feel better. It is important that you take the full course of Indometacin prescribed by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Indometacin can cause side effects, although not everybody gets them.

Very serious side effects - If you suffer from any of the following at any time during your treatment STOP TAKING Indometacin and seek immediate 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 Indometacin and tell your doctor if you

experience:

■    Indigestion or heartburn

■    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms

Other serious side effects - If you suffer from any of the following STOP TAKING Indometacin and tell your doctor immediately:

Allergic reaction, which may cause the following:

■    difficulty in breathing and dizziness (anaphylaxis), tight chest, breathlessness, wheezing, shortness of breath, swelling and irritation inside the nose, swelling of the face, throat or tongue, sore dry itchy skin, or severe skin rashes

■    blistering of the skin, mouth, eyes and genitals, scaling or peeling of the skin (Steven-Johnson syndrome)

Liver problems, which may cause the following:

■    high temperature, feeling tired, loss of appetite, stomach pain, being sick (hepatitis)

■    yellowing of the skin or whites of the eyes (jaundice)

■    itchy rash, fever, excessive sweating

Kidney failure

■    swelling, especially of the legs and feet, little or no urine output, thirst and a dry mouth, rapid heart rate, feeling dizzy when you stand up, loss of appetite, feeling or being sick, feeling confused, anxious and restless or sleepy, pain on one side of the back, just below the rib cage

Blood problems which may cause the following:

■    sudden bruising or bleeding from multiple sites in the body

Aseptic meningitis

■    headache, fever, stiff neck, feeling or being sick, feeling disorientated

Other possible side effects:

Rare or infrequent side effects

■    loss of appetite

■    abdominal discomfort

■    abdominal pain or worsening of the condition in patients with ulcerative colitis or Crohns's disease or development of this condition

■    flushing

■    protein in the urine, which causes the urine to be foamy and blood in the urine

■    increase in urea in the blood (detected through a blood test)

■    low level of white blood cells, which may make infections more likely

■    small round flat dark-red spots caused by bleeding into the skin

■    bruising

■    changes in the number and type of blood cells, which may cause weakness, bruising, make infections more likely, pale yellow skin, breathlessness and increase the risk of bleeding

■    blurred or double vision

■    complete or partial loss of vision due to inflammation of the optic nerve

■    pain in and around the eye

■    deafness

■    nose bleed

The following side effects reported infrequently, usually disappear but if they become severe, treatment may need to be stopped:

■    feeling anxious

■    fainting

■    hearing problems

■    fits

■    coma

■    weakness, tingling or numbness

■    involuntary movements

■    difficulty sleeping

■    mental problems such as feeling as things are not real (depersonalisation)

■    worsening of epilepsy and tremors, stiffness and shuffling (Parkinsonism)

Other side effects reported

■    feeling or being sick

■    constipation

■    diarrhoea

■    wind (flatulence)

■    indigestion

■    stomach pain

■    inflamed mouth ulcers

■    itching, itchy rash, skin rash resulting from bleeding into the skin from small blood vessels, tender bruise like swellings on the shins

■    inflammation of the blood vessels

■    increased sensitivity to light

■    loss of hair

■    sweating

■    worsening of skin disease, which causes scaly pink patches (psoriasis)

■    swelling, particularly the hands, feet and around the eyes aching, stiff joints (oedema)

■    increase in blood pressure

■    low blood pressure, which may cause light headedness, fainting or dizziness, especially when going from sitting or lying position to standing up.

■    faster or irregular heart, feeling your heart beat, chest pain

■    shortness of breath or ankle swelling

■    inflammation of the kidney which can cause swollen ankles or high blood pressure

■    abnormal liver function tests (detected during liver blood tests)

■    visual disturbances

■    headache (usually disappears when treatment is continued or dose reduced. If headache persists treatment should be stopped)

■    light-headedness

■    tingling or numbness in the hands or feet

■    depression

■    feeling confused

■    seeing or hearing things that are not real

■    hearing problems

■    feeling of dizziness or "spinning" (vertigo)

■    dizziness

■    feeling unwell

■    tiredness or feeling sleepy

■    difficulty in speaking

■    swelling in the brain

■    nervousness

■    ringing in the ears

■    muscle weakness

■    acceleration of cartilage deterioration

■    inflammation of the lining of the stomach, which may cause pain or discomfort in the upper abdomen

■    vaginal bleeding

■    enlarged or tender breasts

■    enlargement of breasts in men

■    increase in blood sugar

■    sugar in the urine

■    high levels of blood potassium which can cause abnormal heart rhythm

If you have rheumatoid arthritis and been taking Indometacin for a long time, you may experience deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina).

Patients on long term therapy should have eye tests.

Medicines such as Indometacin may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

15 How to store Indometacin

Keep all medicines out of the reach and sight of children.

Store in the original package in order to protect from light. Store below 30°C.

Do not use Indometacin after the expiry date, which is shown on the label or carton. The expiry date refers to the last day of that month.

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 to protect the environment.

15 Further information

What Indometacin contains

The active ingredient is Indometacin 25mg or 50mg.

The other ingredients are magnesium stearate, sodium lauryl sulphate, sodium starch glycolate and lactose.

The capsule shell contains gelatine, erythrosin (E127), quinoline yellow (E104) and titanium dioxide (E171).

What Indometacin looks like and contents of the pack

Indometacin Capsules BP 25mg are ivory coloured with the markings IND 25.

Indometacin Capsules BP 50mg are ivory coloured with the markings IND 50.

Indomethacin Capsules BP 25mg are available in packs of 28, 30, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 capsules

Indomethacin Capsules BP 50mg are available in packs of 28, 100, 250, 500 or 1000 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon,

St Neots, Cambridgeshire PE198ET United Kingdom

Product Licence Numbers:

Indometacin 25mg: PL 11311/0355 Indometacin 50mg: PL 11311/0356

Date of last revision: March 2013

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Till-Ver.12.1s