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PACKAGE LEAFLET: INFORMATION FOR THE USER

INDOMETACIN 25mg CAPSULES

Indometacin

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

The name of your medicine is Indometacin 25mg capsules. They contain the active ingredient called Indometacin.

Indometacin is one of the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are painkillers and reduce inflammation.

Indometacin Capsules are used for:

•    Arthritis (characterised by pain and stiffness in your body) like:

•    Rheumatoid arthritis, an inflammatory joint disease (including juvenile rheumatoid arthritis or Still’s disease, occurring mainly in children causing joint swelling, stiffness and sometimes reduced motion).

•    Ankylosing spondylitis (a type of arthritis of the spine)

•    Osteoarthritis (causing pain, swelling and reduced motion in your joints), often related to aging or to an injury.

•    Degenerative joint disease of hip

•    Acute musculoskeletal disorders

•    Low Back Pain

•    Acute Gout (severe joint pain and swelling)

•    Inflammation, pain and oedema (swelling caused by excessive fluid accumulating in body tissue) following orthopaedic procedures

•    Dysmenorrhoea or Period Pain.

2. BEFORE YOU TAKE INDOMETACIN CAPSULES

Do not take Indometacin Capsules if you:

•    are allergic (hypersensitive) to indometacine, aspirin, other NSAIDs (for example ibuprofen) or any of the ingredients in the capsule. See section 6.

•    have spontaneous swelling of the lips, cheeks, eyelids, tongue, soft palate, pharynx, and glottis, frequently associated with allergy to food or drugs and lasting from several hours to several days

•    suffer from asthma, especially if you also have frequent stuffed or runny nose or swelling of the inside of the nose

•    suffer from liver or kidney disease.

•    have ever had bleeding in your digestive tract

•    have or had two or more episodes of peptic ulcers, stomach bleeding or perforation.

•    get blurred or poorer vision, blind spots, or changes in colour vision

•    are in the last three months of pregnancy.

Take special care with Indometacin Capsules if you

•    suffer from high blood pressure

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

•    have bleeding disorders or blood clotting problems

•    suffer from epilepsy

•    suffer from ulcers or holes in the stomach or intestine

•    have or ever had Crohn’s disease (inflammation of the digestive system) or ulcerative colitis (disease that causes ulcers in the lining of the rectum and colon)

•    have or ever had lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys)

•    suffer from a psychiatric disorder (mental problems) or tremor, stiffness and shuffling

•    currently have an infection (treated or not) or are receiving treatment with live vaccines

•    suffer from a condition called systemic lupus erythematosus [(SLE) problem with the body’s normal immune system response] or any other connective tissue disorder

•    are due to have an operation, including dental surgery.

•    suffer from neurological syndrome called Parkinsonism.

Note: Medicines such as Indometacin Tablets may be associated with a small increased risk of heart attack 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 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.

Taking other medicines

You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Indometacin Capsules.

Examples of medicines that can affect Indometacin Capsules are:

•    any other anti-inflammatory pain killers

•    Salicylates or other NSAIDs including Diflunisal

•    SSRI antidepressants

•    Metformin or Sulphonylureas to treat diabetes

•    Atenolol, Captopril, Doxazosin, Hydralazine, Losartan, Nifedipine, Propranolol or Quinipril to treat high blood pressure

•    Haloperidol to treat mental problems

•    Zalcitabine (antiviral)

•    Zidovudine to treat human immunodeficiency virus (HIV) infection

•    Benzodiazepines like Diazepam to treat depression

•    Cyclophosphamide to treat certain type of cancer

•    Desmopressin to treat night-time bed wetting

•    diuretics (water tablets)

•    Digoxin to treat heart

•    Lithium to stabilise, normalise or even-out mood swings

•    Cyclosporin used to dampen down the body’s immune reactions

•    Mifepristone used to induce abortion in first two months of pregnancy

•    Corticosteroids

•    Warfarin to prevent blood clots

•    Clopidogrel used as an anti-platelet agent

•    Ciprofloxacin antibiotics called quinolones

•    Tacrolimus to prevent rejection of liver transplants

•    Phenytoin to treat epilepsy

•    Probenecid to treat gout

•    Baclofen - muscle relaxants

•    Muromonab-CD3 used to reduce the body’s natural immunity in patients who receive organ (for example, kidney) transplants

•    Tiludronic acid to treat bone diseases

•    Triamterene to control fluid levels in the body

•    Vasodilators (relaxes the smooth muscle in blood vessels)

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

Effects on laboratory tests

Indometacin Capsules may alter the results of some blood or urine tests. If you your doctor or go into hospital, let them know what medicines you are taking.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your symptoms carefully and will probably order certain tests (like liver, blood, eye tests, etc) to check your body's response to Indomethacin. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Pregnancy and Breast-feeding

Indometacin Capsules and Ibuprofen belongs to a group of medicines which 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. Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking ibuprofen, call your doctor. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

NSAIDs can cause headache, dizziness, drowsiness, fatigue and visual changes. If you are affected, do not drive or use machinery.

Important Information about some of the ingredients of Indometacin Capsules

Indometacin Capsules contain Lactose Monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Also contains Tartrazine (E102). May cause allergic reactions.

3. HOW TO TAKE INDOMETACIN CAPSULES

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

These capsules should be swallowed whole preferably with meals, milk or an indigestion remedy (antacid).The usual dose is:

Adults:

The usual dose is 50-200mg each day in divided doses.

Acute gouty arthritis: The usual dose is 150-200mg each day in divided doses until all symptoms and signs subside.

Dysmenorrhoea: The usual dose is upto 75mg each day starting with onset of cramps or bleeding, and continuing for as long as the symptoms usually last.

Elderly:

The risk of side effects is greater in the elderly, so your doctor will give you the lowest dose possible, and take special care of you.

Children: Not recommended.

Ibuprofen may be associated with a small increase 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 take more Indometacin Capsules than you should

If you or someone you know accidentally takes a lot more than the stated dose (an overdose), you should contact a doctor immediately or go to the nearest A& E department. Symptoms of overdose include feeling sick, vomiting, intense headache, drowsiness, dizziness, mental confusion, disorientation, laziness and fainting.

If you forget to take Indometacin Capsules

If you forget to take a dose, 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 one.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Indometacin Capsules can cause side effects,

although not everybody gets them.

If any of the following happens, STOP TAKING Indometacin

capsules and tell your doctor immediately or go to the nearest

hospital emergency department:

•    Rare allergic (Hypersensitive) reactions such as difficulty of breathing, swelling of your face, throat or tongue, skin rash itching, hives, blisters, blood spots, swelling of the skin with wheals and, less often, blistering skin diseases which may appear like a burn, or as a red/purple rash, or a scaly skin

•    become jaundiced (yellow skin or eyes)

•    have indigestion or heartburn, abdominal pains (pains in your stomach) or other abdominal symptoms

•    have prolonged headache, tell your doctor.

•    Aseptic meningitis can occur in some patients. This may show as a combination of symptoms such as headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light. If you experience any of these symptoms seek medical attention immediately.

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

•    If you pass blood in your faeces, pass black tarry stools or vomit

blood or dark particles that look like coffee grounds.

Other side effects are:

•    Effects on the blood - changes in the numbers and types of blood cells. If you develop bruising, sore throats, nose bleeds or infections tell your doctor who may wish to test your blood.

•    Effects on the nervous system - fatigue, drowsiness, dizziness, headaches, problems with speech, fainting, nervousness, coma, lightheadedness, 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.

•    Effects on the eye - pain in and around the eye, blurred or double vision, inflammation of the optic nerve, deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina).

•    Effects on the ears - ringing or buzzing or other hearing disturbances (rarely deafness).

•    Effects on the heart - swelling especially of ankles, high or low blood pressure, chest pain, fast or irregular heart beats and heart failure.

•    Effects on the stomach - feeling or being sick, abdominal pain or discomfort, loss of appetite, constipation or diarrhoea, flatulence, inflammation of the mouth or guts or worsening of these conditions and ulceration of the intestines which can cause bleeding, obstruction or can perforate (burst), worsening of Crohn’s disease or ulcerative colitis.

•    Effects on the liver - inflammation, jaundice (yellow skin or eyes see above).

•    Effects on the skin - sensitivity to light, worsening of psoriasis.

•    Effects on the kidney - inflammation, disease or failure, blood or protein in the urine and increase in blood urea.

•    Other effects - increase in blood sugar, sugar in the urine, high blood potassium, bleeding from the vagina, breast changes (enlargement, tenderness, breast development in men), flushing, sweating, mouth ulcers, muscle weakness and worsening of cartilage damage.

If any of the side effects gets serious, or if you notice any side effects

not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE INDOMETACIN CAPSULES

Keep out of the reach and sight of children.

Do not store above 25°C. Keep them in the original pack. Do not take these capsules after the expiry date shown on the pack. 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.

6. FURTHER INFORMATION

What Indometacin Capsules contains

The active substance is Indometacin. The other ingredients are Polysorbate 80, Colloidal Anhydrous Silica, Lactose Monohydrate and Purified Talc. The capsule shell contains Gelatin and the colours Erythrosin (E127), Tartrazine (E102) and Titanium Dioxide (E171).

What Indometacin Capsules looks like and contents of the pack

Indometacin 25mg capsules are ivory coloured, hard gelatin capsules.

Pack sizes: 84, 100, 250, 500 and 1000 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Special Concept Development (UK) Limited,

Unit 1-7 Colonial Way, Watford,

Hertfordshire, WD24 4YR

PL 36722/0029

This leaflet was last revised in 11/2013