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Indometacin Suppositories 100mg

Please read this leaflet carefully before you start to take your medicine.

It gives you important information about your medicine.

If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.

Keep the leaflet until you have finished the medicine.

What’S In Your Medicine

The active ingredient in this medicine is Indometacin. This is the new name for Indomethacin. The ingredient itself has not changed.

Indometacin Suppositories come in one strength and are yellow. Each suppository contains 100mg of Indometacin and
vegetable fat.

Indometacin Suppositories are available in pack sizes of 10s. Your suppositories are made by

Actavis

Barnstaple

EX32 8NS

who are also the Marketing Authorisation holder.

About Your Medicine

Indometacin is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

These medicines are pain killers which reduce swelling.

Indometacin Suppositories may be used for:

inflammatory diseases of the joints or surrounding tissue such as rheumatoid arthritis, osteoarthritis and degenerative hip disease

deformity and stiffening of the backbone (ankylosing spondylitis)

muscular pain, low back pain and pain following bone or joint surgery

period pain

gout.

Before Using Your Medicine

Do not use Indometacin Suppositories if you:

have ever had an allergic reaction to indometacin suppositories or any of the ingredients in the suppository. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

have experienced asthma attacks, allergic skin reactions swelling, especially of the throat, or rashes, or a runny nose while taking aspirin or any other NSAIDs or COX II inhibitors (e.g. celecoxib)

have haemorrhoids (piles) or inflammation or bleeding of the back passage

have now or have previously had stomach ulcers or bleeding in the digestive system

have severe liver, kidney or heart disease

suffer with nasal polyps

are in the last three months of pregnancy

are giving the suppositories to a child under 12 years old.

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 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.

Check with your doctor or pharmacist before using Indometacin Suppositories if you:

have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product as it contains lactose

have bleeding disorders or blood clotting problems

suffer from a psychiatric disorder, epilepsy or parkinsonism

have kidney problems

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

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

suffer from asthma

suffer from any diseases of the bowel such as Crohn’s disease or ulcerative colitis

have systemic lupus erythematosus (SLE) or other connective tissue disorders

are due to have an operation.

Check with your doctor or pharmacist if you are taking any of the following:

aspirin or related medicines (salicylates)

other NSAIDs including diflunisal

quinolone antibiotics (such as ciprofloxacin)

SSRI antidepressants (eg paroxetine)

sulphonylureas (used to treat diabetes)

medicines used to treat high blood pressure (such as atenolol, captopril, doxazosin, hydralazine, losartan, nifedipine, propranolol or quinipril)

anti-platelet medicine or drugs to stop the blood clotting

lithium or haloperidol (psychiatric medicines)

anti-viral medicines (such as zidovudine or ritonivir)

cardiac glycosides (used to treat heart conditions eg digoxin)

ciclosporin or tacrolimus (immune system medicine)

corticosteroids (anti-inflammatories)

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

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

thiazides, furosemide and triamterene (control fluid levels in the body)

mifepristone (used to induce abortion)

baclofen (muscle relaxant)

pentoxifylline (used to treat vascular disease)

probenecid (a treatment for gout)

tiludronic acid (used to treat bone diseases)

Pregnancy and Breast-feeding:

Indometacin Suppositories 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 you ARE pregnant or are breast feeding
speak to your doctor or pharmacist before taking this medicine.

Driving and using machines:

Indometacin Suppositories may make you feel drowsy, dizzy or affect your vision. Make sure you are not affected before you drive or operate machinery.

Other precautions you should take:

Indometacin Suppositories 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.

Using Your Medicine

Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions exactly, and those on the pharmacy label. If you do not understand anything, ask your doctor or pharmacist.

The usual dosage(s) are described below:

Adults: One suppository to be inserted into your back passage (rectum) at night and repeated in the morning if necessary.

Elderly: Your doctor may prescribe you a different dose and monitor your progress more closely.

Children: Not recommended.

These suppositories should be used as instructed and inserted into the back passage, they must not be swallowed.

If you forget to use Indometacin Suppositories:

If you forget to use a suppository, use another as soon as you remember unless it is nearly time to use the next one.

NEVER insert two suppositories at the same time. Use the remaining doses at the correct time.

If you use more Indometacin Suppositories than you should:

Do not insert more suppositories than your doctor tells you to. If you insert more than the stated dose or you or a child accidentally swallows a suppository, go to the nearest hospital casualty department or tell your doctor immediately. If an overdose has been taken there may be signs such as headache, feeling or being sick, stomach pain or bleeding, drowsiness, dizziness, ringing in the ears or fainting.

After Using Your Medicine

Like many medicines, indometacin may occasionally cause side-effects in some patients, particularly when you first start taking it. These may include effects on the nervous system such as headaches and dizziness. If you get a prolonged headache, tell your doctor.

If you develop a rash or become jaundiced (yellow skin or eyes) stop taking indometacin and talk to your doctor immediately.

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 suffer from any of the following at any time during your treatment STOP USING the medicine and seek immediate medical help: pass blood in your faeces, pass black tarry stools or vomit blood or dark particles that look like coffee grounds. STOP USING the medicine and tell your doctor if you experience: indigestion or heartburn, abdominal pains (pains in your stomach) or other abdominal symptoms.

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.

Allergic reactions - skin rash which may be itchy, itching, redness, swelling especially of the throat, difficulty breathing, asthma and fluid in the lungs.

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).

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, muscle weakness, worsening of cartilage damage and mouth ulcers.

Effects associated with the use of Indometacin Suppositories - bleeding, inflammation, burning pain, discomfort, itching or the feeling of a full back passage.

Tell your doctor if you notice or are worried by any of the side effects listed or notice any other effects not listed.

If you get any other unusual effects, tell your doctor or pharmacist immediately and seek advice.

Storing Your Medicine

Do not use the suppositories after the end of the expiry month (use by date) shown on the product packaging.

Keep the suppositories stored in a cool place.

Do not transfer them to another container.

KEEP INDOMETACIN SUPPOSITORIES OUT OF THE REACH AND SIGHT OF CHILDREN IN A SECURE PLACE.

REMEMBER that this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Return all unused medicines to your pharmacist for safe disposal.

Date of last revision: March 2007

If you would like a leaflet with larger text, please contact 01271 311257.