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INFLAMID 25MG

Active substance(s): INDOMETACIN / INDOMETACIN / INDOMETACIN

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PATIENT INFORMATION LEAFLET
INDOMETACIN 25mg CAPSULES
Inflamid 25mg 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.
IN THIS LEAFLET
1. What Indometacin Capsules are and what they are used for
2. What you need to know before you take Indometacin Capsules
3. How to take Indometacin Capsules
4. Possible side effects
5. How to store Indometacin Capsules
6. Contents of the pack and other information
1. WHAT INDOMETACIN CAPSULES ARE AND WHAT THEY ARE USED FOR
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
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOMETACIN CAPSULES
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 applies 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, breast-feeding and fertility
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.
3. HOW TO TAKE INDOMETACIN CAPSULES
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.
4. POSSIBLE SIDE EFFECTS
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, sensitivity to light, worsening of psoriasis, hair loss, sweating
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.

5. HOW TO STORE INDOMETACIN CAPSULES
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 25oC) 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Indometacin Capsules contain
The name of your medicine is Indometacin Capsules. Each capsule contains 25mg 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”.
Indometacin 25mg Capsules are available in packs of 28, 84, 100, 500 and 1000 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.

PL 06453/0013
This leaflet was last revised August 2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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