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INDOMETHACIN 25MG CAPSULES

Active substance(s): INDOMETHACIN

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INDOMETACIN PIL 03.02.2014:Layout 1

2/4/14

1:56 PM

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PATIENT INFORMATION LEAFLET

INDOMETACIN 25MG CAPSULE

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 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. See section 4.
In this leaflet:
1. What Indometacin is and what it is used for
2. What you need to know before you take Indometacin
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 IS AND WHAT IT IS USED FOR
• Indometacin belongs to the group of medicine known as nonsteroidal anti-inflammatory drugs or NSAID’s.
• Indometacin is used for degenerative hip disease, ankylosing
spondylitis, rheumatoid arthritis, to reduce swelling, muscular
pain, low back pain, pain following bone or joint surgery, gout
and period pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
INDOMETACIN
Do not take Indometacin if you:
• think you are pregnant or you are planning to get pregnant or
are breast feeding.
• have polyps in your nose, associated with itching, nettle
rash, wheezing or swelling of the face, lips, tongue and
throat. Difficulties in swallowing or breathing.
• are allergic to Indometacin or any of the other ingredients in
this medicine (listed in section 6)
• are allergic (hypersensitive) to aspirin, ibuprofen or other
NSAIDs
• are taking other NSAIDs (e.g. naproxen) including COX II
inhibitors (e.g. celecoxib)
• have, or have ever had, peptic ulceration (ulcer in your
stomach or duodenum), or bleeding in your digestive tract,
suffer from persistent stomach problem. Symptoms may
include vomiting particles that look like coffee-grounds, black
tarry stools and blood in your faeces (stools/ motions)
• have severe liver, kidney or heart problems
Warnings and precautions
Talk to your doctor or pharmacist before taking Indometacin if
you:
• are epileptic, have Parkinson’s disease, psychiatric problem
• have high blood pressure, heart disease or have tendency to
fluid retention
• are being treated for infection (or sepsis) or have a fever
• suffer from asthma.
• Suffer from any disease of the bowel such as Crohn’s
disease or ulcerative colitis
• Currently have an infection (treated or not) or are receiving
treatment with live vaccines
• Suffer with systemic lupus erythematosus (SLE) or any other
connective tissue disorder. Are due to have an operation
• suffer from kidney or liver disease, diabetes or heart failure
• have problem with blood clotting
• have rheumatoid arthritis
• have a bleeding or blood clotting disorder
• have diabetes, suffer from peripheral arterial disease
• have a decreased amount of fluid around the cells of the
body (extracellular volume depletion)
• are allergic to Indometacin or any of the other ingredients of
this medicine (listed in section 6)

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 or high cholesterol or are a
smoker) you should discuss your treatment with your doctor or
pharmacist.
Children: Indometacin capsules must not be used in children.

Other medicines and Indometacin
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. Indometacin capsules
may alter the results of some blood or urine tests. If you see
another doctor or go in to hospital, let them know what
medicine you are taking.
You should discuss the matter with your doctor if you are
taking any of the following:
• aspirin or other non-steroidal anti-inflammatory drugs or
diflunisal for pain relief
• corticosteroids, which are drugs given to treat a variety of
conditions such as allergies and hormone imbalance
• anticoagulants such as warfarin to prevent blood clots
• certain drugs for depression called selective serotonin
reuptake inhibitors (SSRI)
• medicines such as acetylsalicylic acid to prevent platelet
clumping
• quinolone antibiotics (such as ciprofloxacin)
• lithium or haloperidol (psychiatric medicines)
• antiviral medicines (such as zidovudine or ritonavir)
• phenytoin (for epilepsy)
• diazepam (for anxiety, difficulty sleeping, alcohol withdrawal,
seizures and muscle spasm)
• medicines used to treat high blood pressure such as beta
blockers (e.g. atenolol), alpha blockers (e.g. prazosin), ACE
inhibitors (e.g. lisinopril), angiotensin II receptor antagonists
(e.g. valsartan), hydralazine or nifedipine
• sulphonylureas (used to treat diabetes)
• cardiac glycosides (used to treat heart conditions eg digoxin)
• ciclosporin or tacrolimus (immune system medicine),
methotrexate (used to treat some cancers, severe psoriasis
and severe rheumatoid arthritis)
• mifepristone (used to induce abortion)
• desmopressin (for diabetes insipidus and frequent urination
during the night)
• diuretics (water tablets) such as triamterene, thiazides (e.g.
bendroflumethiazide) or furosemide
• baclofen (a muscle relaxant), probenecid (for gout)
• pentoxifylline (for blood vessel disease and leg ulcers)
• tiludronic acid (for Paget’s disease of bone).
If any of these applies to you please tell your doctor
immediately.
Pregnancy, breast-feeding and fertility
Indometacin Capsules may make it more difficult to become
pregnant. If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.

Driving and using machines
Indometacin may cause dizziness, drowsiness, fatigue and
visual disturbance are possible in some people, if it happens 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.

Surgery
If you are about to have, or have recently had surgery, please
contact your doctor before using this medicine.
Indometacin contains Lactose:
Lactose (a type of sugar): If you have been told that you have
intolerance to some sugars, contact your doctor before taking
this medicine.

3. HOW TO TAKE INDOMETACIN
Always take this medicine exactly as described in this leaflet or
as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.

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It is important to take your medicine with food or with an
antacid; this will help you to prevent any stomach disturbance.
The recommended dose is
Adults:
Acute rheumatoid arthritis: initially 25mg two or three times a
day.
Chronic joint disorders: 25mg two or three times a day. Your
doctor may increase your dose depending on your response,
up to a maximum of 200mg a day.
Sudden worsening of a chronic disorder: up to 150-200mg
a day. Your doctor will decide on the best dose for you.
Acute muscle and bone disorders: initially 50mg two or three
times a day for 10-14 days. Your doctor will decide on the best
dose for you, depending on the severity of your condition.
Lower back pain: 50mg two or three times a day for 5-10
days. Your doctor will decide on the best dose for you,
depending on the severity of your condition.
Acute attack of gout: 50mg three or four times a day until
symptoms decrease.
After muscle or bone surgery: 100-150mg a day in divided
doses, to be taken until symptoms decrease.
Dosage in dysmenorrhoea : up to 75mg a day.
Elderly: If you are elderly, your doctor will give you the lowest
effective dose for the shortest amount of time.
Children: Indometacin is not recommended for children.

If you take more Indometacin than you should:
If you or anyone else has swallowed a lot of the capsules all
together contact your nearest hospital casualty department or
doctor immediately. Take your medication with you.
Symptoms of overdose are headache, feeling or being sick
(nausea/vomiting), stomach pain, bleeding in the stomach or
intestines, diarrhoea, disorientation, excitement, coma,
drowsiness, dizziness, ringing or buzzing in the ears, fainting,
mental confusion, feeling tired, numbness, burning, prickling,
itching, or tingling sensation of the skin, fits or seizures, kidney
failure, liver damage.

If you forget to take Indometacin
If you miss one dose of your medicine take one as soon as you
remember unless it is nearly time to take the next one. Do not
take a double dose to make up for a forgotten dose. Take the
remaining doses at the correct time.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all the medicines, this medicine can cause side effects,
although not everybody gets them.
The most common side effects are headache, dizziness and
indigestion.
Serious side effects
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine 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.
• allergic reactions - difficulty breathing or swallowing,
asthma, sudden decrease in blood pressure, swelling of the
face, lips, tongue or throat.

STOP TAKING the medicine and tell your doctor if you
experience:
• indigestion or heartburn, abdominal pain (pains in your
stomach) or other abnormal stomach symptoms.
• skin reactions such as itching, pale or red irregular raised
patches with severe itching (hives), disorder characterised by
blood spots, bruising and discolouring of the skin (purpura),
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)
• aseptic meningitis can occur in some patients. This may
show combination of symptoms such as headache, fever,
stiff neck and tiredness.
Medicines such as Indometacin may be associated with a small
increased risk of heart attack (“myocardial infarction”) or stroke.
Other side effects - If you experience any of the following
other side effects contact your doctor or pharmacist:
• Effects on the nervous system: Fatigue, drowsiness,
dizziness, headaches, convulsions, sleeplessness, fainting,
coma, loss of sensation, lightheadedness, vertigo, tiredness,

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anxiety, speech problem, confusion, mental disturbances
and rarely pins and needles, muscle weakness and
involuntary muscle movements.
Effects on the stomach, intestine and colon: Abdominal
pain or discomfort, loss of appetite, nausea, vomiting,
constipation, diarrhoea, flatulence, inflammation of mouth or
guts or worsening of these conditions and ulceration of
intestine which can cause bleeding and worsening of
ulcerative colitis and ulcer in and or bleeding from the gullet,
Inflammation of the pancreas causing pain and tenderness in
the abdomen and back (pancreatitis),intestinal strictures and
regional ileitis have been rarely reported.
Effects on the eye: Pain in the eye or other vision
disturbances, infrequently blurred or double vision.
Effects on the ear: Ringing in the ear or other hearing
disturbances (rarely deafness).
Effects on the blood: Small purple red spots, nosebleeds,
bruising, disorder characterised by blood spots, blood
clotting throughout the body, disturbance of blood count,
reduction in blood cell production by the bone marrow. If you
notice increased bruising, nosebleeds, sore throats,
infections, excessive tiredness, breathlessness on exertion,
or abnormal paleness of the skin, you should tell your doctor
who may want you to have a blood test.
Effects on the heart: High or low blood pressure, increased
or decreased blood pressure, increased or irregular heart
rate, chest pain, heart failure and abnormal heart burn.
Effects on the liver: Inflammation of the liver, jaundice
(yellow skin or eyes).
Effects on the kidney: Inflammation, disease or failure,
blood or protein in the urine and increase in blood urea.
Effects on the Skin: Inflammation of blood vessels,
sensitivity to sunlight or artificial light (e.g. sun beds), tender
red lumps usually on the legs (erythema nodosum), hair loss,
sweating, worsening of psoriasis (itchy scaly pink patches on
the elbows, knees, scalp and other parts of the body
Effects on reproductive system: Bleeding from the vagina,
breast enlargement or tenderness, enlarged breasts in men.
Other effects: Increased level of sugar in the blood, high
level of potassium in the blood.

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
Keep this medicine out of the sight and reach of children
• This medicine should not be used after the expiry date stated
on the pack.
• Store in a cool and dry place, below 30˚C.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Indometacin Capsules contain:
• The active substance is 25mg of the active ingredient
Indometacin BP.
• The other ingredients are:
Lactose, colloidal silicon dioxide and sodium lauryl sulphate.

What Indometacin Capsules looks like and contents of
pack:
Ivory coloured, hard, gelatine capsules, size 3. Overprinted
‘25’and ‘PHARMVIT’.

Pack sizes of Indometacin 25mg are:
Indometacin is available in the pack sizes of 28, 56, 84 & 500
Capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer:
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone:
0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or audio format or
additional copies, please contact the licence holder at the
address (or telephone, fax) above
PL 04556 / 0002

Reference: 00020114/01

The leaflet was revised in January 2014

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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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