INDOMETACIN CAPSULES BP 50MG

Active substance: INDOMETHACIN MICRONISED

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• 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.
• Metabolism:
- high blood sugar
- sugar in the urine
- high blood levels of potassium (muscle cramps
or pain, irregular heart beat, unusual tiredness or
weakness).
• Nervous system:
- headache, dizziness, lightheadedness, spinning
sensation (vertigo), tiredness, fainting, a feeling of
general discomfort and illness, drowsiness, coma,
fluid in the brain causing swelling
- depression, nervousness, confusion,
hallucinations, anxiety and other mental health
problems, a feeling of unreality (that the mind is
separated from the body), difficulty sleeping
- speech disorder, fits or seizures, worsening of
epilepsy, disorder of the nerves causing tingling
and numbness, pins and needles
- uncontrolled movements, worsening of
parkinsonism (tremor, stiffness and shuffling).
• Heart:
- fluid retention causing swelling, chest pain, heart
failure
- high and low blood pressure
- racing heart beat, irregular heart beat,
palpitations
• Blood vessels:
- flushing.
• Breathing:
- increase in the number of white blood cells in the
lungs
- narrowing of the airways in those who have a
history of asthma or allergic disease.
• Stomach and intestines:
- loss of appetite
- development or worsening of ulcerative colitis or
Crohns disease
- inflammation of the pancreas causing pain
and tenderness in the abdomen and back
(pancreatitis).
• 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).

• Liver:
- blocked bile flow (pale coloured stools, dark urine,
itching).
• Muscle and bone:
- muscle weakness, increased breakdown of
cartilage.
• Kidneys:
- blood in the urine
- nephrotic syndrome (increased protein in urine
and fluid retention)
- too much protein in the urine
- inflammation of the kidneys, reduced kidney
function or kidney failure.
• Reproductive system:
- bleeding from the vagina
- breast enlargement or tenderness, enlarged
breasts in men.
If you notice any of these side effects, or they get
worse or you notice any side effects not listed,
please tell your doctor or pharmacist.

Indometacin 25mg
and 50mg capsules
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.
• 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.
• 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.

5 How to store Indometacin capsules

Keep out of the reach and sight of children.
Store below 25°C in a dry place. Protect from light.
Do not take Indometacin capsules after the expiry
date which is stated on the label/carton/bottle.
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.

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

6 Further information
What Indometacin capsules contain

• The active substance (the ingredient that makes the
medicine work) is indometacin PhEur. Each capsule
contains either 25mg or 50mg indometacin.
• The other ingredients are starch 1500, powdered
cellulose, colloidal silicon dioxide, magnesium
stearate, yellow iron oxide (E172), titanium dioxide
(E171), gelatin, shellac glaze, iron oxide black (E172),
propylene glycol.

1 What Indometacin capsules are and

What Indometacin capsules look like and
contents of the pack

what they are used for

Indometacin capsules belong to a group of medicines
called non-steroidal anti-inflammatory drugs
(NSAIDs). These medicines are pain killers which
reduce swelling.

Indometacin capsules are ivory, hard, gelatin capsules.
Pack size is 28.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.

Indometacin capsules are for:
• inflammatory diseases of the joints such
as rheumatoid arthritis, osteoarthritis and
degenerative hip disease
• pain and stiffness in the backbone (ankylosing
spondylitis)
• sprains and strains (acute muscle and bone
disorders)
• lower back pain
• pain and swelling following muscle or bone surgery
• period pain
• gout.

This leaflet was last revised
in July 2013.

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

AAAF5110 50740411

• are in the last three months of pregnancy
• are allergic (hypersensitive) to indometacin or
any of the ingredients of Indometacin capsules (see
section 6)
• are allergic (hypersensitive) to aspirin, ibuprofen
or other NSAIDs or you have developed signs of
asthma (wheezing), runny nose, swelling of the face,
lips, tongue or throat, or a skin rash with pale or red
irregular raised patches with severe itching, when
taking these medicines
• are taking other NSAIDs (e.g. naproxen) including
COX II inhibitors (e.g. celecoxib)
• suffer with angioneurotic oedema (swelling of the
face, lips, tongue or throat)
• have or have had a history of two or more
episodes of peptic ulcer (ulcer in your stomach
or duodenum) or bleeding in your stomach or
intestines in the past. 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
• have nasal obstruction (nasal polyps).
Indometacin capsules must not be used in
children.

Check with your doctor before taking
Indometacin capsules if you are:

• elderly (see “Other warnings”)
• to have a vaccination with a live vaccine
• a woman trying to become pregnant or
undergoing investigation for infertility
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
• taking medicines poisonous to the kidneys such
as cisplatin or vancomycin.

or if you have:

• a history of high blood pressure or congestive
heart failure
• a bleeding or blood clotting disorder
• a mental health problem e.g. mood changes
• epilepsy
• Parkinson’s Disease (tremor, stiffness and
shuffling)
• an infection or sepsis (severe infection)

AAAF5110 50740411



page 4 Actavis, Barnstaple, EX32 8NS, UK

Indomentacin Capsules 25mg & 50mg 28 Capsules PIL - UK
item no: AAAF5110 50740411

dimensions:

print proof no: 2

pharmacode: 3691

origination date: 18.06.13

min pt size:

originated by: SA
approved for print/date

2 Before you take Indometacin capsules
Do not take Indometacin capsules if you:

296x210 Reel fed

colours/plates:
1. Black
2.
3.
4.
5.

R.Wrey (BST Technical)

6.
Non Printing Colours

revision date: 31.07.13

Technical Approval

revised by: SA

date sent:

05/06/13

supplier: Actavis UK

technically app. date:

05/06/13

1.
2.
3.

296x210 reel fed bi-fold leaflet profile UK BST

(DR/RW/MC 10.02.11)

page 1

• any liver, kidney or heart problems
• fluid retention which may be caused by diseases
of the heart or kidneys
• asthma or a history of asthma
• have or have a history of gastrointestinal diseases
such as ulcerative colitis or Crohns disease
• systemic lupus erythematosus (SLE) or other
connective tissue disorders
• diabetes
• a decreased amount of fluid around the cells of
the body (extracellular volume depletion)
• peripheral arterial disease (a problem with the
circulation in the legs).

• haloperidol (an antipsychotic drug)
• zalcitabine, zidovudine or ritonavir (for HIV
infection)
• cardiac glycosides e.g. digoxin (for heart failure and
irregular heart beat)
• ciclosporin, tacrolimus or muromonab-CD3 (to
suppress the immune system)
• corticosteriods e.g. prednisolone (used in many
different diseases)
• cyclophosphamide or methotrexate (to treat some
types of cancer and rheumatoid arthritis)
• desmopressin (for diabetes insipidus and frequent
urination during the night)
• diuretics (water tablets) such as triamterene,
thiazides (e.g. bendroflumethiazide) or furosemide
• lithium (for some mental health problems)
• mifepristone (for termination of pregnancy).
Indometacin capsules should not be taken within
8-12 days of taking mifepristone
• baclofen (a muscle relaxant)
• pentoxifylline (for blood vessel disease and leg
ulcers)
• probenecid (for gout)
• tiludronic acid (for Paget’s disease of bone).

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
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.
Taking pain killers for headaches too often or for too
long can make them worse.

Dose
• 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.

If you are in the last three months of pregnancy, you
must not take Indometacin capsules. You should
only take Indometacin capsules in the first six
months of pregnancy or if you are breast-feeding
under medical supervision. Always ask your doctor
before taking any medicine.

Driving and using machines

• Elderly:
If you are elderly, your doctor will give you the
lowest effective dose for the shortest amount of
time.

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

Tests

Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
including medicines obtained without a prescription,
particularly:
• other non-steroidal anti-inflammatory drugs
(NSAIDs) including aspirin, naproxen or COX II
inhibitors (e.g. celecoxib) or diflunisal (for pain and
inflammation)
• quinolone antibiotics e.g. ciprofloxacin (to treat
infections)
• medicines which thin the blood or which prevent
blood clotting, such as warfarin or antiplatelet drugs
such as clopidogrel
• selective serotonin reuptake inhibitors (SSRIs) e.g.
fluoxetine (for depression)
• metformin or sulphonylureas e.g. gliclazide (for
diabetes)
• 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
(vasodilator) or nifedipine

• Children:
Indometacin capsules must not be used in children.

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.

If you take more Indometacin capsules than
you should

It is important not to take too many capsules. Contact
your doctor or nearest hospital casualty department
immediately, if you have taken more capsules than
you should or a child accidentally swallows any.
Symptoms of overdose are headache, feeling or
being sick, stomach pain, bleeding in the stomach
or intestines, diarrhoea, disorientation, excitement,
coma, drowsiness, dizziness, ringing or buzzing in
the ears, fainting, fits or seizures, kidney failure, liver
damage.

Surgery

If you are about to have, or have recently had
surgery, please contact your doctor before using this
medicine.

If you forget to take Indometacin capsules

If you forget to take your capsules, take the missed
dose as soon as you remember, unless it is nearly
time for your next dose. Do not take a double dose to
make up for one you have missed.



page 2

Indomentacin Capsules 25mg & 50mg 28 Capsules PIL - UK
item no: AAAF5110 50740411

dimensions:

print proof no: 2

pharmacode: 3691

origination date: 18.06.13
approved for print/date

Always take Indometacin capsules exactly as your
doctor has told you. If you are not sure, check with
your doctor or pharmacist.
Swallow the capsules with or after food, milk or
antacids (indigestion remedy) to reduce side effects
on the stomach and intestines.

Pregnancy and breast-feeding

Taking other medicines

min pt size:

originated by: SA

3 How to take Indometacin capsules

296x210 Reel fed

colours/plates:
1. Black
2.
3.
4.
5.

R.Wrey (BST Technical)

6.
Non Printing Colours

revision date: 31.07.13

Technical Approval

revised by: SA

date sent:

05/06/13

supplier: Actavis UK

technically app. date:

05/06/13

1.
2.
3.

296x210 reel fed bi-fold leaflet profile UK BST

4 Possible side effects

Like all medicines, Indometacin capsules can cause
side effects, although not everybody gets them.
STOP TAKING the medicine and seek immediate
medical help if you develop any of the following at
any time during your treatment:
• signs of bleeding in the stomach:
- Pass blood in your faeces (stools/motions)
- Pass black tarry stools
- Vomit any blood or dark particles that look like
coffee grounds
• signs of an allergic reaction:
- 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
• effects on the stomach such as feeling or being
sick, inflammation of the stomach lining, small
intestine or mouth, constipation, diarrhoea,
wind, perforation of previous intestinal damage,
narrowing of or blockage in the intestine
• abnormal liver function (as seen in blood tests)
• liver disease: yellowing of the skin or whites of the
eyes (jaundice), inflammation of the liver (hepatitis)
causing fatigue, weakness, loss of appetite, weight
loss, abdominal pain, fever
• 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 (stiff neck, headache, feeling or
being sick, fever, disorientation) especially in those
who already have an auto-immune disease such as
systemic lupus erythematosus or mixed connective
tissue disease.
Medicines such as Indometacin may be associated
with a small increased risk of heart attack (“myocardial
infarction”) or stroke (see Section 2 ‘Other warnings’).
Tell your doctor or pharmacist if you notice any of
the following side effects:
• Eyes:
- blurred and double vision
- inflammation of the optic nerve (which may
cause eye pain and loss of vision)
- eye pain
- changes in your sight.
• Ear:
- ringing or buzzing in the ears
- hearing disturbances including deafness.

(DR/RW/MC 10.02.11)

page 3

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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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