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INDOMETACIN SUPPOSITORIES BP 100MG

Active substance(s): INDOMETACIN

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Indometacin 100mg suppositories
Read all of this leaflet carefully before you start using this medicine.

Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
again.

• 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.
• 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.
In this leaflet:
1 What Indometacin suppositories are and
what they are used for
2 Before you use Indometacin suppositories
3 How to use Indometacin suppositories
4 Possible side effects
5 How to store Indometacin suppositories
6 Further information
1 What Indometacin suppositories are and

what they are used for

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

2 Before you use Indometacin suppositories
Do not use Indometacin suppositories if you:
• are in the last three months of pregnancy
• are allergic (hypersensitive) to indometacin or any
of the ingredients of Indometacin suppositories (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) or 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 had bleeding in your stomach or intestines or
perforation after taking NSAIDs
• have nasal obstruction (nasal polyps)
• have piles (haemorrhoids) or inflammation or
bleeding of the back passage.
Indometacin suppositories must not be used in
children.

Check with your doctor before using
Indometacin suppositories 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 a medicine which is 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
• mental health problems e.g. mood changes
• epilepsy
• Parkinson’s Disease (tremor, stiffness and shuffling)
• any infection or sepsis (severe infection)
• 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).

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 or high
cholesterol or are a smoker) you should discuss your
treatment with your doctor or pharmacist.
Taking painkillers for headaches too often or for too
long can make them worse.

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, 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
• 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)
• corticosteroids e.g. prednisolone (used in many
different diseases)
• cyclophosphamide or methotrexate (to treat some
types of cancer, psoriasis or 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 (used for termination of pregnancy).
Indometacin suppositories should not be used 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).

Pregnancy and breast-feeding

If you are in the last three months of pregnancy, you
must not use Indometacin suppositories. You should
only use Indometacin suppositories 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

Indometacin suppositories may make you feel drowsy,
dizzy or affect your vision. Make sure you are not affected
before you 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.

148x420 Leaflet Pre-Folded Profile - Sarong (BST)

Indometacine 100mg Suppositories PIL UK
item no:

AAAH5392

dimensions: 148 x 420

print proof no:

7

pharmacode:

origination date: 5.1.15
approved for print/date

min pt size:

colours/plates:

Indomethacin Suppositories
100mg x 10 (UK)

1. black

JDE No.:

2.
3.
4.

8 pt

originated by:

db

revision date:

20.2.15

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

50839488

Dimensions: 148x420 (Pre-Folded)
Component: Leaflet for Sarong

5.

Pharmacode: 6599

6.

Date Sent:
22/12/14
Technologist: M.Cort

Non Printing Colours
1. profile
2.
3.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

3 How to use Indometacin suppositories

Always use Indometacin suppositories exactly as your
doctor has told you. If you are not sure, check with your
doctor or pharmacist.
For rectal use only.
Dose
• Adults (including the elderly):
Insert one suppository into your back passage at night
and repeat in the morning if necessary. Your doctor
will give you the lowest effective dose for the shortest
amount of time.
• Children:
Indometacin suppositories must not be used in
children.

If you use more Indometacin suppositories
than you should

It is important not to use too many suppositories.
Contact your doctor or nearest hospital casualty
department immediately, if you have used more
suppositories than you should or a child accidentally
swallows a suppository. Symptoms of overdose are
pain in the upper part of the stomach, bleeding in
the stomach or intestines, diarrhoea, disorientation,
excitation, coma, dizziness, fainting, fits, liver damage,
feeling or being sick, stomach pain, loss of appetite,
drowsiness, headache, ringing or buzzing in the ears,
restlessness, agitation and kidney failure.

If you forget to use Indometacin suppositories

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

4 Possible side effects

Like all medicines, Indometacin suppositories can cause
side effects, although not everybody gets them.
STOP USING 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 USING 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:
· 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).

· Eyes:
- blurred and double vision
- inflammation of the optic nerve (which may cause
eye pain and loss of vision)
- eye pain
- changes to your sight.
· Ear:
- ringing or buzzing in the ears
- hearing disturbances including deafness.
· 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.

• Nervous system:
- headache, dizziness, lightheadedness, spinning
sensation (vertigo), tiredness, fainting, coma, fluid
in the brain causing swelling, a feeling of general
discomfort and illness, drowsiness
- 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).
· Blood vessels:
- flushing.
· 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)
- effects on the back passage include painful inability
to empty the bowel or bladder, inflammation,
irritation, bleeding, burning pain, discomfort and
itching of the back passage.
· Liver:
- blocked bile flow.
· 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).
· 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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 suppositories

Keep out of the reach and sight of children.
Store in a cool place.
Do not use Indometacin suppositories after the expiry
date which is stated on the carton.
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 suppositories contain

• The active substance (the ingredient that makes the
medicine work) is indometacin. Each suppository
contains 100mg indometacin.
• The other ingredients are vegetable fat.

What Indometacin suppositories look like and
contents of the pack
Indometacin suppositories are yellow suppositories.
Pack size is 10.

Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in February 2015

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

· Heart:
- fluid retention causing ankle swelling, chest pain,
heart failure
- high or low blood pressure
- racing heart beat, irregular heart beat, palpitations

50839488

AAAH5392

148x420 Leaflet Pre-Folded Profile - Sarong (BST)

Indometacine 100mg Suppositories PIL UK
item no:

AAAH5392

dimensions: 148 x 420

print proof no:

7

pharmacode:

origination date: 5.1.15
approved for print/date

min pt size:

colours/plates:

Indomethacin Suppositories
100mg x 10 (UK)

1. black

JDE No.:

2.
3.
4.

8 pt

originated by:

db

revision date:

20.2.15

Technical Approval

revised by:

db

date sent:

n/a

supplier:

Actavis UK

approved:

n/a

50839488

Dimensions: 148x420 (Pre-Folded)
Component: Leaflet for Sarong

5.

Pharmacode: 6599

6.

Date Sent:
22/12/14
Technologist: M.Cort

Non Printing Colours
1. profile
2.
3.

Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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