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INDOCID SUPPOSITORIES 100MG

Active substance(s): INDOMETHACIN / INDOMETHACIN / INDOMETHACIN

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Indocid® Suppositories
Indomethacin
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
• 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 Indocid Suppositories are and what
they are used for
2. Before you use Indocid Suppositories
3. How to use Indocid Suppositories
4. Possible Side Effects
5. How to store Indocid Suppositories
6. Contents of the pack and other information
1. WHAT INDOCID SUPPOSITORIES ARE
AND WHAT THEY ARE USED FOR
Indocid Suppositories contain the active
ingredient indomethacin.
This belongs to a group of medicines known
as ‘non-steroidal anti-inflammatory agents’
or NSAlDs. These work by reducing the
body’s ability to produce Inflammation, which
may cause pain and discomfort.
Your doctor has prescribed Indocid for you
because you are suffering from one of the
following:
• Rheumatoid arthritis (disease mainly of
the joints)
• Osteoarthritis (disease of the joints)
• Ankylosing spondylitis (a form of arthritis
which mainly affects the back)
• Pain, inflammation, and swelling following
orthopaedic surgery.
• Musculoskeletal disorders (muscles and
bone disorders).
• Period pain.
• Low back pain.
• Disease of the hip joint.
• Acute gouty arthritis (a form of arthritis in
which crystals build up in the joints).
2. BEFORE YOU
SUPPOSITORIES

USE

INDOCID

Do not use Indocid Suppositories
• If you are hypersensitive (allergic) to
indomethacin or any of the other
ingredients in Indocid Suppositories (for
example, if you have experienced
breathing difficulties, skin rashes which
look like nettle rash, or a runny nose) or
If you are hypersensitive to aspirin or
another non-steroidal anti-inflammatory
medicine. A full list of the ingredients is in
section 6 - Further information.
• If you have a peptic ulcer (ulcer in your
stomach or duodenum) or bleeding in your
stomach, or have had two episodes of peptic
ulcers, stomach bleeding or perforation.
• If you are suffering from inflammation of
the rectum causing soreness, bleeding
and sometimes a discharge of mucus
and/or pus from your anus.
• If you have polyps (soft fleshy swellings
that grow inside the nose) in your nose,
associated with itching, nettle rash,
wheezing, or swelling of the face, lips,
tongue and/or throat or difficulties in
swallowing or breathing.
Take special care with Indocid
Suppositories
• If you are epileptic
• If you have Parkinson’s disease
• If you have a psychiatric problem
• If you have heart disease, high blood
pressure or have a tendency for
fluid retention
• If you are being treated for infection or
you have a fever
• If you know you suffer from asthma,
digestive tract, liver or kidney disease,
diabetes or heart failure
• If you have a problem with your
blood clotting.
• If you are having blood tests, make sure
that the doctor doing them knows that
you are taking Indocid.
• If you have rheumatoid arthritis your
doctor may want to examine your eyes at

Risk of heart attack or stroke
Medicines such as Indocid may be associated
with a small increased risk of heart attack
(‘Myocardial Infarction’) or stroke. Any risk
is likely with high doses and prolonged
treatment. Do not exceed the recommended
dose or duration of treatment. 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 other medicines
Tell your doctor or pharmacist if you are
taking any of the following:
• Aspirin or similar medicines.
• Other non-steroidal anti-inflammatory
medicines including diflunisal.
• Anticoagulants, which thin the blood.
• A medicine for gout called probenecid.
• Methotrexate, a drug used in the treatment
of cancer, severe skin disease and
rheumatoid arthritis.
• Cyclosporin, a drug used to prevent the
body from rejecting a recent organ or
bone-marrow transplant, and to treat
severe skin disease and rheumatoid
arthritis.
• Lithium for treatment of mental disorders.
• Diuretics (water tablets).
• Cardiac glycosides, such as digoxin,
medicines used in the treatment of
congestive heart failure and certain
alterations of heart rhythm.
• Antihypertensive medicines for the
treatment of high blood pressure.
• A nasal decongestant called
phenylpropanolamine usually found in
over-the-counter cold relief preparations.
• Corticosteroid drugs, including antiInflammatory and replacement therapies.
• Mifepristone, a treatment used in
emergency for termination of pregnancy.
• Antibiotics from the quinolone group of
antibiotics.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice
before taking this medicine. If you are
pregnant or planning to become pregnant
or if you are breastfeeding, Indocid 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.
Driving and using machines
Indocid can cause headaches, dizziness,
drowsiness and visual disturbances in some
people. If this happens to you, avoid activities
which require you to be alert; for example,
driving a car and operating machinery.
3. HOW TO USE INDOCID SUPPOSITORIES
Always use Indocid Suppositories exactly
as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
Suppositories must not be taken by
the mouth.
They are to be placed in the rectum (back
passage). Empty your bowels (if necessary)
before use. Remove the suppository from
the foil and, lying on your back or your side
with your knees bent up, push the suppositorypointed end first - up into your back passage.
Lie still for a minute or so, and then wash
your hands. The suppository should remain
in place and dissolve completely.
The amount you use will depend upon your
condition.
Dosage:
The usual adult dosage is one suppository
to be inserted into the rectum once or twice
a day. One should be used at bedtime and
if another is necessary it should be used in
the morning.
Not recommended for use in children.
If you use more Indocid Suppositories
than you should
If you use too many suppositories by mistake
or someone else accidentally uses your
suppositories, contact your doctor
immediately or go to the nearest casualty
department.
If you forget to use Indocid Suppositories
If you forget to take the suppository, take it
as soon as you remember. If it is nearly time
for your next dose, just carry on with the
next dose as normal. Do not use an extra
suppository to make up for forgotten doses.
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intervals during your treatment with
Indocid. You should see your doctor if
you notice any change in your vision

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PACKAGE LEAFLET:
INFORMATION FOR THE
USER

If you stop using Indocid Suppositories
and anaemia may be seen with symptoms
You should use Indocid Suppositories for as
of severe chills, mouth ulcers, headache,
long as your doctor tells you to. It may be
shortness of breath and dizziness.
dangerous to stop using them without your
Eye disorders:
doctor’s advice.
• Infrequently, blurred vision, double vision,
4. POSSIBLE SIDE EFFECTS
pain in the eye and other visual
disturbances.
Like all medicines, Indocid can cause side
effects although not everybody gets them. Problems with the ear:
If you experience an allergic reaction, • Ringing in the ears and other hearing
STOP TAKING the medicine and seek
disturbances, including deafness rarely.
immediate medical help:
Other side effects:
Symptoms of allergic reactions are:
• Bleeding from the vagina in women;
• Itching;
• Increased levels of sugar in the blood,
• Rashes;
sugar in the urine, high levels of potassium
• Sensitivity to sunlight;
in the blood, which are generally diagnosed
• Loss of hair; swollen face, lips, tongue
by laboratory tests;
and throat;

Flushing and sweating;
• Difficulty in breathing and swallowing;

Bleeding from the nose;
inflammation of blood or lymph glands

Breast changes including enlargement
(lymph glands are all over the body but
and tenderness in men and women;
are noticeable in the neck and armpit when

Ulcers in the lining of the mouth.
swollen as bean shaped);
• Severe light headedness or dizziness due Side effects associated with the use of
to a rapid fall in blood pressure.
Indocid suppositories
• The allergic reaction may include problems • Bleeding, inflammation, burning pain,
with the liver, kidneys or blood cells (see
discomfort, itching or the feeling of a full
below for liver, kidney and blood problems).
back passage.
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
• Inflammation of the pancreas, symptoms
may include severe upper stomach pain,
often with nausea and vomiting.

Laboratory tests
Misleading results have been seen with
patients having a Dexamethasone
suppression test (DST) while using
this medicine.

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 the
Yellow Card Scheme.
STOP TAKING the medicine and tell your Website: www.‌mhra.gov.‌uk/yellowcard
doctor if you experience:
By reporting side effects you can help
• Indigestion or heartburn
provide more information on the safety of
• Abdominal pain (pains in your stomach) this medicine.
or other abnormal stomach symptoms.
5. HOW
TO
STORE
INDOCID
Medicines such as Indocid may be
SUPPOSITORIES
associated with a small increased risk of
heart attack (‘Myocardial Infarction’) Keep out of the reach and sight of children.
Do not use Indocid Suppositories after the
or stroke.
expiry date which is stated on the carton.
Other side effects include:
The expiry date refers to the last day of
Problems with the central nervous system: that month.
• Headache, dizziness, light-headedness, Do not store above 25 °C.
depression, vertigo (sensation that things Store in the original package to protect
around you are moving) and tiredness from light.
(including feeling unwell and listlessness). Medicines should not be disposed of via
• Reactions reported infrequently include wastewater or household waste.
anxiety, confusion, fainting, drowsiness, Ask your pharmacist how to dispose of
fits, coma, peripheral neuropathy which medicines no longer required.
may be experienced as loss of sensation, These measures will help to protect the
numbness, tingling, and pricking environment.
sensations, sensitivity to touch, or muscle
weakness, involuntary muscle movements, 6. CONTENTS OF THE PACK AND OTHER
INFORMATION
sleeplessness, hallucinations (seeing or
hearing things that are not there), mental What Indocid Suppositories contain
disorders including a loss of personal The active ingredient in Indocid Suppositories
identity. Rarely, pins and needles, speech is indomethacin.
problems, worsening of epilepsy and Indocid Suppositories are available as
parkinsonism symptoms (symptoms that polyethylene glycol suppositories containing
mimic those of Parkinson’s disease such 100mg indomethacin.
as tremor or abnormal movements). Indocid Suppositories also contain:
If these side effects are severe you may Butylhydroxyanisole, buytlhydroxytoluene,
need to stop treatment with this medicine. edetic acid, glycerol, polyethylene glycol
You should talk to your doctor.
8000, Macrogol 4000, purified water.
What Indocid Suppositories looks like and
the contents of the pack
Indocid Suppositories are available in
strips of 10
Marketing Authorisation Holder
The Marketing Authorisation is held by Aspen
Pharma Trading Limited, 3016 Lake Drive,
Citywest Business Campus, Dublin
24, Ireland
Service-Tel: 0800 088 7392
Liver disorders:
(+ 44 1748 828 391)
• Rarely, inflammation of the liver and Manufacturer
jaundice, symptoms of which may be Famar S.A, 49th KM, Athens-Lamia Nat
yellowing of the eyes and skin.
Road, 19011, Avlona, Greece.

Problems with the digestive system:
• The most frequent reactions are nausea,
loss of appetite, vomiting, trapped wind,
constipation, and diarrhoea.
• Reactions reported infrequently include
inflammation of the mouth and stomach,
wind, narrowing and/or obstruction of the
intestines which may be seen as a swollen
abdomen, and vomiting.

Heart and kidney disorders:
This leaflet was last amended June 2016
• High or low blood pressure, abnormal
heartbeat, chest pain, palpitations, heart
failure, kidney problems which can lead
to water retention, reduction in the amount
of urine passed, protein and blood in the
urine, increased levels of urea in the blood.
• These changes in urine and blood
composition would normally be picked up
in urine or blood tests.
Blood disorders:
• Infrequently, blood disorders which are
usually detected in blood tests, but may
be seen as pale skin, tiredness, fever, sore
throat and mouth, small red spots on the
skin, bruising or prolonged bleeding after
Injury. Blood disorders such as leucopenia
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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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