INDOCID SUPPOSITORIES 100MG

Active substance: INDOMETHACIN

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ASPEN Artwork Panel

Replacement Code:
NA

Indocid® Suppositories
Indomethacin

Market/Pack Owner
UK
Drawing Ref. Number :
160x475mm
No. of Colours:
1
Colour Format:
Process
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ASPEN Artwork Panel • August 2011 • Version 2

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PHARMA
CODE
58

150 mm Measuring Bar

Product Name:
Indocid

Read aII of this leaflet carefully before
you start taking this medicine.
•  eep this leaflet. You may need to read
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it again.
• f you have any further questions, ask
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your doctor or pharmacist
•  his medicine has been prescribed for
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you. Do not pass it on to others. It may
harm them even if their symptoms are
the same as yours.
• f any of the side effects gets serious, or
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if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1.  hat Indocid Suppositories are and
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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. Further information
1.  HAT INDOCID SUPPOSITORIES ARE
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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:
•  heumatoid arthritis (disease mainly of
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the joints)
• Osteoarthritis (disease of the joints)
•  nkylosing spondylitis (a form of arthritis
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which mainly affects the back)
•  ain, inflammation, and swelling following
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orthopaedic surgery.
•  usculoskeletal disorders (muscles and
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bone disorders).
• Period pain.
• Low back pain.
• Disease of the hip joint.
•  cute gouty arthritis (a form of arthritis
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in which crystals build up in the joints).
2.  EFORE YOU USE INDOCID
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SUPPOSITORIES
Do not use Indocid Suppositories
• f you are hypersensitive (allergic)
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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.
• f you have a peptic ulcer (ulcer in your
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stomach or duodenum) or bleeding
in your stomach, or have had two
episodes of peptic ulcers, stomach
bleeding or perforation.
• f you are suffering from inflammation of
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the rectum causing soreness, bleeding
and sometimes a discharge of mucus
and/or pus from your anus.
• f you have polyps (soft fleshy swellings
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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
• f you have heart disease, high blood
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pressure or have a tendency for fluid
retention
• f you are being treated for infection or
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you have a fever
• f you know you suffer from asthma,
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digestive tract, liver or kidney disease,
diabetes or heart failure
• f you have a problem with your blood
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clotting.
• f you are having blood tests, make sure
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that the doctor doing them knows that
you are taking Indocid.

• f you have rheumatoid arthritis your
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doctor may want to examine your eyes
at intervals during your treatment with
Indocid. You should see your doctor if
you notice any change in your vision
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.
•  ther non-steroidal anti-inflammatory
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medicines including diflunisal.
• Anticoagulants, which thin the blood.
• A medicine for gout called probenecid.
•  ethotrexate, a drug used in the
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treatment of cancer, severe skin disease
and rheumatoid arthritis.
•  yclosporin, a drug used to prevent the
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body from rejecting a recent organ or
bone-marrow transplant, and to treat
severe skin disease and rheumatoid
arthritis.
•  ithium for treatment of mental disorders.
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• Diuretics (water tablets).
•  ardiac glycosides, such as digoxin,
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medicines used in the treatment of
congestive heart failure and certain
alterations of heart rhythm.
•  ntihypertensive medicines for the
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treatment of high blood pressure.
•  nasal decongestant called
A
phenylpropanolamine usually found in
over-the-counter cold relief preparations.
•  orticosteroid drugs, including anti-
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Inflammatory and replacement therapies.
•  ifepristone, a treatment used in
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emergency for termination of pregnancy.
•  ntibiotics from the quinolone group of
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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.  OW TO USE INDOCID
H
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

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PACKAGE LEAFLET:
INFORMATION FOR THE
USER

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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.

Market/Pack Owner
UK
Drawing Ref. Number :
160x475mm
No. of Colours:
1
Colour Format:
Process

You should use Indocid Suppositories for
as long as your doctor tells you to. It may
be dangerous to stop using them without
your doctor’s advice.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Indocid can cause side
effects although not everybody gets them.

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If you stop using Indocid Suppositories

PHARMA
CODE

150 mm Measuring Bar

Product Name:
Indocid

If you experience an allergic reaction,
STOP TAKING the medicine and seek
immediate medical help:
Symptoms of allergic reactions are:
• Itching;
• Rashes;
• Sensitivity to sunlight;
•  oss of hair; swollen face, lips, tongue and
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throat;
•  ifficulty in breathing and swallowing;
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inflammation of blood or lymph glands
(lymph glands are all over the body but are
noticeable in the neck and armpit when
swollen as bean shaped);
•  evere light headedness or dizziness due
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to a rapid fall in blood pressure.
•  he allergic reaction may include problems
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with the liver, kidneys or blood cells
(see below for liver, kidney and blood
problems).
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
•  omit any blood or dark particles that look
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like coffee grounds
STOP TAKING the medicine and tell
your doctor if you experience:
• Indigestion or heartburn
•  bdominal pain (pains in your stomach) or
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other abnormal stomach symptoms.
Medicines such as Indocid may be
associated with a small increased risk
of heart attack (‘Myocardial Infarction’)
or stroke.
Other side effects include:
Problems with the central nervous
system:
•  eadache, dizziness, light-headedness,
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depression, vertigo (sensation that things
around you are moving) and tiredness
(including feeling unwell and listlessness).
•  eactions reported infrequently include
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anxiety, confusion, fainting, drowsiness,
fits, coma, peripheral neuropathy
which may be experienced as loss of
sensation, numbness, tingling, and
pricking sensations, sensitivity to touch,
or muscle weakness, involuntary muscle
movements, sleeplessness, hallucinations
(seeing or hearing things that are not
there), mental disorders including a loss of
personal identitiy. Rarely, pins and needles,
speech problems, worsening of epilepsy
and parkinsonism symptoms (symptoms
that mimic those of Parkinson’s disease
such as tremor or abnormal movements).
If these side effects are severe you may
need to stop treatment with this medicine.
You should talk to your doctor.
Problems with the digestive system:
•  he most frequent reactions are nausea,
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loss of appetite, vomiting, trapped wind,
constipation, and diarrhoea.
•  eactions reported infrequently include
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inflammation of the mouth and stomach,
wind, narrowing and/or obstruction of the
intestines which may be seen as a swollen
abdomen, and vomiting.
Liver disorders:



•  arely, inflammation of the liver and
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jaundice, symptoms of which may be
yellowing of the eyes and skin.

Heart and kidney disorders:
•  igh or low blood pressure, abnormal
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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.
•  hese changes in urine and blood
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composition would normally be picked up
in urine or blood tests.
Blood disorders:
• nfrequently, blood disorders which are
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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 and anaemia may
be seen with symptoms of severe chills,
mouth ulcers, headache, shortness of
breath and dizziness.
Eye disorders:
• nfrequently, blurred vision, double
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vision, pain in the eye and other visual
disturbances.
Problems with the ear:
•  inging in the ears and other hearing
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disturbances, including deafness rarely.
Other side effects:
• Bleeding from the vagina in women;
• ncreased levels of sugar in the
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blood, sugar in the urine, high levels
of potassium in the blood, which are
generally diagnosed by laboratory tests;
• Flushing and sweating;
• Bleeding from the nose;
•  reast changes including enlargement
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and tenderness in men and women;
• Ulcers in the lining of the mouth.
Side effects associated with the use of
Indocid suppositories
•  leeding, inflammation, burning pain,
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discomfort, itching or the feeling of a full
back passage.
Laboratory tests
Misleading results have been seen
with patients having a Dexamethasone
suppression test (DST) while using this
medicine.
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.
5.  OW TO STORE INDOCID
H
SUPPOSITORIES
Keep out of the reach and sight of children.
Do not use Indocid Suppositories after the
expiry date which is stated on the carton.
The expiry date refers to the last day of
that month.
Do not store above 25 °C.
Store in the original package to protect
from light.
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 Indocid Suppositories contain
The active ingredient in Indocid
Suppositories is indomethacin.
Indocid Suppositories are available
as polyethylene glycol suppositories
containing 100mg indomethacin.
Indocid Suppositories also contain:
Butylhydroxyanisole, buytlhydroxytoluene,
edetic acid, glycerol, polyethylene glycol
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, 12/13 Exchange
Place, I.F.S.C, Dublin 1, Ireland
Manufacturer
Famar S.A, 49th KM, Athens-Lamia Nat
Road, 19011, Avlona, Greece.
This leaflet was last amended April 2012

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your suppositories, contact your doctor
immediately or go to the nearest casualty
department.

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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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