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INDOCID SUPPOSITORIES 100MG

Active substance: INDOMETHACIN

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ASPEN Artwork Panel

Indocid® Suppositories
Indomethacin

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.

Read aII 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. Do not pass it on to others. It may
harm them even if their symptoms are the
same as yours.
• 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.
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. Further 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.

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
anti‑Inflammatory 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.
TO
USE
3. H O W
SUPPOSITORIES

INDOCID

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 suppository‑
pointed 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.

AW Version:
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New Item Code:
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Replacement:
31022463
Market:
UK
Product Name:
Indocid Suppositories
Number of Colours:
1
BLACK

Manufacturing Site:
xxxxxxxxxxxxxxxx

160 mm Measuring Bar

• If you have rheumatoid arthritis your 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

Drawing Ref. Number:
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Drawing Version:
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Originated by:
Liviu Lungu
Originated at:
APTL
Originated on:
22 Aug 2014
Amended on:
N/A

ASPEN Signature Panel
Artwork Studio‘s Check:

Date Signature

Proof Reader‘s Check:

Date Signature

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ASPEN Artwork Panel • May 2013 • Version 5

PACKAGE LEAFLET:
INFORMATION FOR THE
USER

ASPEN Artwork Panel

4. POSSIBLE SIDE EFFECTS
Like all medicines, Indocid can cause side
effects although not everybody gets them.
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;
• Loss of hair; swollen face, lips, tongue
and throat;
• Difficulty in breathing and swallowing;
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);
• Severe light headedness or dizziness due
to a rapid fall in blood pressure.
• The allergic reaction may include problems
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
• Vomit any blood or dark particles that look
like coffee grounds
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.
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:
• Headache, dizziness, light-headedness,
depression, vertigo (sensation that things
around you are moving) and tiredness
(including feeling unwell and listlessness).
• Reactions reported infrequently include
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 identity. 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:
• 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.
Liver disorders:
• Rarely, inflammation of the liver and
jaundice, symptoms of which may be
yellowing of the eyes and skin.

Heart and kidney disorders:
• 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.

Eye disorders:
• Infrequently, blurred vision, double
vision, pain in the eye and other visual
disturbances.
Problems with the ear:
• Ringing in the ears and other hearing
disturbances, including deafness rarely.
Other side effects:
• Bleeding from the vagina in women;
• Increased levels of sugar in the 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;
• Breast changes including enlargement and
tenderness in men and women;
• Ulcers in the lining of the mouth.
Side effects associated with the use of
Indocid suppositories
• Bleeding, inflammation, burning pain,
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. H O W
TO
STORE
SUPPOSITORIES

INDOCID

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, 3016 Lake
Drive, Citywest Business Campus, Dublin
24, Ireland
Service-Tel: 0800 088 7392
(+ 44 1748 828 391)
Manufacturer
Famar S.A, 49th KM, Athens-Lamia Nat
Road, 19011, Avlona, Greece.
This leaflet was last amended August 2014

New Item Code:
xxxxxxxxxxxxxxxx
Replacement:
31022463
Market:
UK
Product Name:
Indocid Suppositories
Number of Colours:
1
BLACK

Manufacturing Site:
xxxxxxxxxxxxxxxx

160 mm Measuring Bar

If you stop using Indocid Suppositories
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.

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
and anaemia may be seen with symptoms
of severe chills, mouth ulcers, headache,
shortness of breath and dizziness.

Page:
2 of 2

Drawing Ref. Number:
xxxxxxxxxxxxxxxx
Drawing Version:
xxxxxxxxxxxxxxxx
Originated by:
Liviu Lungu
Originated at:
APTL
Originated on:
22 Aug 2014
Amended on:
N/A

ASPEN Signature Panel
Artwork Studio‘s Check:

Date Signature

Proof Reader‘s Check:

Date Signature

Technical Site Check:

Date Signature

Market Approval:

Date Signature

ASPEN Artwork Panel • May 2013 • Version 5

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.

AW Version:
1

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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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