INDOCID CAPSULES 25MG

Active substance: INDOMETHACIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Indocid Capsules 25mg and 50mg
Indocid-R 75mg Capsules (sustained release)
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. 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.
2.
3.
4.
5.
6.

What Indocid Capsules are and what they are used for
Before you take Indocid Capsules
How to take Indocid Capsules
Possible Side Effects
How to store Indocid Capsules
Further Information

1. WHAT INDOCID CAPSULES ARE AND WHAT THEY ARE USED FOR
The active ingredient in your medicine is indomethacin. This belongs to a group of medicines known as
‘non-steroidal anti-inflammatory agents’ or NSAIDs. 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.
Osteoarthritis.
Ankylosing spondylitis.
Pain, inflammation, and swelling following orthopaedic surgery.
Musculoskeletal disorders.
Period pain.
Low back pain.
Disease of the hip joint.

In addition, Indocid Capsules (but not Indocid-R Capsules) may be prescribed for acute gouty arthritis.
2. BEFORE YOU TAKE INDOCID CAPSULES

Do not take Indocid capsules


If you are hypersensitive (allergic) to indomethacin or any of the other ingredients in Indocid
Capsules (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 antiinflammatory medicine.
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 have polyps 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 capsules
Tell your doctor before taking these capsules if you:








are epileptic
have Parkinson’s disease
have a psychiatric problem
have heart disease, high blood pressure or have a tendency for fluid retention
are being treated for infection or you have a fever
know you suffer from asthma, digestive tract, liver or kidney disease, diabetes or heart failure
have a problem with your blood clotting.

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.
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. If 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.
If you are having blood tests, make sure that the doctor doing them knows that you are taking Indocid.

Taking other medicines
Please tell your doctor if you are taking any of the following medicines:












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, are planning to
become pregnant or if you are breast-feeding. 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 TAKE INDOCID CAPSULES
Always take Indocid capsules exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Take with or after food.
The amount you take will depend upon your condition.
The usual adult dosage is between 50 and 200 mg a day.
With Indocid-R Capsules, this means the usual adult dosage is one or two capsules a day.
Not recommended for use in children.

If you take more Indocid capsules than you should
If you take too many capsules by mistake or someone else accidentally takes your capsules, contact your
doctor immediately or go to the nearest casualty department.

If you forget to take Indocid capsules
If you forget to take, 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 capsule to make up for forgotten doses.

If you stop taking Indocid capsules
You should take Indocid capsules for as long as your doctor tells you to. It may be dangerous to stop
taking them without your doctor’s advice.

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:
Serious allergic reactions include 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; 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 above for symptoms of each).
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.
Common (affecting less than 1 in 10 patients receiving the medicine)



Headache, dizziness, light-headedness, depression, vertigo and tiredness (including feeling
unwell and listlessness).
Nausea, loss of appetite, vomiting, trapped wind, constipation, and diarrhoea. Ulcers may
develop with symptoms of stomach pain and bleeding.

Uncommon (affecting less than 1 in 100 patients receiving the medicine)





Anxiety, confusion, fainting, drowsiness, convulsions, coma, loss of sensation, muscle weakness,
involuntary muscle movements, sleeplessness, hallucinations and mental disorders.
Pins and needles, speech problems, worsening of epilepsy (fits), tremor, stiffness and shuffling
which can be temporary and often disappear with continued or reduced dosage.
Inflammation of the mouth and stomach, wind, narrowing and/or obstruction of the intestines
which may be seen as a swollen abdomen, and vomiting.
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 which are usually detected in blood tests, but may be seen as pallor, tiredness,
fever, sore throat and mouth, small red spots on the skin, bruising or prolonged bleeding after
injury. Difficulty in breathing may occur in patients already suffering from asthma or allergies.
Blurred vision, double vision, pain in the eye and other visual disturbances.
Ringing in the ears and other hearing disturbances.

Rare (affecting less than 1 in 1000 patients receiving the medicine)
 Intestine ulcers.
 Inflammation of the liver and jaundice, symptoms of which may be yellowing of the eyes and skin
caused by liver and blood problems.
 Deafness.
 Increase protein in urine measured by a urine test, inflammation of the kidney which can cause
swollen ankles or high blood pressure.
 Bleeding from the vagina in women; flushing and sweating; bleeding from the nose; breast
changes including enlargement and tenderness in men and women; and ulcers in the lining of the
mouth.
 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.

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. HOW TO STORE INDOCID CAPSULES
Keep out of the reach and sight of children.
Do not use Indocid capsules after the expiry date which is stated on the carton. The expiry date refers to
the last day of that month.
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 capsules contain
The active ingredient in Indocid Capsules and Indocid-R Capsules is indomethacin
Indocid Capsules come in two strengths. The ivory opaque capsules marked ‘MSD 25’ contain 25 mg
indomethacin. The ivory opaque capsules marked ‘MSD 50’ contain 50 mg indomethacin.

Indocid-R is an ivory and transparent capsule carrying white and blue pellets marked ‘MSD 693’ and
contains 75 mg indomethacin.
Indocid 25mg and 50mg Capsules contain: colloidal silicon dioxide, lactose, liquid lecithin concentrate,
magnesium stearate E572, gelatin, titanium dioxide E171 and yellow ferric oxide E172.
Indocid-R capsules also contain: indigo carmine E132, magnesium stearate E572, maize starch,
methylhydroxypropylcellulose E464, microcrystalline cellulose E460, poly(vinyl acetate-crotonic acid)
copolymer, sucrose, gelatin, titanium dioxide E171, yellow iron oxide E172.

What Indocid capsules looks like and the contents of the pack
Indocid capsules are available
Indocid Capsules are supplied in packs of 90.
Indocid-R Capsules are supplied in packs of 30.

Marketing Authorisation Holder
The Marketing Authorisation is held by
Aspen Pharma Trading Ltd.
12/13 Exchange Place,
Custom House Docks,
International Financial Service Centre,
Dublin 1,
Ireland

Manufacturer
Merck Manufacturing Division,
Merck Sharp & Dohme Limited,
Cramlington, Northumberland,
NE23 3JU,
United Kingdom

Date Last Amended: March 2013

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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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