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INDOMETACIN CAPSULE 25MG

Active substance(s): INDOMETACIN / INDOMETACIN / INDOMETACIN

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PROPOSED
PATIENT INFORMATION LEAFLET

INDOMETACIN Capsules 25 mg and 50 mg
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
−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.
What is in this leaflet
1. What Indometacin Capsules are and what it is used for
2. What you need to know before you take Indometacin Capsules
3. How to take Indometacin Capsules
4. Possible side effects
5. How to store Indometacin Capsules
6. Contents of the pack and other information
1. What Indometacin Capsules are and what it is used for
Indometacin capsules belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).These medicines
are pain killers which reduce swelling.
Indometacin capsules 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
 Acute gout
 Pain and swelling following muscle or bone joint surgery
 Period pain
2. What you need to know before you take Indometacin Capsules
Do not take Indometacin Capsules if:
 You are allergic (hypersensitive) to indometacin or any of the other ingredients of this medicine (listed in section 6).
 You are in the last three months of pregnancy
 You have or have had a history of two or more episodes of peptic ulcer (stomach ulcer 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)
 You are allergic (hypersensitive) to aspirin ,ibuprofen or other NSAIDs or you have developed signs of asthma
(wheezing), runny nose ,swelling of the lips, tongue, throat or face, or a skin rash with pale or red irregular raised
patches with severe itching when taking these medicines
 You are taking other NSAIDs (e.g. naproxen)including COX II inhibitors (e.g. celecoxib)
 You suffer with angioneurotic oedema (swelling of the face, lips, tongue or throat)
 You have severe liver, kidney or heart problems
 You have nasal obstruction (nasal polyps).
Warning and precautions
Medicines such as Indometacin Capsules 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.

PROPOSED
Taking pain killers for headaches too often or for too long can make them worse.
Talk to your doctor before taking Indometacin Capsules if:
 You have heart disease, high blood pressure or retention of fluids
 You suffer from liver or kidney disease, or heart failure
 You suffer from asthma, epilepsy or Parkinson’s disease(tremor, stiffness and shuffling)
 You have a psychiatric disorder
 You are having treatment for a fever or an infection, or are receiving treatment with live vaccines
 You have a blood-clotting problem or are taking medicines to stop your blood clotting
 You have an inflammatory disorder of connective tissue (Systemic Lupus Erythematosus)
 You are elderly, have ulcerative colitis or Crohn’s disease, as there is a higher risk of stomach problems (e.g. ulcers or
bleeding)
 You are due to have an operation
 You are 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.
 You have fluid retention which may be caused by diseases of the heart or kidneys
 You have diabetes
 You have a decreased amount of fluid around the cells of the body (extracellular volume depletion)
 You have peripheral arterial disease (a problem with the circulation in the legs).
Regular blood and eye tests are recommended when taking this medicine for prolonged treatment. If you are having blood
tests, tell the doctor that you are taking Indometacin. If you notice any changes in your vision, you should tell your doctor.
Indometacin capsules must not to be used in children.
Other medicines and Indometacin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
 Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. Aspirin, Ibuprofen, Naproxen or COX II inhibitors(e.g. Celecoxib) or
Diflunisal (for pain and inflammation) and Keterolac
 Lithium (for treatment of mental disorders)
 Haloperidol (for hyperactivity, agitation and mania)
 Ciclosporin (to treat severe skin disease and rheumatoid arthritis, and to prevent organ rejection after organ transplant)
 Diuretics (water tablets) such as Triamterene ,Thiazides,(e.g. Bendroflumethiazide )or Furosemide
 Desmopressin (to prevent and control excessive thirst, urination and dehydration caused by injury/surgery
 Cyclophosphamide or Methotrexate (used in the treatment of some types of cancer and rheumatoid arthritis)
 Anti-coagulants (for thinning the blood)
 Phenytoin (for treating epilepsy)
 Probenecid (for treating gout)
 Tiludronic acid (to treat a disease of the bones)
 Cardiac glycosides e.g. Digoxin (for treatment of heart failure and changes of heart rhythm)
 Quinolone antibiotics e.g. ciprofloxacin (for treatment of infections)
 Anti-hypertensives (for treatment of high blood-pressure) or heart conditions, such as captopril and lisinopril (ACE
inhibitors), doxazosin and prazosin (alpha-blockers), atenolol and propranolol (beta-blockers), candersatan and losartan,
hydralazine, nifedipine, pentoxifylline
 Corticosteroids (for treatment of asthma or other inflammatory disorders)
 Mifepristone (for abortion) taken within 8-12 days
 Ciclosporin ,Tacrolimus or Muromonab-CD3 (for immune system suppression)
 Baclofen, a muscle-relaxant
 Metformin or Sulphonylureas e.g. Gliclazide for diabetes
 Zalcitabine , Ritonavir or Zidovudine to treat viral infections
 Selective Serotonin Reuptake Inhibitors (SSRIs) e.g.Fluoxetine for depression
Some of the drugs listed above may interact with indometacin, so that the effect of the action of indometacin may be affected
and your doctor may therefore wish to consider an alternative medicine.

PROPOSED
Tests and Surgery
Indometacin may alter the results of some blood, liver or kidney. If you go into hospital, or are about to have, or have recently
had surgery, or have treatment for other conditions, tell the doctor that you are taking Indometacin.
Pregnancy and breast-feeding
Do not take Indometacin if you are in the last three months of your pregnancy. You should only take Indometacin capsules in
first six months of pregnancy or if you are breast-feeding under medical supervision. Always ask your doctor before taking any
medicines.
Driving and using machines
Indometacin capsules may make you feel drowsy, dizzy or affect your vision. Make sure you are not affected before you drive or
operate machinery.
Indometacin capsules contains Lactose
If you know you have intolerance to lactose or other sugars contact your doctor before taking Indometacin Capsules.
3. How to take Indometacin capsules.
Always take Indometacin Capsules exactly as your doctor has told you. Check with your doctor or pharmacist if you are not
sure.
Take this medicine by mouth together with or after food, milk, or an antacid (medicine used to neutralise excess acid in the
stomach), and only in the doses prescribed by your doctor. You will be prescribed the lowest effective dose for the shortest time
necessary to treat your symptoms. Do not take more of it and do not take it more often, or for a longer time, than your doctor
has ordered. Do not take if you have, or have ever had, peptic ulceration (ulcer in your stomach or duodenum) or bleeding in
your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
Usual doses stated below:
Adults:
i. Chronic rheumatic disorders, including chronic rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, usual
recommended dose is: 25 mg two to three times daily followed by a gradual increase of 25mg a day if necessary. The
usual maximum daily dose is 150mg. Your doctor will decide the best dose for you.
ii. Sudden flare up of long term condition: up to 150-200 mg a day. Your doctor will decide the best dose for you.
iii. Acute rheumatoid arthritis, usual recommended dose is: 25 mg two or three times a day.
iv. Muscle and bone disorders: typical dose is 50 mg two or three times a day, according to severity for 10-14 days.
Normally 150 mg daily, rarely 200 mg daily.
v. Acute musculo-skeletal disorders: 50 mg two or three times daily, according to severity for 10 to 14 days. Your doctor will
decide the best dose for you.
vi. Lower back pain: 50 mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.
vii. Acute attack of gout: 50 mg three to four times daily. Your doctor may increase or decrease your dose depending upon
the severity of your symptoms.
viii. After muscle of bone surgery: 100-150 mg daily in divided doses, to be taken until symptoms decrease.
ix. Painful periods – Up to a maximum of 75 mg a day can be taken at the start of period pain for a few days until the pain
lasts.
Elderly:
Extra care is required in older patients who may be more liable to adverse reactions. The lowest dose should be used, and the
patient should be checked by the doctor every four weeks after commencing treatment to make sure that there is no bleeding
from the stomach or bowel.
Use in children:
Not recommended for children.
If you take more Indometacin Capsules than you should
If you think you may have taken an overdose of this medicine or a child accidentally swallows any capsule, you must obtain
emergency help at once. Go to your doctor or nearest hospital casualty department straight away. Take with you any remaining
tablets and the container so that the medicine can be identified.

PROPOSED
Symptoms of overdoses are headache, feeling or being sick, stomach pain, bleeding in the stomach or intestines, diarrhoea,
disorientation, excitement, coma, drowsiness, dizziness, ringing or buzzing in the ears, fainting, fits, or seizures, kidney failure,
liver damage.
If you forgot to take Indometacin capsules
Should you miss a dose of this medicine, take the missed dose as soon as you remember, unless it is nearly time for your next
dose. Do not take a double dose to make up for one you have missed.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP TAKING the medicine and tell your doctor if you experience:
 An allergic reaction
Allergic reactions may cause:
- wheezing, asthma, difficulty in swallowing and breathing, swelling and irritation inside the nose
- rapid fall in blood pressure resembling a shock-like state
- redness, itching, rashes, scaling, blistering or peeling of skin
- swelling of eyelids, lips, tongue, throat, hands, feet or ankles
 Pass blood in your faeces (stools/motions)
 Pass black tarry stools
 Vomit any blood or dark particles that look like coffee grounds.
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate
medical help:
 Indigestion or heartburn
 Abdominal pain (pains in your stomach) or other abnormal stomach symptoms
 aseptic meningitis which may cause stiff neck, headache, vomiting, nausea ,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.
Problems with the Central Nervous System:
Headache, dizziness, light-headedness, depression, confusion, nervousness, lack of self awareness, a spinning sensation
affecting balance, feeling unwell and listless. Anxiety, fainting, numbness or tingling, fits, drowsiness, loss of conscious, build up
of fluid in the brain, coma, involuntary muscle movements, sleeplessness, hallucination, mental disturbances, pins and needles,
speech problems, a worsening of Parkinsonism and epilepsy. These effects are often of a passing nature, and disappear when
the dosage is reduced. However sometimes severe reactions require that your doctor will stop treatment with Indometacin.
Digestive system side effects:
The more frequent reactions are nausea, loss of appetite, vomiting, abdominal discomfort due to trapped wind, constipation and
diarrhoea. Ulcers of the gullet, stomach, or elsewhere in the small or large bowel, developing or worsening of ulcerative colitis
or Crohn’s disease sometimes with bleeding from these ulcers. Developing or worsening of ulcerative colitis or Crohn’s disease.
The symptoms of bleeding from the ulcers in the intestine may be bringing up blood, or bright red or black stools. Infrequently
there may be inflammation of the mouth and stomach, narrowing of the intestines, or obstruction of the intestines, which can
appear as a swollen abdomen.
Liver disorders:
The liver may function abnormally, with rarely inflammation of the liver and jaundice, which may appear as yellowing of the eyes
and skin.
Kidney disorders:
 Inflammation, damage or failure of the kidneys.
 Sugar, protein or blood in your urine.
 Nephrotic Syndrome(increased protein in urine and fluid retention)

PROPOSED
Heart disorders:
Medicines such as Indometacin Capsules may be associated with a small increased risk of heart attack (“myocardial infarction”)
or stroke. Increased blood pressure, flushing, fluid retention, rapid heartbeats, alteration in heart rhythm, palpitations, a fall in
blood pressure, chest pain or heart failure have also been reported.
Skin disorders:
Circular red patches, red or purple discolouring of the skin due to inflammation of blood vessels, tender red lumps under the
skin, worsening of psoriasis, itching, rashes, loss of hair, sweating. Sensitivity to light causing skin irritation.
Blood disorders:
Infrequently blood disorders of various types, these may cause paleness, tiredness, fever with a sore throat. Bruising and small
blue spots on the skin or prolonged bleeding after an injury. Blood tests will detect the anaemia causing the problem. High
levels of potassium (hyperkalaemia) or sugar (hyperglycaemia) in the blood, nosebleeds, blood clotting throughout the body,
disturbance of blood count.
Problems with the ears and eyes:
Disturbances of vision, inflammation of the optic nerve, pain in or around eye, ringing in the ears, hearing disturbances, deposits
in the cornea and disturbances of the retina.
Problem with the muscles and bones:
 Muscle weakness, accelerated deterioration of cartilage
Problems with the breasts and reproductive system:
 Bleeding from the vagina
 Enlargement or tenderness of the breasts, breast development in men
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 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 Capsules
Keep this medicine out of the sight and reach of children.
Store in a well-closed container below 25ºC in a dry place.
Do not take this medicine after the expiry date, which is stated on the label/carton and on the container. The expiry date refers
to the last day of that month.
Do not throw away any medicines via wastewater or house hold waste .Ask your pharmacist how to throw away medicine you
no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Indometacin capsules contains
The active substance is Indometacin Ph.Eur, in Indometacin capsules 25mg and 50 mg.
The other ingredients in Indometacin 25 mg Capsules are: Lactose, sodium lauryl sulphate, anhydrous colloidal silica,
magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), gelatin.
The other ingredients in Indometacin 50 mg Capsules are: Lactose, sodium lauryl sulphate, anhydrous colloidal silica,
magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), quinoline yellow (E104),
erythrocine (E127), gelatin.
What Indometacin capsules look like and contents of the pack
Indometacin 25 mg capsules are ivory capsules printed INDO 25 or plain capsules.
Indometacin 50 mg capsules are ivory capsules printed INDO 50 or plain capsules.
The capsules come in blisters packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 capsules.
Not all pack sizes may be marketed

PROPOSED
Marketing Authorisation Holder
Chelonia Healthcare Limited, 11 Boumpoulinas, Nicosia 1060, Cyprus.
Manufacturer
Meridian Healthcare (UK) Ltd, 208-214 York Road, London SW11 3SD.
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was revised in 08/2016.

Expand Transcript

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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