Patient leaflet - Indometacin capsules BP 25 mg
1. What Indometacin Capsules are and what they are used for
This medicine contains the active ingredient Indometacin which belongs to a group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), which are used for pain relief and reducing inflammation (swelling).
This medicine is used to relieve pain, swelling and redness in a number of conditions affecting the joints, muscles and bones, including rheumatoid and osteo-arthritis, degenerative hip disease, pain and stiffness in the backbone (ankylosing spondylitis) or lower back, pain or swelling in muscles or bones following surgery and for sprains and strains. It is also used for acute gout and 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 to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as shortness of breath, skin rash, itching, blocked nose or swollen face or lips
- are allergic (hypersensitive) to ibuprofen, aspirin or to other non-steroidal anti-inflammatory drugs (NSAIDs), or you have developed signs of asthma (wheezing), runny nose, angioneurotic oedema (swelling of the face, lips, tongue or throat), or a skin rash with pale or red irregular raised patches with severe itching, when taking these medicines
- have nasal obstruction (nasal polyps)
- have a peptic ulcer (ulcer in your stomach or duodenum), or bleeding in your stomach or intestine, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
- have had stomach bleeding or perforation ever caused by taking NSAIDs. Symptoms may include vomiting particles that look like coffee-ground, black tarry stools and blood in your faeces (stools/motions)
- have severe liver, kidney or heart failure
- are in the last 3 months of pregnancy or while you are breast-feeding (see “Pregnancy and breast-feeding” section below). Indometacin Capsules must not be used in children.
Warnings and precautions
Talk to your doctor before taking Indometacin Capsules if you:
- are already taking another non-steroidal anti-inflammatory drug (NSAID), including naproxen, aspirin or cyclooxygenase (COX-2 inhibitors) NSAIDs such as celecoxib or rofecoxib as taking more than one NSAID at the same time may increase the possibility of developing the unwanted gastrointestinal effects (e.g. sickness, heartburn, abdominal pain etc.)
- are elderly (see “Other warnings”)
- suffer from mental illness (e.g. mood changes)
- suffer from liver, kidney or heart problems, congestive heart failure, high blood pressure or fluid retention
- have diabetes mellitus
- have Parkinson’s disease (tremors, stiffness and shuffling)
- suffer from epilepsy
- an infection or sepsis (severe infection)
- have a blood clotting/bleeding disorder
- have high blood levels of potassium
- have asthma or have a history of bronchial asthma
- have gastrointestinal problems or have ever suffered from a stomach or intestinal disorder (e.g. ulcerative colitis or Crohn’s disease)
- suffer from systemic lupus erythematosus (SLE - an allergic condition which causes joint pain, skin rashes and fever) or a connective tissue disorder
- are on antibiotic therapy, i.e. if you have an infection or sepsis, or if you have recently been vaccinated, or are due to be vaccinated
- are taking medicines that may affect the functioning of the kidneys e.g. such as cisplatin (an anti-cancer medicine) or vancomycin (an antiobiotic)
- have a decreased amount of fluid around the cells of your body (extracellular volume depletion)
- have peripheral arterial disease (a problem with the circulation in the legs)
- are in the first 6 months of pregnancy, planning to become pregnant or breast-feeding. 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. Other warnings
If you are elderly or you have previously had stomach ulcers, you have a higher risk of getting side effects, especially from the stomach. Your doctor should therefore prescribe the lowest dose that gives you sufficient relief. If you experience any unusual symptoms from the stomach, you must tell your doctor about it.
Medicines such as indometacin 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 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 painkillers for headaches too often or for too long can make them worse.
You could encounter headache, dizziness and light-headedness when you start taking this medicine. If it continues for a long period, stop taking the medicine and see your doctor immediately.
Other medicines and Indometacin Capsules
Check with your doctor or pharmacist before taking these capsules if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, particularly:
- other non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, naproxen or COX II inhibitors (e.g. celecoxib) or diflunisal (for pain and inflammation)
- medicines to thin the blood or prevent blood clotting e.g. warfarin or anti-platelet drugs e.g. clopidogrel
- anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine
- medicines to treat high blood pressure such as beta blockers e.g. atenolol and propranolol, alpha-blockers e.g. prazosin, ACE inhibitors e.g. captopril and lisinopril, angiotensin-II receptor antagonists e.g. valsartan, or the drugs diazoxide, hydralazine or nifedipine
- diuretic medicines (water tablets) such as furosemide, triamterene and thiazides (e.g. Bendroflumethiazide)
lithium or haloperidol (for mental illness/ an antipsychotic drug) or medicine to treat anxiety, sleeping difficulty, alcohol withdrawal, seizures and muscle spasm e.g. diazepam
- corticosteroids (for replacement therapy or inflammatory disorders) e.g. hydrocortisone or prednisolone
- probenecid for gout
- treatment to prevent rejection following an organ transplant e.g ciclosporin, tacrolimus or muromonab-CD3
- methotrexate or cyclophosphamide (to treat some types of cancer and rheumatoid arthritis)
- quinolone antibiotics to treat infections e.g. ciprofloxacin
- cardiac glycosides e.g. digoxin (used to slow the heart rate and which are also given in chronic heart failure)
- mifepristone (used for the termination of pregnancies “the morning after pill”) Indometacin capsules should be taken within 8-12 days of taking mifepristone
- drospirenone (a contraceptive pill)
- baclofen (a treatment for muscle spasm/a muscle relaxant)
- phenytoin (to treat epilepsy)
- pentoxifylline (used to treat problems with peripheral blood vessels)
- desmopressin (used in the treatment of diabetes insipidus and frequent urination during the night)
- tiludronic acid (used to treat Paget’s disease)
- metformin or sulfonylureas e.g. gliclazide for diabetes
- antiviral medications (for HIV infection) e.g. zidovudine, ritonavir, zalcitabine
- antacids used to relieve heartburn, acid indigestion and upset stomach.
Tests
Your doctor may want to carry out tests to monitor your kidney and liver function, the levels of blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have or have had a history of high blood pressure or heart failure your doctor may also want to monitor you. If you have rheumatoid arthritis you may be advised to have regular eye tests to check your sight.
Indometacin can cause false-negative results in the dexamethasone suppression test (DST). If you need to take this test tell the doctor you are taking indometacin.
Surgery
If you are about to have, or have recently had surgery, please contact your doctor before using this medicine.
Pregnancy, breast-feeding and fertility
Do not take Indometacin Capsules if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected.
You should not take Indometacin Capsules during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Indometacin can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.
You should not take Indometacin Capsules while breast-feeding unless considered necessary by your doctor.
Driving and using machines
Do not drive or operate machinery if you experience dizziness, drowsiness, fatigue or visual disturbances when you start taking this medicine. Indometacin Capsules contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Information on sodium
This medicine contains less than 1mmol sodium (23 mg) per capsule, that is to say essentially “sodium free”.
Package leaflet: Information for the patient
INDOMETACIN Capsules
| Process Black |
3. How to take Indometacin Capsules
The capsules should be swallowed whole after food or with a drink of milk or an antacid (indigestion remedy) to reduce side effects on the stomach and intestines.
Your doctor will decide the dose that is best for you depending on the condition being treated. Always take this medicine as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual recommended dose is:
Adults:
- Acute rheumatoid arthritis: initially 25mg two or three times a day.
- Chronic joint disorders: 25mg two or three times a day. Your doctor may increase your dose depending on your response, up to a maximum of 200mg a day.
- Sudden worsening of a chronic disorder: up to 150-200mg a day. Your doctor will decide on the best dose for you.
- Acute muscle and bone disorders: initially 50mg two or three times a day for 10-14 days. Your doctor will decide on the best dose for you, depending on the severity of your condition.
- Lower back pain: 50mg two or three times a day for 5-10 days. Your doctor will decide on the best dose for you, depending on the severity of your condition.
- Acute attack of gout: 50mg three or four times a day until symptoms decrease.
- After muscle or bone surgery: 100-150mg a day in divided doses, to be taken until symptoms decrease.
Period pain: Up to 75mg daily, continuing for as long as symptoms last.
Elderly: Caution should be exercised and therapy should only start at the lowest recommended dose for the shortest possible time. Children: Indometacin should not be used in children.
If you take more Indometacin Capsules than you should
It is important not to take too many capsules. Contact your doctor straight away or go to the nearest hospital casualty department immediately, if you have taken more capsules than you should or a child accidently swallows any. Take with you any remaining capsules and the pack so that the medicine can be identified.
Symptoms of overdose 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 forget to take Indometacin Capsules
If you miss a dose of this medicine, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES to make up for one you have missed. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
There will be fewer side effects if you take the lowest effective dose for the shortest time necessary.
If any of the following occur STOP TAKING the capsules and IMMEDIATELY seek medical help:
Signs of a stomach ulcer or bleeding in your stomach:
- pass blood in your faeces (stools/motions)
- pass black tarry stools
- vomit any blood or dark particles that look like coffee grounds.
Signs of an allergic reaction:
- wheezing or shortness of breath, difficulty in breathing or swallowing, asthma
- swelling of the face, throat, lips or tongue
- shock and in severe cases collapse.
- decrease in blood pressure
Blood disorders such as clotting throughout the body, disturbance of blood count, reduction in blood cell production by the bone marrow. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion, or abnormal paleness of the skin, small purple red spots, you should tell your doctor who may want you to have a blood test.
Kidney disorders such as nephrotic syndrome (increased protein in urine and fluid retention), inflammation of the kidneys, reduced kidney function or kidney failure.
Other side effects:
Breathing:
- increase in the number of white blood cells in the lungs
- narrowing of the airways in those who have a history of asthma or allergic disease.
Skin:
- inflammation of blood vessels
- itching, pale or red irregular raised patches with severe itching (hives), disorder characterised by blood spots, bruising and discolouring of the skin (purpura)
STOP TAKING the capsules and tell your doctor as soon as possible if you experience any of the following:
- stomach pain or other abnormal stomach symptoms, indigestion or heartburn
- allergic skin reactions which can include severe skin rash or itching, bruising, painful red areas, red tender nodules on the skins usually on the legs (erythema nodosum), flaking, peeling or blistering and severe serious reactions called Stevens-Johnson syndrome and toxic epidermal necrolysis (causing blistering of the skin-resembles severe burns, mouth, eyes and genitals, fever), circular, irregular red patches on the skin of the hands and arms (erythema multiforme)
- yellowing of your skin or the whites of your eyes and/or pale stools, dark urine (blocked bile flow), inflammation of liver (hepatitis) causing loss of appetite, fatigue, weakness, abdominal pain, weight loss abnormal liver function (as seen in blood tests)
- passing more or less urine than normal, difficult or painful urination, cloudy or foamy urine, blood in urine, too much protein in urine, pain in the back, fever, rash, swelling (particularly of the ankles), high blood pressure, as these may be signs of kidney problems. Medicines such as indometacin may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. (see Section 2 ‘Other warnings’).
Tell your doctor if you notice any of the following side effects:
Very rare effects (that may affect up to 1 in 10,000 people):
- inflammation of the pancreas causing severe pain in the abdomen and back (pancreatitis)
Rare effects (that may affect up to 1 in 1,000 people):
- difficulty in sleeping, difficulty speaking, confusion, anxiety, psychiatric problems, fainting, coma
- weakness, tingling or numbness, muscle weakness, involuntary jerky movements, fits, worsening of epilepsy, tremor, stiffness and shuffling
- increase in blood sugar level, sugar in the urine, high levels of blood potassium which can cause abnormal heart rhythm, muscle cramps or pain, unusual tiredness or weakness
- ringing or buzzing in the ears, hearing disturbances including deafness.
Other effects which have been reported:
- high blood pressure (symptoms may include headache, dizziness or blurred vision), oedema (water retention), heart failure (symptoms include tiredness, increased heart rate, flushing, shortness of breath or swollen ankles)
- feeling or being sick, loss of appetite, diarrhoea, constipation, flatulence (wind), sore mouth, inflammation of the stomach lining or the ileum (small intestine) with additional symptoms of stomach pain or discomfort, weight loss, fever, belching and indigestion
- worsening of the symptoms of colitis and Crohn’s disease
- blood disorders including severe reduction in the number of white or red blood cells which may cause pale skin, tiredness, weakness or breathlessness and increase the risk of bleeding or bruising or make infections more likely, sore throat, nose bleeds or increased levels of urea (a waste product) in the blood
- skin rash or itching, increased sensitivity to sunlight or artificial light (sunbeds), hair loss, worsening of a skin condition called psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts of the body)., sweating
- headache, dizziness, light-headedness, spinning sensation (vertigo), a feeling of general discomfort and illness, coma, anxiety and other mental health problems, a feeling of unreality (that the mind is separated from the body), difficulty sleeping, speech disorder, fits or seizures, worsening of epilepsy, uncontrolled movements, worsening of parkinsonism (tremor, stiffness and shuffling). ringing in the ears or other hearing disturbances, tiredness, lack of energy, drowsiness, confusion, “pins and needles” in the hands and feet (disorders of the nerves causing tingling and numbness), depression, hallucinations, nervousness, fluid in the brain causing swelling
- eyesight problems (such as blurred or double vision, partial or complete loss of vision, pain in or around the eye), deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina), inflammation of optic nerve
- fast or irregular heartbeat (tachycardia or arrhythmia), feeling your heartbeat, chest pain, low blood pressure (symptoms may include light-headedness, dizziness or fainting)
- aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck, feeling or being sick, skin rash, eyes being very sensitive to bright light, disorientation
- flushing, bleeding from the vagina, changes in the breast (enlargement or tenderness), breast development in males
- worsening of cartilage damage.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Opaque plastic containers: Keep the capsules in the pack provided in order to protect from heat, light and moisture. Blister packs: Store below 25°C. Keep the blisters in the outer carton in order to protect from light and moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Indometacin Capsules contain
Indometacin Capsules are available in two strengths. Each capsule contains either 25mg or 50mg of indometacin as the active ingredient. The capsules also contain the following ingredients: talc, magnesium stearate, sodium starch glycolate, sodium lauryl sulphate, lactose, quinoline yellow (E104), titanium dioxide (E171) and gelatin. The capsules are printed with an ink containing shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide.
What Indometacin Capsules look like and contents of the pack
Indometacin Capsules 25mg are ivory coloured shells printed with ‘IND 25’ and company logo.
Indometacin Capsules 50mg are ivory coloured shells printed with ‘IND 50’ and company logo.
Indometacin Capsules are available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 capsules (not all pack sizes may be marketed). Marketing Authorisation Holder and Manufacturer:
Crescent Pharma Ltd., Key House, Sarum Hill, Basingstoke, RG21 8SR, UK.