Indometacin capsule 25 mg – patient leaflet, side effects, dosage

1. What Indometacin Capsules are and what they are used for

Indometacin Capsules belong 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
• Pain and swelling following muscle or bone surgery
• Period pain
• Gout.

2. What you need to know before you take Indometacin Capsules

Do not take Indometacin Capsules if you:

• are in the last three months of pregnancy or while you are breast-feeding (see “pregnancy and breast-feeding”)
• are allergic to indometacin or any of the other ingredients of this medicine (listed in section 6)
• are allergic to aspirin, ibuprofen or other NSAIDs or you have developed signs of asthma (wheezing), runny nose, swelling of the face, lips, tongue, throat or a skin rash with pale or red irregular raised patches with severe itching when taking these medicines
• are taking other NSAIDs (e.g. naproxen) including COX II inhibitors (e.g. celecoxib)
• suffer with angioneurotic oedema (swelling of the face, lips, tongue or throat)
• have or have had a history of two or more episodes of peptic ulcer (ulcer in your stomach 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)
• have severe liver, kidney or heart problems
• have nasal obstruction (nasal polyps).

Indometacin Capsules must not to be used in children.

Warning and precautions

Talk to your doctor before taking Indometacin Capsules if you are:

• elderly (see ”Other Warnings”)
• to have a vaccination with a live vaccine
• 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
• taking medicines poisonous to the kidneys such as cisplatin or vancomycin.

or if you have:

• a history of high blood pressure or congestive heart failure
• a bleeding or blood clotting disorder
• a mental health problem e.q mood changes
• epilepsy
• Parkinson’s disease (tremor, stiffness and shuffling)
• an infection or sepsis (severe infection)
• any liver, kidney or heart problems
• fluid retention which may be caused by diseases of the heart or kidneys
• asthma or a history of asthma
• have or have a history of gastrointestinal disease such as ulcerative colitis or Crohn’s disease,
• systemic lupus erythematosus (SLE) or other connective tissue disorders
• diabetes
• a decreased amount of fluid around the cells of the body (extracellular volume depletion)
• peripheral arterial disease (a problem with the circulation in the legs).

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 Capsules may be associated with a small increased risk of heart attack 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.

Taking painkillers for headaches too often or for too long can make them worse.

Other medicines and Indometacin Capsules

Tell your doctor or pharmacist 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)
• quinolone antibiotics e.g. ciprofloxacin (for treatment of infections)
• medicines which thin the blood, or which prevent blood clotting, such as warfarin or antiplatelet drugs such as clopidogrel
• selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine (for depression)
• metformin or sulphonylureas e.g. gliclazide (for diabetes)
• phenytoin (for epilepsy)

• diazepam (for anxiety, difficulty sleeping, alcohol withdrawal, seizures, and muscle spasm)

• medicine used to treat high blood pressure such as beta-blockers (e.g. atenolol), alpha-blockers (e.g. prazosin), ACE inhibitors (e.g. lisinopril), angiotensin II receptor antagonists (e.g. valsartan), hydralazine (vasodilator) or nifedipine
• haloperidol (an antipsychotic drug)
• zalcitabine, zidovudine or ritonavir (for HIV infections)
• cardiac glycosides e.g. digoxin (for heart failure and irregular heartbeat)
• ciclosporin, tacrolimus or muromonab-CD3 (for immune system suppression)
• corticosteroids e.g. prednisolone (used in many different diseases)
• cyclophosphamide or methotrexate (to treat some types of cancer and rheumatoid arthritis)
• desmopressin (for diabetes insipidus and frequent urination during the night)
• diuretics (water tablets) such as triamterene, thiazides (e.g. bendroflumethiazide) or furosemide
• lithium (for treatment of mental disorders)
• mifepristone (for termination of pregnancy). Indometacin Capsules should not be taken within 8-12 days of taking mifepristone
• baclofen (a muscle-relaxant)
• pentoxifylline (for blood vessel disease and leg ulcers)
• probenecid (for gout)
• antacids (used to relieve heartburn, upset stomach or acid indigestion)
• tiludronic acid (for Paget’s disease of bone).

Pregnancy and breast-feeding

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 Capsules 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.

Driving and using machines

Indometacin Capsules may make you feel drowsy, dizzy, tired or affect your vision. Make sure you are not affected before you drive or operate machinery.

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.

Surgery

If you are about to have, or have recently had surgery, please contact your doctor before using this medicine..

Indometacin capsules contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

3. How to take Indometacin Capsules.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the capsules with, or immediately after food or with milk or antacids (indigestion remedy) to reduce side effects on the stomach and intestines.

Recommended doses stated below:

Adults:

• Acute rheumatoid arthritis: initially 25 mg two or three times a day.
• Chronic joint disorders: 25 mg two or three times a day. Your doctor may increase your dose depending on your response, up to a maximum of 200 mg a day.
• Sudden worsening of a chronic disorder: up to 150-200 mg a day. Your doctor will decide the best dose for you.
• Acute muscle and bone disorders: initially 50 mg 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: 50 mg two or three times daily 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: 50 mg three or four times a day until symptoms decrease.
• After muscle or bone surgery: 100-150 mg a day in divided doses, to be taken until symptoms decrease.
• Period pain: up to a maximum of 75 mg a daily, continuing for as long as symptoms last.

Elderly:

If you are elderly, your doctor will give you the lowest effective dose for the shortest amount of time.

Children:

Indometacin Capsules must 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 or nearest hospital casualty department immediately, if you have taken more capsules than you should or a child accidentally swallows any.

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

If you forget to take your capsules, 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 a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKING the medicine and seek immediate medical help if you develop any of the following at any time during your treatment::

• signs of bleeding in the 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 reactions:

  • difficulty in breathing or swallowing, asthma, sudden decrease blood pressure
  • swelling of the face lips, tongue or throat

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
• effects on the stomach such as feeling or being sick, inflammation of the stomach lining, small intestine or mouth, constipation, diarrhoea, wind, perforation of previous intestinal damage, narrowing of or blockage in the intestine
• abnormal liver function (as seen in blood tests)
• liver disease: yellowing of the skin or whites of the eyes (jaundice), inflammation of the liver (hepatitis) causing fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever
• skin reactions such as itching, pale or red irregular raised patches with severe itching (hives), disorder characterised by blood spots, bruising and discolouring of the skin (purpura), blisters or skin that is red, flaky or peeling such as severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome)
• aseptic meningitis (stiff neck, headache, 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.

Medicines such as Indometacin Capsules may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. (see Section 2 “Other warnings”).

Tell your doctor or pharmacist if you notice any of the following side effects:

• Eyes:

  • blurred or double vision
  • inflammation of the optic nerve (which may cause eye pain and loss of vision)
  • eye pain
  • changes in your sight.

• Ear:

  • ringing or buzzing in the ears
  • hearing disturbances including deafness.

• Blood:

  • small purple red spot, nosebleeds, bruising, disorder characterised by blood spots, blood 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, you should tell your doctor who may want you to have a blood test.

• Metabolism:

  • high blood sugar
  • sugar in the urine
  • high blood levels of potassium (muscle cramps or pain, irregular heartbeat, unusual tiredness or weakness).

• Nervous System:

  • headache, dizziness, light-headedness, spinning sensation (vertigo), tiredness, fainting, a feeling of general discomfort and illness, drowsiness, coma, fluid in the brain causing swelling
  • depression, confusion, nervousness, hallucination, 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, a worsening of epilepsy, numbness or tingling, pins and needles
  • uncontrolled movements, worsening of parkinsonism (tremor, stiffness and shuffling).

• Heart:

  • fluid retention causing swelling, chest pain, heart failure (symptoms include shortness of breath, tiredness, increased heart rate, flushing, swelling - especially of the ankles)
  • high and low blood pressure (symptoms include dizziness, fainting, light-headedness, nausea, heart attack)
  • racing heartbeat, irregular heartbeat, palpitations.

• Blood vessels:

  • flushing.

• 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.

• Stomach and intestines:

  • loss of appetite
  • developing or worsening of ulcerative colitis or Crohn’s disease
  • inflammation of the pancreas causing pain and tenderness in the abdomen and back (pancreatitis).

• Skin:

  • inflammation of blood vessels
  • sensitivity to light or artificial light (e.g. sun beds)
  • tender red lumps usually on the legs (erythema nodosum)
  • hair loss, sweating
  • worsening of psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts of the body).

• Liver:

  • blocked bile flow (pale coloured stools, dark urine, itching).

• Muscles and bones:

  • muscle weakness, increased breakdown of cartilage

• Kidneys:

  • blood in your urine
  • nephrotic syndrome (increased protein in urine and fluid retention)
  • too much protein in the urine
  • Inflammation of the kidneys, reduced kidney function or kidney failure.

• Reproductive system:

  • bleeding from the vagina
  • breast enlargement or tenderness, enlarged breasts in men.

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 label/carton and on the container. The expiry date refers to the last day of that month.

Store in a well-closed container below 25ºC in a dry place.

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

The active substance is indometacin. Each capsule contains either 25mg or 50 mg indometacin.

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

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 October 2022.