Indolar SR capsules 75 mg – patient leaflet, side effects, dosage

1. WHAT INDOLAR CAPSULES ARE AND WHAT THEY ARE USED FOR

Indolar Capsules contain a medicine called indometacin. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines are pain killers which reduce inflammation.

Indolar Capsules are for:

• inflammatory disease of the joints such as rheumatoid arthritis, osteoarthritis and degenerative hip disease.

• disorders occurring around a joint such as inflammation of:

  • fluid surrounding a joint (bursitis)
  • tendons (tendinitis)
  • a joint membrane (synovitis)
  • the lining of a tendon (tenosynovitis)
  • the capsule surrounding a joint (capsulitis).
• 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INDOLAR CAPSULES

Do not take Indolar Capsules if you:

• are in the last three months of pregnancy.

• are allergic (hypersensitive) to indomethacin or any of the ingredients of Indolar Capsules

  (see section 6).

• are allergic (hypersensitive) to aspirin, ibuprofen or other NSAIDs (e.g. diclofenac or naproxen). You may have developed signs of asthma (wheezing), runny nose, 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.
• 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 had stomach or intestinal bleeding or perforation after taking NSAIDs.
• have nasal obstruction (nasal polyps).
• are taking any other NSAIDs (e.g. COX-2 inhibitors such as celecoxib, etoricoxib or lumiracoxib).
• have a blood clotting problem.

Indolar Capsules must not be used in children.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Indolar 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 a medicine which is poisonous to the kidneys such as cisplatin or vancomycin.
• about to have, or have recently had surgery.

Or if you have:

• a history of high blood pressure, heart failure (symptoms may include increasing breathlessness and ankle swelling).
• a bleeding or blood clotting disorder.
• mental health problems e.g. mood changes.
• epilepsy.
• Parkinson’s Disease (tremor, stiffness and shuffling).
• any 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, a history of asthma, a chest infection or lung disease.
• a history of gastrointestinal diseases such as ulcerative colitis, Crohn’s disease, diverticulitis or cancer.
• systemic lupus erythematosus (SLE) which causes joint pain, skin rash and fever, or other connective tissue disorders.
• diabetes.
• a decreased amount of fluid around the cells of the body (extracellular volume depletion).
• rheumatoid arthritis (regular eye examinations are recommended).
• peripheral arterial disease (a problem with the circulation in the legs).
• a condition that causes your skin to blister (Stevens-Johnson syndrome or toxic epidermal necrolysis).

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 indomethacin 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.

Other medicines and Indolar Capsules

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have obtained without a prescription, particularly:

• other non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin, ibuprofen, naproxen, or COX-2 inhibitors (e.g. celecoxib) or diflunisal (used for pain and inflammation)
• quinolone antibiotics e.g. ciprofloxacin and norfloxacin (used to treat infections)
• medicines that thin the blood or which prevent blood clotting, such as warfarin, heparin, or antiplatelet drugs such as clopidogrel
• selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or venlafaxine (used for depression)
• metformin or sulphonylureas e.g. gliclazide (used for diabetes)
• diazepam (used for anxiety, difficulty sleeping, alcohol withdrawal, seizures and muscle spasm)
• medicines 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), nifedipine or losartan
• haloperidol (an antipsychotic drug)
• zalcitabine, zidovudine or ritonavir (used for viral infections)
• cardiac glycosides e.g. digoxin (used for heart failure and irregular heart beat)
• ciclosporin, tacrolimus or muromonab-CD3 (used to supress the immune system)
• corticosteroids e.g. prednisolone (used in many different diseases)
• cyclophosphamide, methotrexate or erlotinib (used to treat some types of cancer or rheumatoid arthritis)
• penicillamine (used to treat rheumatoid arthritis)
• desmopressin (used for diabetes insipidus and frequent urination during the night)
• diuretics (water tablets) such as triamterene, thiazides (e.g. bendroflumethiazide) or furosemide, potassium-sparing diuretics (e.g. amiloride, spironolactone)
• lithium (used for some mental health problems)
• mifepristone (used for termination of pregnancy). Indolar Capsules should not be taken within 8-12 days of taking mifepristone
• baclofen (a muscle relaxant)
• pentoxifylline (used for blood vessel disease and leg ulcers)
• probenecid (used for gout)
• tiludronic acid (used for Paget’s disease of bone)
• sibutramine (used to treat obesity)
• phenytoin (used to treat epilepsy)
• phenylpropanolamine used to treat nasal congestion associated with colds, allergies, hay fever or other respiratory illness.

Taking Indolar Capsules with food and drink

• Avoid drinking alcohol whilst you are taking Indolar Capsules as they may increase the risk of bleeding in your stomach or gut.
• Take Indolar Capsules with food or milk to reduce stomach problems.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Indolar 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 Indolar 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, Indolar 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.

Breastfeeding

If you are breastfeeding, you should ask your doctor for advice as small amounts of indomethacin (the active ingredient) can pass into breast milk and should be avoided.

Fertility

Indolar Capsules may make it more difficult to become pregnant and is not recommended in women attempting to conceive. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

Indolar Capsules may make you feel tired, drowsy, dizzy or affect your vision. Make sure you are not affected before you drive or operate machinery. Do not drink alcohol as this can make the symptoms worse.

Indolar Capsules contain sucrose and lactose

This medicine contains sucrose and lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tests

Your doctor may want to carry out tests to monitor your kidney and liver function, your sight, the levels of blood cells and the effects on your stomach and intestines (especially if you are elderly). If you have or have a history of high blood pressure or heart failure (when the heart is unable to pump blood effectively around the body) 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.

3. HOW TO TAKE INDOLAR CAPSULES

Always take Indolar Capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow each capsule whole, with food or milk to reduce side effects on the stomach and intestines. Take your capsules at the same time each day.

Dose

Adults: One capsule once or twice a day, depending on your response. For period pain one capsule a day should be taken, starting when cramps or bleeding begin and continued 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 and adolescents: Indolar Capsules must not be used in children or adolescents.

If you take more Indolar Capsules than you should

It is important not to take too many capsules. If you have taken more than you should, contact your doctor or nearest hospital casualty department immediately. Show them the pack or this leaflet. Symptoms of overdose are pain in the upper part of the stomach, bleeding in the stomach or intestines, diarrhoea, disorientation, tiredness, confusion, excitation, coma, dizziness, ringing or buzzing in the ears, fainting, ‘pins and needles’, numbness, fits, liver damage, feeling or being sick, stomach pain, loss of appetite, drowsiness, headache, ringing or buzzing in the ears, restlessness, agitation and kidney failure.

If you forget to take Indolar 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 one you have missed.

If you stop taking Indolar Capsules

Do not stop treatment without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Indolar Capsules 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 reaction:

• difficulty breathing or swallowing, asthma, sudden decrease in 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 may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

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

Blood:

• small purple red spots, 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 heart beat, unusual tiredness or weakness).

Eyes:

• blurred and 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.

Nervous system:

• headache, dizziness, lightheadedness, spinning sensation (vertigo), tiredness, fainting, coma, fluid in the brain causing swelling, a feeling of general discomfort and illness, drowsiness - depression, nervousness, confusion, hallucinations, anxiety and other mental health problems, a feeling of unreality to the self (that the mind is separated from the body), difficulty sleeping
• speech disorder, fits or seizures, worsening of epilepsy, disorder of the nerves causing tingling and numbness, pins and needles, uncontrolled movements, worsening of parkinsonism (tremor, stiffness and shuffling).

Heart:

• fluid retention causing ankle swelling, chest pain, heart failure
• high or low blood pressure
• racing heart beat, irregular heart beat, 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
• development or worsening of ulcerative colitis or Crohns disease
• inflammation of the pancreas causing pain and tenderness in the abdomen and back (pancreatitis).

Liver:

• blocked bile flow.

Skin:

• inflammation of blood vessels
• sensitivity to sunlight 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).

Muscle and bone:

• muscle weakness, increased breakdown of cartilage.

Kidneys:

• 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.

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 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: 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.

If any of these side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE INDOLAR CAPSULES

Keep out of the reach and sight of children.

Store in a cool dry place and protect from light.

Do not use Indolar Capsules after the expiry date which is stated on the carton/label/bottle. The expiry date refers to the last day of that month.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Indolar Capsules contain

• The active substance (the ingredient that makes the medicine work) is indometacin.

  Each capsule contains 75 mg indometacin.

• The other ingredients are: sucrose, corn starch, lactose, povidone, talc, magnesium stearate and polymethacrylates.
• The capsule shell contains: gelatin, titanium dioxide (E171), erythrosine (E172), indigotine (E132) and yellow iron oxide (E172).

What Indolar Capsules look like and contents of the pack

Indolar SR Capsules 75mg are slow release dark blue/clear hard capsules.

They are available in polypropylene securitainers with polyethylene closures (plastic pot with plastic lid) containing 28, 30, 56, 60, 84, 90 or 100 capsules.

Not all pack sizes may be marketed.

Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.

Marketing Authorisation Holder

Ennogen IP Ltd, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS

UK

This leaflet was last revised in 03/2026.

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