Patient leaflet - Indomethacin capsules BP 25 mg

1. What Indometacin is and what it is used for

Indometacin belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Indometacin is a pain-reliever and works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles.

Indometacin is used to treat the following conditions:

Rheumatoid arthritis
Osteoarthritis
Ankylosing spondylitis (arthritis in the spine)
Musculo-skeletal disorders such as sprains and strains
Lower back pain
Inflammation, pain and swelling following bone, muscle or joint operations
Period pain (primary dysmenorrhoea)
Disease of the hip joint
Gout

2. What you need to know before you take Indometacin

Do not take Indometacin:

If you are allergic to Indometacin, other NSAIDs or any of the other ingredients of this medicine (listed in section 6)
If you have taken other NSAIDs before (including aspirin and ibuprofen) and had a reaction, such as asthma, runny nose, swelling (angioedema), skin rashes (see section 4 “Possible side effects”)
If you are in the third trimester (last 3 months) of pregnancy (see ’Pregnancy’ section)
If you currently have or have had a history (two or more episodes) of peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach or intestines
If you have severe liver, kidney or heart failure
If you have a history of stomach bleeding or perforation after taking NSAIDs
If you have a growth in your nose (nasal polyps)
If this medicine is intended for a child
If you have a blood clotting disorder

Warnings and precautions

Talk to your doctor before taking Indometacin:

If you are taking other NSAIDs such as aspirin (see “Other medicines and Indometacin” section)
If you suffer from or have a history of bronchial asthma
If you have a history of intestinal disease such as ulcerative colitis or Crohn’s disease, especially if you are elderly. Treatment should commence on the lowest dose possible. Combination treatment with protective medicines should be considered and also if you require a low dose of aspirin, or other medicines likely to increase risk of stomach problems
If you are about to or have recently had surgery
If you suffer from liver problems
If you have problems with your kidneys, as you should be closely monitored and a lower daily dose should be used
If you suffer from or have a history of heart problems, including high blood pressure, heart failure and heart disease or are at risk of heart disease (for example have high cholesterol, you smoke, or have diabetes)
If you suffer from conditions prone to fluid retention, as the use of NSAIDs may result in deterioration of kidney function and may cause fluid retention and swelling which may further aggravate these conditions. Your dose of Indometacin should be kept as low as possible and kidney function should be monitored
If you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disorders
If you are a woman trying to conceive a baby (see ’Pregnancy and breast-feeding and fertility’ section)
If you are elderly, as you are more at risk of having side effects, especially stomach bleeding and perforation
If you currently have an infection (treated or not) as Indometacin may mask the signs and symptoms of an infection, so antibiotic therapy should be started promptly if an infection occurs during treatment with Indometacin
If you are due to have a vaccination with a “live” vaccine
If you are taking diuretics, have diabetes, low blood volume or a serious blood infection (sepsis)
If you suffer from a mental disorder, epilepsy or parkinsonism (tremor, stiffness and shuffling) as Indometacin may aggravate these disorders
If you have rheumatoid arthritis as eye changes may occur and periodic eye examinations are recommended
If you are taking corticosteroids, Selective Serotonin-Reuptake Inhibitors (SSRI’s), anticoagulants such as warfarin or anti-platelet medicines such as clopidogrel (see “Other medicines and Indometacin” section)
If you have peripheral arterial disease (a problem with the circulation in the legs).

Other medicines and Indometacin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. Indometacin should not be taken with the following:

Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as diflunisal, aspirin, ketorolac or Cox-2 inhibitors such as celecoxib
- Ritonavir, used to treat HIV and AIDS
- Triamterene, used to treat high blood pressure and water retention (diuretic)

Other medicines which may interact with Indometacin:

Cardiac glycosides, such as digoxin, used to treat heart conditions
Ciclosporin, tacrolimus or muromonab-CD3, used to suppress the body’s immune system after an organ transplant
Mifepristone, used in the termination of pregnancy. Indometacin should not be used for 8-12 days after mifepristone has been given as it can reduce the effect of mifepristone
Quinolone antibiotics, such as ciprofloxacin, used to treat bacterial infections
Methotrexate or penicillamine, used to treat some cancers, psoriasis and rheumatoid arthritis
Medicines that thin the blood or which prevent blood clotting, such as warfarin, heparin, or antiplatelet drugs such as clopidogrel
Diuretics, such as furosemide and thiazides
Probenecid, used to treat gout
Medicines for high blood pressure, such as doxazosin (alpha blockers), captopril (ACE inhibitors), atenolol (beta−blockers), losartan (angiotensin II antagonists), hydralazine and nifedipine (calcium channel blockers)
Medicines which dilate blood vessels, such as iloprost
Corticosteroids, such as hydrocortisone, used to reduce inflammation
Lithium and haloperidol, used to treat mental illness
Selective Serotonin Reuptake Inhibitors (SSRIs), such as paroxetine or venlafaxine, used to treat depression
Zidovudine, zalcitabine used to treat viral infections
Medicines used to treat diabetes such as metformin and sulfonylureas, such as glibenclamide
Phenytoin (used to treat epilepsy)
Diazepam, used to treat anxiety and as a sedative
Baclofen, used as a muscle relaxant
Cyclophosphamide or erlotinib, used to treat certain cancers (chemotherapy drug)
Desmopressin, used for night-time bed wetting (hormone preparation)
Tiludronic acid, used to treat bone disease
Pentoxifylline, used to treat poor circulation
Sibutramine, used to treat obesity
Phenylpropanolamine used to treat nasal congestion associated with colds, allergies, hay fever or other respiratory illness
Vancomycin, antibiotic used to treat bacterial infections.

Effects on laboratory tests

Indometacin may cause a false-negative result in the Dexamethasone Suppression Test (DST).

Indometacin with food, drink or alcohol

Indometacin should be taken with food or milk in order to reduce the risk of stomach problems.
Avoid drinking alcohol as it may increase the risk of bleeding in the stomach.

Pregnancy and 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 for advice before taking Indometacin.

Pregnancy

Do not take Indometacin 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 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.

Breast-feeding

If you are breast-feeding, you should ask your doctor for advice before taking Indometacin, as small amounts of Indometacin can pass into breast milk, therefore, it should be avoided whilst breast-feeding.

Fertility

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.
If indometacin is used when attempting to conceive, the dose should be kept as low and duration of treatment as short as possible.

Driving and using machines

Indometacin 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.

Indometacin 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.

Indometacin contains sodium

The 25mg capsule contains less than 1 mmol sodium (23 mg) per capsule that is to say essentially ‘sodium-free’. The 50mg capsule contains 32 mg sodium (main component of cooking/table salt) in each capsule This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to take Indometacin

Always take Indometacin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

These capsules are to be taken orally
These capsules should be taken with food or milk in order to reduce the risk of stomach problems
Side effects may be minimised by using the lowest effective dose for the shortest length of time necessary to control your symptoms _{Till-Ver.16.2}

Indometacin 25/50 mg Caps

Package leaflet

Till-Ver.16.2

TW207508 (SmPC)

[All]

[NA]

[TBA]

9 points (Reg text)

Till-Ver.16 24/09/2025 24/09/2025 31/12/2025 31/12/2025

Black C

Adults:

The recommended dosage range is 50mg - 200mg a day given in divided doses.
For chronic (long-lasting) conditions, your treatment should be started on a low dose and gradually increased to give the best result.

Acute gouty arthritis

The usual dose is 150mg - 200mg a day given in divided doses.
Treatment should continue until all symptoms disappear.

Period pain (dysmenorrhoea)

The usual dose is up to 75mg a day.
Treatment should start with the onset of cramps or bleeding and continue for as long as the symptoms last.

Elderly

If you are elderly, you are more prone to side-effects. The lowest effective dose should be taken and for the shortest time possible.
Your doctor will monitor you regularly for signs of gastrointestinal bleeding.

Use in children

These capsules are not recommended for use in children.

If you take more Indometacin than you should

If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.

Symptoms of overdose include: pain in the stomach, bleeding in the stomach or intestines, diarrhoea, disorientation, excitation, coma, dizziness, ringing or buzzing in the ears, fainting, fits, liver damage, feeling or being sick, loss of appetite, drowsiness, headache, restlessness, agitation and kidney failure.

If you forget to take Indometacin

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Indometacin

It is important that you keep taking this medicine for as long as your doctor has told you to.

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

4. Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)
Other allergic reactions:
o Difficulty in breathing, wheezing, shortness of breath
(asthma, bronchospasm, dysponea)
o Swelling and irritation inside the nose (rhinitis)
o Severe itching (pruritus), skin rashes with the formation
of wheals (urticaria), skin rash caused by small blood vessels bleeding into the skin (purpura), peeling of the skin over large areas of the body/blistering of the skin (exfoliative/bullous dermatoses)
o Swelling of parts of the body (angioedema)
Severe blistering of the skin, mouth, eyes and genitals (Stevens Johnson syndrome, toxic epidermal necrolysis)
Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)
Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia)
Pass black stools due to a bleed from the stomach or duodenum (first part of the small intestine) (melaena)
Vomit any blood or dark particles that look like coffee grounds (haematemesis)
Pass blood in your faeces (stools/motions)

Other side effects (frequency not known):

Loss of appetite (anorexia)
Stomach problems including stomach pain/discomfort or worsening of the condition in patients with ulcerative colitis or Crohns’s disease or development of this condition. Stomach ulcers, inflammation of the stomach (gastritis), inflammation of the pancreas (pancreatitis)
Increase in blood sugar levels (hyperglycaemia)
Sugar in the urine (glycosuria)
High levels of blood potassium (hyperkalaemia)
Flushing
Visual disturbances including complete or partial loss of vision due to inflammation of the optic nerve (optic neuritis). Blurred vision and/or double vision (diplopia), pain in or around the eye (orbital/periorbital)
If you have rheumatoid arthritis and have been taking Indometacin for a long time, you may experience deposits in the front surface of the eye (cornea) or effects on the back surface of the eye (retina). If you are on long term treatment you should have eye tests
Nose bleeds (epistaxis)
Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
A reduction in white blood cells (neutropenia, leukopenia)
Severe reduction in blood cells, which can cause weakness, bruising or make infections more likely (aplastic anaemia), reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
Low level of white blood cells, which may make infections more likely (agranulocytosis)
Abnormal condition of the bone marrow in which it is unable to produce normal amounts of red blood cells, white blood cells, and platelets leaving the immune system in a weakened state and vulnerable to infection (bone marrow depression)
Broken blood vessels that form tiny pin-point red/purple spots on the skin (petechiae)
Bruising (ecchymosis)
Feeling (nausea) or being sick (vomiting)
Constipation
Diarrhoea
Wind (flatulence)
Indigestion (dyspepsia)
Hair loss (alopecia)
Blood clotting disorders
Inflammation of the blood vessels (angiitis)
Inflammatory condition that causes red, tender lumps to form just below the skin surface that usually affects the lower legs (erythema nodosum)
- Increased sensitivity to light (photosensitivity)
- Sweating
- Worsening of psoriasis (itchy scaly pink patches on the elbows, knees, scalp and other parts of the body)
- Low blood pressure (hypotension)
- Heart problems including faster heartbeat (tachycardia), irregular heartbeat (arrhythmia), feeling your heartbeat (palpitations), chest pain, heart failure
- Medicines such as Indometacin (NSAIDs) may be associated with an increased risk of heart attack (myocardial infarction) or stroke, particularly at high doses and in long term treatment
- High blood pressure (hypertension)
- Kidney problems including inflammation of the kidney (interstitial nephritis), protein in the urine (proteinuria), blood in the urine (haematuria), reduced kidney function or kidney failure
- Abnormal liver function tests (detected during liver blood tests)
- Liver problems including inflammation of the liver (hepatitis), yellowing of the skin or whites of the eyes (jaundice)
- Headache (usually disappears when treatment is continued or dose is reduced. If headache persists, treatment should be stopped)
- Tingling or numbness in the hands or feet (paraesthesia)
- Involuntary movements
- Difficulty sleeping (insomnia)
- Fits and/or worsening of epileptic fits and parkinsonism (tremors, stiffness and shuffling)
- Inflammation of the lining of the brain (aseptic meningitis), especially if you suffer from existing auto-immune disorders, such as Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease. Symptoms include; stiff neck, headache, feeling or being sick, fever, feeling disorientated
- Depression
- Feeling of dizziness or “spinning” (vertigo)
- Slurred, slow speech which is difficult to understand (dysarthria)
- Light-headedness, fainting (syncope)
- Coma
- Swelling in the brain (cerebral oedema)
- Feeling nervous or anxious
- Mental problems such as seeing or hearing things that are not real (hallucinations), feeling detached from yourself (depersonalisation)
- Weakness, tingling or numbness (peripheral neuropathy)
- Confusion
- Ringing in the ears (tinnitus), hearing problems (rarely deafness)
- Dizziness
- Feeling unwell (malaise)
- Feeling drowsy or tired/sleepy (fatigue)
- Muscle weakness
- Acceleration of cartilage deterioration
- Vaginal bleeding
- Enlargement or tenderness of the breasts, including enlargement of breasts in men (gynaecomastia)

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 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

Keep this medicine out of the sight and reach of children.
Store below 30°C. Store in the original package in order to protect from light.
Do not use Indometacin after the expiry date, which is stated on the label/carton/blister after EXP. 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 throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Indometacin contains:

Each 25 mg capsule contains 25 mg of Indometacin.
Each 50 mg capsule contains 50 mg of Indometacin.

The other ingredients are: magnesium stearate, sodium lauryl sulfate, sodium starch glycolate and lactose. The capsule shell contains: gelatin, erythrosine (E127), quinoline yellow (E104) and titanium dioxide (E171).

What Indometacin looks like and contents of the pack:

Indometacin 25 mg are size 3, ivory opaque coloured body and cap containing white to almost-white powder, imprinted “IND 25” in black ink on cap.
Indometacin 50 mg are size 1, ivory opaque coloured body and cap containing white to almost-white powder, imprinted “IND 50” in black ink on cap.

Indometacin is available in:

Indometacin 25mg Capsules are available in blister packs or containers of 28, 30, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 capsules.
Indometacin 50mg Capsules are available in blister packs or containers of 28, 100, 250, 500 or 1000 capsules. Not all pack sizes or pack types may be marketed.

Product Licence Numbers:

Indometacin 25 mg: PL 11311/0355
Indometacin 50 mg: PL 11311/0356

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

This leaflet was last revised in December 2025