INDOMETACIN CAPSULES BP 50 MG - patient leaflet, side effects, dosage

Tl How to store Indometacin capsules

Keep out of the sight and reach of children.

Store below 25°C in a dry place. Protect from light. Do not take Indometacin capsules after the expiry date which is stated on the label/carton/bot­tle.

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.

6l contents of the pack and other information

What Indometacin capsules contain

• The active substance (the ingredient that makes the medicine work) is indometacin PhEur. Each capsule contains either 25mg or 50mg indometacin.
• The other ingredients are starch 1500, powdered cellulose, colloidal silicon dioxide, magnesium stearate, yellow iron oxide (E172), titanium dioxide (E171), gelatin, shellac glaze, iron oxide black (E172), propylene glycol.

What Indometacin capsules look like and contents of the pack

Indometacin capsules are ivory, hard, gelatin capsules. Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Accord, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in November 2019

If you would like a leaflet with larger * text, please contact 01271 385257.

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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:

• 3] What Indometacin capsules are and what they are used for

31 What you need to know before you take Indometacin capsules

31 How to take Indometacin capsules

4l Possible side effects

How to store Indometacin capsules 6l Contents of the pack and other

information

31 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.

Indometacin 25mg and 50mg capsules

31 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 (hypersensitive) to indometacin or any of the ingredients of Indometacin capsules (see section 6)
• are allergic (hypersensitive) to aspirin, ibuprofen or other NSAIDs or you 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
• 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 oftwo 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 be used in children.

Warnings 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.g. 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 diseases 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 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 Indometacin capsules Please tell your doctor or pharmacist if you are taking, or have recently taken, 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 (to treat 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 sulfonylureas e.g. gliclazide (for diabetes)
• phenytoin (for epilepsy)
• diazepam (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) or nifedipine
• haloperidol (an antipsychotic drug)
• zalcitabine, zidovudine or ritonavir (for HIV infection)
• cardiac glycosides e.g. digoxin (for heart failure and

irregular heart beat)

• ciclosporin, tacrolimus or muromonab-CD3 (to suppress the immune system)
• corticosteriods 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 some mental health problems)
• 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 three months of pregnancy. You should only take Indometacin capsules in the first six months of pregnancy or if you are breast-feeding under medical supervision. Always ask your doctor before taking any medicine.

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.

51 How to take Indometacin capsules

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

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

Dose

• 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:

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 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 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.

4] possible side effects

Like all medicines, Indometacin 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 (see Section 2 ‘Other warnings’).

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

• 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.

• 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).

• Nervous system:

• – headache, dizziness, lightheadedness, spinning sensation (vertigo), tiredness, fainting, a feeling of general discomfort and illness, drowsiness, coma, fluid in the brain causing swelling

• – depression, nervousness, confusion, hallucinations, anxiety and other mental health problems, a feeling of unreality (that the mind is separated from the body), difficulty sleeping