Indometacin 25mg Capsules
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INDOMETACIN 25MG CAPSULES
Indometacin
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 personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. You must contact a doctor if your symptoms worsen or do not improve after 3 days.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet:
1. What Indometacin Capsules are and what they are used for
2. What you need to know before you take Indometacin Capsules
3. How to take Indometacin Capsules
4. Possible side effects
5. How to store Indometacin Capsules
6. Contents of the pack and other information_
1. What Indometacin Capsules are and what they are used for
The name of your medicine is Indometacin 25 mg Capsules. The active ingredient is Indometacin.
Indometacin Capsules belong to a group of medicines called non steroidal anti-inflammatory drugs (NSAIDs). Indometacin capsules are used for:
• inflammatory diseases 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.
• 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.
• are allergic (hypersensitive) to indometacin or any of the ingredients of 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 have included coffee ground vomiting, black stools and stomach pains.
• have severe liver, kidney or heart problems.
• have had stomach or intestinal bleeding or perforation after taking NSAIDs.
• have nasal obstruction (nasal polyps).
Indometacin capsules must not be used in children.
Check with your doctor before taking Indometacin capsules if you are:
• elderly (see ‘Warnings and Precautions').
• 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 or heart failure (symptoms may include increasing breathlessness and ankle swelling).
• a bleeding or blood clotting disorder.
• mental health problems e.g. mood changes.
• epilepsy (fits).
• 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 or a history of asthma.
• or have a history of gastrointestinal diseases such as ulcerative colitis (inflammation which causes abdominal pain or diarrhoea), Crohns disease or pre- existing sigmoid lesions (such as diverticulum or carcinoma).
• systemic lupus erythematosus (allergic reaction which causes joint pain, skin rashes and fever) or other connective tissue disorders. Stevens-Johnson syndrome (serious skin illness with blistering of the skin, mouth, eyes and genitals) or toxic epidermal necrolysis (serious illness with blistering of the skin)
• diabetes.
• a decreased amount of fluid around the cells of the body (extracellular volume depletion).
• rheumatoid arthritis.
• peripheral arterial disease (a problem with the circulation in the legs).
Warnings and Precautions
• 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.
• if you have heart problems, previous stroke or think that you might be at a 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.
• 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. Your doctor may wish to monitor your progress if you have liver or kidney problems.
Other medicines and Indometacin Capsules
Tell your doctor or pharmacist if you are taking or recently taken or might
take any other medicines.
The following medicines can affect Indometcain:
• other non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, naproxen or COX II inhibitors (e.g. celecoxib) or diflunisal (used for pain and inflammation).
• quinolone antibiotics e.g. ciprofloxacin (used 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. venlafaxine, fluoxetine (used for depression).
• metformin or sulphonylureas e.g. gliclazide (used for diabetes)
• hydantoins (e.g. phenytoin (used for epilepsy))
• 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) or nifedipine.
• 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 suppress the immune system).
• corticosteriods e.g. prednisolone (used in many different diseases).
• cyclophosphamide or methotrexate (used to treat some types of cancer, severe psoriasis and rheumatoid arthritis).
• desmopressin (used for diabetes insipidus and frequent urination during the night).
• diuretics (water tablets-control fluid levels in the body) such as triamterene, thiazides (e.g. bendroflumethiazide) or furosemide.
• lithium (used for some mental health problems).
• mifepristone (used for termination of pregnancy). Indometacin 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).
• penicillamine (used for treating rheumatoid arthritis)
Pregnancy, breast-feeding and fertility
• If you are in the last three months of pregnancy you must not use Indometacin capsules. You should not use these capsules in the first six months of pregnancy or if you are breastfeeding.
• Always ask your doctor or pharmacist for advice before taking any medicine.
Driving and operating machinery
• These capsules may cause dizziness, drowsiness, fatigue and
visual disturbances
• Do NOT drive or operate machines if affected.
Indometacin Capsules contain Lactose
• This medicine contains LACTOSE.
• If you have been previously told by your doctor you have intolerance to some sugars (such as lactose), 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.
| 3. How to take Indometacin Capsules |
Your doctor has decided the dose which is best for you. Always follow your doctor’s instructions exactly, and those on the pharmacy label. If you are not sure, ask your doctor or pharmacist. The usual dosage(s) are described below:
Dose:
Adults: 50-200mg daily.
Acute joint disease: Initially 25mg two or three times a day.
Long term joint disease: 25mg two or three times daily increasing by 25mg up to 150mg daily, rarely more than 200mg daily is necessary.
Sudden flare up of long term condition. Up to 150-200mg daily.
Severe muscular aches and pains: Initially 50mg two or three times daily, according to severity for 10-14 days. Normally 150mg daily, rarely 200mg daily.
For treatment of dysmenorrhoea (period pain): Up to 75mg (3 capsules) daily starting with the onset of symptoms and continuing for as long as they usually last
Lumbago. 50mg two or three times daily, according to severity, usually for 5 days but may be up to 10 days.
Gout: 50mg three or four times daily until symptoms subside.
Following orthopaedic procedures: 100-150mg daily in divided doses. Elderly: Your doctor may prescribe you a different dose and monitor your progress more closely.
Children: Not recommended.
Take with or after food, milk or an indigestion remedy (antacid).
If you take more Indometacin Capsules than you should
Contact your nearest hospital A&E (casualty department) or your doctor immediately. Take your medicine in its original packaging with you in order
to enable the doctor to identify your medication easily.
If you forget to take Indometacin Capsules
If you forget to take a dose, take it as soon as you remember and then go on as before.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE
4. Possible side effects
Like all medicines, Indometacin Capsules can cause side effects, although not everybody gets them.
Do not use if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
If you suffer from any of the following at any time during your treatment STOP USING the medicine and seek immediate medical help.
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds
• An allergic reaction (hypersensitivity) which may cause difficulty breathing or swallowing, asthma, sudden decrease in blood pressure (with symptoms of light headedness and dizziness), swelling of the face, lips, tongue or throat. Skin reactions may also occur causing itching, pale or red irregular raised patches with severe itching (hives), blood spots, bruising and discolouring to skin (purpura), blisters, red, flaky or peeling skin, a severe rash with 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)
• A severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome)
• Stiff neck, headache, feeling or being sick, fever, disorientation (not knowing where you are).
These may be signs of aseptic meningitis, which has been reported in patients with underlying connective tissue disorders like systemic lupus erythematosus.
STOP USING the medicine and tell your doctor if you experience.
• indigestion or heartburn
• abdominal pain (pains in your stomach)
Tell your doctor if you notice any of the following side effects.
• Blood: changes in the numbers and types of blood cells, blood clotting throughout the body, reduction in blood cell production by the bone marrow. If you develop bruising, nosebleeds, sore throats, tell
your doctor who may wish 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. visual disturbances, headache, dizziness, light headedness, tiredness, speech disorder, fainting, spinning sensation (vertigo), coma, fluid in the brain (may cause headaches and vomiting), general discomfort and illness, difficulty sleeping, feeling drowsy, nervousness, confusion, hallucinations (seeing things that are not there), depression, anxiety and other mental health problems like depersonalisation (a feeling that you are detached from yourself), fits (epilepsy), disorder of the nerves causing tingling and numbness, uncontrolled movements, parkinsonism (tremor, stiffness and shuffling).
• Eyes: blurred or double vision, inflammation of the optic nerve at the back of the eye (which may cause eye pain and loss of vision), pain in and around the eye, deposits on the surface at the front of the eye (cornea), disturbances to the surface at the back of the eye (retina).
• Ear: ringing or buzzing in the ears, hearing disturbances and rarely deafness.
• Heart: high or low blood pressure, racing or irregular heart beat (palpitations), chest pain, heart failure (which may cause increasing breathlessness and ankle swelling).
• Blood vessels: flushing
• Breathing: increase in the number of white blood cells in the lungs (pulmonary eosinophilia), narrowing of the airways in those who have a history of asthma or allergic disease.
• Stomach and intestines: gastrointestinal bleeding sometimes fatal (particularly in the elderly), loss of appetite, feeling or being sick, inflammation of the stomach lining (gastritis), mouth (ulcerative stomatitis), constipation, diarrhoea, ulceration of the intestines which can cause bleeding, obstruction or can perforate (burst), ulceration of the oesophagus and rarely development or worsening of ulcerative colitis or Crohns disease, nausea, vomiting, flatulence, dyspepsia (upset stomach) and rarely pancreatitis (inflammation of the pancreas causing severe pain and tenderness in the stomach and back).
• Liver: blocked bile flow, inflammation of the liver (hepatitis) which may cause fatigue. Weakness, loss of appetite, weight loss, abdominal pain and fever, yellowing of the skin or whites of the eyes (jaundice) and abnormal liver function (e.g. raised ALT and AST-seen on blood tests).
• 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: increase in blood levels of urea (seen in blood tests), blood or 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.
Medicines such as Indometacin may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
| 5. How to store Indometacin Capsules
• Keep this medicine out of the reach and sight of children.
• Do not store above 250C. Store in the original package to protect from light.
• Do not use the capsules after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.
• 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
• The other ingredients are. lactose, maize starch, sodium glycollate, magnesium stearate, gelatin and titanium dioxide.
What Indometacin Capsules look like and contents of the pack
• The capsules are white and printed with BL 25 containing a white powder
• They are available in packs of 28, 250 or 500 capsules.
• Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Name and address. Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone. 0044 (0)1442 200922
Fax. 0044 (0)1442 873717
E-mail. info@bristol-labs.co.uk
Indometacin 25mg Capsules; PL 17907/0173 This leaflet was last revised in February 2012 §
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.