Eccoxolac
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ECCOXOLAC ®
ETODOLAC 300 MG CAPSULES
Read all of this leaflet carefully before you start taking this medicine._
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your 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.
• 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.
In this leaflet:
1. What Eccoxolac Capsules are and what they are used for
2. Before you take Eccoxolac Capsules
3. How to take Eccoxolac Capsules
4. Possible side effects
5. How to store Eccoxolac Capsules
6. Further information
1. WHAT ECCOXOLAC CAPSULES ARE AND WHAT THEY ARE USED FOR
Eccoxolac Capsules belong to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Eccoxolac Capsules are used to relieve some of the symptoms caused by arthritis (Osteoarthritis and Rheumatoid arthritis) such as inflammation, swelling, stiffness and joint pain.
2. BEFORE YOU TAKE ECCOXOLAC CAPSULES Do not take Eccoxolac Capsules if you:
• are allergic (hypersensitive) to etodolac or any of the ingredients of Eccoxolac Capsules (see section 6).
• have had an allergic reaction after taking aspirin, ibuprofen or other nonsteroidal anti-inflammatory drugs (NSAIDs). An allergic reaction may include swelling of the face or throat, a nettle rash, asthma or itchy and runny nose.
• have a peptic ulcer ( a hole in the stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding.
• have had perforation related to previous non-steroidal anti-inflammatory drugs therapy
• have a severe heart failure, liver or renal failure
• are in the last three months of pregnancy (last trimester)
Take special care with Eccoxolac Capsules Tell your doctor or pharmacist before taking Eccoxolac Capsules if you:
• have any kidney or liver problems or heart problems, especially if you are also taking diuretics (water tablets) and are elderly. The dose should be as low as possible and you should have regular checks
• have a blood disorder
• have high blood pressure or heart failure
• suffer from fluid retention (swelling of legs, ankles, or feet)
• have or had bronchial asthma or breathing difficulties
• suffer from auto-immune disorders such as mixed connective tissue disease, systemic lupus erythematosus (a disease affecting the skin, joints and kidneys).
Important information about your medicine
Medicines such as Eccoxolac 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.
Please speak to your doctor if you have any factors that may put you at a greater risk of suffering a heart attack or stroke such as:
• you are a smoker
• you have any heart problems
• you have high cholesterol
• you have high blood pressure
• You have diabetes
If you are told you need a blood test or urine test, tell your doctor you are taking Eccoxolac Capsules as the drug may affect the results.
Serious gastrointestinal side effects such as bleeding, ulceration and perforation can occur at any time with or without warning symptoms in patients treated with NSAIDs. If any sign of gastrointestinal bleeding occurs, Eccoxolac Capsules should be stopped immediately.
Serious skin reactions including allergic reactions such as extensive rash, peeling or blistering of the skin, continuous itching may appear during the early course of the therapy or within the first month of treatment. These reactions have been reported very rarely with the use of NSAIDs. If any sign of skin reactions occurs Eccoxolac Capsules should be stopped immediately.
Taking other medicines
Please inform your doctor pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed but bought/obtained without a prescription
Do not take Eccoxolac Capsules in combination with:
• other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or ibuprofen
Care is needed if you are taking:
• warfarin (used to prevent blood clotting)
• ciclosporin (used to help with organ transplants)
• digoxin (used to treat certain heart problems)
• lithium (used to treat manic depression)
• mifepristone (used to terminate pregnancy)
• methotrexate (used to treat conditions such as cancer, or rheumatoid arthritis)
• anti-hypertensives (medicines used to treat high blood pressure)
• antibiotics known as quinolone such as ciprofloxacin, ofloxacin or levofloxacin
• corticosteroids (used to treat skin rashes)
Taking Eccoxolac Capsules with alcohol
Do not take alcohol while taking Eccoxolac. Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine.
Pregnancy and breast-feeding
Do not take Eccoxolac Capsules if you are pregnant, may be pregnant or are breastfeeding.
Eccoxolac Capsules 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Eccoxolac Capsules may cause dizziness, drowsiness or visual disturbances in some individuals. DO NOT drive or operate machines if you are affected.
Important information about some of the ingredients of Eccoxolac Capsules
This medicine contains a small amount of an inactive ingredient 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 ECCOXOLAC CAPSULES
Always take Eccoxolac Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Take Eccoxolax Capsules by mouth with water. Take with or after food. Adults and Elderly:
• The usual adult dose is one 300 mg capsule twice a day.
• Alternatively, two 300 mg capsules may be taken once a day.
The elderly have an increased risk of having side effects. A lower dose with a lesser duration may be recommended in elderly patients.
Your doctor will monitor you regularly for gastrointestinal side effects like bleeding during the therapy.
Children:
Eccoxolac Capsules are not recommended for use in children.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Eccoxolac Capsules at the right time, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.
If you have taken more Eccoxolac Capsules than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken.
Symptoms of overdose include headache, nausea, vomiting, epigastric pain, passage of black tarry stools, diarrhoea, disorientation, excitation, drowsiness, dizziness, ringing in the ear, fainting, occasionally fits and coma. Kidney failure and liver damage have also been reported.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Eccoxolac Capsules can cause side effects, although not everybody gets them.
Medicines such as Eccoxolac capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any of the following happen, stop taking Eccoxolac Capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of lips or tongue or eyelids with difficulty breathing.
• severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
• allergic reactions such as extensive rash, peeling or blistering of the skin, continuous itching, swelling, wheezing, shortness of breath or difficulty breathing
These are rare serious allergic reactions
Consult your doctor immediately and stop taking Eccoxolac Capsules if you experience:
• gastrointestinal bleeding (rectal bleeding, passage of black stools, vomiting of blood or material that looks like coffee grounds, severe abdominal or stomach pain. Gastrointestinal problems can occur in some individuals at any time following long-term treatment with this class of medicines (NSAIDs).
If you experience any of the following serious side effects, stop taking Eccoxolac
Capsules and tell your doctor:
• infection around the brain or spinal cord (meningitis). Symptoms include fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This side effect has been reported especially in patients having autoimmune disorders such as mixed connective tissue disease, systemic lupus erythematosus (a disease affecting the skin, joints and kidneys).
• chills and fever, unusual bleeding or bruising or frequent infections
• irregular or troubled breathing
• irregular or pounding heartbeat
• heart problems which can cause shortness of breath or ankle swelling
• heartburn
• mouth sores
• blurred vision, sudden dimming or loss of vision
• confusion
• ringing or buzzing in ears
• abnormal liver function, liver disease, yellowing of eyes or skin (jaundice) caused by liver or blood problems
• dark discolouration of urine, bloody or cloudy urine or any problem with urination such as difficult, burning or painful urination, increased frequency of urination, sudden large increase or decrease in the amount of urine.
• fluid retention (swelling of legs, ankles or feet)
• inflammation of the pancreas, which causes severe pain in the back and stomach, often with nausea and vomiting (pancreatitis)
• Inflammation of blood vessels, often with skin rash
Less serious side effects that may occur:
• diarrhoea, nausea or vomiting,
• headache, disorientation,
• seeing or hearing things that are not real (hallucination)
• exacerbation of colitis (Inflammation which causes abdominal pain or diarrhoea) or Crohn’s disease (an inflammatory disease that can affect any part of the gastrointestinal tract)
• indigestion, constipation, bloated feeling or feeling of fullness, abdominal pain
• dizziness,
• drowsiness or light-headedness,
• trouble in sleeping,
• sensation of numbness or tingling over the limbs,
• tremors,
• skin reactions such as redness, severe itching or blisters on exposure to sunlight,
• weakness, fatigue,
mental depression and nervousness.
If any of the 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 ECCOXOLAC CAPSULES Keep out of the reach and sight of children.
Store in the original package.
Do not use Eccoxolac Capsules after the expiry date that is stated on the outer packaging.
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. FURTHER INFORMATION
What Eccoxolac Capsules contain:
• The active ingredient is 300mg of Etodolac.
• Other inactive ingredients are lactose, anhydrous silica, sodium lauryl sulphate, sodium starch glycollate, povidone, magnesium stearate, microcrystalline cellulose and talc.
What Eccoxolac Capsules look like and contents of the pack:
Eccoxolac 300 mg Capsules are grey/red hard gelatine capsules of size ‘0’ imprinted with ‘ELT300’ on the cap and ‘R’ on the body in black ink, containing a white to off-white granular powder.
The capsules are available in blister strips of 10 or 15 capsules each in boxes of 60 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE United Kingdom
Manufacturer:
Ranbaxy Ireland Ltd.
Spafield, Cork Road Cashel, Co. Tipperary Republic of Ireland
This leaflet was last revised: April 2011