Etopan XL (Etodolac)
How does it work?
Etopan XL tablets contain the active ingredient etodolac, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation. (NB. Etodolac is also available without a brand name, ie as the generic medicine.)
Etodolac works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. Etodolac blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.
Cyclo-oxygenase does not only produce prostaglandins that cause inflammation. It also produces prostaglandins that have useful roles in the body. There are two different forms of cyclo-oxygenase, COX-1 and COX-2. COX-2 is the form that (among other things) produces prostaglandins that cause inflammation. COX-1 does not produce inflammatory prostaglandins, but does produce others that have useful effects, including some that are involved in maintaining a healthy stomach and intestinal lining.
Traditional NSAIDs, such as ibuprofen or diclofenac, block the action of both COX-1 and COX-2 and this is why they can sometimes cause side effects such as stomach irritation and peptic ulcers. Etodolac belongs to a new generation of NSAIDs that selectively block the action of COX-2. This means that it stops the production of inflammatory prostaglandins, without stopping the production of prostaglandins that protect the stomach and intestines. It therefore reduces pain and inflammation, but is less likely than traditional NSAIDs to cause side effects on the stomach and intestines (although such side effects are still possible).
Etodolac is used to relieve the pain of osteoarthritis and rheumatoid arthritis, which is a result of inflammation in the joints.
Etopan XL tablets are sustained release tablets. They are designed to release the etodolac slowly and continuously over a few hours. This provides prolonged pain relief, so these tablets are taken once a day. The tablets must be swallowed whole to avoid damaging the sustained release action.
What is it used for?
- Rheumatoid arthritis.
- Etopan XL tablets should be swallowed whole and not broken, crushed or chewed. They should preferably be taken with food.
- This medicine may cause dizziness, drowsiness or visual disturbances and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
- Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.
- NSAIDs, inlcuding etodolac, can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see end of factsheet). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people having treatment with this medicine should stop taking it and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine, for example vomiting blood and/or passing black/tarry/bloodstained stools.
- Studies have suggested that use of some NSAIDs may be associated with a small increase in the risk of heart attacks and stroke (particularly if used in high doses or for long periods of time). For this reason, if you have risk factors for heart disease or stroke, such as diabetes, high blood pressure, high cholesterol or smoking, your doctor will need to assess the overall benefits and risks before deciding if this medicine is suitable for you. You should tell your doctor if you experience shortness of breath, chest pains or ankle swelling while taking the medicine. Ask your doctor or pharmacist for further information.
- Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.
- If you have heart failure, liver disease or kidney disease, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.
- During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.
Use with caution in
- Elderly people.
- History of disorders affecting the stomach or intestines.
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- Kidney disease.
- Liver disease.
- Heart failure.
- Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
- Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
- Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
- History of high blood pressure (hypertension).
- Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
- History of asthma.
- History of allergies.
- People with blood clotting problems or taking anticoagulant medicines.
- Diseases affecting connective tissue, eg systemic lupus erythematosus.
Not to be used in
- People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
- Active peptic ulcer or bleeding from the gut, or a history of this.
- People who have previously experienced bleeding or perforation of the gut as a result of taking an NSAID.
- Severe heart failure.
- This medicine is not recommended for children.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The manufacturer states that this medicine should not be used during pregnancy. This is particularly important in the first and third trimesters. If taken in the third trimester NSAIDs may delay labour, increase the length of labour and cause complications in the newborn baby. Some evidence suggests that NSAIDs should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.
- The safety of this medicine for use during breastfeeding has not been established. For this reason, the manufacturer states that it should be avoided by women who are breastfeeding. Seek medical advice from your doctor.
- This medication is to be swallowed whole, not chewed.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
- Disturbances of the gut such as indigestion, diarrhoea, constipation, nausea, vomiting or abdominal pain.
- Excess gas in the stomach and intestines (flatulence)
- Inflammation of the lining of the mouth (stomatitis).
- Visual disturbances.
- Skin reactions such as rash and itch.
- Abnormal reaction of the skin to light, usually a rash (photosensitivity).
- Difficulty in sleeping (insomnia).
- Retention of water in the body tissues (fluid retention), resulting in swelling (oedema).
- Sensation of ringing, or other noise in the ears (tinnitus).
- Difficulty in breathing (dyspnoea).
- Ulceration or bleeding in the stomach or intestines.
- Allergic reactions such as severe skin rashes, swelling of the lips, tongue and throat (angioedema) or narrowing of the airways (bronchospasm).
- Kidney, liver or blood disorders.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Etodolac should not be used in combination with painkilling doses of aspirin or any other NSAID taken by mouth, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of COX-2 such as celecoxib or etoricoxib should also be avoided for the same reason.
There may be an increased risk of ulceration or bleeding from the gut if etodolac is taken with corticosteroids such as prednisolone.
There may also be an increased risk of bleeding from the gut if etodolac is taken with the following medicines:
- anti-blood-clotting (anticoagulant) medicines such as warfarin
- anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
- SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
Etodolac may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking etodolac with an anticoagulant should be closely monitored by their doctor. The dose of anticoagulant may need reducing.
There may be an increased risk of side effects on the kidneys if etodolac is used with any of the following medicines:
- ACE inhibitors, eg enalapril
- angiotensin II receptor antagonists, eg losartan
- diuretics, eg furosemide
Etodolac may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, including the following:
- ACE inhibitors such as captopril
- angiotensin II receptor antagonists, eg losartan
- beta-blockers such as propranolol
- diuretics such as furosemide.
Etodolac may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People using etodolac with any of these should be closely monitored by their doctor:
Other medicines containing the same active ingredient
Etodolac modified release tablets are also available without a brand name, ie as the generic medicine.