Axorid (Ketoprofen, omeprazole)
How does it work?
Axorid capsules contain two active ingredients, ketoprofen and omeprazole. Ketoprofen is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID) and is used to relieve pain and inflammation in arthritis. Omeprazole is used to prevent the potential side effects of ketoprofen on the gut.
Ketoprofen 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. Ketoprofen blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.
Prostaglandins have a useful role in helping to protect the lining of the stomach and intestines from attack by stomach acid. As ketoprofen reduces the production of these prostaglandins, it can allow the stomach acid to irritate the lining of the stomach and intestines. This can cause ulcers or bleeding. Omeprazole is included in Axorid capsules to counteract this effect. It works by reducing the production of stomach acid.
The combination of medicines in Axorid capsules is used to relieve pain and inflammation in people with rheumatoid arthritis, ankylosing spondylitis and osteoarthritis who have already had, or are at high risk of getting stomach or duodenal ulcers.
Axorid capsules are modified-release capsules, which means they are designed to release the medicine steadily over the day to provide continuous pain relief. The capsules are taken once a day and should be swallowed whole, not broken, chewed or crushed, as this would damage the modified-release action.
What is it used for?
- Rheumatoid arthritis.
- Ankylosing spondylitis.
Axorid capsules are prescribed to people who need to keep taking an NSAID to relieve the pain of their condition, but who are at a high risk of getting a peptic ulcer or have previously had a peptic ulcer.
- Axorid capsules should be swallowed whole and not broken, crushed or chewed. They should preferably be taken with food.
- This medicine may cause dizziness 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.
- Even though Axorid capsules contain omeprazole to try to minimise the side effects of ketoprofen on the gut (for example ulceration, bleeding or perforation of the stomach or intestinal lining), these types of side effects are still possible. Side effects on the gut are more likely to occur in elderly people and in people taking high doses of ketoprofen. The risk can also be increased by taking certain other medicines (see end of page for details). 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. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, 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). 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. 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 cirrhosis of the liver, heart failure 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.
- The omeprazole in this medicine may lead to a slightly increased risk of stomach infections such as salmonella, due to the decreased acidity in the stomach.
- This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may also cause allergic reactions (possibly delayed).
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.
- Decreased kidney function.
- Decreased liver function.
- Heart failure.
- High blood pressure (hypertension).
- 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).
- Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
- People with blood clotting disorders or taking anticoagulant medicines.
- People with history of photosensitivity.
- History of asthma.
- History of allergies.
- 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.
- Bleeding in the stomach or intestine.
- People with bleeding in the brain or other active bleeding in the body.
- Severe liver failure.
- Severe kidney failure.
- Severe heart failure.
- This medicine is not recommended for children under 15 years old.
- Allergy to E218 or E216.
- Axorid capsules contain sucrose and are not suitable for people with with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
This medicine should not be used if you are allergic to 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.
- This medicine is not recommended for use in pregnancy unless considered essential by your doctor. This is particularly important in the third trimester. If taken in the third trimester it 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.
- This medicine may pass into breast milk, but in such small quantities that it is unlikely to harm the baby. However, the manufacturer recommends that this medicine is avoided by women who are breastfeeding, unless it is considered essential by your doctor. Seek medical advice from your doctor.
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.
Common (affect between 1 in 10 and 1 in 100 people)
- Spinning sensation.
- Difficulty sleeping (insomnia).
- Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting, flatulence or abdominal pain.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Skin reaction, such as itching, rash, increased sweating, photosensitivity.
- Changes in mood.
- Visual disturbances, such as blurred vision, loss of focus.
- Change in taste.
- Sensation of ringing or other noise in the ears (tinnitus).
- Changes in the levels of liver enzymes.
- Hair loss (alopecia).
- Swollen ankles, feet or hands (peripheral oedema).
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Pain in the muscles and joints.
- Muscle weakness.
- Pins and needles (paraesthesia).
- Heart failure.
- High blood pressure.
- Lightheadedness or feeling faint.
- Ulceration in the stomach or intestine.
- Bleeding from the stomach or intestine.
- Kidney, liver or blood disorders.
- Brownish-black discoloration of the tongue, if also taking the antibiotic clarithromycin.
Very rare (affect less than 1 in 10,000 people)
- Decreased numbers of white blood cells or platelets in the blood (leucopenia or thrombocytopenia).
- Decreased numbers of all types of blood cells in the blood (agranulocytosis or pancytopenia).
- Decreased level of sodium in the blood (hyponatraemia).
- Inflammation of the liver (hepatitis).
- Dry mouth or inflammation of the mouth (stomatitis).
- Kidney inflammation (interstitial nephritis).
- Abnormal enlargement of breasts in men (gynaecomastia).
- Severe skin reactions.
The side effects listed above may not include all of the side effects reported by the medicine'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.
Ketoprofen should not be taken in combination with painkilling doses of aspirin or any other oral NSAID, 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 in the gut if ketoprofen is taken with corticosteroids such as prednisolone.
There may also be an increased risk of bleeding in the gut if ketoprofen is taken with the following medicines:
- anti-blood-clotting (anticoagulant) medicines such as warfarin or heparin
- anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
- dabigatran etexilate
- SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
Ketoprofen 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 taking ketoprofen with any of these should be closely monitored by their doctor:
Ketoprofen may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin or phenindione. As this may increase the risk of bleeding, people taking ketoprofen with an anticoagulant should be closely monitored by their doctor.
There may be an increased risk of side effects on the kidneys if ketoprofen is taken with any of the following medicines:
- ACE inhibitors, eg enalapril
- angiotensin II receptor antagonists, eg losartan
- diuretics, eg furosemide
Ketoprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, such as the following:
- ACE inhibitors such as captopril
- angiotensin II receptor antagonists, eg losartan
- beta-blockers such as propranolol
- diuretics such as furosemide.
This medicine should not be taken by people taking the anti-HIV medicine atazanavir. This is because omeprazole decreases the blood level of atazanavir and could make it less effective at treating HIV infection.
Omeprazole may increase the blood levels of the following medicines and may therefore increase the risk of their side effects:
- benzodiazepines such as diazepam, triazolam, lorazepam or flurazepam
- cilostazol (omeprazole should be avoided in people taking cilostazol)
- raltegravir (omeprazole should be avoided in people taking raltegravir)
Omeprazole may increase the anti-blood-clotting effect of the anticoagulant medicine warfarin. If you are taking warfarin it is recommended that your blood clotting time (INR) is checked after starting and stopping this medicine.
Due to its effect on the acidity in the stomach, omeprazole may reduce the absorption of the following medicines from the stomach, which could make them less effective:
The herbal remedy St John's wort may reduce the amount of omeprazole in the blood and could make it less effective. It should not be taken in combination with this medicine.
The anti-HIV medicine tipranavir may reduce the amount of omeprazole in the blood and could make it less effective.
Omeprazole can reduce the oral absorption of vitamin B12.
Omeprazole may reduce the blood levels of ulipristal, a medicine used as an emergency contraceptive. This would make it less effective at preventing an unwanted pregnancy.
Proton pump inhibitors such as omeprazole are not recommended for people taking the antiplatelet medicine clopidogrel. This is because recent evidence has shown that proton pump inhibitors can make the clopidogrel less effective at preventing heart attacks and strokes. If you are currently taking this medicine in combination with clopidogrel, you should consult your doctor to discuss this. This medicine should only be used in combination with clopidogrel if your doctor feels it is essential.
Other medicines containing the same active ingredients
There are currently no other medicines available in the UK that contain both ketoprofen and omeprazole as the active ingredients. Ketoprofen and omeprazole are both available separately.