How does it work?

Axorid capsules contain two active ingredients, ketoprofen andomeprazole. Ketoprofen is a type of medicine called a non-steroidalanti-inflammatory drug (NSAID) and is used to relieve pain and inflammation inarthritis. Omeprazole is used to prevent the potential side effects ofketoprofen on the gut.

Ketoprofen works by blocking the action of a substance in thebody called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in theproduction of various chemicals in the body, some of which are known asprostaglandins. Prostaglandins are produced by the body in response to injuryand certain diseases and conditions, and cause pain, swelling and inflammation.Ketoprofen blocks the production of these prostaglandins and is thereforeeffective at reducing inflammation and pain.

Prostaglandins have a useful role in helping to protect thelining of the stomach and intestines from attack by stomach acid. As ketoprofenreduces the production of these prostaglandins, it can allow the stomach acidto irritate the lining of the stomach and intestines. This can cause ulcers orbleeding. 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 torelieve pain and inflammation in people with rheumatoid arthritis, ankylosingspondylitis and osteoarthritis who have already had, or are at high risk ofgetting stomach or duodenal ulcers.

Axorid capsules are modified-release capsules, which means theyare designed to release the medicine steadily over the day to providecontinuous pain relief. The capsules are taken once a day and should beswallowed whole, not broken, chewed or crushed, as this would damage themodified-release action.

What is it used for?

• Rheumatoid arthritis.
• Ankylosing spondylitis.
• Osteoarthritis.

Axorid capsules are prescribed to people who need to keep takingan NSAID to relieve the pain of their condition, but who are at a high risk ofgetting apeptic ulcer or havepreviously had a peptic ulcer.

Warning!

• 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).
• Diabetes.
• Smokers.
• 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 ofits ingredients. Please inform your doctor or pharmacist if you have previouslyexperienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, 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.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Drowsiness.
• Headache.
• 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.
• Confusion.
• Hallucinations.
• 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).
• Agitation.
• Depression.
• Abnormal enlargement of breasts in men (gynaecomastia).
• Severe skin reactions.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before taking this medicine. Similarly, check with yourdoctor or pharmacist before taking any new medicines while taking this one, toensure that thecombination is safe.

Ketoprofen should not be taken in combination with painkillingdoses of aspirin or any other oral NSAID, egibuprofen, as this increases the risk of side effects on thestomach and intestines. Selective inhibitors of COX-2 such ascelecoxib or etoricoxib should also beavoided for the same reason.

There may be an increased risk of ulceration or bleeding in thegut if ketoprofen is taken with corticosteroids such asprednisolone.

There may also be an increased risk of bleeding in the gut ifketoprofen 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
• erlotinib
• SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine.

Ketoprofen may reduce the removal of the following medicinesfrom the body and so may increase the blood levels and risk of side effects ofthese medicines. People taking ketoprofen with any of these should be closelymonitored by their doctor:

• lithium
• methotrexate.

Ketoprofen may enhance the effect of blood-thinning oranti-clotting medicines (anticoagulants) such as warfarin orphenindione. As this may increase the risk of bleeding, peopletaking ketoprofen with an anticoagulant should be closely monitored by theirdoctor.

There may be an increased risk of side effects on the kidneys ifketoprofen is taken with any of the following medicines:

• ACE inhibitors, eg enalapril
• angiotensin II receptor antagonists, eg losartan
• ciclosporin
• diuretics, eg furosemide
• tacrolimus.

Ketoprofen may oppose the blood pressure lowering effects ofcertain 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-HIVmedicine atazanavir. This is because omeprazole decreases theblood level of atazanavir and could make it less effective attreating HIV infection.

Omeprazole may increase the blood levels of the followingmedicines and may therefore increase the risk of their sideeffects:

• benzodiazepines such as diazepam, triazolam, lorazepam or flurazepam
• cilostazol (omeprazole should be avoided in people taking cilostazol)
• citalopram
• digoxin
• escitalopram
• phenytoin
• raltegravir (omeprazole should be avoided in people taking raltegravir)
• tacrolimus.

Omeprazole may increase the anti-blood-clotting effect of theanticoagulant medicine warfarin. If you are taking warfarin itis recommended that your blood clotting time (INR) is checked after startingand stopping this medicine.

Due to its effect on the acidity in the stomach, omeprazole mayreduce the absorption of the following medicines from the stomach, which couldmake them less effective:

• itraconazole
• ketoconazole
• lapatinib.

The herbal remedy St John's wort may reduce theamount of omeprazole in the blood and could make it less effective. It shouldnot be taken in combination with this medicine.

The anti-HIV medicine tipranavir may reduce theamount of omeprazole in the blood and could make it less effective.

Omeprazole can reduce the oral absorption of vitaminB₁₂.

Omeprazole may reduce the blood levels ofulipristal, 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 recommendedfor people taking the antiplatelet medicine clopidogrel. This is because recentevidence has shown that proton pump inhibitors can make theclopidogrel less effective at preventing heart attacks andstrokes. If you are currently taking this medicine in combination withclopidogrel, you should consult your doctor to discuss this.This medicine should only be used in combination with clopidogrelif your doctor feels it is essential.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK thatcontain both ketoprofen and omeprazole as the active ingredients. Ketoprofenand omeprazole are both available separately.