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| ARCOXIA FULL DESCRIPTION |
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How does it work?
Arcoxia tablets contain the active ingredient etoricoxib, which is a type of medicine known as a non-steroidal anti-inflammatory drug (NSAID).
NSAIDs work by blocking the action of a substance in the body called cyclo-oxygenase. Cyclo-oxygenase is involved in producing prostaglandins, in response to injury or certain diseases. These prostaglandins cause pain, swelling and inflammation. Because NSAIDs block the production of these prostaglandins, they are effective at relieving pain and inflammation.
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. Etoricoxib 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).
This medicine can be taken with or without food, but may start to work quicker if taken without food.
What is it used for?
- Acute gout
- Inflammatory disease of the joints (rheumatoid arthritis)
- Osteoarthritis
Warning!
NEW ADVICE: The UK medicines regulatory authority (MHRA) is recommending that all people taking this medicine should make a non-urgent appointment with their GP to have their treatment reviewed. This advice comes as a result of a European review of the safety of COX-2 inhibitors, following trials that suggested two other medicines in this class, rofecoxib and celecoxib, might increase the risk of heart attacks and strokes. The review of the evidence suggests that, as a class, the COX-2 inhibitors may cause an increased risk of heart attacks and stroke when compared to placebo (no treatment). If you have a history of heart disease or stroke your doctor will review your treatment and prescribe you an alternative medicine for your symptoms. If you have risk factors for heart disease, such as diabetes, high cholesterol or smoking, your doctor will need to assess the overall benefits and risks before deciding if this medicine is still suitable for you. In general, if this medicine is suitable, your doctor will prescribe the lowest effective dose for as short a time as possible to control your symptoms, because the risks may increase with higher doses and the longer the medicine is taken. Ask your doctor or pharmacist for further information.
This medicine can sometimes cause liver problems. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms.
Stop taking this medicine and consult your doctor if you develop any of the following symptoms while taking this medicine: skin rash, skin blistering or peeling, sores inside your mouth, other signs of an allergic reaction, or signs of bleeding in the stomach or intestine, such as passing a black or blood-stained bowel movement or vomiting blood.
This medicine may hide fever, which is a sign of infection. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.
People with impaired kidney, liver or heart function should have their kidney function monitored while taking this medicine.
Your blood pressure should be regularly monitored while you are taking this medicine.
This medicine may cause fatigue and dizziness. You should take care when performing potentially hazardous activites, such as driving or operating machinery, until you know how this medicine affects you and are sure you can perform such activities safely.
Use with caution in
- People over 65 years of age
- Decreased kidney function
- Decreased liver function
- Liver cirrhosis
- Dehydration
- Swelling due to excess fluid retention (oedema)
- High blood pressure (hypertension)
- Raised levels of fats such as cholesterol in the blood (hyperlipidaemia)
- Diabetes
- Smokers
- Narrowing of the arteries in the extremities (peripheral arterial disease)
- History of perforation, ulceration or bleeding in the stomach or intestines
Not to be used in
- Children under 16 years of age
- Active peptic ulcer
- Bleeding from the stomach or intestines
- Inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- Uncontrolled high blood pressure (hypertension)
- Moderate to severe 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
- Moderate to severely decreased kidney function
- Severely decreased liver function
- Pregnancy
- Breastfeeding
- People who have developed asthma, nasal inflammation (rhinitis), nasal polyps, swelling of the face, lips and tongue (angioedema) or itchy rash (urticaria) following the use of aspirin or other NSAIDs
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malsorption
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.
This medicine should not be used during pregnancy, particularly during the third trimester, as it may be harmful to the unborn baby. It is also not recommended for women who are attempting to conceive. Seek medical advice from your doctor.
It is not known whether this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.
Side effects
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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Headache
- Dizziness
- Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
- Weakness or loss of strength (asthenia)
- Fatigue
- Cold or flu-like symptoms
- Rash
- Blurred vision
- Difficulty in sleeping (insomnia)
- Muscle cramps
- Weight gain
- Excessive fluid retention in the body tissues, resulting in swelling (oedema)
- Nosebleeds (epistaxis)
- Difficulty in breathing (dyspnoea)
- High blood pressure (hypertension)
- Chest pain
- Heart failure
- Anxiety
- Ulceration or bleeding of the stomach or intestine
- Liver or kidney 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 you start treatment with 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.
This medicine may be taken with low-dose (75mg daily) aspirin. However, the combination may carry an increased risk of ulceration or bleeding in the stomach or intestines compared to taking etoricoxib on its own. Etoricoxib should not be taken with higher daily doses of aspirin. For more information and advice ask your doctor or pharmacist.
This medicine should not be taken with other non-steroidal anti-inflammatory drugs (NSAIDs), eg ibuprofen, diclofenac, as using more than one NSAID together may also increase the risk of side effects on the gut.
This medicine may increase the anti-blood-clotting effect of warfarin. People taking warfarin or other anticoagulant medicines at the same time as this medicine should therefore have their blood-clotting time (INR) regularly monitored, particularly in the first few days of treatment with etoricoxib and following any dose changes.
This medicine may reduce the effect of diuretics and other medicines for high blood pressure (antihypertensives).
There may be an increased risk of side effects on the kidneys if this medicine is taken with any of the following, and people taking any of these medicines in combination with etoricoxib should have their kidney function monitored.
- ACE inhibitors, eg enalapril, captopril
- ciclosporin
- diuretics
- tacrolimus.
This medicine may increase the blood levels of the following medicines:
- lithium (your lithium blood level should be monitored if you are starting, changing dose, or stopping etoricoxib while taking lithium).
- methotrexate (people taking methotrexate should be well monitored for any side effects of methotrexate while taking etoricoxib.
- ethinylestradiol in oral contraceptives (this may increase the risk of side effects from these pills. Discuss this with your doctor.)
- digoxin.
Rifampicin may decrease the blood level of this medicine.
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