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Etoricoxib (Generic Arcoxia)
Description
Etoricoxib (Arcoxia) is approved in over 60 different countries in the world except in the United States where the FDA Food and Drugs Administration still needs some more safety and efficacy related data for its key ingredient Etoricoxib, before clearing the drug for human use. The drug is presently being referred for the therapeutic treatments of rheumatoid arthritis, osteoarthritis, chronic lower back pains, gout as well as for the acute pains of ankylosing spondylitis disorders.
Etoricoxib (Arcoxia)is used for the following:
• acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA)
• relief of chronic musculoskeletal pain
• relief of acute pain
• to treat acute gouty arthritis
Etoricoxib (Arcoxia) reduces pain and inflammation by blocking COX-2, an enzyme in the body.
Etoricoxib (Arcoxia) does not block COX-1, the enzyme involved in protecting the stomach from ulcers.
Etoricoxib (Arcoxia) relieves pain and inflammation with less risk of stomach ulcers compared to NSAIDS.
In clinical studies, the risk of developing ulcers on Etoricoxib (Arcoxia) was lower
than with NSAIDs. Some people developed ulcers whether they were taking Etoricoxib (Arcoxia) or placebo in these studies; however the rate was higher on Etoricoxib (Arcoxia).
Your doctor may have prescribed Etoricoxib (Arcoxia) for another reason. Ask
your doctor if you have any questions about why Etoricoxib (Arcoxia) has been
prescribed for you.
Etoricoxib (Arcoxia) is not addictive.
Before using
Do not take Etoricoxib (Arcoxia) if:
• you have an allergy to Etoricoxib (Arcoxia) or any of the ingredients listed at the end of this leaflet
• the packaging is torn or shows signs of tampering
• The expiry date on the pack has passed.
• If you take this medicine after the expiry date has passed, it may not work.
• you are pregnant or intend to become pregnant
Etoricoxib (Arcoxia) is not recommended for use during late pregnancy. If there
is a need to consider using Etoricoxib (Arcoxia) during your pregnancy, your doctor
will discuss with you the benefits and risks of using it.
• you are breast-feeding or plan to breast-feed
It is not known if Etoricoxib (Arcoxia) passes into breast milk. You and your
doctor should discuss whether you should stop breast-feeding or not
take Etoricoxib (Arcoxia).
• you have or have had any medical conditions, especially the
following: history of angina, heart attack or a blocked artery in your
heart, kidney disease, liver disease, heart failure, high blood
pressure
• you have had an allergic reaction to aspirin or other anti-inflammatory medicines (commonly known as NSAIDs)
• Symptoms of an allergic reaction may include asthma, pinkish itchy swellings on the skin (hives), runny or blocked nose.
• you have an infection
• If you take Etoricoxib (Arcoxia) while you have an infection, it may hide
fever and may make you think, mistakenly, that you are better or that
your infection is less serious than it might be.
• You have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
• Tell your doctor if you are taking any other medicines, including
medicines that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Cautions
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.
The use of this medicine is not recommended if you have 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.
Possible side effects
The following are some of the side effects that are known to be
associated with this medicine: 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, 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.
Drug interactions
t 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 oppose 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 medicines. People
taking any of these medicines in combination with etoricoxib should
have their kidney function monitored, particularly if elderly:
• ACE inhibitors, eg enalapril, captopril
• angiotensin II antagonists, eg losartan
• 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.
• oestrogens in oral contraceptives or HRT (this may increase the risk
of side effects from these medicines. Discuss this with your doctor.)
• digoxin.
Rifampicin may decrease the blood level of this medicine and therefore make it less effective at treating pain.
