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Description
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?
Warning!
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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.
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NSAIDs 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 below). 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.
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COX-2 inhibitors may carry an increased risk
of heart attacks and stroke when compared to placebo (no treatment). If
you have risk factors for heart disease or stroke, such as diabetes,
high cholesterol or smoking, your doctor will need to assess the
overall benefits and risks before deciding if this medicine is 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. Do not exceed the prescribed
dose. 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.
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Your blood pressure should be regularly monitored while you are taking this medicine.
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People with impaired kidney, liver or heart function should have their kidney function monitored while taking this medicine.
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During long-term treatment your doctor may
want to take regular blood tests to monitor your liver function.
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 while
taking this medicine, as they may be signs of a liver problem.
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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.
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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.
Use with caution in
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Elderly people
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History of disorders affecting the stomach or intestines, such as ulceration or bleeding
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Decreased kidney function
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Decreased liver function
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Liver cirrhosis
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Dehydration
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History of heart failure
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Swelling due to excess fluid retention (oedema)
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High blood pressure (hypertension)
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Raised levels of fats such as cholesterol in the blood (hyperlipidaemia)
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Diabetes
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Smokers
Not to be used in
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Children and adolescents under 16 years of age
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People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions
such as asthma attacks, itchy rash (urticaria), nasal polyps, nasal
inflammation (rhinitis) or swelling of the lips, tongue and throat
(angioedema)
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Severely decreased liver function
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Moderate to severely decreased kidney function
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Active peptic ulcer or bleeding from the gut
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Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
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Uncontrolled high blood pressure (hypertension)
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Heart failure
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Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack
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Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke
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Poor circulation in the arteries of the legs or feet (peripheral arterial disease)
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Pregnancy
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Breastfeeding.
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Rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malsorption (Arcoxia tablets contain lactose).
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.
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This medicine should not be used in
pregnancy, particularly the third trimester, as 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.
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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.
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Headache
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Dizziness
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Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting, indigestion, flatulence or abdominal pain
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Excessive fluid retention in the body tissues, resulting in swelling (oedema)
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High blood pressure (hypertension)
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Weakness or loss of strength (asthenia)
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Fatigue
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Cold or flu-like symptoms
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Skin reactions such as rash and itch
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Blurred vision
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Difficulty in sleeping (insomnia)
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Muscle cramps
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Weight gain
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Anxiety
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Depression
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Nosebleeds (epistaxis)
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Shortness of breath (dyspnoea)
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Chest pain
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Heart attack or stroke
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Ulceration or bleeding of the stomach or intestine
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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 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:
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ACE inhibitors, eg enalapril, captopril
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angiotensin II antagonists, eg losartan
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ciclosporin
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diuretics
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tacrolimus.
This medicine may increase the blood levels of the following medicines:
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lithium (your lithium blood level should be
monitored if you are starting, changing dose, or stopping etoricoxib
while taking lithium).
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methotrexate (people taking methotrexate should be well monitored for any side effects of methotrexate while taking etoricoxib.
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oestrogens in oral contraceptives or HRT
(this may increase the risk of side effects from these medicines.
Discuss this with your doctor.)
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digoxin.
Rifampicin may decrease the blood level of this medicine and therefore make it less effective at treating pain.
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