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ARCOXIA 60MG FILM-COATED TABLETS

Active substance(s): ETORICOXIB

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Arcoxia® 60mg Film-Coated Tablets
Etoricoxib 60mg Film-Coated Tablets
Tauxib 60mg Film-Coated Tablets
Arcoxia® 90mg Film-Coated Tablets
Etoricoxib 90mg Film-Coated Tablets
Tauxib 90mg Film-Coated Tablets
(etoricoxib)
Patient Information Leaflet
This medicine is available using the above names but will be
referred to as Arcoxia throughout this leaflet. Please note this
leaflet may refer to other strengths of the medicine Arcoxia 30mg
tablets, Arcoxia 120mg tablets. This leaflet has been written to help
you get the best effect from your medicine.

Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1) What Arcoxia is and what it is used for
2) What you need to know before you take Arcoxia
3) How to take Arcoxia
4) Possible side effects
5) How to store Arcoxia
6) Contents of the pack and other information
1) WHAT ARCOXIA IS AND WHAT IT IS USED FOR
What is Arcoxia?
• Arcoxia contains the active substance etoricoxib. Arcoxia is
one of a group of medicines called selective COX-2
inhibitors. These belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
What is Arcoxia used for?
• Arcoxia helps to reduce the pain and swelling (inflammation)
in the joints and muscles of people 16 years of age and
older with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
• Arcoxia is also used for the short term treatment of
moderate pain after dental surgery in people 16 years of age
and older.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual
breakdown of cartilage that cushions the ends of the bones. This
causes swelling (inflammation), pain, tenderness, stiffness and
disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the
joints. It causes pain, stiffness, swelling, and increasing loss of
movement in the joints it affects. It may also cause inflammation in
other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful
inflammation and redness in the joints. It is caused by deposits of
mineral crystals in the joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and
large joints.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARCOXIA
Do not take Arcoxia:
• if you are allergic (hypersensitive) to etoricoxib or any of the
other ingredients of this medicine (listed in section 6)
• if you are allergic to non-steroidal anti-inflammatory drugs
(NSAIDs), including aspirin and COX-2 inhibitors (see
Possible Side Effects, section 4)
• if you have a current stomach ulcer or bleeding in your
stomach or intestines
• if you have serious liver disease
• if you have serious kidney disease
• if you are or could be pregnant or are breast-feeding (see
‘Pregnancy, breast-feeding and fertility’)
• if you are under 16 years of age
• if you have inflammatory bowel disease, such as Crohn’s
Disease, Ulcerative Colitis, or Colitis
• if you have high blood pressure that has not been controlled
by treatment (check with your doctor or nurse if you are not
sure whether your blood pressure is adequately controlled)
• if your doctor has diagnosed heart problems including heart
failure (moderate or severe types), angina (chest pain)
• if you have had a heart attack, bypass surgery, peripheral
arterial disease (poor circulation in legs or feet due to
narrow or blocked arteries)
• if you have had any kind of stroke (including mini-stroke,
transient ischaemic attack or TIA). Etoricoxib may slightly
increase your risk of heart attack and stroke and this is why
it should not be used in those who have already had heart
problems or stroke.
If you think any of these are relevant to you, do not take the tablets
until you have consulted your doctor.

Product: Arcoxia Tablets PLPI10380/1644&1645 Dimensions: 210mm x 400mm

Warnings and precautions
Talk to your doctor or pharmacist before taking Arcoxia if:
• You have a history of stomach bleeding or ulcers.
• You are dehydrated, for example by a prolonged bout of
vomiting or diarrhoea.
• You have swelling due to fluid retention.
• You have a history of heart failure, or any other form of heart
disease.
• You have a history of high blood pressure. Arcoxia can
increase blood pressure in some people, especially in high
doses, and your doctor will want to check your blood
pressure from time to time.
• You have any history of liver or kidney disease.
• You are being treated for an infection. Arcoxia can mask or
hide a fever, which is a sign of infection.
• You have diabetes, high cholesterol, or are a smoker. These
can increase your risk of heart disease.
• You are a woman trying to become pregnant.
• You are over 65 years of age.
If you are not sure if any of the above apply to you, talk to your
doctor before taking Arcoxia to see if this medicine is suitable for
you.
Arcoxia works equally well in older and younger adult patients. If
you are over 65 years of age, your doctor will want to appropriately
keep a check on you. No dosage adjustment is necessary for
patients over 65 years of age.
Children and adolescents
Do not give this medicine to children and adolescents under 16
years of age.
Other medicines and Arcoxia
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including medicines obtained
without a prescription.
In particular if you are taking any of the following medicines, your
doctor may want to monitor you to check that your medicines are
working properly, once you start taking Arcoxia:
• medicines that thin your blood (anticoagulants), such as
warfarin
• rifampicin (an antibiotic)
• methotrexate (a drug used for suppressing the immune
system, and often used in rheumatoid arthritis)
• ciclosporin or tacrolimus (drugs used for suppressing the
immune system)
• lithium (a medicine used to treat some types of depression)
• medicines used to help control high blood pressure and
heart failure called ACE inhibitors and angiotensin receptor
blockers, examples include enalapril and ramipril, and
losartan and valsartan
• diuretics (water tablets)
• digoxin (a medicine for heart failure and irregular heart
rhythm)
• minoxidil (a drug used to treat high blood pressure)
• salbutamol tablets or oral solution (a medicine for asthma)
• birth control pills (the combination may increase your risk of
side effects)
• hormone replacement therapy (the combination may
increase your risk of side effects)
• aspirin, the risk of stomach ulcers is greater if you take
Arcoxia with aspirin.
- aspirin for prevention of heart attacks or stroke:
Arcoxia can be taken with low-dose aspirin. If you are
currently taking low-dose aspirin to prevent heart attacks
or stroke, you should not stop taking aspirin until you talk
to your doctor
- aspirin and other non-steroidal anti-inflammatory
drugs (NSAIDs):
do not take high dose aspirin or other anti-inflammatory
medicines while taking Arcoxia.
Arcoxia with food and drink
The onset of the effect of Arcoxia may be faster when taken
without food.
Pregnancy, breast-feeding and fertility
Pregnancy
Arcoxia tablets must not be taken during pregnancy. If you are
pregnant or think you could be pregnant, or if you are planning to
become pregnant, do not take the tablets. If you become pregnant,
stop taking the tablets and consult your doctor. Consult your doctor
if you are unsure or need more advice.
Breast-feeding
It is not known if Arcoxia is excreted in human milk. If you are
breast-feeding, or planning to breast-feed, consult your doctor
before taking Arcoxia. If you are using Arcoxia, you must not
breast-feed.
Fertility
Arcoxia is not recommended in women attempting to become
pregnant.
Driving and using machines
Dizziness and sleepiness have been reported in some patients
taking Arcoxia.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or
sleepiness.
Arcoxia contains lactose
If you have been told by your doctor that you are unable to tolerate
some sugars, contact your doctor before taking this medicinal
product.

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3) HOW TO TAKE ARCOXIA
Always take this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Do not take more than the recommended dose for your condition.
Your doctor will want to discuss your treatment from time to time. It
is important that you use the lowest dose that controls your pain
and you should not take Arcoxia for longer than necessary. This is
because the risk of heart attacks and strokes might increase after
prolonged treatment, especially with high doses.
There are different strengths available for this medicinal product
and depending on your disease your doctor will prescribe the tablet
strength that is appropriate for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once a day, increase to a
maximum of 60 mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should only
be used for the acute painful period, limited to a maximum of 8
days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum
of 3 days treatment.
People with liver problems
• If you have mild liver disease, you should not take more
than 60 mg a day.
• If you have moderate liver disease, you should not take
more than 30 mg a day.
Use in children and adolescents
Arcoxia tablets should not be taken by children or adolescents
under 16 years of age.
Elderly
No dose adjustment is necessary for elderly patients. As with other
medicines, caution should be exercised in elderly patients.
Method of administration
Arcoxia is for oral use. Take the tablets once a day. Arcoxia can be
taken with or without food.
If you take more Arcoxia than you should
You should never take more tablets than the doctor recommends.
If you do take too many Arcoxia tablets, you should seek medical
attention immediately.
If you forget to take Arcoxia
It is important to take Arcoxia as your doctor has prescribed. If you
miss a dose, just resume your usual schedule the following day. Do
not take a double dose to make up for the forgotten tablet.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you develop any of these signs you should stop Arcoxia and
talk to your doctor immediately (see What you need to know
before you take Arcoxia section 2):
• shortness of breath, chest pains, or ankle swelling appear or
if they get worse
• yellowing of the skin and eyes (jaundice) – these are signs
of liver problems
• severe or continual stomach pain or your stools become
black
• an allergic reaction- which can include skin problems such
as ulcers or blistering, or swelling of the face, lips, tongue, or
throat which may cause difficulty in breathing
The frequency of possible side effects listed below is defined using
the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
The following side effects can occur during treatment with Arcoxia:
Very common
• stomach pain
Common
• dry socket (inflammation and pain after a tooth extraction)
• swelling of the legs and/or feet due to fluid retention
(oedema)
• dizziness, headache
• palpitations (fast or irregular heartbeat), irregular heart
rhythm (arrhythmia),
• increased blood pressure
• wheezing or shortness of breath (bronchospasms)
• constipation, wind (excessive gas), gastritis (inflammation of
the lining of the stomach), heartburn, diarrhoea, indigestion
(dyspepsia)/stomach discomfort, nausea, being sick
(vomiting), inflammation of the oesophagus, mouth ulcers
Product: Arcoxia Tablets PLPI10380/1644&1645 Dimensions: 210mm x 400mm

changes in blood tests related to your liver
bruising
weakness and fatigue, flu-like illness
Uncommon
• gastroenteritis (inflammation of the gastrointestinal tract that
involves both the stomach and small intestine/stomach flu),
upper respiratory infection, urinary tract infection
• changes in laboratory values (decreased number of red
blood cells, decreased number of white blood cells, platelets
decreased)
• hypersensitivity (an allergic reaction including hives which
may be serious enough to require immediate medical
attention)
• appetite increases or decreases, weight gain
• anxiety, depression, decreases in mental sharpness; seeing,
feeling or hearing things that are not there (hallucinations)
• taste alteration, inability to sleep, numbness or tingling,
sleepiness
• blurred vision, eye irritation and redness
• ringing in the ears, vertigo (sensation of spinning while
remaining still)
• abnormal heart rhythm (atrial fibrillation), fast heart rate,
heart failure, feeling of tightness, pressure or heaviness in
the chest (angina pectoris), heart attack
• flushing, stroke, mini-stroke (transient ischaemic attack),
severe increase in blood pressure, inflammation of the blood
vessels
• cough, breathlessness, nose bleed
• stomach or bowel bloating, changes in your bowel habits,
dry mouth, stomach ulcer, inflammation of the stomach
lining that can become serious and may lead to bleeding,
irritable bowel syndrome, inflammation of the pancreas
• swelling of the face, skin rash or itchy skin, redness of the
skin
• muscle cramp/spasm, muscle pain/stiffness
• high levels of potassium in your blood, changes in blood or
urine tests relating to your kidney, serious kidney problems
• chest pain
Rare
• angioedema (an allergic reaction with swelling of the face,
lips, tongue and/or throat which may cause difficulty in
breathing or swallowing, which may be serious enough to
require
immediate
medical
attention)/anaphylactic/anaphylactoid reactions including
shock (a serious allergic reaction that requires immediate
medical attention)
• confusion, restlessness
• liver problems (hepatitis)
• low blood levels of sodium
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions




Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on
the safety of this medicine.
5) HOW TO STORE ARCOXIA
• Keep out of the sight and reach of children.
• Do not use Arcoxia after the expiry date which is stated on
the pack. The expiry date refers to the last day of the month.
• Blisters: Store in the original package in order to protect
from moisture.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Arcoxia contains
• The active substance is etoricoxib. Each film-coated tablet
contains 60 mg or 90 mg of etoricoxib.
• The other ingredients are: calcium hydrogen phosphate
(anhydrous), carnauba wax, croscarmellose sodium,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, titanium dioxide, and glycerol
triacetate. The 60 mg tablets also contain yellow ferric oxide
(E172, colouring agent) and indigo carmine lake (E132,
colouring agent).
What Arcoxia looks like and contents of the pack
Arcoxia Tablets are available in two strengths:
60 mg dark green, apple-shaped, biconvex film-coated tablets
marked plain on one side and ‘200’ on the other.
90 mg white, apple-shaped, biconvex film-coated tablets marked
plain on one side and ‘202’ on the other.
Pack sizes:
60mg and 90mg strengths: Available as blister packs of 20 tablets
and 30 tablets.
Manufacturer:
This product is manufactured by: Merck Sharp & Dohme B.V.,
Haarlem, Holland and procured from within the EU by the Product
Licence Holder Swinghope Ltd, Commerce Way, Edenbridge TN8
6ED and repackaged by Kent Pharmaceuticals Ltd, Repton Road,
Measham, DE12 7DT, UK.

POM

Arcoxia® 60mg Film-coated Tablets PL No: 10380/1644
Arcoxia® 90mg Film-coated Tablets PL No: 10380/1645

Arcoxia® is a trademark of Merck & Co., Inc., Whitehouse Station,
NJ, USA.
Leaflet revision and issue date: 04/01/2018
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