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ETORICOXIB 120MG FILM COATED TABLETS

Active substance(s): ETORICOXIB

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Arcoxia® 120mg Film-coated Tablets/
Etoricoxib 120mg Film-coated Tablets
(etoricoxib)

This product is available using either of the above names but will be
referred to as Arcoxia throughout this leaflet. This medicine is also available
in 30mg, 60mg and 90mg strengths.
Patient Information Leaflet
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 non-steroidal 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.
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 breastfeeding, 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.

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
• 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, pharmacist or nurse. 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.
• Store in the original package. 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.
• If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your doctor or pharmacist who will tell you what
to do.

6) Contents of the pack and other information
What Arcoxia contains
• The active substance is etoricoxib. Each tablet contains 120mg of
etoricoxib.
• The other ingredients are: calcium hydrogen phosphate (anhydrous),
carnauba wax, croscarmellose sodium, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, titanium
dioxide, glycerol triacetate, yellow ferric oxide (E172, colouring agent) and
indigo carmine lake (E132, colouring agent).
What Arcoxia looks like and contents of the pack
Pale Green, apple-shaped, biconvex film-coated tablets marked ‘204’ on
one side and plain on the reverse.
Arcoxia 120mg Film-coated tablets are available as blisters packs of 5 and
30 tablets.
PL 10383/1700

Arcoxia 120mg Film-coated Tablets/
Etoricoxib 120mg Film-coated Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp & Dohme B.V.,
Waarderweg 39, Haarlem, The Netherlands. Procured from within the EU
and repackaged by Product Licence Holder Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS
Leaflet date: 19.08.2015
Arcoxia® is registered trade mark of Merck Sharp & Dohme Corp., New
Jersey, USA.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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