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TAUXIB 60MG FILM-COATED TABLETS

Active substance(s): ETORICOXIB

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Patient Information Leaflet: information for the user
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
Arcoxia® 120mg film-coated tablets / Etoricoxib 120mg
film-coated tablets / Tauxib 120mg film-coated tablets
(etoricoxib)
This product is available in the above names and strengths, but will be
referred to as Arcoxia throughout the remainder of this leaflet.
This product is available in multiple strengths and all strengths will be
referred to throughout this 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 antiinflammatory 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.
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 or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side effects,
you can help provide more information on the safety of this medicine.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2,
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie,
e-mail: medsafety@hpra.ie
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/
yellowcard
5.

How to store Arcoxia

 Keep your tablets out of the sight and reach of children.
 Do not put the tablets into another container, as they might get
mixed up.
 Store in the original blister pack and do not remove the tablet from
its blister until you are ready to take it, as the tablets are moisture
sensitive.
 There are no other special storage conditions required for this
medicine.
 Do not take the tablets if they are past the expiry date which is
clearly marked on the pack.
 If your doctor tells you to stop taking this medicine, return any
unused tablets to your doctor or pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
 If your tablets have become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you
what to do.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines that are
no longer required. These measures will help to protect the
environment.
6.

Contents of the pack and other information

What ARCOXIA contains
 The active ingredient in Arcoxia is etoricoxib.
 Other ingredients: calcium hydrogen phosphate (anhydrous),
carnauba wax, croscarmellose sodium, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
titanium dioxide (E171) and glycerol triacetate.
What ARCOXIA looks like and contents of the pack
Arcoxia 60mg Tablets: Green coloured, apple-shaped, biconvex
film-coated tablets marked ‘200’ on one side and plain on the other
side. Each film-coated tablet contains 60mg of etoricoxib.
Arcoxia 90mg Tablets: White coloured, apple-shaped, biconvex
film-coated tablets marked ‘202’ on one side and plain on the other
side. Each film-coated tablet contains 90mg of etoricoxib.
Arcoxia 120 mg Tablets: Pale-green coloured, apple-shaped,
biconvex film-coated tablets marked ‘204’ on one side and plain on the
other side. Each film-coated tablet contains 120mg of etoricoxib.
Arcoxia 60mg Tablets and Arcoxia 120mg Tablets also contain yellow
iron oxide (E172) and indigo carmine lake (E132).
Arcoxia 60mg Tablets and Arcoxia 90mg Tablets are available in
blister packs containing 20 or 30 tablets. Arcoxia 120mg Tablets are
available in packs containing 5, 10 or 30 tablets.
Manufacturer
This product is manufactured by:
Merck Sharp & Dohme B.V. Haarlem, Netherlands.
Or
Frosst Iberica SA. Alcala De Henares, Madrid, Spain.
Or
Merck & Co., Inc., Merck Manufacturing Division (MMD), Elkton, USA.
It is procured from within the EU. Parallel Import Product Licence
holder: G Pharma Ltd, Salford M50 2PU.
PL 16369/1299 Arcoxia 60 mg Film Coated Tablets
PL 16369/1300 Arcoxia 90 mg Film Coated Tablets
PL 16369/1301 Arcoxia 120 mg Film Coated Tablets

POM

Leaflet revision date: 11/08/2015
Arcoxia is a registered trademark of Merck & Co Inc

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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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