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AUXIB 30 MG FILM-COATED TABLETS

Active substance(s): ETORICOXIB

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Package leaflet: Information for the user
AUXIB® 30 mg film-coated tablets
AUXIB® 60 mg film-coated tablets
AUXIB® 90 mg film-coated tablets
AUXIB® 120 mg film-coated tablets
Etoricoxib
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 AUXIB is and what it is used for
2.
What you need to know before you take AUXIB
3.
How to take AUXIB
4.
Possible side effects
5.
How to store AUXIB
6.
Contents of the pack and other information
1.

What AUXIB is and what it is used for

What is AUXIB
• AUXIB contains the active substance etoricoxib. AUXIB 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 AUXIB used for?
• AUXIB 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.
• AUXIB 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 AUXIB

Do not take AUXIB:
• 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 AUXIB 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. AUXIB 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. AUXIB 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 AUXIB
to see if this medicine is suitable for you.
AUXIB 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 AUXIB
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 AUXIB:














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 AUXIB with aspirin.
-aspirin for prevention of heart attacks or stroke:
AUXIB 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 AUXIB

AUXIB with food and drink

The onset of the effect of AUXIB may be faster when taken without food
Pregnancy, breast-feeding, and fertility
Pregnancy
AUXIB 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 AUXIB is excreted in human milk. If you are breast-feeding, or planning to
breast-feed, consult your doctor before taking AUXIB. If you are using AUXIB, you must not
breast-feed.
Fertility
AUXIB is not recommended in women attempting to become pregnant.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking AUXIB.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
AUXIB 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 AUXIB

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 AUXIB 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 60 mg once a day, increased to a maximum of 90 mg once a day if
needed.

Ankylosing spondylitis
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if
needed.
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
AUXIB 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
AUXIB is for oral use. Take the tablets once a day. AUXIB can be taken with or without food.
If you take more AUXIB than you should
You should never take more tablets than the doctor recommends. If you do take too many
AUXIB tablets, you should seek medical attention immediately.
If you forget to take AUXIB
It is important to take AUXIB 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 AUXIB and talk to your doctor
immediately:
(see What you need to know before you take AUXIB 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 AUXIB:
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.
Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971
Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: medsafety@hpra.ire
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
5.

How to store AUXIB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
Bottles: Keep the container tightly closed in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What AUXIB contains


The active substance is etoricoxib. Each film coated tablet contains 30, 60, 90 or 120 mg of
etoricoxib.



The other ingredients are:

Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium
stearate, microcrystalline cellulose.
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide
(E171), triacetin. The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172,
colouring agent) and indigo carmine lake (E132, colouring agent).
What AUXIB looks like and contents of the pack
AUXIB tablets are available in four strengths:
30 mg tablets: Blue-green, apple-shaped biconvex tablets debossed ‘101’ on one side and ‘ACX
30’ on the other side.
60 mg tablets: Dark green, apple-shaped, biconvex tablets debossed ‘200’ on one side and plain
on the other side.
90 mg tablets: White, apple-shaped, biconvex tablets debossed ‘202’ on one side and plain on the
other side.
120 mg tablets: Pale-green, apple-shaped, biconvex tablets debossed ‘204’ on one side and plain
on the other side.
Pack sizes:
30 mg:
Pack sizes of 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets in
blisters.
60 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98
(2 packs of 49) tablets in blisters; or 30 and 90 tablets in bottles with desiccant containers. The
desiccant (one or two containers) in the bottle, used to keep the tablets dry, should not be
swallowed.
90 and 120 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs
of 49) tablets in blisters; or 30 and 90 tablets in bottles with desiccant containers. The desiccant
(one or two containers) in the bottle, used to keep the tablets dry, should not be swallowed.
60, 90 and 120 mg
Aluminium/aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder

Manufacturer

Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon,
Hertfordshire EN11 9BU, UK

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Merck Sharp & Dohme Ltd.
Shotton Lane
Cramlington
Northumberland NE23 3JU
United Kingdom

This medicinal product is authorized in the Member States of the EEA under the following
names:
France
Germany
Italy
Portugal
Spain
Sweden
United Kingdom

TUROX
EXINEF
ALGIX, EXINEF, TAUXIB
EXXIV, TUROX
EXXIV, ACOXXEL
TUROX
AUXIB, EXXIV, TUROX, ACOXXEL

This leaflet was last revised in April 2016.
© Merck Sharp & Dohme Limited 2016. All rights reserved.
AUXIB PIL.ACX.15.UK.4562.II-WS-156

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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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