TAUXIB 60MG FILM-COATED TABLETS

Active substance: ETORICOXIB

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PACKAGE 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)

ARCOXIA works equally well in older and younger adult patients. If you
are elderly (i.e., over 65 years of age), your doctor will want to
appropriately keep a check on you. No dosage adjustment is necessary
for elderly patients.
Children and adolescents
Do not give this medicine to children and adolescents under 16 years of
age.

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

Other medicines and ARCOXIA
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines obtained
without a prescription.

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.

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)
 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
 lithium (a medicine used to treat some types of depression)
 diuretics (water tablets)
 ciclosporin or tacrolimus (drugs used for suppressing the immune
system)
 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
 hormone replacement therapy
 aspirin, the risk of stomach ulcers is greater if you take ARCOXIA with
aspirin.
 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
 do not take high dose aspirin or other anti-inflammatory
medicines while taking ARCOXIA

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

 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).
 ARCOXIA helps to reduce the pain and swelling (inflammation) in the
joints and muscles of people with osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis and gout.
 ARCOXIA is also used for the short term treatment of moderate pain
after dental surgery.
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 ARCOXIA (see Further information, 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
and breast feeding’)
 if you are under 16 years of age
 if you have inflammatory bowel disease, such as Crohn’s Disease,
Ulcerative Colitis, or Colitis
 if your doctor has diagnosed heart problems including heart failure
(moderate or severe types), angina (chest pain) or if you have had a
heart attack, bypass surgery, peripheral arterial disease (poor
circulation in legs or feet due to narrow or blocked arteries), or 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 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 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 are a woman trying to become pregnant.
 You are elderly (i.e., over 65 years of age).
 You have diabetes, high cholesterol, or are a smoker. These can
increase your risk of heart disease.
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.

Pregnancy and breast-feeding
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.
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.
ARCOXIA with food and drink
The onset of the effect of ARCOXIA may be faster when taken without
food.
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.
ARCOXIA Tablets should not be taken by children or adolescents under
16 years of age.
Take ARCOXIA Tablets by mouth once a day. ARCOXIA can be taken
with or without food.
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.
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.

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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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