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TAUXIB 90 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ARCOXIA® 60 mg film-coated tablets/
TAUXIB 60 mg film-coated tablets
ARCOXIA® 90 mg film-coated tablets/
TAUXIB 90 mg film-coated tablets
(etoricoxib)

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Your medicine may be called any of the above names but will be referred to as Arcoxia
throughout the remainder of the leaflet.
In this leaflet:
1. What Arcoxia is and what it is used for
2. Before you take Arcoxia
3. How to take Arcoxia
4. Possible side effects
5. How to store Arcoxia
6. Further information
1. WHAT ARCOXIA IS AND WHAT IT IS USED FOR

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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)
• 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

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.

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.

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.

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.





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.

Taking Arcoxia with food and drink
Arcoxia tablets may be taken with or without food. 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.

What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.

Important information about some of the ingredients of Arcoxia
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.

2. BEFORE YOU TAKE ARCOXIA

3. HOW TO 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)

Always take Arcoxia exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

If you think any of these are relevant to you, do not take the tablets until you have
consulted your doctor.
Take special care with Arcoxia
Arcoxia may not be suitable for you, or you may need to be monitored regularly while
taking it if any of the following apply to you:












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.
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.

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.
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 product, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Arcoxia 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:
• 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)
Not known (frequency cannot be estimated from the available data).
The following side effects can occur during treatment with Arcoxia:
Common
Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind, nausea,
indigestion (dyspepsia), stomach pain or discomfort, heartburn, changes in blood tests
related to your liver, swelling of the legs and/or feet due to fluid retention (oedema),
increased blood pressure, palpitations, bruising, dry socket (inflammation and pain after a
tooth extraction).
Uncommon
Stomach or bowel bloating, chest pain, heart failure, feeling of tightness, pressure or
heaviness in the chest (angina pectoris), heart attack, stroke, mini-stroke (transient
ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection,
high levels of potassium in your blood, changes in blood or urine tests relating to your
kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers,
taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable
bowel syndrome, inflammation of the oesophagus, blurred vision, eye irritation and
redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight
gain, muscle cramp/spasm, muscle pain/stiffness, inability to sleep, sleepiness,
numbness or tingling, anxiety, depression, decreases in mental sharpness,
breathlessness, cough, swelling of the face, flushing, skin rash or itchy skin, urinary tract
infection, platelets decreased, decreased number of red blood cells, decreased number of
white blood cells.
Rare
Low blood levels of sodium, redness of the skin.
Very Rare
Allergic reactions (which may be serious enough to require immediate medical attention)
including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty
in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin
reactions, inflammation of the stomach lining or stomach ulcers that can become serious
and may lead to bleeding, liver problems, serious kidney problems, severe increase in
blood pressure, confusion, seeing, feeling or hearing things that are not there
(hallucinations).
Not known
Yellowing of the skin and eyes (jaundice), liver failure, inflammation of the pancreas, fast
heart rate, irregular heart rhythm (arrhythmia), restlessness, inflammation of the blood
vessels.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
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.
If the tablets become discoloured or show any other signs of deterioration, you should
seek the advice of your 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 no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Arcoxia contains
• The active substance is etoricoxib. Each film coated tablet contains 60 or 90 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 60 mg tablets also contain yellow iron oxide (E172, colouring agent) and indigo
carmine lake (E132, colouring agent).
What Arcoxia looks like and contents of the pack
60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘200’ on one side
and plain on the other.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘202’ on one side and
plain on the other.
Pack sizes:
Arcoxia 60 mg Film coated Tablets: Pack size of 20 (4 blister strips of 5 tablets) or 30
(6 blister strips of 5 tablets).
Arcoxia 90 mg Film coated Tablets: Pack size of 20 (4 blister strips of 5 tablets) or 30
(6 blister strips of 5 tablets).

Manufacturer
Frosst Iberica S.A., Via Complutense, 140, Alcala de Henares, Madrid, E- 28805 Spain.
Procured from within the EU. Product Licence Holder and repackaged by: S.C.A.C. Ltd.,
Unit 2a, Bandeath Industrial Estate, Throsk, Stirling, FK7 7NP, United Kingdom.
POM
 

30984/0063 Arcoxia 60 mg film-coated tablets
30984/0064 Arcoxia 90 mg film-coated tablets

This leaflet was last approved in 08.11.2012
Arcoxia® is a registered trademark of Merck Sharp & Dohme Corp.,
Whitehouse Station, N.J., U.S.A.

 

 

Expand Transcript

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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