ARCOXIA 120MG TABLETS

Active substance: ETORICOXIB

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ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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
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 the cartilage that cushions the ends of the bones.
This causes swelling (inflammation), pain, tenderness, stiffness and disability.

PROOF HISTORY:
v.3 - waymade - 26/10/12

Leaflet Flat Size = 180 x 429

Read all of the 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.

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.

DATE:
DATE:

UK PIL GRANTED AUGUST 2012

6464/2091 92 85F
CODE:

26/10/12
DATE OF PROOF:

04-1957

DT
Arcoxia 60 90 120 mg tabs

PRE-PRESS NO.:

2. Before you take Arcoxia
Do not take Arcoxia:
• if you are allergic (hypersensitive) to etoricoxib or any of the 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.

PRODUCT:

CUSTOMER: Waymade

ARTWORKER:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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

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.
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 asprin. If you are currently taking low-dose asprin to prevent heart attacks or stroke,
you should not stop taking asprin until you talk to your doctor.
- Do not take high-dose asprin or other anti-inflammatory medicines while taking Arcoxia.
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 breast-feeding, or planning to breast-feed, consult your doctor before
taking Arcoxia. If you are using Arcoxia, you must not breast-feed.
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.
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.

WARNING!

These products are known by the above names. Throughout this leaflet they will usually be collectively referred to as Arcoxia.
Another strength (30 mg) is also available.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

WARNING!

(etoricoxib)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARCOXIA® 60 mg Tablets
ARCOXIA® 90 mg Tablets
ARCOXIA® 120 mg Tablets

000-0000F

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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).

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.3 - waymade - 26/10/12

Leaflet Flat Size = 180 x 429

Acute pain conditions
Etoricoxib should be used only for the acute painful period.

DATE:
26/10/12
DATE OF PROOF:

Rare
Low blood levels of sodium, redness of the skin.

UK PIL GRANTED AUGUST 2012

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).
6464/2091 92 85F

DT

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.

CODE:

Q.A.
APPROVED:
04-1957

ARTWORKER:
Arcoxia 60 90 120 mg tabs
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

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).

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 your tablets 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.
Blisters: Store in the original package to protect them from moisture, as the tablets are moisture sensitive.
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 looks like and contents of the pack
What Arcoxia contains
The active ingredient in Arcoxia Tablets is etoricoxib. Each film-coated tablet contains 60, 90 or 120 mg of etoricoxib.
The other ingredients are calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline
cellulose (core) and carnauba wax, lactose monohydrate, hypromellose, titanium dioxide, glycerol triacetate.
The 60 and 120 mg tablets also contain yellow ferric oxide (E172) and indigo carmine (E132).
What Arcoxia looks like and contents of the pack
Arcoxia Tablets are available in three strengths:
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.
120 mg pale-green, apple-shaped, biconvex film-coated tablets marked ‘204’ on one side and plain on the other.
Arcoxia 60 mg and 90 mg tablets are available as blister packs of 30 tablets.
Arcoxia 120 mg tablets are available as packs of 5 and 30 tablets.
POM

PL No: 6464/2091 60 mg
PL No: 6464/2092 90 mg
PL No: 6464/2085 120 mg

This product is manufactured by Merck & Co Inc, USA, Merck Manufacturing Division (MMD), Elkton, USA, or, Frosst Iberica S.A.,
Alcana de Henares, Madrid, Spain, or Merck Sharp & Dohme B.V., Haarlem, Holland and is procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 26.10.2012
ARCOXIA is a registered trademark of Merck & Co. Inc.

WARNING!

Ankylosing spondylitis
The recommended dose is 90 mg once a day.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Rheumatoid arthritis
The recommended dose is 90 mg once a day.

WARNING!

Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

3. How to take Arcoxia
Always take Arcoxia exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Arcoxia should not be taken by children and adolescents under 16 years of age.
Take Arcoxia 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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

In this leaflet:
1. What Etoricoxib is and what it is used for
2. Before you take Etoricoxib
3. How to take Etoricoxib
4. Possible side effects
5. How to store Etoricoxib
6. Further information




1. What Etoricoxib is and what it is used for
Etoricoxib 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).
Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis,
rheumatoid arthritis, ankylosing spondylitis and gout.
Etoricoxib 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 the cartilage that cushions the ends of the bones.
This causes swelling (inflammation), pain, tenderness, stiffness and disability.

PROOF HISTORY:
v.3 - waymade - 26/10/12

Leaflet Flat Size = 180 x 429

Read all of the 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.

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.

UK PIL GRANTED AUGUST 2012

6464/2091 92 85F

26/10/12
DATE OF PROOF:
CODE:

DT
Etoricoxib 60 90 120 mg tabs

04-1957

ARTWORKER:

DATE:

DATE:

2. Before you take Etoricoxib
Do not take Etoricoxib:
• if you are allergic (hypersensitive) to etoricoxib or any of the ingredients of Etoricoxib (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.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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

Take special care with Etoricoxib
Etoricoxib 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. Etoricoxib 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. Etoricoxib 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 Etoricoxib to see if this medicine is suitable
for you.
Etoricoxib works equally well in older and younger adult patients. If you are elderly (ie. over 65 years of age), your doctor will want to
appropriately keep a check on you. No dosage adjustment is necessary for elderly patients.
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 Etoricoxib:
• 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 Etoricoxib with aspirin
- Etoricoxib can be taken with low-dose asprin. If you are currently taking low-dose asprin to prevent heart attacks or stroke,
you should not stop taking asprin until you talk to your doctor.
- Do not take high-dose asprin or other anti-inflammatory medicines while taking Etoricoxib.
Pregnancy and breast-feeding
Etoricoxib 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 Etoricoxib is excreted in human milk. If you are breast-feeding, or planning to breast-feed, consult your doctor
before taking Etoricoxib. If you are using Etoricoxib, you must not breast-feed.
Taking Etoricoxib with food and drink
Etoricoxib tablets may be taken with or without food. The onset of the effect of Etoricoxib may be faster when taken without food.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking Etoricoxib.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
Important information about some of the ingredients of Etoricoxib
Etoricoxib 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.

WARNING!

Your medicine is known by the above names and strengths. Throughout this leaflet they will be collectively referred to as Etoricoxib.
Another strength (30mg) is also available.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Patient Information Leaflet

27mm

WARNING!

ETORICOXIB 60 mg Tablets
ETORICOXIB 90 mg Tablets
ETORICOXIB 120 mg Tables

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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 Etoricoxib than you should
You should never take more tablets than the doctor recommends. If you do take too many Etoricoxib tablets, you should seek
medical attention immediately.
If you forget to take Etoricoxib
It is important to take Etoricoxib 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, Etoricoxib can cause side effects, although not everybody gets them.
If you develop any of these signs you should stop Etoricoxib 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).

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.3 - waymade - 26/10/12

Leaflet Flat Size = 180 x 429

Acute pain conditions
Etoricoxib should be used only for the acute painful period.

The following side effects can occur during treatment with Etoricoxib:
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).

Q.A.
APPROVED:

DATE:

04-1957

DT

26/10/12

PRE-PRESS NO.:

ARTWORKER:

DATE OF PROOF:

Waymade

Etoricoxib 60 90 120 mg tabs

6464/2091 92 85F

CUSTOMER:

PRODUCT:

CODE:

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.

UK PIL GRANTED AUGUST 2012

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 Etoricoxib
Keep your tablets out of the sight and reach of children.
Do not use Etoricoxib after the expiry date which is stated on the pack. The expiry date refers to the last day of the month.
Blisters: Store in the original package to protect them from moisture, as the tablets are moisture sensitive.
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 Etoricoxib looks like and contents of the pack
What Etoricoxib contains
The active ingredient in Etoricoxib Tablets is etoricoxib. Each film-coated tablet contains 60, 90 or 120 mg of etoricoxib.
The other ingredients are calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline
cellulose (core) and carnauba wax, lactose monohydrate, hypromellose, titanium dioxide, glycerol triacetate.
The 60 and 120 mg tablets also contain yellow ferric oxide (E172) and indigo carmine (E132).
What Etoricoxib looks like and contents of the pack
Etoricoxib Tablets are available in three strengths:
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.
120 mg pale-green, apple-shaped, biconvex film-coated tablets marked ‘204’ on one side and plain on the other.
Etoricoxib 60 mg and 90 mg tablets are available as blister packs of 30 tablets.
Etoricoxib 120 mg tablets are available as packs of 5 and 30 tablets.
POM

PL No: 6464/2091 60 mg
PL No: 6464/2092 90 mg
PL No: 6464/2085 120 mg

This product is manufactured by Merck & Co Inc, USA, Merck Manufacturing Division (MMD), Elkton, USA, or, Frosst Iberica S.A.,
Alcana de Henares, Madrid, Spain, or Merck Sharp & Dohme B.V., Haarlem, Holland and is procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 26.10.2012

WARNING!

Ankylosing spondylitis
The recommended dose is 90 mg once a day.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Rheumatoid arthritis
The recommended dose is 90 mg once a day.

WARNING!

Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

3. How to take Etoricoxib
Always take Etoricoxib exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Etoricoxib should not be taken by children and adolescents under 16 years of age.
Take Etoricoxib by mouth once a day. Etoricoxib 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 Etoricoxib for longer than necessary.
This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.

Expand view ⇕

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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