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ARCOXIA 90MG TABLETS

Active substance: ETORICOXIB

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CUSTOMER: Waymade
Arcoxia 60mg 90mg120mg Tabs

CODE:

06464/2091 92 85E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

PRODUCT:

08/10/14

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 08/10/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED JULY 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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

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. Contents of the pack and other 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.) 08.10.2014
ARCOXIA is a registered trademark of Merck & Co. Inc.

(etoricoxib)
Patient Information Leaflet

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.
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.
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
Contents of the pack and other 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.
Pg 2

WARNING!

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.

WARNING!

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.

CUSTOMER:

Waymade

CODE:

06464/2091 92 85E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

PRODUCT:

Arcoxia 60mg 90mg120mg Tabs

08/10/14

Q.A.
APPROVED:
DATE:

PROOF HISTORY:
v.1 - waymade - 08/10/14

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED JULY 2014
REPORTING OF SIDE EFFECTS

Pg 2

Pg 3

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.

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.

Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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.
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
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.
Arcoxia with food and drink
The onset of the effect of Arcoxia may be faster when taken without food.

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)
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

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

Uncommon:

gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small
intestine/stomach flu), upper respiratory infection, urinary tract infection

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

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

Rare:


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.

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.







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, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

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.
Pg 3

WARNING!

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.

WARNING!

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.

Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

06 1257

PRODUCT:

ARTWORKER:

DT

DATE OF PROOF:

08/10/14

CODE:

Etoricoxib 60mg 90mg 120mg Tabs
06464/2091 92 85E

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 08/10/14

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED JULY 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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

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. Contents of the pack and other 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

Patient Information Leaflet

This product is known as the above name but throughout this leaflet will be referred to Etoricoxib. Another
strength (30 mg) is also available.
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.
What is in this leaflet
1. What Etoricoxib is and what it is used for
2. What you need to know before you take Etoricoxib
3. How to take Etoricoxib
4. Possible side effects
5. How to store Etoricoxib
6. Contents of the pack and other 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 cartilage that cushions the
ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability.

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

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.

Leaflet revision and issue date (Ref.) 08.10.2014

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 Etoricoxib
Do not take Etoricoxib:

if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of Etoricoxib (see
Contents of the pack and other 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 Etoricoxib 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. 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.

Pg 2

WARNING!

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.

WARNING!

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.

CUSTOMER: Waymade

PRE-PRESS NO.:

06 1257

PRODUCT:

ARTWORKER:

DT

DATE OF PROOF:

01/09/14

CODE:

Etoricoxib 60mg 90mg 120mg Tabs

Q.A.
APPROVED:
DATE:

PROOF HISTORY:
v.1 - waymade - 08/10/14

CUSTOMER
APPROVED:
DATE:

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

06464/2091 92 85E

Leaflet Flat Size = 296 x 317

UK PIL DATED JULY 2014
REPORTING OF SIDE EFFECTS

Pg 2

Pg 3

Etoricoxib 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.

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.

Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Other medicines and Etoricoxib
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.
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 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 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.
Etoricoxib with food and drink
The onset of the effect of Etoricoxib may be faster when taken without food.

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

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

Uncommon:

gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small
intestine/stomach flu), upper respiratory infection, urinary tract infection

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

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

Rare:


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.
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.

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

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.







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, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

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.
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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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