ETORICOXIB 60 MG FILM COATED TABLETS

Active substance: ETORICOXIB

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501784/PL1f

®

Arcoxia 60 mg Film Coated Tablets
(etoricoxib)
Patient Information Leaflet
®
The name of your medicine is Arcoxia 60 mg Film Coated
Tablets, throughout this leaflet it will be referred to as
®
Arcoxia . Other strengths are 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 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.
®

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.
®

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.
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.

Continued overleaf

®

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.
®

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)
The following side effects can occur during treatment with
®
Arcoxia :

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
Rare:
• angioedema (an allergic reaction with swelling of the face,
lips, tongue and/or throat which may cause difficulty in
breathing or swallowing, which may be serious enough to
require immediate medical attention) anaphylactic
/anaphylactoid reactions including shock (a serious
allergic reaction that requires immediate medical
attention)
• confusion, restlessness
• liver problems (hepatitis)
• low blood levels of sodium
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
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.
®

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 you notice any sign of deterioration or discolouration
of the tablets, please tell your pharmacist immediately.
• 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 contains
• The active substance is etoricoxib. Each film coated
tablet contains 60 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, yellow
ferric oxide (E172, colouring agent) and indigo carmine
lake (E132, colouring agent).
®

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

What Arcoxia looks like and contents of the pack
®
Arcoxia tablets are green, apple-shaped, biconvex film®
coated tablets debossed ‘200’ on one side and ‘Arcoxia 60’
on the other.
Pack sizes: 28 tablets in blisters.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers
Frosst Iberica S.A., Via Complutense 140, Alcala de Henares,
E-28805, Madrid, Spain.
Merck Sharp & Dohme B.V, Waarderweg 39, 2031 BN
Haarlem, The Netherlands.
®

Arcoxia 60 mg Film Coated Tablets
PL No: 18067/0360
POM
®

Arcoxia is a registered trademark of Merck & Co. Inc.
th
Leaflet Revised: 13 February 2014.
To request a copy of this leaflet in Braille, large print or audio
501784/PL1f
please call 01622 690172.

501786/PL1f

Etoricoxib 60 mg Film Coated Tablets
Patient Information Leaflet
The name of your medicine is Etoricoxib 60 mg Film Coated
Tablets, throughout this leaflet it will be referred to as
Etoricoxib. Other strengths are 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.
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
ETORICOXIB
Do not take Etoricoxib:
• if you are allergic (hypersensitive) to etoricoxib or any
of the other 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.

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

Continued overleaf

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.
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 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)
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

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
Rare:
• angioedema (an allergic reaction with swelling of the face,
lips, tongue and/or throat which may cause difficulty in
breathing or swallowing, which may be serious enough to
require immediate medical attention) anaphylactic
/anaphylactoid reactions including shock (a serious
allergic reaction that requires immediate medical
attention)
• confusion, restlessness
• liver problems (hepatitis)
• low blood levels of sodium
• liver failure, yellowing of the skin and/or eyes (jaundice)
• severe skin reactions
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
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.
5) HOW TO STORE ETORICOXIB
• Keep 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.
• Store in the original package. Protect from moisture.
• If you notice any sign of deterioration or discolouration
of the tablets, please tell your pharmacist immediately.
• 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 contains
• The active substance is etoricoxib. Each film coated
tablet contains 60 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, yellow
ferric oxide (E172, colouring agent) and indigo carmine
lake (E132, colouring agent).
What Etoricoxib looks like and contents of the pack
Etoricoxib tablets are green, apple-shaped, biconvex filmcoated tablets debossed ‘200’ on one side and ‘Etoricoxib 60’
on the other.
Pack sizes: 28 tablets in blisters.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd both at St James’ House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers
Frosst Iberica S.A., Via Complutense 140, Alcala de Henares,
E-28805, Madrid, Spain.
Merck Sharp & Dohme B.V, Waarderweg 39, 2031 BN
Haarlem, The Netherlands.
Etoricoxib 60 mg Film Coated Tablets
PL No: 18067/0360
POM
th

Leaflet Revised: 13 February 2014.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.
501786/PL1f

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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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