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ARCOXIA 30MG TABLETS

Active substance(s): ETORICOXIB

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Package leaflet: Information for the user

Arcoxia® 30mg tablets
(etoricoxib)

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 over 65 years of
age, your doctor will want to appropriately keep a check on you. No dosage adjustment is
necessary for patients over 65 years of age.

Children and Adolescents
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. see section 4.
The name of your medicine is Arcoxia 30mg tablets, but will be referred as Arcoxia
throughout this leaflet. Please note that the leaflet also contains information about other
strengths Arcoxia 60mg, 90mg and 120mg Tablets.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Arcoxia is and what it is used for
What you need to know before you take Arcoxia
How to take Arcoxia
Possible side effects
How to store Arcoxia
Contents of the pack and other information

1. What Arcoxia is and what it is used for
What is Arcoxia?
-

Arcoxia contains the active substance etoricoxib. Arcoxia is one of a group of medicines
called selective COX-2 inhibitors. These belong to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?
-

Arcoxia helps to reduce the pain and swelling (inflammation) in the joints and muscles of
people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
Arcoxia is also used for the short term treatment of moderate pain after dental surgery in
people 16 years of age and older.

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

Other medicines and Arcoxia
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)
ciclosporin or tacrolimus (drugs used for suppressing the immune system)
lithium (a medicine used to treat some types of depression)
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
diuretics (water tablets)
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 (the combination may increase your risk of side effects)
hormone replacement therapy (the combination may increase your risk of side effects)
aspirin, the risk of stomach ulcers is greater if you take Arcoxia with aspirin.
- aspirin for prevention of heart attacks or stroke:
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
- aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):
do not take high dose aspirin or other anti-inflammatory medicines while taking Arcoxia.

Arcoxia with food and drink

What is osteoarthritis?

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

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.

Pregnancy, breast-feeding and fertility

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 this
medicine (listed in 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, breast-feeding
and fertility’)
if you are under 16 years of age
if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or
Colitis
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 your doctor has diagnosed heart problems including heart failure (moderate or severe
types), angina (chest pain)
if you have had a heart attack, bypass surgery, peripheral arterial disease (poor
circulation in legs or feet due to narrow or blocked arteries)
if you have had 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 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 have diabetes, high cholesterol, or are a smoker. These can increase your risk of
heart disease.
You are a woman trying to become pregnant.
You are over 65 years of age.

Pregnancy
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.
Breast –feeding
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.
Fertility
Arcoxia is not recommended in women attempting to become pregnant.

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.
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.
There are different strengths available for this medicinal product and depending on your
disease your doctor will prescribe the tablet strength that is appropriate for you.
The recommended dose is:
Osteoarthritis:
The recommended dose is 30mg once a day, increase to a maximum of 60mg once a day if
needed.
Rheumatoid arthritis:
The recommended dose is 90mg once a day.
Ankylosing spondylitis:
The recommended dose is 90mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout:
The recommended dose is 120mg 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 90mg 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 60mg a day.
If you have moderate liver disease, you should not take more than 30mg a day.

Use in children and adolescents
Arcoxia tablets should not be taken by children or adolescents under
16 years of age.

Elderly

.6.

No dose adjustment is necessary for elderly patients. As with other medicines, caution should
be exercised in elderly patients.

What Arcoxia contains

Method of administration
Arcoxia is for oral use. Take the tablets once a day. Arcoxia can be taken with or without
food.

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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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 (see What you need to know before you take Arcoxia section 2):
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

Uncommon:

















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

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 take Arcoxia after the expiry date which is stated on the blister or carton label after
‘Exp’- The expiry date refers to the last day of the month.
Store in the original package in order to protect from moisture.
If your medicine become discoloured or show any signs of deterioration, seek the advice of
your pharmacist.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

Contents of the pack and other information

The active substance is etoricoxib.
Each film-coated tablet contains 30mg etoricoxib.
The other ingredients are:
Tablet 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) and indigo carmine lake (E132 ).

What Arcoxia looks like and contents of the pack
Arcoxia are blue-green apple-shaped, biconvex film-coated tablets marked with ‘ACX 30’ on
one side and ‘101’ on the other.
Arcoxia is available in blister packs containing 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem,
Netherlands.
Procured from within the EU and repackaged by the Product Licence holder :
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Arcoxia® 30mg tablets; PL No: 18799/2379
Leaflet date: 02.09.2015
Arcoxia® is a registered trademark of Merck Sharp & Dohme Limited.

POM

Package leaflet: Information for the user

Etoricoxib
30mg film-coated Tablets

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 over 65 years of
age, your doctor will want to appropriately keep a check on you. No dosage adjustment is
necessary for patients over 65 years of age.

Children and Adolescents
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. see section 4.
The name of your medicine is Etoricoxib 30mg film-coated Tablets, but will be referred as
Etoricoxib throughout this leaflet. Please note that the leaflet also contains information about
other strengths Etoricoxib 60mg, 90mg and 120mg Tablets.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Etoricoxib is and what it is used for
What you need to know before you take Etoricoxib
How to take Etoricoxib
Possible side effects
How to store Etoricoxib
Contents of the pack and other information

1. What Etoricoxib is and what it is used for
What is Etoricoxib?
-

Etoricoxib contains the active substance Etoricoxib. 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).

What is Etoricoxib used for?
-

Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles
of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
Etoricoxib is also used for the short term treatment of moderate pain after dental surgery
in people 16 years of age and older.

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

Other medicines and Etoricoxib
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)
ciclosporin or tacrolimus (drugs used for suppressing the immune system)
lithium (a medicine used to treat some types of depression)
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
diuretics (water tablets)
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 (the combination may increase your risk of side effects)
hormone replacement therapy (the combination may increase your risk of side effects)
aspirin, the risk of stomach ulcers is greater if you take Etoricoxib with aspirin.
- aspirin for prevention of heart attacks or stroke:
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
- aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):
do not take high dose aspirin or other anti-inflammatory medicines while taking Etoricoxib.

Etoricoxib with food and drink

What is osteoarthritis?

The onset of the effect of Etoricoxib may be faster when taken without food.

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.

Pregnancy, breast-feeding and fertility

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 this
medicine (listed in 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, breast-feeding
and fertility’)
if you are under 16 years of age
if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or
Colitis
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 your doctor has diagnosed heart problems including heart failure (moderate or severe
types), angina (chest pain)
if you have had a heart attack, bypass surgery, peripheral arterial disease (poor
circulation in legs or feet due to narrow or blocked arteries)
if you have had 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 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 have diabetes, high cholesterol, or are a smoker. These can increase your risk of
heart disease.
You are a woman trying to become pregnant.
You are over 65 years of age.

Pregnancy
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.
Breast –feeding
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.
Fertility
Etoricoxib is not recommended in women attempting to become pregnant.

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.
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.
There are different strengths available for this medicinal product and depending on your
disease your doctor will prescribe the tablet strength that is appropriate for you.
The recommended dose is:
Osteoarthritis:
The recommended dose is 30mg once a day, increase to a maximum of 60mg once a day if
needed.
Rheumatoid arthritis:
The recommended dose is 90mg once a day.
Ankylosing spondylitis:
The recommended dose is 90mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout:
The recommended dose is 120mg 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 90mg 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 60mg a day.
If you have moderate liver disease, you should not take more than 30mg a day.

Use in children and adolescents
Etoricoxib tablets should not be taken by children or adolescents under
16 years of age.

Elderly

.6.

No dose adjustment is necessary for elderly patients. As with other medicines, caution should
be exercised in elderly patients.

What Etoricoxib contains

Method of administration
Etoricoxib is for oral use. Take the tablets once a day. Etoricoxib can be taken with or without
food.

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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine 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 (see What you need to know before you take Etoricoxib section 2):
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
changes in laboratory values (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

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 take Etoricoxib after the expiry date which is stated on the blister or carton label after
‘Exp’- The expiry date refers to the last day of the month.
Store in the original package in order to protect from moisture.
If your medicine become discoloured or show any signs of deterioration, seek the advice of
your pharmacist.
Medicines should not be disposed via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

Contents of the pack and other information

The active substance is Etoricoxib.
Each film-coated tablet contains 30mg Etoricoxib.
The other ingredients are:
Tablet 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) and indigo carmine lake (E132 ).

What Etoricoxib looks like and contents of the pack
Etoricoxib are blue-green apple-shaped, biconvex film-coated tablets marked with ‘ACX 30’
on one side and ‘101’ on the other.
Etoricoxib is available in blister packs containing 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem,
Netherlands.
Procured from within the EU and repackaged by the Product Licence holder :
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Etoricoxib 30mg film-coated tablets; PL No: 18799/2379
Leaflet date: 02.09.2015

POM

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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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