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ARCOXIA 30MG TABLETS

Active substance: ETORICOXIB

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Package leaflet: Information for the user
®

Arcoxia 30mg tablets
(etoricoxib)

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.

Read all of the 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.

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

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

• 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 lowdose 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

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
ia
• 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 breastfeeding’)
• 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)

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:

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.

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 should not be taken by children or adolescents under 16 years of age.
Take Arcoxia by mouth once a day. Arcoxia can be taken with or without food.
Do not take more than the recommended dose for your condition. Your doctor will
want to discuss your treatment from time to time. It is important that you use the
lowest dose that controls your pain and you should not take Arcoxia for longer than
necessary. This is because the risk of heart attacks and strokes might increase after
prolonged treatment, especially with high doses.
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.

If you think any of these are relevant to you, do not take the tablets until you have
consulted your doctor.

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Arcoxia if:

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.







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.

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

6. Further information
What Arcoxia contains
The active substance is etoricoxib.
Each film-coated tablet contains 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

POM

Leaflet date: 22.01.2015
Arcoxia is a registered trademark of Merck Sharp & Dohme Limited.

Package leaflet: Information for the user

Etoricoxib 30mg film-coated tablets
Read all of the 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.
The name of your medicine is Etoricoxib 30mg film-coated tablets but will be
referred as Etoricoxib throughout this leaflet. Please note that this leaflet also
contains information about the other strengths such as Etoricoxib 60mg, 90mg and
120mg film-coated tablets.
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 breastfeeding’)
• 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 lowdose 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.
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 should not be taken by children or adolescents under 16 years of age.
Take Etoricoxib by mouth once a day. Etoricoxib can be taken with or without food.
Do not take more than the recommended dose for your condition. Your doctor will
want to discuss your treatment from time to time. It is important that you use the
lowest dose that controls your pain and you should not take Etoricoxib for longer
than necessary. This is because the risk of heart attacks and strokes might increase
after prolonged treatment, especially with high doses.
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.
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, 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 take your tablets after the expiry date which is stated on the carton or blister
label after ‘Exp’. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
If your medicine becomes discoloured or show any signs of deterioration, seek the
advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6. Further information
What Etoricoxib contains
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: 22.01.2015

POM

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Source: Medicines and Healthcare Products Regulatory Agency

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