ARCOXIA 120MG TABLETS
Active substance(s): ETORICOXIB
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Package leaflet: Information for the user
®
ARCOXIA
120mg Tablets
(etoricoxib)
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 120mg Tablets, but will be referred as Arcoxia throughout this leaflet. Please note that the leaflet
also contains information about other strengths such as Arcoxia 30mg, 60mg and 90mg Tablets.
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
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 non-steroidal 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.
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.
Children and adolescents
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
The onset of the effect of Arcoxia may be faster when taken without food.
Pregnancy, breast-feeding and fertility
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.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
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.
2. What you need to know before you take Arcoxia
Arcoxia contains lactose
If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
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.
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.
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
No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
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.
5. How to store Arcoxia
Keep out of the sight and reach of children.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or 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.
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
Store in the original package to protect from moisture.
Do not store above 25˚C.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
.6. Contents of the pack and other information
What Arcoxia contains
The active ingredient in Arcoxia Tablets is etoricoxib. Each film-coated tablet contains 120mg of etoricoxib.
The other ingredients are calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline
cellulose, carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, yellow ferric oxide (E172) and
indigo carmine lake (E132).
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:
What Arcoxia looks like and contents of the pack
Arcoxia are pale-green, apple-shaped, biconvex film coated tablets marked ‘204’ on one side and ‘ARCOXIA 120’ on the other.
Very Common
stomach pain
Arcoxia® 120mg Tablets; PL No: 18799/2595
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 heart-beat), 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, heartfailure, 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
Arcoxia are available as blister packs of 7 and 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The 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.
Leaflet date: 30.09.2015
Arcoxia is a registered trademark of Merck Sharp & Dohme Limited
POM
Package leaflet: Information for the user
ETORICOXIB
120mg Tablets
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 120mg Tablets, but will be referred as Etoricoxib throughout this leaflet. Please note that the
leaflet also contains information about other strengths such as Etoricoxib 30mg, 60mg and 90mg 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
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.
Children and adolescents
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
The onset of the effect of Etoricoxib may be faster when taken without food.
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.
Pregnancy, breast-feeding and fertility
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.
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.
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.
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.
Fertility
Etoricoxib is not recommended in women attempting to become pregnant.
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.
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.
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
No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
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.
5. How to store Etoricoxib
Keep out of the sight and reach of children.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or 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.
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 heart-beat), 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, heartfailure, 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
Store in the original package to protect from moisture.
Do not store above 25˚C.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
.6. Contents of the pack and other information
What Etoricoxib contains
The active ingredient in Etoricoxib Tablets is etoricoxib. Each film-coated tablet contains 120mg of etoricoxib.
The other ingredients are calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline
cellulose, carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, yellow ferric oxide (E172) and
indigo carmine lake (E132).
What Etoricoxib looks like and contents of the pack
Etoricoxib 120mg Tablets are pale-green, apple-shaped, biconvex film coated tablets marked ‘204’ on one side and ‘ARCOXIA 120’ on
the other.
Etoricoxib 120mg Tablets are available as blister packs of 7 and 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The 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 120mg Tablets; PL No: 18799/2595
Leaflet date: 30.09.2015
POM
®
ARCOXIA
120mg Tablets
(etoricoxib)
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 120mg Tablets, but will be referred as Arcoxia throughout this leaflet. Please note that the leaflet
also contains information about other strengths such as Arcoxia 30mg, 60mg and 90mg Tablets.
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
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 non-steroidal 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.
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.
Children and adolescents
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
The onset of the effect of Arcoxia may be faster when taken without food.
Pregnancy, breast-feeding and fertility
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.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
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.
2. What you need to know before you take Arcoxia
Arcoxia contains lactose
If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
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.
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.
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
No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
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.
5. How to store Arcoxia
Keep out of the sight and reach of children.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or 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.
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
Store in the original package to protect from moisture.
Do not store above 25˚C.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
.6. Contents of the pack and other information
What Arcoxia contains
The active ingredient in Arcoxia Tablets is etoricoxib. Each film-coated tablet contains 120mg of etoricoxib.
The other ingredients are calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline
cellulose, carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, yellow ferric oxide (E172) and
indigo carmine lake (E132).
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:
What Arcoxia looks like and contents of the pack
Arcoxia are pale-green, apple-shaped, biconvex film coated tablets marked ‘204’ on one side and ‘ARCOXIA 120’ on the other.
Very Common
stomach pain
Arcoxia® 120mg Tablets; PL No: 18799/2595
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 heart-beat), 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, heartfailure, 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
Arcoxia are available as blister packs of 7 and 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The 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.
Leaflet date: 30.09.2015
Arcoxia is a registered trademark of Merck Sharp & Dohme Limited
POM
Package leaflet: Information for the user
ETORICOXIB
120mg Tablets
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 120mg Tablets, but will be referred as Etoricoxib throughout this leaflet. Please note that the
leaflet also contains information about other strengths such as Etoricoxib 30mg, 60mg and 90mg 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
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.
Children and adolescents
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
The onset of the effect of Etoricoxib may be faster when taken without food.
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.
Pregnancy, breast-feeding and fertility
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.
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.
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.
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.
Fertility
Etoricoxib is not recommended in women attempting to become pregnant.
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.
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.
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
No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
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.
5. How to store Etoricoxib
Keep out of the sight and reach of children.
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.
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.
If you have any further questions on the use of this medicine, ask your doctor or 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.
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 heart-beat), 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, heartfailure, 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
Store in the original package to protect from moisture.
Do not store above 25˚C.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
.6. Contents of the pack and other information
What Etoricoxib contains
The active ingredient in Etoricoxib Tablets is etoricoxib. Each film-coated tablet contains 120mg of etoricoxib.
The other ingredients are calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline
cellulose, carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, yellow ferric oxide (E172) and
indigo carmine lake (E132).
What Etoricoxib looks like and contents of the pack
Etoricoxib 120mg Tablets are pale-green, apple-shaped, biconvex film coated tablets marked ‘204’ on one side and ‘ARCOXIA 120’ on
the other.
Etoricoxib 120mg Tablets are available as blister packs of 7 and 28 tablets.
Manufactured by: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The 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 120mg Tablets; PL No: 18799/2595
Leaflet date: 30.09.2015
POM
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
