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ARCOXCIA 90MG TABLETS

Active substance(s): ETORICOXIB

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S782 LEAFLET Arcoxia 20151117

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARCOXIA® 90mg TABLETS
(etoricoxib)

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



Your medicine is known as Arcoxia 90mg Tablets but will be
referred to as Arcoxia throughout the following patient information
leaflet.




Information regarding other strengths i.e. 30mg, 60mg and 120mg
is also present in the below leaflet.



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.

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




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

5. How to store Arcoxia
6. Contents of the pack and other information

Other medicines and Arcoxia

1. WHAT ARCOXIA IS AND WHAT IT IS USED FOR

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines, including medicines obtained
without a prescription.

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 antiinflammatory 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.

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.

What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and
large joints.

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARCOXIA
Do not take Arcoxia:

Pregnancy, breast-feeding and fertility



Pregnancy













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.

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 breastfeed.
Fertility
Arcoxia is not recommended in women attempting to become
pregnant.
Driving and using machines
Dizziness and sleepiness have been reported in some patients
taking Arcoxia.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or
sleepiness.
Arcoxia contains lactose
If you have been told by your doctor that you are unable to tolerate
some sugars, contact your doctor before taking this medicinal
product.

3. HOW TO TAKE ARCOXIA
Always take this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

Uncommon


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 30 mg once a day, increase to a
maximum of 60 mg once a day if needed.








Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions





Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should
only be used for the acute painful period, limited to a maximum
of 8 days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a
maximum of 3 days treatment.






gastroenteritis (inflammation of the gastrointestinal tract that
involves both the stomach and small intestine/stomach flu),
upper respiratory infection, urinary tract infection
changes in laboratory values (decreased number of red blood
cells, decreased number of white blood cells, platelets
decreased)
hypersensitivity (an allergic reaction including hives which may
be serious enough to require immediate medical attention)
appetite increases or decreases, weight gain
anxiety, depression, decreases in mental sharpness; seeing,
feeling or hearing things that are not there (hallucinations)
taste alteration, inability to sleep, numbness or tingling,
sleepiness
blurred vision, eye irritation and redness
ringing in the ears, vertigo (sensation of spinning while
remaining still)
abnormal heart rhythm (atrial fibrillation), fast heart rate, heart
failure, feeling of tightness, pressure or heaviness in the chest
(angina pectoris), heart attack
flushing, stroke, mini-stroke (transient ischaemic attack), severe
increase in blood pressure, inflammation of the blood vessels
cough, breathlessness, nose bleed
stomach or bowel bloating, changes in your bowel habits, dry
mouth, stomach ulcer, inflammation of the stomach lining that
can become serious and may lead to bleeding, irritable bowel
syndrome, inflammation of the pancreas
swelling of the face, skin rash or itchy skin, redness of the skin
muscle cramp/spasm, muscle pain/stiffness
high levels of potassium in your blood, changes in blood or
urine tests relating to your kidney, serious kidney problems
chest pain

Rare
People with liver problems





If you have mild liver disease, you should not take more than 60
mg a day.
If you have moderate liver disease, you should not take more
than 30 mg a day.

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.







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.

If you take more Arcoxia than you should
You should never take more tablets than the doctor recommends. If
you do take too many Arcoxia tablets, you should seek medical
attention immediately.
If you forget to take Arcoxia
It is important to take Arcoxia as your doctor has prescribed. If you
miss a dose, just resume your usual schedule the following day. Do
not take a double dose to make up for the forgotten tablet.

5. HOW TO STORE ARCOXIA


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store in the original package to protect from moisture.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you develop any of these signs you should stop Arcoxia and
talk to your doctor immediately (see What you need to know
before you take Arcoxia section 2):





shortness of breath, chest pains, or ankle swelling appear or if
they get worse
yellowing of the skin and eyes (jaundice) – these are signs of
liver problems
severe or continual stomach pain or your stools become black
an allergic reaction- which can include skin problems such as
ulcers or blistering, or swelling of the face, lips, tongue, or throat
which may cause difficulty in breathing

The frequency of possible side effects listed below is defined using
the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Arcoxia contains


The active substance in Arcoxia is etoricoxib.
Each film-coated tablet contains 90mg of the active ingredient,
etoricoxib.



Arcoxia also contains the following inactive ingredients: dibasic
calcium phosphate anhydrous, croscarmellose sodium,
magnesium stearate, carnauba wax, microcrystalline cellulose,
lactose monohydrate, hypromellose, glyceryl triacetate and
titanium dioxide E171.

What Arcoxia looks like and contents of the pack
Arcoxia Tablets are white, apple shaped, biconvex, film-coated
tablets marked ‘202’ on one side and plain on the other side.
Arcoxia Tablets are available as blister packs of 20 or 30 tablets.
Product Licence holder

Rare (affects 1 to 10 users in 10,000)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Very rare (affects less than 1 user in 10,000)

Manufacturer

Uncommon (affects 1 to 10 users in 1,000)

This product is manufactured by
The following side effects can occur during treatment with Arcoxia:



Very common





stomach pain

Merck Sharp and Dohme B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands.
Merck Sharp & Dohme Ltd.,
Shotton Lane, Cramlington, Northumberland, NE23 3JU,
United Kingdom.

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

POM

PL: 19488/0782

Leaflet revision date: 17 November 2015
Arcoxia is a registered trade mark of Merck & Co Inc USA.
S782 LEAFLET Arcoxia 20151117

S782 LEAFLET Etoricoxib 20151117

PACKAGE LEAFLET: INFORMATION FOR THE USER

ETORICOXIB 90mg TABLETS
Your medicine is known as Etoricoxib 90mg Tablets but will be
referred to as Etoricoxib Tablets throughout the following patient
information leaflet.
Information regarding other strengths i.e. 30mg, 60mg and 120mg
is also present in the below leaflet.
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.

What is in this leaflet
1. What Etoricoxib Tablets are and what they are used for
2. What you need to know before you take Etoricoxib Tablets

Warnings and precautions
Talk to your doctor or pharmacist before taking Etoricoxib Tablets 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 Tablets
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 Tablets 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 Tablets to see if this medicine is
suitable for you.
Etoricoxib Tablets work 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 Etoricoxib Tablets
4. Possible side effects
5. How to store Etoricoxib Tablets
6. Contents of the pack and other information

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

1. WHAT ETORICOXIB TABLETS ARE AND WHAT THEY ARE
USED FOR
What is Etoricoxib Tablets?


Etoricoxib Tablets contain the active substance etoricoxib.
Etoricoxib Tablets are 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).

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 Tablets:


What is Etoricoxib Tablets used for?










Etoricoxib Tablets help 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 Tablets are 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.












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 Tablets with aspirin.
- aspirin for prevention of heart attacks or stroke:
Etoricoxib Tablets 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 Tablets.

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 TABLETS
Do not take Etoricoxib Tablets:













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.

ETORICOXIB TABLETS with food and drink
The onset of the effect of Etoricoxib Tablets may be faster when
taken without food.
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.
Breast-feeding
It is not known if Etoricoxib Tablets are excreted in human milk. If
you are breast-feeding, or planning to breast-feed, consult your
doctor before taking Etoricoxib Tablets. If you are using Etoricoxib
Tablets, you must not breast-feed.
Fertility
Etoricoxib Tablets are not recommended in women attempting to
become pregnant.
Driving and using machines
Dizziness and sleepiness have been reported in some patients
taking Etoricoxib Tablets.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or
sleepiness.
Etoricoxib Tablets contain 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 TABLETS
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 Tablets for longer than
necessary. This is because the risk of heart attacks and strokes
might increase after prolonged treatment, especially with high
doses.

Uncommon






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 30 mg once a day, increase to a
maximum of 60 mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.






Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should
only be used for the acute painful period, limited to a maximum
of 8 days treatment.





Postoperative dental surgery pain



The recommended dose is 90 mg once daily, limited to a
maximum of 3 days treatment.

Rare


People with liver problems



gastroenteritis (inflammation of the gastrointestinal tract that
involves both the stomach and small intestine/stomach flu),
upper respiratory infection, urinary tract infection
changes in laboratory values (decreased number of red blood
cells, decreased number of white blood cells, platelets
decreased)
hypersensitivity (an allergic reaction including hives which may
be serious enough to require immediate medical attention)
appetite increases or decreases, weight gain
anxiety, depression, decreases in mental sharpness; seeing,
feeling or hearing things that are not there (hallucinations)
taste alteration, inability to sleep, numbness or tingling,
sleepiness
blurred vision, eye irritation and redness
ringing in the ears, vertigo (sensation of spinning while
remaining still)
abnormal heart rhythm (atrial fibrillation), fast heart rate, heart
failure, feeling of tightness, pressure or heaviness in the chest
(angina pectoris), heart attack
flushing, stroke, mini-stroke (transient ischaemic attack), severe
increase in blood pressure, inflammation of the blood vessels
cough, breathlessness, nose bleed
stomach or bowel bloating, changes in your bowel habits, dry
mouth, stomach ulcer, inflammation of the stomach lining that
can become serious and may lead to bleeding, irritable bowel
syndrome, inflammation of the pancreas
swelling of the face, skin rash or itchy skin, redness of the skin
muscle cramp/spasm, muscle pain/stiffness
high levels of potassium in your blood, changes in blood or
urine tests relating to your kidney, serious kidney problems
chest pain

If you have mild liver disease, you should not take more than 60
mg a day.
If you have moderate liver disease, you should not take more
than 30 mg a day.

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

Etoricoxib Tablets should not be taken by children or adolescents
under 16 years of age.







Elderly

Reporting of side effects

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

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.

Etoricoxib Tablets are for oral use. Take the tablets once a day.
Etoricoxib Tablets can be taken with or without food.

By reporting side effects, you can help provide more information on
the safety of this medicine.

Use in children and adolescents

5. HOW TO STORE ETORICOXIB TABLETS
If you take more Etoricoxib Tablets than you should



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Store in the original package to protect from moisture.



Do not use after the expiry date printed on the carton label or
blister strip.

If you forget to take Etoricoxib Tablets



It is important to take Etoricoxib Tablets 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 your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

You should never take more tablets than the doctor recommends. If
you do take too many Etoricoxib Tablets, you should seek medical
attention immediately.

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

6. CONTENT OF THE PACK AND OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS

What Etoricoxib Tablets contains

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



The active substance in Etoricoxib Tablets is etoricoxib.
Each film-coated tablet contains 90mg of the active ingredient,
etoricoxib.



Etoricoxib Tablets also contain the following inactive
ingredients: dibasic calcium phosphate anhydrous,
croscarmellose sodium, magnesium stearate, carnauba wax,
microcrystalline cellulose, lactose monohydrate, hypromellose,
glyceryl triacetate and titanium dioxide E171.

If you develop any of these signs you should stop Etoricoxib
Tablets and talk to your doctor immediately (see What you
need to know before you take Etoricoxib Tablets 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)

What Etoricoxib Tablets look like and contents of the pack
Etoricoxib Tablets are white, apple shaped, biconvex, film-coated
tablet marked ‘202’ on one side and plain on the other side.
Etoricoxib Tablets are available as blister packs of 20 or 30 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by



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

Merck Sharp and Dohme B.V., Waarderweg 39, 2031 BN
Haarlem, The Netherlands.
Merck Sharp & Dohme Ltd.,
Shotton Lane, Cramlington, Northumberland, NE23 3JU,
United Kingdom.

Very common

POM



Leaflet revision date: 17 November 2015

stomach pain

PL: 19488/0782
S782 LEAFLET Etoricoxib 20151117

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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