ARCOXIA 90MG TABLETS

Active substance: ETORICOXIB

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Transcript
Ref: 0510/110613/1/F

®

Arcoxia 90mg Tablets
(etoricoxib)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Arcoxia 90mg Tablets and will be referred to as
Arcoxia throughout the leaflet.
In this leaflet:
1 What Arcoxia is and what it is used for
2 Before you take Arcoxia
3 How to take Arcoxia
4 Possible side effects

Take special care with Arcoxia
Arcoxia may not be suitable for you, or you may need to be monitored
regularly while taking it if any of the following apply to you:
* You have a history of stomach bleeding or ulcers
* You are dehydrated, for example by a prolonged bout of vomiting or
diarrhoea
* You have swelling due to fluid retention
* You have a history of heart failure, or any other form of heart disease
* You have a history of high blood pressure. Arcoxia can increase blood
pressure in some people, especially in high doses, and your doctor will
want to check your blood pressure from time to time
* You have any history of liver or kidney disease.
* You are being treated for an infection. Arcoxia can mask or hide a fever,
which is a sign of infection.
* You are a woman trying to become pregnant
* You are elderly (i.e., over 65 years of age).
* You have diabetes, high cholesterol, or are a smoker. These can increase
your risk of heart disease.

5 How to store Arcoxia
6 Further information

1

What Arcoxia is and what it is used for

* Arcoxia is one of a group of medicines called selective COX-2 inhibitors.

These belong to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
* Arcoxia helps to reduce the pain and swelling (inflammation) in the joints
and muscle of people with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
* Arcoxia is also used for short term treatment of moderate pain after dental
surgery.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual breakdown
of the cartilage that cushions the ends of the bones. This causes swelling
(inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It
causes pain, stiffness, swelling and increasing loss of movement in the joints
it affects. It may also cause inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation
and redness in the joints. It is caused by deposits of mineral crystals in the
joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large
joints.

2

Before you take Arcoxia

Do not take Arcoxia:
* If you are allergic (hypersensitive) to etoricoxib or any of the other
ingredients of Arcoxia (see Further Information, section 6)
* if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs),
including aspirin and COX-2 inhibitors (see Possible Side Effects, section
4)
* if you have current stomach ulcer or bleeding in your stomach or intestines
* if you have serious liver disease
* if you have serious kidney disease
* if you are or could be pregnant or are breast feeding (see’ Pregnancy and
breast feeding)
* if you are under 16 years of age
* if you have inflammatory bowel disease, such as Crohn’s Disease,
Ulcerative Colitis, or Colitis
* if your doctor has diagnosed heart problems including heart failure
(moderate or severe types), angina (chest pain), or if you have had a
heart attack, bypass surgery, peripheral arterial disease (poor circulation in
legs or feet due to narrow or blocked arteries), or any kind of stroke
(including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may
slightly increase your risk of heart attack and stroke and this is why it
should not be used in those who have already had heart problems or
stroke.
* If you have high blood pressure that has not been controlled by treatment
(check with your doctor or nurse if you are not sure whether your
blood pressure is adequately controlled).
If you think any of these are relevant to you, do not take the tablets until you
have consulted your doctor.

If you are not sure if any of the above apply to you, talk to your doctor
before taking Arcoxia to see if this medicine is suitable for you.
Arcoxia works equally well in older and younger adult patients. If you are
elderly (i.e. over 65 years of age), your doctor will want to appropriately keep
a check on you. No dosage adjustment is necessary for elderly patients.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
In particular if you are taking any of the following medicines, your doctor may
want to monitor you to check that your medicines are working properly, once
you start taking Arcoxia:
* medicines that thin your blood (anticoagulants), such as warfarin
* rifampicin (an antibiotic)
* methotrexate (a drug used for suppressing the immune system, and often
used in rheumatoid arthritis)
* medicines used to help control high blood pressure and heart failure called
ACE inhibitors and angiotensin receptor blockers, examples include
enalapril and ramapril, and losartan and valsartan
* lithium (a medicine used to treat some types of depression)
* diuretics (water tablets)
* ciclosporin or tacrolimus (drugs used for suppressing the immune system)
* digoxin (a medicine for heart failure and irregular heart rhythm)
* minoxidil (a drug used to treat high blood pressure)
* salbutamol tablets or oral solution (a medicine for asthma)
* birth control pills
* hormone replacement therapy
* aspirin, the risk of stomach ulcers is greater if you take Arcoxia with
aspirin.
- Arcoxia can be taken with low-dose aspirin. If you are currently taking
low-dose aspirin to prevent heart attacks or stroke, you should not
stop taking aspirin until you talk to your doctor
- do not take high dose aspirin or other anti-inflammatory medicines while
taking Arcoxia
Pregnancy and breast-feeding
Arcoxia tablets must not be taken during pregnancy. If you are pregnant or
think you could be pregnant, or if you are planning to become pregnant, do
not take the tablets. If you become pregnant, stop taking the tablets and
consult your doctor. Consult your doctor if you are unsure or need more
advice.
It is not known if Arcoxia is excreted in human milk. If you are breast
feeding, or planning to breast-feed, consult your doctor before taking
Arcoxia. If you are using Arcoxia, you must not breast-feed.
Taking Arcoxia with food and drink
Arcoxia tablets may be taken with or without food. The onset of the effect of
Arcoxia may be faster when taken without food.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking
Arcoxia. Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
Important information about some of the ingredients of 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.

3

How to take Arcoxia

Always take Arcoxia exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Arcoxia Tablets should not be taken by children or adolescents under 16
years of age.
Take Arcoxia Tablets by mouth once a day. Arcoxia can be taken with or
without food.

Ref: 0510/110613/1/B

®

Arcoxia 90mg Tablets
(etoricoxib)
Patient Information Leaflet (continued)
Do not take more than the recommended dose for your condition. Your
doctor will want to discuss your treatment from time to time. It is important
that you use the lowest dose that controls your pain and you should not take
Arcoxia for longer than necessary. This is because the risk of heart attacks
and strokes might increase after prolonged treatment, especially with high
doses.
Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60
mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.

Rare:
Low blood levels of sodium, redness of the skin.
Very Rare:
Allergic reactions (which may be serious enough to require immediate
medical attention) including hives, swelling of the face, lips, tongue, and/or
throat which may cause difficulty in breathing or swallowing, bronchospasm
(wheezing or shortness of breath), severe skin reactions, inflammation of the
stomach lining or stomach ulcers that can become serious and may lead to
bleeding, liver problems, serious kidney problems, severe increase in blood
pressure, confusion, seeing, feeling or hearing things that are not there
(hallucinations).
Not known:
Yellowing of the skin and eyes (jaundice), liver faliure, inflammation of the
pancreas, fast heart rate, irregular heart rhythm (arrhythmia), restlessness,
inflammation of the blood vessels.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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.
5
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3
days treatment.
People with liver problems
* If you have mild liver disease, you should not take more than 60 mg a day.
* If you have moderate liver disease, you should not take more than 30 mg
a day.
If you take more Arcoxia than you should
You should never take more tablets than the doctor recommends. If you do
take too many Arcoxia Tablets, you should seek medicial attention
immediately.
If you forget to take Arcoxia
It is important to take Arcoxia as your doctor has prescribed. If you miss a
dose, just resume your usual schedule the following day. Do not take a
double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask you doctor
or pharmacist.

4

Possible side effects

Like all medicines, Arcoxia can cause side-effects, although not
everybody gets them.
If you develop any of these signs you should stop Arcoxia and talk to
your doctor immediately:
* shortness of breath, chest pains, or ankle swelling appear or if they get
worse
* yellowing of the skin and eyes (jaundice) - these are signs of liver
problems
* severe or continual stomach pain or your stools become black
* an allergic reaction - which can include skin problems such as ulcers or
blistering, or swelling of the face, lips, tongue, or throat which may cause
difficulty in breathing.
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
The following side effects can occur during treatment with ARCOXIA:
Common:
Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind,
nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn,
changes in blood tests related to your liver, swelling of the legs and/or feet
due to fluid retention (oedema), increased blood pressure, palpitations,
bruising, dry socket (inflammation and pain after a tooth extraction).
Uncommon:
Stomach or bowel bloating, chest pain, heart failure, feeling of tightness,
pressure or heaviness in the chest (angina pectoris), heart attack, stroke,
mini-stroke (transient ischaemic attack), abnormal heart rhythm
(atrial fibrillation), upper respiratory infection, high levels of potassium in your
blood, changes in blood or urine tests relating to your kidney, changes in
your bowel habits including constipation, dry mouth, mouth ulcers, taste
alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting),
irritable bowel syndrome, inflammation of the oesophagus, blurred vision,
eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite
increases or decreases, weight gain, muscle cramp/spasm, muscle
pain/stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety,
depression, decreases in mental sharpness, breathlessness, cough, swelling
of the face, flushing, skin rash or itchy skin, urinary tract infection, platelets
decreased, decreased number of red blood cells, decreased number of
white blood cells.

How to store Arcoxia

Keep out of the sight and reach of children.
Do not use Arcoxia after the expiry date which is stated on the pack.
The expiry date refers to the last day of the month.
Blisters: Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Further information

What Arcoxia contains
The active ingredient in Arcoxia Tablets is etoricoxib. Each film coated tablet
contains 90mg of etoricoxib.
The other ingredients are; calcium hydrogen phosphate (anhydrous),
carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, titanium dioxide (E172),
and glycerol triacetate.
What Arcoxia looks like and contents of the pack
Arcoxia Tablets are White, apple shaped, biconvex tablets engraved with ‘202’
on one side and plain on the other side. Each blister strip contains 5 tablets,
in boxes of 20 or 30 Tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Merck Sharp & Dohme B.V, Waarderweg 39,
Haarlem, The Netherlands and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0510

Arcoxia is a registered trademark of Merck & Co.Inc.
Leaflet revision date: 11/06/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0510/110613/2/F

Etoricoxib 90mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
* 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Etoricoxib 90mg Film-coated Tablets and will be
referred to as Etoricoxib throughout the leaflet.
In this leaflet:
1 What Etoricoxib is and what it is used for
2 Before you take Etoricoxib
3 How to take Etoricoxib
4 Possible side effects
5 How to store Etoricoxib
6 Further information

Take special care with Etoricoxib
Etoricoxib may not be suitable for you, or you may need to be monitored
regularly while taking it if any of the following apply to you:
* You have a history of stomach bleeding or ulcers
* You are dehydrated, for example by a prolonged bout of vomiting or
diarrhoea
* You have swelling due to fluid retention
* You have a history of heart failure, or any other form of heart disease
* You have a history of high blood pressure. Etoricoxib can increase blood
pressure in some people, especially in high doses, and your doctor will
want to check your blood pressure from time to time
* You have any history of liver or kidney disease.
* You are being treated for an infection. Etoricoxib can mask or hide a fever,
which is a sign of infection.
* You are a woman trying to become pregnant
* You are elderly (i.e., over 65 years of age).
* You have diabetes, high cholesterol, or are a smoker. These can increase
your risk of heart disease.
If you are not sure if any of the above apply to you, talk to your doctor
before taking Etoricoxib to see if this medicine is suitable for you.
Etoricoxib works equally well in older and younger adult patients. If you are
elderly (i.e. over 65 years of age), your doctor will want to appropriately keep
a check on you. No dosage adjustment is necessary for elderly patients.

1

*
*
*

What Etoricoxib is and what it is used for

Etoricoxib is one of a group of medicines called selective COX-2 inhibitors.
These belong to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints
and muscle of people with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
Etoricoxib is also used for the short term treatment of moderate pain after
dental surgery

What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual breakdown
of the cartilage that cushions the ends of the bones. This causes swelling
(inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It
causes pain, stiffness, swelling and increasing loss of movement in the joints
it affects. It may also cause inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation
and redness in the joints. It is caused by deposits of mineral crystals in the
joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large
joints.

2

Before you take Etoricoxib

Do not take Etoricoxib:
* If you are allergic (hypersensitive) to etoricoxib or any of the other
ingredients of Etoricoxib (see Further Information, section 6)
* if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs),
including aspirin and COX-2 inhibitors (see Possible Side Effects, section
4)
* if you have current stomach ulcer or bleeding in your stomach or intestines
* if you have serious liver disease
* if you have serious kidney disease
* if you are or could be pregnant or are breast feeding (see’ Pregnancy and
breast feeding)
* if you are under 16 years of age
* if you have inflammatory bowel disease, such as Crohn’s Disease,
Ulcerative Colitis, or Colitis
* if your doctor has diagnosed heart problems including heart failure
(moderate or severe types), angina (chest pain), or if you have had a
heart attack, bypass surgery, peripheral arterial disease (poor circulation in
legs or feet due to narrow or blocked arteries), or any kind of stroke
(including mini-stroke, transient ischaemic attack or TIA). Etoricoxib may
slightly increase your risk of heart attack and stroke and this is why it
should not be used in those who have already had heart problems or
stroke.
* If you have high blood pressure that has not been controlled by treatment
(check with your doctor or nurse if you are not sure whether your
blood pressure is adequately controlled).
If you think any of these are relevant to you, do not take the tablets until you
have consulted your doctor.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
In particular if you are taking any of the following medicines, your doctor may
want to monitor you to check that your medicines are working properly, once
you start taking Etoricoxib:
* medicines that thin your blood (anticoagulants), such as warfarin
* rifampicin (an antibiotic)
* methotrexate (a drug used for suppressing the immune system, and often
used in rheumatoid arthritis)
* medicines used to help control high blood pressure and heart failure called
ACE inhibitors and angiotensin receptor blockers, examples include
enalapril and ramapril, and losartan and valsartan
* lithium (a medicine used to treat some types of depression)
* diuretics (water tablets)
* ciclosporin or tacrolimus (drugs used for suppressing the immune system)
* digoxin (a medicine for heart failure and irregular heart rhythm)
* minoxidil (a drug used to treat high blood pressure)
* salbutamol tablets or oral solution (a medicine for asthma)
* birth control pills
* hormone replacement therapy
* aspirin, the risk of stomach ulcers is greater if you take Etoricoxib with
aspirin.
- Etoricoxib can be taken with low-dose aspirin. If you are currently taking
low-dose aspirin to prevent heart attacks or stroke, you should not
stop taking aspirin until you talk to your doctor
- do not take high dose aspirin or other anti-inflammatory medicines while
taking Etoricoxib
Pregnancy and breast-feeding
Etoricoxib tablets must not be taken during pregnancy. If you are pregnant or
think you could be pregnant, or if you are planning to become pregnant, do
not take the tablets. If you become pregnant, stop taking the tablets and
consult your doctor. Consult your doctor if you are unsure or need more
advice.
It is not known if Etoricoxib is excreted in human milk. If you are breast
feeding, or planning to breast-feed, consult your doctor before taking
Etoricoxib. If you are using Etoricoxib, you must not breast-feed.
Taking Etoricoxib with food and drink
Etoricoxib tablets may be taken with or without food. The onset of the effect
of Etoricoxib may be faster when taken without food.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking
Etoricoxib. Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
Important information about some of the ingredients of Etoricoxib
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 Etoricoxib exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Etoricoxib Tablets should not be taken by children or adolescents under 16
years of age.
Take Etoricoxib Tablets by mouth once a day. Etoricoxib can be taken with or
without food.

Ref: 0510/110613/2/B

Etoricoxib 90mg Film-coated Tablets
Patient Information Leaflet (continued)
Do not take more than the recommended dose for your condition. Your
doctor will want to discuss your treatment from time to time. It is important
that you use the lowest dose that controls your pain and you should not take
Etoricoxib for longer than necessary. This is because the risk of heart
attacks and strokes might increase after prolonged treatment, especially with
high doses.
Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60
mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.

Rare:
Low blood levels of sodium, redness of the skin.
Very Rare:
Allergic reactions (which may be serious enough to require immediate
medical attention) including hives, swelling of the face, lips, tongue, and/or
throat which may cause difficulty in breathing or swallowing, bronchospasm
(wheezing or shortness of breath), severe skin reactions, inflammation of the
stomach lining or stomach ulcers that can become serious and may lead to
bleeding, liver problems, serious kidney problems, severe increase in blood
pressure, confusion, seeing, feeling or hearing things that are not there
(hallucinations).
Not known:
Yellowing of the skin and eyes (jaundice), liver failure, inflammation of the
pancreas, fast heart rate, irregular heart rhythm (arrhythmia), restlessness,
inflammation of the blood vessels.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

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.
5
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3
days treatment.
People with liver problems
* If you have mild liver disease, you should not take more than 60 mg a day.
* If you have moderate liver disease, you should not take more than 30 mg
a day.
If you take more Etoricoxib than you should
You should never take more tablets than the doctor recommends. If you do
take too many Etoricoxib Tablets, you should seek medicial attention
immediately.
If you forget to take Etoricoxib
It is important to take Etoricoxib as your doctor has prescribed. If you miss a
dose, just resume your usual schedule the following day. Do not take a
double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask you doctor
or pharmacist.

4

Possible side effects

Like all medicines, Etoricoxib can cause side-effects, although not
everybody gets them.
If you develop any of these signs you should stop Etoricoxib and talk
to your doctor immediately:
* shortness of breath, chest pains, or ankle swelling appear or if they get
worse
* yellowing of the skin and eyes (jaundice) - these are signs of liver
problems
* severe or continual stomach pain or your stools become black
* an allergic reaction - which can include skin problems such as ulcers or
blistering, or swelling of the face, lips, tongue, or throat which may cause
difficulty in breathing.
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
The following side effects can occur during treatment with Etoricoxib:
Common:
Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind,
nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn,
changes in blood tests related to your liver, swelling of the legs and/or feet
due to fluid retention (oedema), increased blood pressure, palpitations,
bruising, dry socket (inflammation and pain after a tooth extraction).
Uncommon:
Stomach or bowel bloating, chest pain, heart failure, feeling of tightness,
pressure or heaviness in the chest (angina pectoris), heart attack, stroke,
mini-stroke (transient ischaemic attack), abnormal heart rhythm
(atrial fibrillation), upper respiratory infection, high levels of potassium in your
blood, changes in blood or urine tests relating to your kidney, changes in
your bowel habits including constipation, dry mouth, mouth ulcers, taste
alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting),
irritable bowel syndrome, inflammation of the oesophagus, blurred vision,
eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite
increases or decreases, weight gain, muscle cramp/spasm, muscle
pain/stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety,
depression, decreases in mental sharpness, breathlessness, cough, swelling
of the face, flushing, skin rash or itchy skin, urinary tract infection, platelets
decreased, decreased number of red blood cells, decreased number of
white blood cells.

How to store Etoricoxib

Keep out of the sight and reach of childern.
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.
Blisters: Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6

Further information

What Etoricoxib contains
The active ingredient in Etoricoxib Tablets is etoricoxib. Each film coated
tablet contains 90mg of etoricoxib.
The other ingredients are; calcium hydrogen phosphate (anhydrous),
carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, titanium dioxide (E172),
and glycerol triacetate.
What Etoricoxib looks like and contents of the pack
Etoricoxib Tablets are White, apple shaped, biconvex tablets engraved with
‘202’ on one side and plain on the other side. Each blister strip contains 5
tablets, in boxes of 20 or 30 Tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Merck Sharp & Dohme B.V, Waarderweg 39,
Haarlem, The Netherlands and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/0510

Leaflet revision date: 11/06/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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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