ARCOXIA 120MG TABLETS

Active substance: ETORICOXIB

View full screen / Print PDF » Download PDF ⇩

Transcript
Arcoxia® 60mg Tablets
Arcoxia® 90mg Tablets
Arcoxia® 120mg Tablets

1151, 1152, 1168
05.03.13[14]

(etoricoxib)
PATIENT INFORMATION LEAFLET
Read all of the leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may want 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.
This medicine is available using any of the above names but will be referred
to as Arcoxia throughout the following.
Arcoxia tablets are also available in other strengths.
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
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 antiinflammatory drugs (NSAIDs).
- Arcoxia helps to reduce the pain and swelling (inflammation) in the joints
and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.
- Arcoxia is also used for the short term treatment of moderate pain after
dental surgery.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual breakdown
of cartilage that cushions the ends of the bones. This causes swelling
(inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It
causes pain, stiffness, swelling, and increasing loss of movement in the
joints it affects. It may also cause inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation
and redness in the joints. It is caused by deposits of mineral crystals in the
joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large
joints.
2. BEFORE YOU TAKE ARCOXIA
Do not take Arcoxia:
- if you are allergic (hypersensitive) to etoricoxib or any of the other
ingredients of Arcoxia (see Further information, section 6)
- if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs),
including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4)
- if you have a current stomach ulcer or bleeding in your stomach or
intestines
- if you have serious liver disease
- if you have serious kidney disease
- if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and
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.

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.
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 ramipril, and losartan and valsartan
- lithium (a medicine used to treat some types of depression)
- diuretics (water tablets)
- ciclosporin or tacrolimus (drugs used for suppressing the immune system)
- digoxin (a medicine for heart failure and irregular heart rhythm)
- minoxidil (a drug used to treat high blood pressure)
- salbutamol tablets or oral solution (a medicine for asthma)
- birth control pills
- hormone replacement therapy
- aspirin, the risk of stomach ulcers is greater if you take Arcoxia with
aspirin.
o 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
o do not take high dose aspirin or other anti-inflammatory medicines
while taking Arcoxia
Pregnancy and breast-feeding
Arcoxia 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 breastfeeding, 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.
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.
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.
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 medical attention
immediately.
If you forget to take Arcoxia
It is important to take Arcoxia as your doctor has prescribed. If you miss a
dose, just resume your usual schedule the following day. Do not take a
double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Arcoxia can cause side effects, although not everybody
gets them.
If you develop any of these signs you should stop Arcoxia and talk to
your doctor immediately:
- shortness of breath, chest pains, or ankle swelling appear or if they get
worse
- yellowing of the skin and eyes (jaundice) – these are signs of liver problems
- severe or continual stomach pain or your stools become black
- an allergic reaction- which can include skin problems such as ulcers or
blistering, or swelling of the face, lips, tongue, or throat which may cause
difficulty in breathing
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
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, ministroke (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.
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.
5. HOW TO STORE ARCOXIA
Keep your tablets out of the sight and reach of children.
Do not put the tablets into another container, as they might get mixed up.
Store in the original blister pack and do not remove the tablet from its blister
until you are ready to take it, as the tablets are moisture sensitive.
There are no other special storage conditions required for this medicine.
Do not take the tablets if they are past the expiry date, which is clearly
marked on the pack.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your doctor for safe disposal. Only keep the tablets if your doctor tells you
to. If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Arcoxia contains
The active ingredient in Arcoxia Tablets is etoricoxib.
Arcoxia 60mg tablets: Green, apple-shaped, biconvex film-coated tablets
marked ‘200’ on one side and plain on the other side, containing 60mg of
etoricoxib.
Arcoxia 90mg tablets: White, apple-shaped, biconvex film-coated tablets
marked ‘202’ on one side and plain on the other side, containing 90mg of
etoricoxib.
Arcoxia 120mg tablets: Pale-green, apple-shaped, biconvex film-coated
tablets marked ‘204’ on one side and plain on the other side, containing
120mg of etoricoxib.
Other ingredients: calcium hydrogen phosphate (anhydrous), carnauba wax,
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, titanium dioxide, and glycerol triacetate.
The 60mg and 120mg tablets also contain yellow iron oxide (E172) and
indigo carmine lake (E132).
Pack sizes: 60mg and 90mg strengths: 20 or 30 tablets per pack
120mg strength: 5 or 30 tablets per pack.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Arcoxia is manufactured by Merck Sharp & Dohme B.V., Waarderweg 39,
Haarlem, The Netherlands. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

Arcoxia 60mg Tablets PL No: 20636/1151
Arcoxia 90mg Tablets PL No: 20636/1152
Arcoxia 120mg Tablets PL No: 20636/1168

Leaflet revision and issue date (Ref) 05.03.13[14]
Arcoxia is a registered trademark of Merck & Co., Inc.

Etoricoxib 60mg Tablets
Etoricoxib 90mg Tablets
Etoricoxib 120mg Tablets

1151, 1152, 1168
05.03.13[14]

PATIENT INFORMATION LEAFLET
Read all of the leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may want 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.
This medicine is available using any of the above names but will be referred
to as Etoricoxib throughout the following.
Etoricoxib tablets are also available in other strengths.
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
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 antiinflammatory drugs (NSAIDs).
- Etoricoxib helps to reduce the pain and swelling (inflammation) in the
joints and muscles of people with osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis and gout.
- Etoricoxib is also used for the short term treatment of moderate pain after
dental surgery.
What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual breakdown
of cartilage that cushions the ends of the bones. This causes swelling
(inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It
causes pain, stiffness, swelling, and increasing loss of movement in the
joints it affects. It may also cause inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation
and redness in the joints. It is caused by deposits of mineral crystals in the
joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large
joints.
2. BEFORE YOU TAKE ETORICOXIB
Do not take Etoricoxib:
- if you are allergic (hypersensitive) to etoricoxib or any of the other
ingredients of Etoricoxib (see Further information, section 6)
- if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs),
including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4)
- if you have a current stomach ulcer or bleeding in your stomach or
intestines
- if you have serious liver disease
- if you have serious kidney disease
- if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and
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.

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.
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 ramipril, and losartan and valsartan
- lithium (a medicine used to treat some types of depression)
- diuretics (water tablets)
- ciclosporin or tacrolimus (drugs used for suppressing the immune system)
- digoxin (a medicine for heart failure and irregular heart rhythm)
- minoxidil (a drug used to treat high blood pressure)
- salbutamol tablets or oral solution (a medicine for asthma)
- birth control pills
- hormone replacement therapy
- aspirin, the risk of stomach ulcers is greater if you take Etoricoxib with
aspirin.
o 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
o do not take high dose aspirin or other anti-inflammatory medicines
while taking Etoricoxib
Pregnancy and breast-feeding
Etoricoxib 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 breastfeeding, 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.
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.
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.
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 medical attention
immediately.
If you forget to take Etoricoxib
It is important to take Etoricoxib as your doctor has prescribed. If you miss a
dose, just resume your usual schedule the following day. Do not take a
double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Etoricoxib can cause side effects, although not everybody
gets them.
If you develop any of these signs you should stop Etoricoxib and talk
to your doctor immediately:
- shortness of breath, chest pains, or ankle swelling appear or if they get
worse
- yellowing of the skin and eyes (jaundice) – these are signs of liver problems
- severe or continual stomach pain or your stools become black
- an allergic reaction- which can include skin problems such as ulcers or
blistering, or swelling of the face, lips, tongue, or throat which may cause
difficulty in breathing
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
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, ministroke (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.
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.
5. HOW TO STORE ETORICOXIB
Keep your tablets out of the sight and reach of children.
Do not put the tablets into another container, as they might get mixed up.
Store in the original blister pack and do not remove the tablet from its blister
until you are ready to take it, as the tablets are moisture sensitive.
There are no other special storage conditions required for this medicine.
Do not take the tablets if they are past the expiry date, which is clearly
marked on the pack.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your doctor for safe disposal. Only keep the tablets if your doctor tells you
to. If your tablets become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Etoricoxib contains
The active ingredient in Etoricoxib Tablets is etoricoxib.
Etoricoxib 60mg tablets: Green, apple-shaped, biconvex film-coated
tablets marked ‘200’ on one side and plain on the other side, containing
60mg of etoricoxib.
Etoricoxib 90mg tablets: White, apple-shaped, biconvex film-coated tablets
marked ‘202’ on one side and plain on the other side, containing 90mg of
etoricoxib.
Etoricoxib 120mg tablets: Pale-green, apple-shaped, biconvex film-coated
tablets marked ‘204’ on one side and plain on the other side, containing
120mg of etoricoxib.
Other ingredients: calcium hydrogen phosphate (anhydrous), carnauba wax,
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, titanium dioxide, and glycerol triacetate.
The 60mg and 120mg tablets also contain yellow iron oxide (E172) and
indigo carmine lake (E132).
Pack sizes: 60mg and 90mg strengths: 20 or 30 tablets per pack
120mg strength: 5 or 30 tablets per pack.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Etoricoxib is manufactured by Merck Sharp & Dohme B.V., Waarderweg 39,
Haarlem, The Netherlands. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

Etoricoxib 60mg Tablets PL No: 20636/1151
Etoricoxib 90mg Tablets PL No: 20636/1152
Etoricoxib 120mg Tablets PL No: 20636/1168

Leaflet revision and issue date (Ref) 05.03.13[14]

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.

Hide
(web3)