Etoricoxib 60mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

Buy It Now

Active ingredient:
Etoricoxib
Available from:
DE Pharmaceuticals
ATC code:
M01AH05
INN (International Name):
Etoricoxib
Dosage:
60mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 10010100
Authorization number:
; PL 00289/1935

Arcoxia 60mg Tablets/Etoricoxib 60mg Tablets

(etoricoxib)

®

Ref: 0898/130519/1/F

Patient Information 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.

Your medicine is called Arcoxia 60mg Tablets / Etoricoxib 60mg Tablets and

will be referred to as Arcoxia throughout the leaflet. Other strengths are

available.

What is in this leaflet

What Arcoxia is and what it is used for

What you need to know before you take Arcoxia

How to take Arcoxia

Possible side effects

How to store Arcoxia

Contents of the pack and other information

What Arcoxia is and what it is used for

What is Arcoxia?

Arcoxia contains the active substance etoricoxib. Arcoxia is one of a group

of medicines called selective COX-2 inhibitors. These belong to a family of

medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

Arcoxia helps to reduce the pain and swelling (inflammation) in the joints

and muscles of people 16 years of age and older with osteoarthritis,

rheumatoid arthritis, ankylosing spondylitis and gout.

Arcoxia is also used for the short term treatment of moderate pain after

dental surgery in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown

of cartilage that cushions the ends of the bones. This causes swelling

(inflammation), pain, tenderness, stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of the joints. It

causes pain, stiffness, swelling, and increasing loss of movement in the

joints it affects. It may also cause inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden, recurring attacks of very painful inflammation

and redness in the joints. It is caused by deposits of mineral crystals in the

joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine and large

joints.

What you need to know before you take Arcoxia

Do not take Arcoxia:

if you are allergic (hypersensitive) to etoricoxib or any of the other

ingredients of 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

if you have a current stomach ulcer or bleeding in your stomach or

intestines

if you have serious liver disease

if you have serious kidney disease

if you are or could be pregnant or are breast-feeding (see ‘Pregnancy,

breast feeding, and fertility’)

if you are under 16 years of age

if you have inflammatory bowel disease, such as Crohn’s Disease,

Ulcerative Colitis, or Colitis

if you have high blood pressure that has not been controlled by treatment

(check with your doctor or nurse if you are not sure whether your blood

pressure is adequately controlled)

if your doctor has diagnosed heart problems including heart failure

(moderate or severe types), angina (chest pain)

if you have had a heart attack, bypass surgery, peripheral arterial disease

(poor circulation in legs or feet due to narrow or blocked arteries)

if you have had any kind of stroke (including mini-stroke, transient

ischaemic attack or TIA).

Etoricoxib may slightly increase your risk of heart attack and stroke and

this is why it should not be used in those who have already had heart

problems or stroke.

If you think any of these are relevant to you, do not take the tablets until you

have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Arcoxia if:

You have a history of stomach bleeding or ulcers.

You are dehydrated, for example by a prolonged bout of vomiting or

diarrhoea.

You have swelling due to fluid retention.

You have a history of heart failure, or any other form of heart disease.

You have a history of high blood pressure. Arcoxia can increase blood

pressure in some people, especially in high doses, and your doctor will

want to check your blood pressure from time to time.

You have any history of liver or kidney disease.

You are being treated for an infection. Arcoxia can mask or hide a fever,

which is a sign of infection.

You have diabetes, high cholesterol, or are a smoker. These can increase

your risk of heart disease.

You are a woman trying to become pregnant.

You are over 65 years of age.

If you are not sure if any of the above apply to you, talk to your doctor

before taking Arcoxia to see if this medicine is suitable for you.

Arcoxia works equally well in older and younger adult patients. If you are

over 65 years of age, your doctor will want to appropriately keep a check on

you. No dosage adjustment is necessary for patients over 65 years of age.

Children and adolescents

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

Other medicines and Arcoxia

Tell your doctor or pharmacist if you are taking, have recently taken or might

take any other medicines, including medicines obtained without a

prescription.

In particular if you are taking any of the following medicines, your doctor may

want to monitor you to check that your medicines are working properly, once

you start taking Arcoxia:

medicines that thin your blood (anticoagulants), such as warfarin

rifampicin (an antibiotic)

methotrexate (a drug used for suppressing the immune system, and often

used in rheumatoid arthritis)

ciclosporin or tacrolimus (drugs used for suppressing the immune

system)

lithium (a medicine used to treat some types of depression)

medicines used to help control high blood pressure and heart failure called

ACE inhibitors and angiotensin receptor blockers, examples include

enalapril and ramipril, and losartan and valsartan

diuretics (water tablets)

digoxin (a medicine for heart failure and irregular heart rhythm)

minoxidil (a drug used to treat high blood pressure)

salbutamol tablets or oral solution (a medicine for asthma)

birth control pills (the combination may increase your risk of side effects)

hormone replacement therapy (the combination may increase your risk of

side effects)

aspirin, the risk of stomach ulcers is greater if you take Arcoxia with aspirin.

- aspirin for prevention of heart attacks or stroke:

Arcoxia can be taken with low-dose aspirin. If you are currently taking

low-dose aspirin to prevent heart attacks or stroke, you should not stop

taking aspirin until you talk to your doctor

- aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take high dose aspirin or other anti-inflammatory medicines while

taking Arcoxia.

Arcoxia with food and drink

The onset of the effect of Arcoxia may be faster when taken without food.

Pregnancy, breast-feeding, and fertility

Pregnancy

Arcoxia tablets must not be taken during pregnancy. If you are pregnant or

think you could be pregnant, or if you are planning to become pregnant, do

not take the tablets. If you become pregnant, stop taking the tablets and

consult your doctor. Consult your doctor if you are unsure or need more

advice.

Breast-feeding

It is not known if Arcoxia is excreted in human milk. If you are

breast-feeding, or planning to breast-feed, consult your doctor

before taking Arcoxia. If you are using Arcoxia, you must not breast-feed.

Fertility

Arcoxia is not recommended in women attempting to become pregnant.

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.

How to take Arcoxia

Always take this medicine exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose for your condition. Your

doctor will want to discuss your treatment from time to time. It is important

that you use the lowest dose that controls your pain and you should not take

Arcoxia for longer than necessary. This is because the risk of heart attacks

and strokes might increase after prolonged treatment, especially with high

doses.

There are different strengths available for this medicinal product and

depending on your disease your doctor will prescribe the tablet strength that

is appropriate for you.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once a day, increase to a maximum of 60

mg once a day if needed.

Rheumatoid arthritis

The recommended dose is 60 mg once a day, increased to a maximum of

90 mg once a day if needed.

Ankylosing spondylitis

The recommended dose is 60 mg once a day, increased to a maximum of

90 mg once a day if needed.

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.

1

1

6

4

5

2

2

3

3

Ref: 0898/130519/1/B

(etoricoxib)

Arcoxia 60mg Tablets/Etoricoxib 60mg Tablets

®

Patient Information Leaflet (continued)

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.

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 medicine, ask your

doctor or pharmacist.

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)

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

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

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

The following side effects can occur during treatment with Arcoxia:

Very Common:

stomach pain

Common:

dry socket (inflammation and pain after a tooth extraction)

swelling of the legs and/or feet due to fluid retention (oedema)

dizziness, headache

palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)

increased blood pressure

wheezing or shortness of breath (bronchospasms)

constipation, wind (excessive gas), gastritis (inflammation of the lining of

the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach

discomfort, nausea, being sick (vomiting), inflammation of the oesophagus,

mouth ulcers

changes in blood tests related to your liver

bruising

weakness and fatigue, flu-like illness

Uncommon:

gastroenteritis (inflammation of the gastrointestinal tract that involves both

the stomach and small intestine/stomach flu), upper respiratory infection,

urinary tract infection

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:

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 or pharmacist. 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.

How to store Arcoxia

Expiry date

Do not use this medicine after the expiry date shown on the carton or blister

strip. If your doctor tells you to stop taking this medicine, return any unused

medicine to your pharmacist for safe disposal.

Only keep this medicine, if your doctor tells you to. If your medicine

becomes discoloured or shows any other signs of deterioration, consult your

pharmacist who will tell you what to do.

Storing your medicine

*

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF

CHILDREN.

*

Store in the original package to protect from moisture.

Important

This leaflet does not tell you everything about your medicine. If you have any

questions or are not sure about anything, ask your doctor or pharmacist.

He/she will have additional information about this medicine and will be able

to advise you.

Contents of the pack and other information

What Arcoxia contains

Each film-coated tablet contains 60mg of etoricoxib as the active ingredient.

Your medicine also contains the following inactive ingredients: Lactose

monohydrate, calcium hydrogen phosphate (anhydrous), croscarmellose

sodium, magnesium stearate, microcrystalline cellulose, carnauba wax,

hypromellose, titanium dioxide (E171), yellow ferric oxide (E172) and

glycerol triacetate, indigo carmine lake (E132).

What Arcoxia looks like and contents of the pack

Your medicine is called Arcoxia 60mg Tablets/Etoricoxib 60mg Tablets but

will be referred to as Arcoxia throughout this leaflet. Arcoxia are green, apple

shaped, biconvex tablets engraved with ‘200’ on one side and plain on the

other side. Each blister strip contains 10 tablets, in boxes of 20 or 30’s.

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

PL 15184/0898

Arcoxia is a registered trademark of Merck Sharp & Dohme Corp.

Leaflet revision date: 13/05/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you.

POM

4

5

6

Arcoxia 60mg Tablets/Etoricoxib 60mg Tablets

(etoricoxib)

®

Ref: 0898/130519/1/F

Patient Information 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.

Your medicine is called Arcoxia 60mg Tablets / Etoricoxib 60mg Tablets and

will be referred to as Arcoxia throughout the leaflet. Other strengths are

available.

What is in this leaflet

What Arcoxia is and what it is used for

What you need to know before you take Arcoxia

How to take Arcoxia

Possible side effects

How to store Arcoxia

Contents of the pack and other information

What Arcoxia is and what it is used for

What is Arcoxia?

Arcoxia contains the active substance etoricoxib. Arcoxia is one of a group

of medicines called selective COX-2 inhibitors. These belong to a family of

medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

What is Arcoxia used for?

Arcoxia helps to reduce the pain and swelling (inflammation) in the joints

and muscles of people 16 years of age and older with osteoarthritis,

rheumatoid arthritis, ankylosing spondylitis and gout.

Arcoxia is also used for the short term treatment of moderate pain after

dental surgery in people 16 years of age and older.

What is osteoarthritis?

Osteoarthritis is a disease of the joints. It results from the gradual breakdown

of cartilage that cushions the ends of the bones. This causes swelling

(inflammation), pain, tenderness, stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of the joints. It

causes pain, stiffness, swelling, and increasing loss of movement in the

joints it affects. It may also cause inflammation in other areas of the body.

What is gout?

Gout is a disease of sudden, recurring attacks of very painful inflammation

and redness in the joints. It is caused by deposits of mineral crystals in the

joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine and large

joints.

What you need to know before you take Arcoxia

Do not take Arcoxia:

if you are allergic (hypersensitive) to etoricoxib or any of the other

ingredients of 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

if you have a current stomach ulcer or bleeding in your stomach or

intestines

if you have serious liver disease

if you have serious kidney disease

if you are or could be pregnant or are breast-feeding (see ‘Pregnancy,

breast feeding, and fertility’)

if you are under 16 years of age

if you have inflammatory bowel disease, such as Crohn’s Disease,

Ulcerative Colitis, or Colitis

if you have high blood pressure that has not been controlled by treatment

(check with your doctor or nurse if you are not sure whether your blood

pressure is adequately controlled)

if your doctor has diagnosed heart problems including heart failure

(moderate or severe types), angina (chest pain)

if you have had a heart attack, bypass surgery, peripheral arterial disease

(poor circulation in legs or feet due to narrow or blocked arteries)

if you have had any kind of stroke (including mini-stroke, transient

ischaemic attack or TIA).

Etoricoxib may slightly increase your risk of heart attack and stroke and

this is why it should not be used in those who have already had heart

problems or stroke.

If you think any of these are relevant to you, do not take the tablets until you

have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Arcoxia if:

You have a history of stomach bleeding or ulcers.

You are dehydrated, for example by a prolonged bout of vomiting or

diarrhoea.

You have swelling due to fluid retention.

You have a history of heart failure, or any other form of heart disease.

You have a history of high blood pressure. Arcoxia can increase blood

pressure in some people, especially in high doses, and your doctor will

want to check your blood pressure from time to time.

You have any history of liver or kidney disease.

You are being treated for an infection. Arcoxia can mask or hide a fever,

which is a sign of infection.

You have diabetes, high cholesterol, or are a smoker. These can increase

your risk of heart disease.

You are a woman trying to become pregnant.

You are over 65 years of age.

If you are not sure if any of the above apply to you, talk to your doctor

before taking Arcoxia to see if this medicine is suitable for you.

Arcoxia works equally well in older and younger adult patients. If you are

over 65 years of age, your doctor will want to appropriately keep a check on

you. No dosage adjustment is necessary for patients over 65 years of age.

Children and adolescents

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

Other medicines and Arcoxia

Tell your doctor or pharmacist if you are taking, have recently taken or might

take any other medicines, including medicines obtained without a

prescription.

In particular if you are taking any of the following medicines, your doctor may

want to monitor you to check that your medicines are working properly, once

you start taking Arcoxia:

medicines that thin your blood (anticoagulants), such as warfarin

rifampicin (an antibiotic)

methotrexate (a drug used for suppressing the immune system, and often

used in rheumatoid arthritis)

ciclosporin or tacrolimus (drugs used for suppressing the immune

system)

lithium (a medicine used to treat some types of depression)

medicines used to help control high blood pressure and heart failure called

ACE inhibitors and angiotensin receptor blockers, examples include

enalapril and ramipril, and losartan and valsartan

diuretics (water tablets)

digoxin (a medicine for heart failure and irregular heart rhythm)

minoxidil (a drug used to treat high blood pressure)

salbutamol tablets or oral solution (a medicine for asthma)

birth control pills (the combination may increase your risk of side effects)

hormone replacement therapy (the combination may increase your risk of

side effects)

aspirin, the risk of stomach ulcers is greater if you take Arcoxia with aspirin.

- aspirin for prevention of heart attacks or stroke:

Arcoxia can be taken with low-dose aspirin. If you are currently taking

low-dose aspirin to prevent heart attacks or stroke, you should not stop

taking aspirin until you talk to your doctor

- aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs):

do not take high dose aspirin or other anti-inflammatory medicines while

taking Arcoxia.

Arcoxia with food and drink

The onset of the effect of Arcoxia may be faster when taken without food.

Pregnancy, breast-feeding, and fertility

Pregnancy

Arcoxia tablets must not be taken during pregnancy. If you are pregnant or

think you could be pregnant, or if you are planning to become pregnant, do

not take the tablets. If you become pregnant, stop taking the tablets and

consult your doctor. Consult your doctor if you are unsure or need more

advice.

Breast-feeding

It is not known if Arcoxia is excreted in human milk. If you are

breast-feeding, or planning to breast-feed, consult your doctor

before taking Arcoxia. If you are using Arcoxia, you must not breast-feed.

Fertility

Arcoxia is not recommended in women attempting to become pregnant.

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.

How to take Arcoxia

Always take this medicine exactly as your doctor has told you. You should

check with your doctor or pharmacist if you are not sure.

Do not take more than the recommended dose for your condition. Your

doctor will want to discuss your treatment from time to time. It is important

that you use the lowest dose that controls your pain and you should not take

Arcoxia for longer than necessary. This is because the risk of heart attacks

and strokes might increase after prolonged treatment, especially with high

doses.

There are different strengths available for this medicinal product and

depending on your disease your doctor will prescribe the tablet strength that

is appropriate for you.

The recommended dose is:

Osteoarthritis

The recommended dose is 30 mg once a day, increase to a maximum of 60

mg once a day if needed.

Rheumatoid arthritis

The recommended dose is 60 mg once a day, increased to a maximum of

90 mg once a day if needed.

Ankylosing spondylitis

The recommended dose is 60 mg once a day, increased to a maximum of

90 mg once a day if needed.

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.

1

1

6

4

5

2

2

3

3

Ref: 0898/130519/1/B

(etoricoxib)

Arcoxia 60mg Tablets/Etoricoxib 60mg Tablets

®

Patient Information Leaflet (continued)

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.

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 medicine, ask your

doctor or pharmacist.

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)

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

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

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

The following side effects can occur during treatment with Arcoxia:

Very Common:

stomach pain

Common:

dry socket (inflammation and pain after a tooth extraction)

swelling of the legs and/or feet due to fluid retention (oedema)

dizziness, headache

palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia)

increased blood pressure

wheezing or shortness of breath (bronchospasms)

constipation, wind (excessive gas), gastritis (inflammation of the lining of

the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach

discomfort, nausea, being sick (vomiting), inflammation of the oesophagus,

mouth ulcers

changes in blood tests related to your liver

bruising

weakness and fatigue, flu-like illness

Uncommon:

gastroenteritis (inflammation of the gastrointestinal tract that involves both

the stomach and small intestine/stomach flu), upper respiratory infection,

urinary tract infection

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:

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 or pharmacist. 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.

How to store Arcoxia

Expiry date

Do not use this medicine after the expiry date shown on the carton or blister

strip. If your doctor tells you to stop taking this medicine, return any unused

medicine to your pharmacist for safe disposal.

Only keep this medicine, if your doctor tells you to. If your medicine

becomes discoloured or shows any other signs of deterioration, consult your

pharmacist who will tell you what to do.

Storing your medicine

*

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF

CHILDREN.

*

Store in the original package to protect from moisture.

Important

This leaflet does not tell you everything about your medicine. If you have any

questions or are not sure about anything, ask your doctor or pharmacist.

He/she will have additional information about this medicine and will be able

to advise you.

Contents of the pack and other information

What Arcoxia contains

Each film-coated tablet contains 60mg of etoricoxib as the active ingredient.

Your medicine also contains the following inactive ingredients: Lactose

monohydrate, calcium hydrogen phosphate (anhydrous), croscarmellose

sodium, magnesium stearate, microcrystalline cellulose, carnauba wax,

hypromellose, titanium dioxide (E171), yellow ferric oxide (E172) and

glycerol triacetate, indigo carmine lake (E132).

What Arcoxia looks like and contents of the pack

Your medicine is called Arcoxia 60mg Tablets/Etoricoxib 60mg Tablets but

will be referred to as Arcoxia throughout this leaflet. Arcoxia are green, apple

shaped, biconvex tablets engraved with ‘200’ on one side and plain on the

other side. Each blister strip contains 10 tablets, in boxes of 20 or 30’s.

Manufacturer and Licence Holder

The tablets are manufactured by Merck Sharp & Dohme Ltd., Shotton Lane,

Cramlington, Northumberland, NE23 3JU, United Kingdom 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

PL 15184/0898

Arcoxia is a registered trademark of Merck Sharp & Dohme Corp.

Leaflet revision date: 13/05/19

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: 01527 505414 to obtain the leaflet

in a format suitable for you.

POM

4

5

6

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Etoricoxib

60 mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 60 mg of etoricoxib.

Excipient with known effect: Also contains 1.68 mg of lactose monohydrate

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Film-coated tablet

60 mg: Green, round, biconvex, film-coated tablets debossed with ‘444’ on

one side and ‘L’ on other side. The tablet diameter is 8.00 mm.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Etoricoxib is indicated in adults and adolescents 16 years of age and older for

the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA),

ankylosing spondylitis, and the pain and signs of inflammation associated with

acute gouty arthritis.

Etoricoxib is indicated in adults and adolescents 16 years of age and older for

the short-term treatment of moderate pain associated with dental surgery.

The decision to prescribe a selective COX-2 inhibitor should be based on an

assessment of the individual patient's overall risks (see sections 4.3, 4.4).

4.2

Posology and method of administration

Posology

As the cardiovascular risks of etoricoxib may increase with dose and duration

of exposure, the shortest duration possible and the lowest effective daily dose

should be used. The patient's need for symptomatic relief and response to

therapy should be re-evaluated periodically, especially in patients with

osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).

Osteoarthritis

The recommended dose is 30 mg once daily. In some patients with insufficient

relief from symptoms, an increased dose of 60 mg once daily may increase

efficacy. In the absence of an increase in therapeutic benefit, other therapeutic

options should be considered.

Rheumatoid arthritis

The recommended dose is 60 mg once daily.

In some patients with insufficient

relief from symptoms, an increased dose of 90 mg once daily may increase

efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg

once daily dose may be appropriate. In the absence of an increase in

therapeutic benefit, other therapeutic options should be considered.

Ankylosing spondylitis

The recommended dose is 60 mg once daily.

In some patients with insufficient

relief from symptoms, an increased dose of 90 mg once daily may increase

efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg

once daily dose may be appropriate. In the absence of an increase in

therapeutic benefit, other therapeutic options should be considered.

Acute pain conditions

For acute pain conditions, etoricoxib should be used only for the acute

symptomatic period.

Acute gouty arthritis

The recommended dose is 120 mg once daily. In clinical trials for acute gouty

arthritis, etoricoxib was given for 8 days.

Postoperative dental surgery pain

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

Some patients may require other postoperative analgesia in addition to

etoricoxib during the three day treatment period.

Doses greater than those recommended for each indication have either not

demonstrated additional efficacy or have not been studied. Therefore:

The dose for OA should not exceed 60 mg daily.

The dose for RA and ankylosing spondylitis should not exceed 90 mg daily.

The dose for acute gout should not exceed 120 mg daily, limited to a

maximum of 8 days treatment.

The dose for postoperative acute dental surgery pain should not exceed 90 mg

daily, limited to a maximum of 3 days.

Special populations

Elderly patients

No dosage adjustment is necessary for elderly patients. As with other drugs,

caution should be exercised in elderly patients (see section 4.4).

Patients with hepatic impairment

Regardless of indication, in patients with mild hepatic dysfunction (Child-

Pugh score 5-6) a dose of 60 mg once daily should not be exceeded. In

patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless

of indication, the dose of 30 mg once daily should not be exceeded.

Clinical experience is limited particularly in patients with moderate hepatic

dysfunction and caution is advised. There is no clinical experience in patients

with severe hepatic dysfunction (Child-Pugh score

10); therefore, its use is

contra-indicated in these patients (see sections 4.3, 4.4 and 5.2).

Patients with renal impairment

No dosage adjustment is necessary for patients with creatinine clearance

ml/min (see section 5.2). The use of etoricoxib in patients with creatinine

clearance <30 ml/min is contra-indicated (see sections 4.3 and 4.4).

Paediatric population

Etoricoxib is contra-indicated in children and adolescents under 16 years of

age (see section 4.3).

Method of administration

Etoricoxib is administered orally and may be taken with or without food. The

onset of the effect of the medicinal product may be faster when Etoricoxib is

administered without food. This should be considered when rapid

symptomatic relief is needed.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed

in section 6.1.

Active peptic ulceration or active gastro-intestinal (GI) bleeding.

Patients who, after taking acetylsalicylic acid or NSAIDs including COX-

2 (cyclooxygenase-2) inhibitors, experience bronchospasm, acute rhinitis,

nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions.

Pregnancy and lactation (see sections 4.6 and 5.3).

Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score

10).

Estimated renal creatinine clearance <30 ml/min.

Children and adolescents under 16 years of age.

Inflammatory bowel disease.

Congestive heart failure (NYHA II-IV).

Patients with hypertension whose blood pressure is persistently elevated

above 140/90mmHg and has not been adequately controlled.

Established ischaemic heart disease, peripheral arterial disease, and/or

cerebrovascular disease.

4.4

Special warnings and precautions for use

Gastrointestinal effects

Upper gastrointestinal complications [perforations, ulcers or bleedings

(PUBs)], some of them resulting in fatal outcome, have occurred in patients

treated with etoricoxib.

Caution is advised with treatment of patients most at risk of developing a

gastrointestinal complication with NSAIDs; the elderly, patients using any

other NSAID or acetylsalicylic acid concomitantly or patients with a prior

history of gastrointestinal disease, such as ulceration and GI bleeding.

There is a further increase in the risk of gastrointestinal adverse effects

(gastrointestinal ulceration or other gastrointestinal complications) when

etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses).

A significant difference in GI safety between selective COX-2 inhibitors +

acetylsalicylic acid vs. NSAIDs + acetylsalicylic acid has not been

demonstrated in long-term clinical trials (see section 5.1).

Cardiovascular effects

Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be

associated with a risk of thrombotic events (especially myocardial infarction

(MI) and stroke), relative to placebo and some NSAIDs. As the cardiovascular

risks of etoricoxib may increase with dose and duration of exposure, the

shortest duration possible and the lowest effective daily dose should be used.

The patient's need for symptomatic relief and response to therapy should be re-

evaluated periodically, especially in patients with osteoarthritis (see sections

4.2, 4.3, 4.8 and 5.1).

Patients with significant risk factors for cardiovascular events (e.g.

hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be

treated with etoricoxib after careful consideration (see section 5.1).

COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for

prophylaxis of cardiovascular thrombo-embolic diseases because of their lack

of antiplatelet effect. Therefore antiplatelet therapies should not be

discontinued (see sections above, 4.5 and 5.1.).

Renal effects

Renal prostaglandins may play a compensatory role in the maintenance of

renal perfusion. Therefore, under conditions of compromised renal perfusion,

administration of etoricoxib may cause a reduction in prostaglandin formation

and, secondarily, in renal blood flow, and thereby impair renal function.

Patients at greatest risk of this response are those with pre-existing

significantly impaired renal function, uncompensated heart failure, or

cirrhosis. Monitoring of renal function in such patients should be considered.

Fluid retention, oedema and hypertension

As with other medicinal products known to inhibit prostaglandin synthesis,

fluid retention, oedema and hypertension have been observed in patients

taking etoricoxib. All Nonsteroidal Anti-inflammatory Drugs (NSAIDs),

including etoricoxib, can be associated with new onset or recurrent congestive

heart failure. For information regarding a dose related response for etoricoxib

see section 5.1. Caution should be exercised in patients with a history of

cardiac failure, left ventricular dysfunction, or hypertension and in patients

with pre-existing oedema from any other reason. If there is clinical evidence of

deterioration in the condition of these patients, appropriate measures including

discontinuation of etoricoxib should be taken.

Etoricoxib may be associated with more frequent and severe hypertension than

some other NSAIDs and selective COX-2 inhibitors, particularly at high

doses. Therefore, hypertension should be controlled before treatment with

etoricoxib (see section 4.3) and special attention should be paid to blood

pressure monitoring during treatment with etoricoxib. Blood pressure should

be monitored within two weeks after initiation of treatment and periodically

thereafter. If blood pressure rises significantly, alternative treatment should be

considered.

Hepatic effects

Elevations of alanine aminotransferase (ALT) and/or aspartate

aminotransferase (AST) (approximately three or more times the upper limit of

normal) have been reported in approximately 1% of patients in clinical trials

treated for up to one year with etoricoxib 30, 60 and 90 mg daily.

Any patients with symptoms and/or signs suggesting liver dysfunction, or in

whom an abnormal liver function test has occurred, should be monitored. If

signs of hepatic insufficiency occur, or if persistently abnormal liver function

tests (three times the upper limit of normal) are detected, etoricoxib should be

discontinued.

General

If during treatment, patients deteriorate in any of the organ system functions

described above, appropriate measures should be taken and discontinuation of

etoricoxib therapy should be considered. Medically appropriate supervision

should be maintained when using etoricoxib in the elderly and in patients with

renal, hepatic, or cardiac dysfunction.

Caution should be used when initiating treatment with etoricoxib in patients

with dehydration. It is advisable to rehydrate patients prior to starting therapy

with etoricoxib.

Serious skin reactions, some of them fatal, including exfoliative dermatitis,

Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been

reported very rarely in association with the use of NSAIDs and some selective

COX-2 inhibitors during post-marketing surveillance (see section 4.8).

Patients appear to be at highest risk for these reactions early in the course of

therapy with the onset of the reaction occurring in the majority of cases within

the first month of treatment. Serious hypersensitivity reactions (such as

anaphylaxis and angioedema) have been reported in patients receiving

etoricoxib (see section 4.8). Some selective COX-2 inhibitors have been

associated with an increased risk of skin reactions in patients with a history of

any drug allergy. Etoricoxib should be discontinued at the first appearance of

skin rash, mucosal lesions, or any other sign of hypersensitivity.

Etoricoxib may mask fever and other signs of inflammation.

Caution should be exercised when co-administering etoricoxib with warfarin

or other oral anticoagulants (see section 4.5).

The use of etoricoxib, as with any medicinal product known to inhibit

cyclooxygenase / prostaglandin synthesis, is not recommended in women

attempting to conceive (see sections 4.6, 5.1, and 5.3).

Important information regarding the ingredients of this medicine

This medicine contains lactose monohydrate. Patients with rare hereditary

problems of galactose intolerance, total lactase deficiency or glucose-galactose

malabsorption should not take this medicinal product.

4.5

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic interactions

Oral anticoagulants: In subjects stabilised on chronic warfarin therapy, the

administration of etoricoxib 120 mg daily was associated with an approximate

13% increase in prothrombin time International Normalised Ratio (INR).

Therefore, patients receiving oral anticoagulants should be closely monitored

for their prothrombin time INR, particularly in the first few days when therapy

with etoricoxib is initiated or the dose of etoricoxib is changed (see section

4.4).

Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may

reduce the effect of diuretics and other antihypertensive drugs. In some

patients with compromised renal function (e.g. dehydrated patients or elderly

patients with compromised renal function) the co-administration of an ACE

inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase

may result in further deterioration of renal function, including possible acute

renal failure, which is usually reversible. These interactions should be

considered in patients taking etoricoxib concomitantly with ACE inhibitors or

angiotensin II antagonists. Therefore, the combination should be administered

with caution, especially in the elderly. Patients should be adequately hydrated

and consideration should be given to monitoring of renal function after

initiation of concomitant therapy, and periodically thereafter.

Acetylsalicylic Acid: In a study in healthy subjects, at steady state, etoricoxib

120 mg once daily had no effect on the anti-platelet activity of acetylsalicylic

acid (81 mg once daily). Etoricoxib can be used concomitantly with

acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose

acetylsalicylic acid). However, concomitant administration of low-dose

acetylsalicylic acid with etoricoxib may result in an increased rate of GI

ulceration or other complications compared to use of etoricoxib alone.

Concomitant administration of etoricoxib with doses of acetylsalicylic acid

above those for cardiovascular prophylaxis or with other NSAIDs is not

recommended (see sections 5.1 and 4.4.).

Ciclosporin and tacrolimus: Although this interaction has not been studied

with etoricoxib, coadministration of ciclosporin or tacrolimus with any

NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.

Renal function should be monitored when etoricoxib and either of these drugs

is used in combination.

Pharmacokinetic interactions

The effect of etoricoxib on the pharmacokinetics of other drugs

Lithium: NSAIDs decrease lithium renal excretion and therefore increase

lithium plasma levels. If necessary, monitor blood lithium closely and adjust

the lithium dosage while the combination is being taken and when the NSAID

is withdrawn.

Methotrexate: Two studies investigated the effects of etoricoxib 60, 90 or 120

mg administered once daily for seven days in patients receiving once-weekly

methotrexate doses of 7.5 to 20 mg for rheumatoid arthritis. Etoricoxib at 60

and 90 mg had no effect on methotrexate plasma concentrations or renal

clearance. In one study, etoricoxib 120 mg had no effect, but in the other

study, etoricoxib 120 mg increased methotrexate plasma concentrations by

28% and reduced renal clearance of methotrexate by 13%. Adequate

monitoring for methotrexate-related toxicity is recommended when etoricoxib

and methotrexate are administered concomitantly.

Oral contraceptives: Etoricoxib 60 mg given concomitantly with an oral

contraceptive containing 35 micrograms ethinyl estradiol (EE) and 0.5 to 1 mg

norethindrone for 21 days increased the steady state AUC0-24hr of EE by

37%. Etoricoxib 120 mg given with the same oral contraceptive concomitantly

or separated by 12 hours increased the steady state AUC0-24hr of EE by 50 to

60%. This increase in EE concentration should be considered when selecting

an oral contraceptive for use with etoricoxib. An increase in EE exposure can

increase the incidence of adverse events associated with oral contraceptives

(e.g., venous thrombo-embolic events in women at risk).

Hormone Replacement Therapy (HRT): Administration of etoricoxib 120 mg

with hormone replacement therapy consisting of conjugated estrogens (0.625

mg PREMARINTM) for 28 days, increased the mean steady state AUC0-24hr

of unconjugated estrone (41%), equilin (76%), and 17-

-estradiol (22%). The

effect of the recommended chronic doses of etoricoxib (30, 60, and 90 mg) has

not been studied. The effects of etoricoxib 120 mg on the exposure (AUC0-

24hr) to these estrogenic components of PREMARIN were less than half of

those observed when PREMARIN was administered alone and the dose was

increased from 0.625 to 1.25 mg. The clinical significance of these increases is

unknown, and higher doses of PREMARIN were not studied in combination

with etoricoxib. These increases in estrogenic concentration should be taken

into consideration when selecting post-menopausal hormone therapy for use

with etoricoxib because the increase in oestrogen exposure might increase the

risk of adverse events associated with HRT.

Prednisone/prednisolone: In drug-interaction studies, etoricoxib did not have

clinically important effects on the pharmacokinetics of prednisone

/prednisolone.

Digoxin: Etoricoxib 120 mg administered once daily for 10 days to healthy

volunteers did not alter the steady-state plasma AUC0-24hr or renal

elimination of digoxin. There was an increase in digoxin Cmax (approximately

33%). This increase is not generally important for most patients. However,

patients at high risk of digoxin toxicity should be monitored for this when

etoricoxib and digoxin are administered concomitantly.

Effect of etoricoxib on drugs metabolised by sulfotransferases

Etoricoxib is an inhibitor of human sulfotransferase activity, particularly

SULT1E1, and has been shown to increase the serum concentrations of ethinyl

estradiol. While knowledge about effects of multiple sulfotransferases is

presently limited and the clinical consequences for many drugs are still being

examined, it may be prudent to exercise care when administering etoricoxib

concurrently with other drugs primarily metabolised by human

sulfotransferases (e.g., oral salbutamol and minoxidil).

Effect of etoricoxib on drugs metabolised by CYP isoenzymes

Based on in vitro studies, etoricoxib is not expected to inhibit cytochromes

P450 (CYP) 1A2, 2C9, 2C19, 2D6, 2E1 or 3A4. In a study in healthy subjects,

daily administration of etoricoxib 120 mg did not alter hepatic CYP3A4

activity as assessed by the erythromycin breath test.

Effects of other drugs on the pharmacokinetics of etoricoxib

The main pathway of etoricoxib metabolism is dependent on CYP enzymes.

CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo. In vitro

studies indicate that CYP2D6, CYP2C9, CYP1A2 and CYP2C19 also can

catalyse the main metabolic pathway, but their quantitative roles have not been

studied in vivo.

Ketoconazole: Ketoconazole, a potent inhibitor of CYP3A4, dosed at 400 mg

once a day for 11 days to healthy volunteers, did not have any clinically

important effect on the single-dose pharmacokinetics of 60 mg etoricoxib

(43% increase in AUC).

Voriconazole and Miconazole: Co-administration of either oral voriconazole

or topical miconazole oral gel, strong CYP3A4 inhibitors, with etoricoxib

caused a slight increase in exposure to etoricoxib, but is not considered to be

clinically meaningful based on published data.

Rifampicin: Co-administration of etoricoxib with rifampicin, a potent inducer

of CYP enzymes, produced a 65% decrease in etoricoxib plasma

concentrations. This interaction may result in recurrence of symptoms when

etoricoxib is co-administered with rifampicin. While this information may

suggest an increase in dose, doses of etoricoxib greater than those listed for

each indication have not been studied in combination with rifampicin and are

therefore not recommended (see section 4.2).

Antacids: Antacids do not affect the pharmacokinetics of etoricoxib to a

clinically relevant extent.

4.6

Fertility, pregnancy and lactation

Pregnancy

No clinical data on exposed pregnancies are available for etoricoxib. Studies

in animals have shown reproductive toxicity (see section 5.3). The potential

for human risk in pregnancy is unknown. Etoricoxib, as with other medicinal

products inhibiting prostaglandin synthesis, may cause uterine inertia and

premature closure of the ductus arteriosus during the last trimester. Etoricoxib

is contraindicated in pregnancy (see section 4.3). If a woman becomes

pregnant during treatment, etoricoxib must be discontinued.

Breastfeeding

It is not known whether etoricoxib is excreted in human milk. Etoricoxib is

excreted in the milk of lactating rats. Women who use etoricoxib must not

breast feed (see sections 4.3 and 5.3).

Fertility

The use of etoricoxib, as with any drug substance known to inhibit COX-2, is

not recommended in women attempting to conceive.

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