Arcoxia 90 mg film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Etoricoxib
Available from:
Imbat Limited
ATC code:
M01AH; M01AH05
INN (International Name):
Etoricoxib
Dosage:
90 milligram(s)
Pharmaceutical form:
Film-coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Coxibs; etoricoxib
Authorization status:
Authorised
Authorization number:
PPA1151/137/003
Authorization date:
2012-06-28

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

ARCOXIA

®

90mg Film-coated Tablets

(etoricoxib)

Your medicine is available using the above name but it will be

referred to as Arcoxia throughout this leaflet.

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you only. Do not

pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

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

1.

What Arcoxia is and what it is used for

What is Arcoxia?

Arcoxia contains the active substance etoricoxib. Arcoxia

is one of a group of medicines called selective COX-2

inhibitors. These belong to a family of medicines called

non-steroidal anti-inflammatory drugs (NSAIDs).

What is ARCOXIA used for?

Arcoxia helps to reduce the pain and swelling

(inflammation) in the joints and muscles of people 16

years of age and older with osteoarthritis, rheumatoid

arthritis, ankylosing spondylitis and gout.

Arcoxia is also used for the short term treatment of

moderate pain after dental surgery in people 16 years of

age and older.

What is osteoarthritis?

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

gradual breakdown of cartilage that cushions the ends of the

bones. This causes swelling (inflammation), pain, tenderness,

stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of

the joints. It causes pain, stiffness, swelling, and increasing

loss of movement in the joints it affects. It may also cause

inflammation in other areas of the body.

What is gout?

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

inflammation and redness in the joints. It is caused by

deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine

and large joints.

2.

What you need to know before you take

Arcoxia

Do not take Arcoxia:

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

the other ingredients of this medicine (listed in section

if you are allergic to non-steroidal anti-inflammatory

drugs (NSAIDs), including aspirin and COX-2 inhibitors

(see Possible Side Effects, section 4)

if you have a current stomach ulcer or bleeding in your

stomach or intestines

if you have serious liver disease

if you have serious kidney disease

if you are or could be pregnant or are breast-feeding

(see ‘Pregnancy, breast feeding and fertility’)

if you are under 16 years of age

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

Disease, Ulcerative Colitis, or Colitis

if you have high blood pressure that has not been

controlled by treatment (check with your doctor or nurse

if you are not sure whether your blood pressure is

adequately controlled)

if your doctor has diagnosed heart problems including

heart failure (moderate or severe types), angina (chest

pain)

if you have had a heart attack, bypass surgery,

peripheral arterial disease (poor circulation in legs or

feet due to narrow or blocked arteries)

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

stroke, transient ischaemic attack or TIA). Etoricoxib

may slightly increase your risk of heart attack and

stroke and this is why it should not be used in those who

have already had heart problems or stroke.

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

tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Arcoxia if:

You have a history of stomach bleeding or ulcers.

You are dehydrated, for example by a prolonged bout of

vomiting or diarrhoea.

You have swelling due to fluid retention.

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

heart disease.

You have a history of high blood pressure. Arcoxia can

increase blood pressure in some people, especially in

high doses, and your doctor will want to check your

blood pressure from time to time.

You have any history of liver or kidney disease.

You are being treated for an infection. Arcoxia can mask

or hide a fever, which is a sign of infection.

You have diabetes, high cholesterol, or are a smoker.

These can increase your risk of heart disease.

You are a woman trying to become pregnant.

You are over 65 years of age.

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

your doctor before taking Arcoxia to see if this medicine

is suitable for you.

Arcoxia works equally well in older and younger adult

patients. If you are over 65 years of age, your doctor will

want to appropriately keep a check on you. No dosage

adjustment is necessary for patients over 65 years of age.

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 monohydrate

If you have been told by your doctor that you are unable to

tolerate some sugars, contact your doctor before taking this

medicinal product.

3.

How to take Arcoxia

Always take this medicine exactly as your doctor has told

you. You should check with your doctor or pharmacist if you

are not sure.

Do not take more than the recommended dose for your

condition. Your doctor will want to discuss your treatment

from time to time. It is important that you use the lowest

dose that controls your pain and you should not take Arcoxia

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

attacks and strokes might increase after prolonged treatment,

especially with high doses.

There are different strengths available for this medicinal

product and depending on your disease your doctor will

prescribe the tablet strength that is appropriate for you.

The recommended dose is:

Osteoarthritis

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

maximum of 60mg once a day if needed.

Rheumatoid arthritis

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

maximum of 90mg once a day if needed.

Ankylosing spondylitis

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

maximum of 90mg once a day if needed.

Acute pain conditions

Etoricoxib should be used only for the acute painful period.

Gout

The recommended dose is 120mg once a day which should

only be used for the acute painful period, limited to a

maximum of 8 days treatment.

Postoperative dental surgery pain

The recommended dose is 90mg once daily, limited to a

maximum of 3 days treatment.

Page 2 of 2

People with liver problems

If you have mild liver disease, you should not take more

than 60mg a day.

If you have moderate liver disease, you should not take

more than 30mg a day.

Use in children and adolescents

Arcoxia tablets should not be taken by children or adolescents

under 16 years of age.

Elderly

No dose adjustment is necessary for elderly patients. As with

other medicines, caution should be exercised in elderly

patients.

Method of administration

Arcoxia is for oral use. Take the tablets once a day. Arcoxia

can be taken with or without food.

If you take more Arcoxia than you should

You should never take more tablets than the doctor

recommends. If you do take too many Arcoxia tablets, you

should seek medical attention immediately.

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.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

If you develop any of these signs you should stop

Arcoxia and talk to your doctor immediately (see ‘What

you need to know before you take Arcoxia’ section 2):

shortness of breath, chest pains, or ankle swelling

appear or if they get worse

yellowing of the skin and eyes (jaundice) – these are

signs of liver problems

severe or continual stomach pain or your stools become

black

an allergic reaction- which can include skin problems

such as ulcers or blistering, or swelling of the face, lips,

tongue, or throat which may cause difficulty in breathing

The frequency of possible side effects listed below is defined

using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

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, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie E-mail: medsafety@hpra.ie

By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Arcoxia

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date (Exp)

which is marked on the carton and blister strips. This

refers to the last day of that month.

Store in the original package in order to protect from

moisture.

Do not use this medicine if you notice discoloration,

damage or any other signs of deterioration.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw

away any medicines you no longer use. These measures

will help protect the environment.

6.

Contents of the pack and other

information

What Arcoxia contains

The active substance is etoricoxib.

Each film-coated tablet contains 90mg of etoricoxib.

The other ingredients are:

Core: calcium hydrogen phosphate (anhydrous),

croscarmellose sodium, magnesium stearate,

microcrystalline cellulose.

Tablet coating: carnauba wax, lactose monohydrate,

hypromellose, titanium dioxide (E171), triacetin.

What Arcoxia looks like and contents of the pack

Arcoxia are white, apple-shaped, biconvex tablets

debossed ‘202’ on one side and ‘Arcoxia 90’ on the other side.

Arcoxia is available in blister packs containing 28 tablets.

Manufacturer

Manufactured by:

Merck Sharp & Dohme B.V., Waarderweg 39, Post Bus 581,

2003 PC Haarlem, The Netherlands.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder:

Imbat Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

Distributed by:

Eurodrug Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

PPA No: 1151/137/3

This medicinal product is authorised in the Member

States of the EEA under the following names:

Belgium,

Luxemburg

Arcoxia 90 mg comprimés pelliculés

Denmark, Estonia,

Iceland, Norway

Arcoxia

Ireland, United

Kingdom

ARCOXIA 90mg film-coated tablets

Austria

Arcoxia 90 mg-Filmtabletten

Czech Rep.

ARCOXIA 90 mg, potahované tablety

Cyprus, Malta

ARCOXIA 90 mg film-coated tablets

Finland

Arcoxia 90 mg tabletti,

kalvopäällysteinen

France

ARCOXIA 90 mg, comprimé pelliculé

Germany

ARCOXIA 90 mg Filmtabletten

Greece

ARCOXIA 90 mg film-coated tablets

Hungary

Arcoxia 90 mg filmtabletta

Italy

ARCOXIA 90 mg compresse rivestite

con film

Latvia

Arcoxia 90 mg apvalkotās tablets

Lithuania

Arcoxia 90 mg plėvele dengtos

tabletės

Netherlands

Arcoxia 90 mg, filmomhulde

tabletten

Poland

ARCOXIA 90 mg tabletki powlekane

Portugal

ARCOXIA 90 mg comprimidos

revestidos por película

Slovakia

ARCOXIA 90 mg

Slovenia

Arcoxia 90 mg filmsko obložene

tablete

Spain

ARCOXIA 90 mg comprimidos

recubiertos con película

Sweden

Arcoxia 90 mg filmdragerade

tabletter

Leaflet issue and revision date (ref): 01.11.16

ARCOXIA

is a registered trademark of Merck Sharp & Dohme

Corp.

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

ARCOXIA

®

90mg Film-coated Tablets

(etoricoxib)

Your medicine is available using the above name but it will be

referred to as Arcoxia throughout this leaflet.

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you only. Do not

pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

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

1.

What Arcoxia is and what it is used for

What is Arcoxia?

Arcoxia contains the active substance etoricoxib. Arcoxia

is one of a group of medicines called selective COX-2

inhibitors. These belong to a family of medicines called

non-steroidal anti-inflammatory drugs (NSAIDs).

What is ARCOXIA used for?

Arcoxia helps to reduce the pain and swelling

(inflammation) in the joints and muscles of people 16

years of age and older with osteoarthritis, rheumatoid

arthritis, ankylosing spondylitis and gout.

Arcoxia is also used for the short term treatment of

moderate pain after dental surgery in people 16 years of

age and older.

What is osteoarthritis?

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

gradual breakdown of cartilage that cushions the ends of the

bones. This causes swelling (inflammation), pain, tenderness,

stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of

the joints. It causes pain, stiffness, swelling, and increasing

loss of movement in the joints it affects. It may also cause

inflammation in other areas of the body.

What is gout?

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

inflammation and redness in the joints. It is caused by

deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine

and large joints.

2.

What you need to know before you take

Arcoxia

Do not take Arcoxia:

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

the other ingredients of this medicine (listed in section

if you are allergic to non-steroidal anti-inflammatory

drugs (NSAIDs), including aspirin and COX-2 inhibitors

(see Possible Side Effects, section 4)

if you have a current stomach ulcer or bleeding in your

stomach or intestines

if you have serious liver disease

if you have serious kidney disease

if you are or could be pregnant or are breast-feeding

(see ‘Pregnancy, breast feeding and fertility’)

if you are under 16 years of age

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

Disease, Ulcerative Colitis, or Colitis

if you have high blood pressure that has not been

controlled by treatment (check with your doctor or nurse

if you are not sure whether your blood pressure is

adequately controlled)

if your doctor has diagnosed heart problems including

heart failure (moderate or severe types), angina (chest

pain)

if you have had a heart attack, bypass surgery,

peripheral arterial disease (poor circulation in legs or

feet due to narrow or blocked arteries)

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

stroke, transient ischaemic attack or TIA). Etoricoxib

may slightly increase your risk of heart attack and

stroke and this is why it should not be used in those who

have already had heart problems or stroke.

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

tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Arcoxia if:

You have a history of stomach bleeding or ulcers.

You are dehydrated, for example by a prolonged bout of

vomiting or diarrhoea.

You have swelling due to fluid retention.

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

heart disease.

You have a history of high blood pressure. Arcoxia can

increase blood pressure in some people, especially in

high doses, and your doctor will want to check your

blood pressure from time to time.

You have any history of liver or kidney disease.

You are being treated for an infection. Arcoxia can mask

or hide a fever, which is a sign of infection.

You have diabetes, high cholesterol, or are a smoker.

These can increase your risk of heart disease.

You are a woman trying to become pregnant.

You are over 65 years of age.

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

your doctor before taking Arcoxia to see if this medicine

is suitable for you.

Arcoxia works equally well in older and younger adult

patients. If you are over 65 years of age, your doctor will

want to appropriately keep a check on you. No dosage

adjustment is necessary for patients over 65 years of age.

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 monohydrate

If you have been told by your doctor that you are unable to

tolerate some sugars, contact your doctor before taking this

medicinal product.

3.

How to take Arcoxia

Always take this medicine exactly as your doctor has told

you. You should check with your doctor or pharmacist if you

are not sure.

Do not take more than the recommended dose for your

condition. Your doctor will want to discuss your treatment

from time to time. It is important that you use the lowest

dose that controls your pain and you should not take Arcoxia

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

attacks and strokes might increase after prolonged treatment,

especially with high doses.

There are different strengths available for this medicinal

product and depending on your disease your doctor will

prescribe the tablet strength that is appropriate for you.

The recommended dose is:

Osteoarthritis

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

maximum of 60mg once a day if needed.

Rheumatoid arthritis

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

maximum of 90mg once a day if needed.

Ankylosing spondylitis

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

maximum of 90mg once a day if needed.

Acute pain conditions

Etoricoxib should be used only for the acute painful period.

Gout

The recommended dose is 120mg once a day which should

only be used for the acute painful period, limited to a

maximum of 8 days treatment.

Postoperative dental surgery pain

The recommended dose is 90mg once daily, limited to a

maximum of 3 days treatment.

Page 2 of 2

People with liver problems

If you have mild liver disease, you should not take more

than 60mg a day.

If you have moderate liver disease, you should not take

more than 30mg a day.

Use in children and adolescents

Arcoxia tablets should not be taken by children or adolescents

under 16 years of age.

Elderly

No dose adjustment is necessary for elderly patients. As with

other medicines, caution should be exercised in elderly

patients.

Method of administration

Arcoxia is for oral use. Take the tablets once a day. Arcoxia

can be taken with or without food.

If you take more Arcoxia than you should

You should never take more tablets than the doctor

recommends. If you do take too many Arcoxia tablets, you

should seek medical attention immediately.

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.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

If you develop any of these signs you should stop

Arcoxia and talk to your doctor immediately (see ‘What

you need to know before you take Arcoxia’ section 2):

shortness of breath, chest pains, or ankle swelling

appear or if they get worse

yellowing of the skin and eyes (jaundice) – these are

signs of liver problems

severe or continual stomach pain or your stools become

black

an allergic reaction- which can include skin problems

such as ulcers or blistering, or swelling of the face, lips,

tongue, or throat which may cause difficulty in breathing

The frequency of possible side effects listed below is defined

using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

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, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie E-mail: medsafety@hpra.ie

By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Arcoxia

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date (Exp)

which is marked on the carton and blister strips. This

refers to the last day of that month.

Store in the original package in order to protect from

moisture.

Do not use this medicine if you notice discoloration,

damage or any other signs of deterioration.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw

away any medicines you no longer use. These measures

will help protect the environment.

6.

Contents of the pack and other

information

What Arcoxia contains

The active substance is etoricoxib.

Each film-coated tablet contains 90mg of etoricoxib.

The other ingredients are:

Core: calcium phosphate dibasic anhydrous,

croscarmellose sodium, magnesium stearate and

microcrystalline cellulose.

Tablet coating: carnauba wax, lactose monohydrate,

hypromellose, titanium dioxide (E171) and triacetin.

What Arcoxia looks like and contents of the pack

Arcoxia 90mg are white, apple-shaped, biconvex tablets

debossed ‘202’ on one side and plain on the other side.

Arcoxia is available in blister packs containing 30 tablets.

Manufacturer

Manufactured by:

Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem,

The Netherlands.

Merck Sharp & Dohme Ltd, Cramlington, Northumberland,

NE23 3JU, UK.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder:

Imbat Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

Distributed by:

Eurodrug Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

PPA No: 1151/137/3

This medicinal product is authorised in the Member

States of the EEA under the following names:

Belgium,

Luxemburg

Arcoxia 90 mg comprimés pelliculés

Denmark, Estonia,

Iceland, Norway

Arcoxia

Ireland, United

Kingdom

ARCOXIA 90mg film-coated tablets

Austria

Arcoxia 90 mg-Filmtabletten

Czech Rep.

ARCOXIA 90 mg, potahované tablety

Cyprus, Malta

ARCOXIA 90 mg film-coated tablets

Finland

Arcoxia 90 mg tabletti,

kalvopäällysteinen

France

ARCOXIA 90 mg, comprimé pelliculé

Germany

ARCOXIA 90 mg Filmtabletten

Greece

ARCOXIA 90 mg film-coated tablets

Hungary

Arcoxia 90 mg filmtabletta

Italy

ARCOXIA 90 mg compresse rivestite

con film

Latvia

Arcoxia 90 mg apvalkotās tablets

Lithuania

Arcoxia 90 mg plėvele dengtos

tabletės

Netherlands

Arcoxia 90 mg, filmomhulde

tabletten

Poland

ARCOXIA 90 mg tabletki powlekane

Portugal

ARCOXIA 90 mg comprimidos

revestidos por película

Slovakia

ARCOXIA 90 mg

Slovenia

Arcoxia 90 mg filmsko obložene

tablete

Spain

ARCOXIA 90 mg comprimidos

recubiertos con película

Sweden

Arcoxia 90 mg filmdragerade

tabletter

Leaflet issue and revision date (ref): 01.11.16

ARCOXIA

is a registered trademark of Merck Sharp & Dohme

Corp.

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

ARCOXIA

®

90mg Film-coated Tablets

(etoricoxib)

Your medicine is available using the above name but it will be

referred to as Arcoxia throughout this leaflet.

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or

pharmacist.

This medicine has been prescribed for you only. Do not

pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

If you get any side effects, talk to your doctor or

pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

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

1.

What Arcoxia is and what it is used for

What is Arcoxia?

Arcoxia contains the active substance etoricoxib. Arcoxia

is one of a group of medicines called selective COX-2

inhibitors. These belong to a family of medicines called

non-steroidal anti-inflammatory drugs (NSAIDs).

What is ARCOXIA used for?

Arcoxia helps to reduce the pain and swelling

(inflammation) in the joints and muscles of people 16

years of age and older with osteoarthritis, rheumatoid

arthritis, ankylosing spondylitis and gout.

Arcoxia is also used for the short term treatment of

moderate pain after dental surgery in people 16 years of

age and older.

What is osteoarthritis?

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

gradual breakdown of cartilage that cushions the ends of the

bones. This causes swelling (inflammation), pain, tenderness,

stiffness and disability.

What is rheumatoid arthritis?

Rheumatoid arthritis is a long term inflammatory disease of

the joints. It causes pain, stiffness, swelling, and increasing

loss of movement in the joints it affects. It may also cause

inflammation in other areas of the body.

What is gout?

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

inflammation and redness in the joints. It is caused by

deposits of mineral crystals in the joint.

What is ankylosing spondylitis?

Ankylosing spondylitis is an inflammatory disease of the spine

and large joints.

2.

What you need to know before you take

Arcoxia

Do not take Arcoxia:

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

the other ingredients of this medicine (listed in section

if you are allergic to non-steroidal anti-inflammatory

drugs (NSAIDs), including aspirin and COX-2 inhibitors

(see Possible Side Effects, section 4)

if you have a current stomach ulcer or bleeding in your

stomach or intestines

if you have serious liver disease

if you have serious kidney disease

if you are or could be pregnant or are breast-feeding

(see ‘Pregnancy, breast feeding and fertility’)

if you are under 16 years of age

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

Disease, Ulcerative Colitis, or Colitis

if you have high blood pressure that has not been

controlled by treatment (check with your doctor or nurse

if you are not sure whether your blood pressure is

adequately controlled)

if your doctor has diagnosed heart problems including

heart failure (moderate or severe types), angina (chest

pain)

if you have had a heart attack, bypass surgery,

peripheral arterial disease (poor circulation in legs or

feet due to narrow or blocked arteries)

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

stroke, transient ischaemic attack or TIA). Etoricoxib

may slightly increase your risk of heart attack and

stroke and this is why it should not be used in those who

have already had heart problems or stroke.

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

tablets until you have consulted your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Arcoxia if:

You have a history of stomach bleeding or ulcers.

You are dehydrated, for example by a prolonged bout of

vomiting or diarrhoea.

You have swelling due to fluid retention.

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

heart disease.

You have a history of high blood pressure. Arcoxia can

increase blood pressure in some people, especially in

high doses, and your doctor will want to check your

blood pressure from time to time.

You have any history of liver or kidney disease.

You are being treated for an infection. Arcoxia can mask

or hide a fever, which is a sign of infection.

You have diabetes, high cholesterol, or are a smoker.

These can increase your risk of heart disease.

You are a woman trying to become pregnant.

You are over 65 years of age.

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

your doctor before taking Arcoxia to see if this medicine

is suitable for you.

Arcoxia works equally well in older and younger adult

patients. If you are over 65 years of age, your doctor will

want to appropriately keep a check on you. No dosage

adjustment is necessary for patients over 65 years of age.

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 monohydrate

If you have been told by your doctor that you are unable to

tolerate some sugars, contact your doctor before taking this

medicinal product.

3.

How to take Arcoxia

Always take this medicine exactly as your doctor has told

you. You should check with your doctor or pharmacist if you

are not sure.

Do not take more than the recommended dose for your

condition. Your doctor will want to discuss your treatment

from time to time. It is important that you use the lowest

dose that controls your pain and you should not take Arcoxia

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

attacks and strokes might increase after prolonged treatment,

especially with high doses.

There are different strengths available for this medicinal

product and depending on your disease your doctor will

prescribe the tablet strength that is appropriate for you.

The recommended dose is:

Osteoarthritis

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

maximum of 60mg once a day if needed.

Rheumatoid arthritis

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

maximum of 90mg once a day if needed.

Ankylosing spondylitis

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

maximum of 90mg once a day if needed.

Acute pain conditions

Etoricoxib should be used only for the acute painful period.

Gout

The recommended dose is 120mg once a day which should

only be used for the acute painful period, limited to a

maximum of 8 days treatment.

Postoperative dental surgery pain

The recommended dose is 90mg once daily, limited to a

maximum of 3 days treatment.

Page 2 of 2

People with liver problems

If you have mild liver disease, you should not take more

than 60mg a day.

If you have moderate liver disease, you should not take

more than 30mg a day.

Use in children and adolescents

Arcoxia tablets should not be taken by children or adolescents

under 16 years of age.

Elderly

No dose adjustment is necessary for elderly patients. As with

other medicines, caution should be exercised in elderly

patients.

Method of administration

Arcoxia is for oral use. Take the tablets once a day. Arcoxia

can be taken with or without food.

If you take more Arcoxia than you should

You should never take more tablets than the doctor

recommends. If you do take too many Arcoxia tablets, you

should seek medical attention immediately.

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.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

If you develop any of these signs you should stop

Arcoxia and talk to your doctor immediately (see ‘What

you need to know before you take Arcoxia’ section 2):

shortness of breath, chest pains, or ankle swelling

appear or if they get worse

yellowing of the skin and eyes (jaundice) – these are

signs of liver problems

severe or continual stomach pain or your stools become

black

an allergic reaction- which can include skin problems

such as ulcers or blistering, or swelling of the face, lips,

tongue, or throat which may cause difficulty in breathing

The frequency of possible side effects listed below is defined

using the following convention:

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

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, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2

Tel: +353 1 6764971 Fax: +353 1 6762517

Website: www.hpra.ie E-mail: medsafety@hpra.ie

By reporting side effects, you can help provide more

information on the safety of this medicine.

5.

How to store Arcoxia

Keep this medicine out of the sight and reach of

children.

Do not use this medicine after the expiry date (Exp)

which is marked on the carton and blister strips. This

refers to the last day of that month.

Store in the original package in order to protect from

moisture.

Do not use this medicine if you notice discoloration,

damage or any other signs of deterioration.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw

away any medicines you no longer use. These measures

will help protect the environment.

6.

Contents of the pack and other

information

What Arcoxia contains

The active substance is etoricoxib.

Each film-coated tablet contains 90mg of etoricoxib.

The other ingredients are:

Core: calcium hydrogen phosphate (anhydrous),

croscarmellose sodium, magnesium stearate,

microcrystalline cellulose.

Tablet coating: carnauba wax, lactose monohydrate,

hypromellose, titanium dioxide (E171), triacetin.

What Arcoxia looks like and contents of the pack

Arcoxia are white, apple-shaped, biconvex tablets

debossed ‘202’ on one side and ‘Arcoxia 90’ on the other side.

Arcoxia is available in blister packs containing 28 tablets.

Manufacturer

Manufactured by:

Merck Sharp & Dohme B.V., Waarderweg 39,

2031 BN Haarlem, The Netherlands.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder:

Imbat Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

Distributed by:

Eurodrug Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

PPA No: 1151/137/3

This medicinal product is authorised in the Member

States of the EEA under the following names:

Belgium,

Luxemburg

Arcoxia 90 mg comprimés pelliculés

Denmark, Estonia,

Iceland, Norway

Arcoxia

Ireland, United

Kingdom

ARCOXIA 90mg film-coated tablets

Austria

Arcoxia 90 mg-Filmtabletten

Czech Rep.

ARCOXIA 90 mg, potahované tablety

Cyprus, Malta

ARCOXIA 90 mg film-coated tablets

Finland

Arcoxia 90 mg tabletti,

kalvopäällysteinen

France

ARCOXIA 90 mg, comprimé pelliculé

Germany

ARCOXIA 90 mg Filmtabletten

Greece

ARCOXIA 90 mg film-coated tablets

Hungary

Arcoxia 90 mg filmtabletta

Italy

ARCOXIA 90 mg compresse rivestite

con film

Latvia

Arcoxia 90 mg apvalkotās tablets

Lithuania

Arcoxia 90 mg plėvele dengtos

tabletės

Netherlands

Arcoxia 90 mg, filmomhulde

tabletten

Poland

ARCOXIA 90 mg tabletki powlekane

Portugal

ARCOXIA 90 mg comprimidos

revestidos por película

Slovakia

ARCOXIA 90 mg

Slovenia

Arcoxia 90 mg filmsko obložene

tablete

Spain

ARCOXIA 90 mg comprimidos

recubiertos con película

Sweden

Arcoxia 90 mg filmdragerade

tabletter

Leaflet issue and revision date (ref): 01.11.16

ARCOXIA

is a registered trademark of Merck Sharp & Dohme

Corp.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

ARCOXIA 90mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 90mg of etoricoxib.

Excipients with known effect: lactose monohydrate

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet.

Product imported from: Hungary and Spain

White, apple-shaped, biconvex tablets debossed ‘202’ on one side and ‘ARCOXIA 90’ on the other side.

Product imported from: Italy

White, apple-shaped, biconvex tablets debossed ‘202’ on one side and plain on the other side.

4 CLINICAL PARTICULARS

As per PA1286/007/003

5 PHARMACOLOGICAL PROPERTIES

As per PA1286/007/003

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Product imported from Hungary & Spain:

Core:

Calcium hydrogen phosphate anhydrous

Croscarmellose sodium

Magnesium stearate

Microcrystalline cellulose

Tablet coating:

Carnauba wax

Lactose monohydrate

Hypromellose

Titanium dioxide (E171)

Triacetin

Product imported from Italy:

Core:

Calcium phosphate dibasic anhydrous

Croscarmellose sodium

Magnesium stearate

Microcrystalline cellulose

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Tablet coating:

Carnauba wax

Lactose monohydrate

Hypromellose

Titanium dioxide (E171)

Triacetin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the blister and outer carton of the product as marketed in

the country of origin.

6.4 Special precautions for storage

Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Aluminum blisters in packs containing 28 or 30 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

Imbat Ltd.

Unit L2

North Ring Business Park

Santry

Dublin 9

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1151/137/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28

June 2012

10 DATE OF REVISION OF THE TEXT

September 2015

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