Arcoxia 90 mg film-coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Etoricoxib
Available from:
IMED Healthcare Ltd.
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:
PPA1463/041/002
Authorization date:
2010-08-06

Package leaflet: Information for the user

ARCOXIA® 60 mg film-coated tablets

ARCOXIA® 90 mg film-coated tablets

Etoricoxib

Read all of this leaflet carefully before you start taking this medicine

because it contains important information for you.

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

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes

any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What ARCOXIA is and what it is used for

2. What you need to know before you take ARCOXIA

3. How to take ARCOXIA

4. Possible side effects

5. How to store ARCOXIA

6. 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 6)

if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs),

including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4)

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

if you have serious liver disease

if you have serious kidney disease

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

feeding and fertility’)

if you are under 16 years of age

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

Ulcerative Colitis, or Colitis

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

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

pressure is adequately controlled)

if your doctor has diagnosed heart problems including heart failure

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

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

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

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

attack or TIA).

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

why it should not be used in those who have already had heart problems or

stroke.

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

have consulted your doctor.

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.

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 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.

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.

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 or pharmacist. This includes any

possible side effects not listed in this leaflet. You can also report side effects

directly (see details below). By reporting side effects, you can help provide

more information on the safety of this medicine.

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel:

+353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail:

medsafety@hpra.ie

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 which is stated on the carton.

The expiry date refers to the last day of that month.

Blisters: Store in the original package in order to protect from moisture. Do not

store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask

your pharmacist how to throw away 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 60 or

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. The 60mg tablets also contain yellow ferric oxide

(E172, colouring agent) and indigo carmine lake (E132, colouring agent).

What ARCOXIA looks like and contents of the pack

ARCOXIA tablets are available in four strengths:

60 mg dark green, apple-shaped, biconvex film coated tablets marked

‘ARCOXIA 60’ on one side and ‘200’ on the other.

90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA

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

Pack sizes of 28 tablets in blisters.

Parallel Product Authorisation Holder and Manufacturer

Product procured from within the EU by the Parallel Product

Authorisation Holder IMED Healthcare Ltd, Unit 625 Kilshane Avenue,

Northwest Business Park, Ballycoolin, Dublin 15, Ireland

Manufacturer: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN

Haarlem, The Netherlands.

Repackager: IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest

Business Park, Ballycoolin, Dublin 15, Ireland

This medicinal product is authorized in the Member States of the EEA

under the following names:

Belgium, Luxembourg

Arcoxia 30 mg, 60 mg, 90 mg, 120

mg, comprimés pelliculés

Arcoxia

Denmark, Estonia, Iceland,

Norway, Ireland, United Kingdom

ARCOXIA 30, 60, 90 or 120 mg film-

coated tablets

Austria

Arcoxia 30 mg, 60 mg, 90 mg, 120

mg-Filmtabletten

Czech Rep

ARCOXIA 30 mg, 60 mg, 90 mg, 120

mg, potahované tablety

Cyprus, Malta

ARCOXIA 30, 60, 90, 120 mg film-

coated tablets

Finland

Arcoxia 30, 60, 90 ja 120 mg tabletti,

kalvopäällysteinen

France

ARCOXIA 30, 60 , 90 mg, comprimé

pelliculé

Germany

ARCOXIA 30/60/90/120 mg

Filmtabletten

Greece

ARCOXIA 30 mg, 60 mg, 90 mg,120

mg film-coated tablets

Hungary

Arcoxia 30 mg, 60 mg, 90 mg, 120

mg filmtabletta

Italy

ARCOXIA 30, 60, 90, 120 mg

compresse rivestite con film

Latvia

Arcoxia 30 mg, 60 mg, 90 mg un 120

mg apvalkotās tablets

Lithuania

Arcoxia 30, 60, 90, 120 mg plėvele

dengtos tabletės

Netherlands

Arcoxia 30 mg, 60 mg, 90 mg, 120

mg, filmomhulde tabletten

Poland

ARCOXIA 30 mg, 60 mg, 90 mg, 120

mg tabletki powlekane

Portugal

ARCOXIA 30 mg, 60 mg, 90 mg, 120

mg comprimidos revestidos por

película

Slovakia

ARCOXIA 30 mg, 60 mg, 90 mg, 120

Slovenia

Arcoxia 30/60/90/120 mg filmsko

obložene tablete

Spain

ARCOXIA 30, 60, 90 y 120 mg

comprimidos recubiertos con

película

Sweden

ARCOXIA 30, 60, 90 y 120 mg

comprimidos recubiertos con

película

This leaflet was last revised in March 2018

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Arcoxia 90 mg Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 90 mg of etoricoxib.

Excipients with known effect:

Lactose 4.0 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated Tablet.

Product imported from Hungary & Romania:

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

4 CLINICAL PARTICULARS

As per PA1997/001/003

5 PHARMACOLOGICAL PROPERTIES

As per PA1997/001/003

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Core:

Calcium hydrogen phosphate (anhydrous)

Croscarmellose sodium

Magnesium stearate

Microcrystalline cellulose

Tablet Coating:

Carnauba wax

Lactose monohydrate

Hypromellose

Titanium dioxide (E171)

Triacetin

6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the blister strips and outer carton of the product on the market 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

Aluminium/aluminium blisters in over-labelled cardboard cartons containing 28 tablets.

6.6 Special precautions for disposal and other handling

No special requirements

7 PARALLEL PRODUCT AUTHORISATION HOLDER

IMED Healthcare Ltd

Unit 625 Kilshane Avenue

Northwest Business Park

Ballycoolin

Dublin 15

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1463/041/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 6

August 2010

10 DATE OF REVISION OF THE TEXT

February 2017

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