Arcoxia 90mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Etoricoxib
Available from:
CST Pharma Ltd
ATC code:
M01AH05
INN (International Name):
Etoricoxib
Dosage:
90mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 10010100; GTIN: 5055946807140

Patient Information Leaflet

Arcoxia

®

60mg Tablets

Arcoxia

®

90mg 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

Your medicine is available by the above names but will be referred to as

Arcoxia throughout the remainder of the leaflet

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.

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 90 mg once a day.

Ankylosing spondylitis

The recommended dose is 90 mg once a day.

Acute pain conditions

Etoricoxib should be used only for the acute painful period.

Gout

The recommended dose is 120 mg once a day which should only be

used for the acute painful period, limited to a maximum of 8 days

treatment.

Postoperative dental surgery pain

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

3 days treatment.

People with liver problems

If you have mild liver disease, you should not take more than 60 mg a

day.

If you have moderate liver disease, you should not take more than

30 mg a day.

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 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.

5. How to store Arcoxia

Keep your tablets out of the sight and reach of children.

If your tablets show any signs of deterioration or discolouration, consult

your pharmacist for advice.

Do not put the tablets into another container, as they might get mixed up.

Store in the original package to protect from moisture.

Do not take the tablets if they are past the expiry date which is clearly

marked on the pack.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

6. Contents of the pack and other information

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

marked ‘ARCOXIA 60’ on one side and ‘200’ on the other, containing 60

mg of etoricoxib.

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

marked ‘ARCOXIA 90’ on one side and ‘202’ on the other, containing 90

mg of etoricoxib.

The active ingredient in ‘Arcoxia’ is etoricoxib.

Arcoxia also contains inactive ingredients: calcium hydrogen phosphate

(anhydrous), carnauba wax, croscarmellose sodium, hypromellose, lactose

monohydrate, magnesium stearate, microcrystalline cellulose, titanium

dioxide (E171), and glycerol triacetate. Arcoxia 60 mg Tablets also

contains yellow ferric oxide (E172, colouring agent) and indigo carmine

lake (E132, colouring agent).

Arcoxia is available in packs of 30.

Arcoxia is manufactured by: Frosst Iberica SA. Ctra Nacionale, 11KM 32 6,

28805 Alcala De Henares, Madrid, Spain.

Merck & Co. Inc. Merck Manufacturing Division, Elkton, USA.

Merck Sharp & Dohme B.V. Haarlem, Holland.

Procured from within the EU. Product Licence Holder: Quadrant

Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton

BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Quadrant Pharmaceuticals Ltd, Tel 01204 473136 for help.

PL 20774/0879 Arcoxia 60mg Tablets

PL 20774/0880 Arcoxia 90mg Tablets

Arcoxia is registered trademark of Merck & Co., Inc.

Date of issue: 3

September 2015

PP11/0879/80/V2

POM

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