ARCOXIA 30MG FILM-COATED TABLETS

Active substance: ETORICOXIB

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Arcoxia® 30mg Film-coated Tablets/Etoricoxib 30mg Film-coated Tablets
Arcoxia® 60mg Film-coated Tablets/Etoricoxib 60mg Film-coated Tablets
(etoricoxib)

This product is available using either of the above names but will be
referred to as Arcoxia throughout this leaflet. This medicine is also available
in 90mg and 120mg strength.
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Arcoxia is and what it is used for
2) Before you take Arcoxia
3) How to take Arcoxia
4) Possible side effects
5) How to store Arcoxia
6) Further information

1) What Arcoxia is and what it is used for




Arcoxia is one of a group of medicines called selective COX-2
inhibitors. These belong to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
Arcoxia helps to reduce the pain and swelling (inflammation) in the
joints and muscles of people with osteoarthritis, rheumatoid arthritis,
ankylosing spondylitis and gout.
Arcoxia is also used for the short term treatment of moderate pain after
dental surgery."

What is osteoarthritis?
Osteoarthritis is a disease of the joints. It results from the gradual
breakdown of cartilage that cushions the ends of the bones. This causes
swelling (inflammation), pain, tenderness, stiffness and disability.
What is rheumatoid arthritis?
Rheumatoid arthritis is a long term inflammatory disease of the joints. It
causes pain, stiffness, swelling, and increasing loss of movement in the
joints it affects. It may also cause inflammation in other areas of the body.
What is gout?
Gout is a disease of sudden, recurring attacks of very painful inflammation
and redness in the joints. It is caused by deposits of mineral crystals in the
joint.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large
joints.

2) Before you take Arcoxia
Do not take Arcoxia:
 if you are allergic (hypersensitive) to etoricoxib or any of the other
ingredients of Arcoxia (see Further information, section 6)
 if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs),
including aspirin and COX-2 inhibitors (see Possible Side Effects,
section 4)
 if you have a current stomach ulcer or bleeding in your stomach or
intestines
 if you have serious liver disease
 if you have serious kidney disease
 if you are or could be pregnant or are breast-feeding (see ‘Pregnancy
and breast feeding’)
 if you are under 16 years of age
 if you have inflammatory bowel disease, such as Crohn’s Disease,
Ulcerative Colitis, or Colitis
 if your doctor has diagnosed heart problems including heart failure
(moderate or severe types), angina (chest pain) or if you have had a
heart attack, bypass surgery, peripheral arterial disease (poor
circulation in legs or feet due to narrow or blocked arteries), or any kind
of stroke (including mini-stroke, transient ischaemic attack or TIA).
Etoricoxib may slightly increase your risk of heart attack and stroke and
this is why it should not be used in those who have already had heart
problems or stroke
 if you have high blood pressure that has not been controlled by
treatment (check with your doctor or nurse if you are not sure whether
your blood pressure is adequately controlled)







You have any history of liver or kidney disease.
You are being treated for an infection. Arcoxia can mask or hide a fever,
which is a sign of infection.
You are a woman trying to become pregnant.
You are elderly (i.e., over 65 years of age).
You have diabetes, high cholesterol, or are a smoker. These can
increase your risk of heart disease.

If you are not sure if any of the above apply to you, talk to your doctor
before taking Arcoxia to see if this medicine is suitable for you.
Arcoxia works equally well in older and younger adult patients. If you are
elderly (i.e., over 65 years of age), your doctor will want to appropriately
keep a check on you. No dosage adjustment is necessary for elderly
patients.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
In particular if you are taking any of the following medicines, your doctor
may want to monitor you to check that your medicines are working properly,
once you start taking Arcoxia:














medicines that thin your blood (anticoagulants), such as warfarin
rifampicin (an antibiotic)
methotrexate (a drug used for suppressing the immune system, and
often used in rheumatoid arthritis)
medicines used to help control high blood pressure and heart failure
called ACE inhibitors and angiotensin receptor blockers, examples
include enalapril and ramipril, and losartan and valsartan
lithium (a medicine used to treat some types of depression)
diuretics (water tablets)
ciclosporin or tacrolimus (drugs used for suppressing the immune
system)
digoxin (a medicine for heart failure and irregular heart rhythm)
minoxidil (a drug used to treat high blood pressure)
salbutamol tablets or oral solution (a medicine for asthma)
birth control pills
hormone replacement therapy
aspirin, the risk of stomach ulcers is greater if you take Arcoxia with
aspirin.
- 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
- do not take high dose aspirin or other anti-inflammatory medicines
while taking Arcoxia

Pregnancy and breast-feeding
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.
It is not known if Arcoxia is excreted in human milk. If you are breastfeeding, or planning to breastfeed, consult your doctor before taking
Arcoxia. If you are using Arcoxia, you must not breast-feed.
Taking Arcoxia with food and drink
Arcoxia tablets may be taken with or without food. The onset of the effect of
Arcoxia may be faster when taken without food.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking
Arcoxia.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
Important information about some of the ingredients of Arcoxia
Arcoxia contains lactose. If you have been told by your doctor that you are
unable to tolerate some sugars, contact your doctor before taking this
medicinal product.

3) How to take Arcoxia
Always take Arcoxia exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.

If you think any of these are relevant to you, do not take the tablets until you
have consulted your doctor.

Arcoxia Tablets should not be taken by children or adolescents under 16
years of age.

Take special care with Arcoxia
Arcoxia may not be suitable for you, or you may need to be monitored
regularly while taking it if any of the following apply to you:
 You have a history of stomach bleeding or ulcers.
 You are dehydrated, for example by a prolonged bout of vomiting or
diarrhoea.
 You have swelling due to fluid retention.
 You have a history of heart failure or any other form of heart disease.
 You have a history of high blood pressure. Arcoxia can increase blood
pressure in some people, especially in high doses, and your doctor will
want to check your blood pressure from time to time.

Take Arcoxia Tablets by mouth once a day. Arcoxia can be taken with or
without food.
Do not take more than the recommended dose for your condition. Your
doctor will want to discuss your treatment from time to time. It is important
that you use the lowest dose that controls your pain and you should not
take Arcoxia for longer than necessary. This is because the risk of heart
attacks and strokes might increase after prolonged treatment, especially
with high doses.

Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60
mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 90 mg once a day.
Ankylosing spondylitis
The recommended dose is 90 mg once a day.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should only be used
for the acute painful period, limited to a maximum of 8 days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3
days treatment.
People with liver problems
 If you have mild liver disease, you should not take more than 60 mg a
day.
 If you have moderate liver disease, you should not take more than 30
mg a day.
If you take more Arcoxia than you should
You should never take more tablets than the doctor recommends. If you do
take too many Arcoxia Tablets, you should seek medical attention
immediately.
If you forget to take Arcoxia
It is important to take Arcoxia as your doctor has prescribed. If you miss a
dose, just resume your usual schedule the following day. Do not take a
double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines, Arcoxia can cause side effects, although not everybody
gets them.
If you develop any of these signs you should stop Arcoxia and talk to
your doctor immediately:
 shortness of breath, chest pains, or ankle swelling appear or if they get
worse
 yellowing of the skin and eyes (jaundice) – these are signs of liver
problems
 severe or continual stomach pain or your stools become black
 an allergic reaction- which can include skin problems such as ulcers or
blistering, or swelling of the face, lips, tongue, or throat which may
cause difficulty in breathing
The frequency of possible side effects listed below is defined using the
following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
The following side effects can occur during treatment with Arcoxia:
Common:
Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea,
wind, nausea, indigestion (dyspepsia), stomach pain or discomfort,
heartburn, changes in blood tests related to your liver, swelling of the legs
and/or feet due to fluid retention (oedema), increased blood pressure,
palpitations, bruising, dry socket (inflammation and pain after a tooth
extraction).
Uncommon:
Stomach or bowel bloating, chest pain, heart failure, feeling of tightness,
pressure or heaviness in the chest (angina pectoris), heart attack, stroke,
mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial
fibrillation), upper respiratory infection, high levels of potassium in your
blood, changes in blood or urine tests relating to your kidney, changes in
your bowel habits including constipation, dry mouth, mouth ulcers, taste
alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting),
irritable bowel syndrome, inflammation of the oesophagus, blurred vision,
eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite
increases or decreases, weight gain, muscle cramp/spasm, muscle
pain/stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety,
depression, decreases in mental sharpness, breathlessness, cough,
swelling of the face, flushing, skin rash or itchy skin, urinary tract infection,
platelets decreased, decreased number of red blood cells, decreased
number of white blood cells.
Rare:
Low blood levels of sodium, redness of the skin.

Very Rare:
Allergic reactions (which may be serious enough to require immediate
medical attention) including hives, swelling of the face, lips, tongue, and/or
throat which may cause difficulty in breathing or swallowing, bronchospasm
(wheezing or shortness of breath), severe skin reactions, inflammation of
the stomach lining or stomach ulcers that can become serious and may
lead to bleeding, liver problems, serious kidney problems, severe increase
in blood pressure, confusion, seeing, feeling or hearing things that are not
there (hallucinations).
Not known:
Yellowing of the skin and eyes (jaundice), liver failure, inflammation of the
pancreas, fast heart rate, irregular heart rhythm (arrhythmia), restlessness,
inflammation of the blood vessels.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5) How to store Arcoxia
 Keep your tablets out of the sight and reach of children.
 Do not use Arcoxia after the expiry date which is stated on the pack. The
expiry date refers to the last day of the month.
 Store in the original package. Protect from moisture.
 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.
 If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your doctor or pharmacist who will tell you what
to do.

6) Further information
What Arcoxia contains
 The active substance is etoricoxib.
30mg: Each film-coated tablet contains 30mg of etoricoxib.
60mg: Each film-coated tablet contains 60mg of etoricoxib.
The other ingredients are: calcium hydrogen phosphate (anhydrous),
carnauba wax, croscarmellose sodium, hypromellose, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, titanium dioxide (E171),
and triacetin.
The 30 mg and 60 mg 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
30 mg tablets:
Blue-green, apple-shaped, biconvex film coated tablets marked ‘ACX 30’ on
one side and ‘101’ on the other.
60 mg tablets:
Dark green, apple-shaped, biconvex film-coated tablets marked ‘ARCOXIA
60’ on one side and ‘200’ on the other.
Arcoxia tablets are available as 28 tablets per pack.
PL 10383/1900
PL 10383/1901

Arcoxia 30mg Film-coated Tablets/
Etoricoxib 30mg Film-coated Tablets
Arcoxia 60mg Film-coated Tablets/
Etoricoxib 60mg Film-coated Tablets

POM
POM

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp & Dohme B.V. Waarderweg
39 2031 BN Haarlem, Holland. Procured from within the EU and
repackaged by Product Licence Holder Primecrown Ltd., 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 04/09/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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