ETORICOXIB 120 MG FILM-COATED TABLETS

Active substance: ETORICOXIB

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Arcoxia® 60mg film-coated tablets
Etoricoxib 60mg film-coated tablets
Arcoxia® 90 mg film-coated tablets
Etoricoxib 90 mg film-coated tablets
Arcoxia® 120 mg film-coated tablets
Etoricoxib 120 mg film-coated tablets

2378, 2379, 2380
13.03.14[8]

(etoricoxib)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
This medicine is available using any of the above names but will be referred
to as Arcoxia throughout the following.
Arcoxia tablets are also available in other strengths.
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
- Arcoxia is one of a group of medicines called selective COX-2 inhibitors.
These belong to a family of medicines called non-steroidal antiinflammatory 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. 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 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)
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 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.
Children and Adolescents
Do not give this medicine to children and adolescents under 16 years of age.

Other medicines and Arcoxia
Please 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)
- 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 breast-feeding,
or planning to breast-feed, consult your doctor before taking Arcoxia. If you
are using Arcoxia, you must not breast-feed.
Arcoxia with food and drink
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.
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.
Arcoxia Tablets should not be taken by children or adolescents under
16 years of age.
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).
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
- 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.
Do not take the tablets if they are past the expiry date, which is clearly
marked on the pack.
o
Do not store above 25 C. Store in the original package.
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 your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Arcoxia contains
Each film-coated tablet contains 60, 90 or 120 mg of etoricoxib.
Also contains calcium hydrogen phosphate anhydrous, carnauba wax,
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, titanium dioxide (E171), and glycerol
triacetate. The 60mg and 120mg tablets also contain yellow iron oxide
(E172) and indigo carmine lake (E132).
Arcoxia 60mg: Dark-green, apple-shaped, biconvex film-coated tablets
debossed with ‘200’ on one side and ‘ARCOXIA 60’ on the other side.
Arcoxia 90mg: White, apple-shaped, biconvex film-coated tablets debossed
with ‘202’ on one side and ‘ARCOXIA 90’ on the other side.
Arcoxia 120mg: Pale-green, apple-shaped, biconvex film-coated tablets
debossed with ‘204’ on one side and ‘ARCOXIA 120’ on the other side.
Pack sizes: Arcoxia 60mg and Arcoxia 90mg are available as 14 or 28
tablets per pack. Arcoxia 120mg are available as 7 or 28 tablets per pack.

MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Merck Sharp & Dohme B.V., Waarderweg 39, NL-2031 BN,
Haarlem, The Netherlands and is procured from within the EU by Product
Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow,
Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

Arcoxia 60mg PL No: 20636/2378
Arcoxia 90mg PL No: 20636/2379
Arcoxia 120mg PL No: 20636/2380

Leaflet revision and issue date (Ref) 13.03.14[8]
Arcoxia is a trademark of Merck Sharp & Dohme Corp.

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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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