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ETORICOXIB 30 MG FILM-COATED TABLETS

Active substance(s): ETORICOXIB / ETORICOXIB

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Package leaflet: Information for the patient



Etoricoxib 30 mg film-coated tablets
Etoricoxib 60 mg film-coated tablets
Etoricoxib 90 mg film-coated tablets
Etoricoxib 120 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 Etoricoxib is and what it is used for
2. What you need to know before you take Etoricoxib
3. How to take Etoricoxib
4. Possible side effects
5. How to store Etoricoxib
6. Contents of the pack and other information

1. What Etoricoxib is and what it is used for
What is Etoricoxib
• Etoricoxib contains the active substance etoricoxib. Etoricoxib 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 Etoricoxib used for?
Etoricoxib 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.



Etoricoxib 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 Etoricoxib
Do not take Etoricoxib:
• if you are allergic 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
acetylsalicylic acid 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 Etoricoxib 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. Etoricoxib 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. Etoricoxib 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
Etoricoxib to see if this medicine is suitable for you.
Etoricoxib 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 Etoricoxib
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

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
Etoricoxib:
• 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)
• acetylsalicylic acid, the risk of stomach ulcers is greater if you take Etoricoxib with
acetylsalicylic acid.
• Acetylsalicylic acid for prevention of heart attacks or stroke:
Etoricoxib can be taken with low-dose acetylsalicylic acid. If you are currently taking
low dose acetylsalicylic acid to prevent heart attacks or stroke, you should not stop
taking acetylsalicylic acid until you talk to your doctor.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs):
do not take high dose acetylsalicylic acid or other anti-inflammatory medicines while
taking Etoricoxib.
Etoricoxib with food and drink
The onset of the effect of Etoricoxib may be faster when taken without food.
Pregnancy, breast-feeding and fertility
Pregnancy
Etoricoxib 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 Etoricoxib is excreted in human milk. If you are breast-feeding, or
planning to breast-feed, consult your doctor before taking Etoricoxib. If you are using
Etoricoxib, you must not breast-feed.
Fertility
Etoricoxib is not recommended in women attempting to become pregnant.
Driving and using machines
Dizziness and sleepiness have been reported in some patients taking Etoricoxib.
Do not drive if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.

3. How to take Etoricoxib
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 Etoricoxib 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 etoricoxib once a day. The dose can be increased to
a maximum of 90 mg.
Ankylosing spondylitis
The recommended dose is 60 mg etoricoxib once a day. The dose can be increased to
a maximum of 90 mg once a day if needed.

Treatment of acute pain
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
Etoricoxib 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
Etoricoxib is for oral use. Take the tablets once a day. Etoricoxib can be taken with or
without food.
If you take more Etoricoxib than you should
You should never take more tablets than the doctor recommends. If you do take to
many Etoricoxib tablets, you should seek medical attention immediately.
If you forget to take Etoricoxib
It is important to take Etoricoxib 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 Etoricoxib and talk to your
doctor immediately (see What you need to know before you take Etoricoxib
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
Other side effects that may occur during treatment with Etoricoxib:
Very Common (may affect more than 1 in 10 people)
stomach pain












Common (may affect up to 1 in 10 people)
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 (may affect up to 1 in 100 people)
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 (may affect up to 1 in 1,000 people)
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 via Yellow
Card Scheme Website: 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 Etoricoxib
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.
This medicinal product does not require any special storage conditions.
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 Etoricoxib contains
• The active substance is etoricoxib.
Each film-coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg etoricoxib.
• The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate,
anhydrous, croscarmellose sodium, sodium stearyl fumarate, colloidal anhydrous
silica in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000,
talc, ferric oxide yellow E172 (in 60 mg tablets) and ferric oxide red E172 (in 90 mg
and 120 mg tablets) in film coating.

30 mg film-coated tablets
Boxes of 7, 14, 28, 30, 56, 60, 84, 98 or 100 tablets in blisters are available.
60 mg film-coated tablets
Boxes of 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets in blisters are available.
90 mg film-coated tablets
Boxes of 5, 7, 14, 20, 28, 30, 50, 56, 60, 84, 98 or 100 tablets in blisters are
available.
120 mg film-coated tablets
Boxes of 5, 7, 14, 20, 28, 30, 56, 60, 84, 98 or 100 tablets in blisters are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Distributed by: Consilient Health (UK) Limited. No.1 Church Road, Richmond upon
Thames, Surrey. TW9 2QE
This leaflet was last revised in 09/2016

What Etoricoxib looks like and contents of the pack
Etoricoxib film-coated tablets are available in four strenghts:
30 mg film-coated tablets are white or almost white, round (diameter: 6 mm), slightly
biconvex, film coated tablets with beveled edges.
60 mg film-coated tablets are slightly brownish yellow, round (diameter: 8 mm),
biconvex, film coated tablets with beveled edges, engraved with mark “60” on one side
of the tablet.
90 mg film-coated tablets are pink, round (diameter: 9 mm), biconvex, film coated
tablets with beveled edges, engraved with mark “90” on one side of the tablet.
120 mg film-coated tablets are brownish red, round (diameter: 10 mm), slightly
biconvex, film coated tablets with beveled edges, scored on one side of the tablet. The
score line is not intended for breaking the tablet.
P0522

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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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