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ETORICOXIB 120 MG FILM COATED TABLET

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

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.

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 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 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 applies 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.

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CODE : 8063299-7803
: 150 x 620 mm_Front/Back Side
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COUNTRY : UK

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DATE : 01-03-2017

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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)
• aspirin, the risk of stomach ulcers is greater if you take Etoricoxib with aspirin.
- aspirin for prevention of heart attacks or stroke:
Etoricoxib 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 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

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 too 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;
The following side effects can 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 1000 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/anapylactoid 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 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 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 pack. The expiry date refers to the
last day of that month.
Bottles: Keep the bottle tightly closed in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture.
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 to protect the environment.
6. Contents of the pack and other information
What Etoricoxib contains


The active substance is etoricoxib.
Etoricoxib 30 mg: Each film coated tablet contains 30 mg of etoricoxib.
Etoricoxib 60 mg: Each film-coated tablet contains 60 mg of etoricoxib.
Etoricoxib 90 mg: Each film-coated tablet contains 90 mg of etoricoxib.
Etoricoxib 120 mg: Each film-coated tablet contains 120 mg of etoricoxib.



The other ingredients are:
Tablet core: calcium phosphate dibasic anhydrous, microcrystalline cellulose, croscarmellose
sodium, hydroxypropyl cellulose, magnesium stearate,
Tablet coat: hypromellose, lactose monohydrate, titanium dioxide (E 171), triacetin, indigo carmine
aluminum lake (E 132), (30 mg, 60 mg, 120 mg film-coated tablets), iron oxide yellow (E 172)
(30 mg, 60 mg, 120 mg film-coated tablets)

Pregnancy
Etoricoxib must not be taken during pregnancy. If you are pregnant, think you may be pregnant or if you
are planning to have a baby, 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.

What Etoricoxib looks like and contents of the pack

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.

Etoricoxib 60 mg Film-coated Tablets are green, round, diameter 8.00 mm ± 0.2 mm, biconvex,
film-coated tablets debossed with “444” on one side and “L” on the other side.

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.
Etoricoxib 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 Etoricoxib
Always take this medicine exactly as your doctor has told you. 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.

Etoricoxib 30 mg Film-coated Tablets are bluish green, round diameter 6.00 mm ± 0.2 mm, biconvex,
film-coated tablets debossed with “443” on one side and “L” on the other side.

Etoricoxib 90 mg Film-coated Tablets are white to off white, round, diameter 9.00 mm + 0.2 mm,
biconvex, film-coated tablets debossed with “445” on one side and “L” on the other side.
Etoricoxib 120 mg Film-coated Tablets are pale-green, round, diameter 10.00 mm + 0.2 mm, biconvex,
film-coated tablets debossed with “446” on one side and “L” on the other side.
Etoricoxib film coated tablets are available in Al//OPA/Al/PVC blisters, Al//PVC/PVdC blisters and Al//
PVC/PE/PVdC blisters in packs 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 & 100 film-coated tablets and in HDPE
bottles, containing 2 silica gel packs (1 gram each), with child resistant PP closure or PP screw cap in
packs of 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court,
Merlin Centre, County Oak Way,
Crawley, West Sussex,
RH11 7XA,
United Kingdom
Manufacturer:
Pharmadox Healthcare Ltd
KW20A, Kordin Industrial Park, Paola
PLA 3000, Malta
This leaflet was last revised in 02/2017.

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.

8063299-7803

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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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