Etoricoxib 60mg Film coated Tablets

• 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.

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

• 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).

• 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.

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.

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.

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.

Ankylosing spondylitis is an inflammatory disease of the spine and large joints

• are allergic (hypersensitive) to etoricoxib or any of the other ingredients of this medicine (listed in section 6)
• are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4)
• have a current stomach ulcer or bleeding in your stomach or intestines
• have serious liver disease
• have serious kidney disease
• are or could be pregnant or are breast-feeding (see ‘Pregnancy, breast feeding, and fertility’)
• are under 16 years of age
• have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis
• 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)
• have heart problems including heart failure (moderate or severe types) or angina (chest pain)
• have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries)
• 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.

Talk to your doctor or pharmacist before taking Etoricoxib if you:

• have previously had stomach bleeding or ulcers.
• are dehydrated, for example by a prolonged bout of vomiting or diarrhoea.
• have swelling due to fluid retention.
• have previously had heart failure, or any other form of heart disease.
• have previously had 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.
• have previously had liver or kidney disease.
• are being treated for an infection. Etoricoxib can mask or hide a fever, which is a sign of infection.
• have diabetes, high cholesterol, or are a smoker. These can increase your risk of heart disease.
• are a woman trying to become pregnant.
• 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.

Do not give this medicine to children and adolescents under 16 years of age.

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 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.

The onset of the effect of Etoricoxib may be faster when taken without food.

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.

Dizziness and sleepiness have been reported in some patients taking Etoricoxib. Do not drive or use any tools or machines if you experience dizziness or sleepiness.

• 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.

Etoricoxib tablets should not be taken by children or adolescents under 16 years of age.

No dose adjustment is necessary for elderly patients but your doctor will want to keep a check on you.

Etoricoxib is for oral use. Take the tablets once a day. Etoricoxib can be taken with or without food.

You should never take more tablets than the doctor recommends. If you do take too many Etoricoxib tablets, you should seek medical attention immediately.

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.

• 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/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

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.co.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is etoricoxib. Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
• The other ingredients are: Core: Dicalcium Phosphate Anhydrous (Calipharm A), Microcrystalline Cellulose (Avicel PH 101), Croscarmellose Sodium (Ac-di-sol), Magnesium Stearate, Microcrystalline Cellulose (Avicel PH 200 LM )
  Tablet coating:
  For 30mg, 60mg and 120mg
  Hypromellose, Titanium Dioxide (E171), Macrogol, Indigo Carmine Aluminium Lake (E132), Iron oxide Yellow (E172), Isopropyl alcohol, Methylene chloride (Dichloromethane)
  For 90mg
  Hypromellose, Titanium Dioxide (E171), Macrogol, Isopropyl alcohol, Methylene chloride (Dichloromethane)

Etoricoxib tablets are available in four strengths:

30 mg tablets: Blue-green round biconvex film coated tablets marked “11” on one side and ‘G’ on other side, approx. 6 mm in diameter.

60 mg tablets: Dark green round biconvex film coated tablets marked “76”on one side and “G” on other side, approx. 8 mm in diameter.

90 mg tablets: White round biconvex film coated tablets marked “757”on one side and “G” on other side, approx. 9 mm in diameter.

120 mg tablets: Pale-green round biconvex film coated tablets marked “758”on one side and “G” on other side, approx. 10.5 mm in diameter.

30 mg tablets: Pack sizes of 5, 28, 30, 90, 98 tablets in blisters.

60, 90 mg tablets: Pack sizes of 7, 14, 20, 28, 30, 50, 90, 100 tablets in blisters.

120 mg tablets: Pack sizes of 2, 5, 7, 14, 20, 28, 30, 90 tablets in blisters.

Not all pack sizes may be marketed.

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