Etoricoxib 90 mg 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

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.

• 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 you with 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.

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.

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.

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.

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Etoricoxib must not be taken during pregnancy. If you are pregnant or think you may be pregnant or 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.

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 taking 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 if you experience dizziness or sleepiness.

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

No dose adjustment is necessary for elderly patients.

Caution should be exercised in elderly patients.

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 a forgotten tablet.

If you get any side effects, talk to your doctor or 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.

The active substance is etoricoxib.

Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.

The other ingredients are:

Tablet core: Calcium hydrogen phosphate, anhydrous; Cellulose microcrystalline; Croscarmellose sodium; Silica colloidal anhydrous; Talc; Magnesium stearate

Film coat: Hypromellose; Hydroxypropylcellulose; Macrogol 6000; Talc; Titanium dioxide E171

The 60 mg tablets also contain brown ferric oxide E172, the 90 mg tablets also contain yellow ferric oxide E172 and 120 mg tablets also contain red ferric oxide E172.

Etoricoxib 30 mg film-coated tablets:

White to off white round biconvex film-coated tablets, approx. 6 mm in diameter.

Etoricoxib 60 mg film-coated tablets:

Light brown round biconvex film-coated tablets, approx. 8 mm in diameter.

Etoricoxib 90 mg film-coated tablets:

Light yellow round biconvex film-coated tablets, approx. 9 mm in diameter.

Etoricoxib 120 mg film-coated tablets:

Light pink round biconvex film-coated tablets, approx. 10 mm in diameter.

Etoricoxib 30 mg film-coated tablets

7, 20, 28, 50, 98 and 100 film-coated tablets

Etoricoxib 60 and 90 mg film-coated tablets

7, 14, 20, 28, 50, 100 film-coated tablets

Etoricoxib 120 mg film-coated tablets

5, 7, 14, 20, 28, 50 and 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Or

Or