Do not take Etoricoxib if you:

• 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.

Warnings and precautions

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.

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, 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.

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 or use any tools or machines if you experience dizziness or sleepiness.