Do not take ARCOXIA

• if you are allergic (hypersensitive) 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 ARCOXIA 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. ARCOXIA 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. ARCOXIA 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 ARCOXIA to see if this medicine is suitable for you.

ARCOXIA 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 ARCOXIA

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 ARCOXIA:

• 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 ARCOXIA with aspirin.
  • aspirin for prevention of heart attacks or stroke:
    ARCOXIA 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 ARCOXIA.

ARCOXIA with food and drink

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

Pregnancy, breast-feeding and fertility

Pregnancy

ARCOXIA 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 ARCOXIA is excreted in human milk. If you are breast-feeding, or planning to breast-feed, consult your doctor before taking ARCOXIA. If you are using ARCOXIA, you must not breast-feed.

Fertility

ARCOXIA is not recommended in women attempting to become pregnant.

Driving and using machines

Dizziness and sleepiness have been reported in some patients taking ARCOXIA.

Do not drive if you experience dizziness or sleepiness.

Do not use any tools or machines if you experience dizziness or sleepiness.

ARCOXIA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

ARCOXIA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.