How does it work?

This medicine contains the active ingredient rofecoxib, which is a type of medicine known as a non-steroidal anti-inflammatory drug (NSAID). NSAIDs work by blocking the action of a substance in the body called cyclo-oxygenase. Cyclo-oxygenase is involved in producing prostaglandins, in response to injury or certain diseases. These prostaglandins cause pain, swelling and inflammation. Because NSAIDs block the production of these prostaglandins, they are effective at relieving pain and inflammation. Cyclo-oxygenase does not only produce prostaglandins that cause inflammation. It also produces prostaglandins that have useful roles in the body. There are two different forms of cyclo-oxygenase, COX-1 and COX-2. COX-2 is the form that (among other things) produces prostaglandins that cause inflammation. COX-1 does not produce inflammatory prostaglandins, but does produce others that have useful effects, including some that are involved in maintaining a healthy stomach and intestinal lining. Traditional NSAIDs, such as ibuprofen or diclofenac, block the action of both COX-1 and COX-2, and this is why they can sometimes cause side effects such as stomach irritation and peptic ulcers. Rofecoxib belongs to a new generation of NSAIDs that selectively block the action of COX-2. This means that it stops the production of inflammatory prostaglandins, without stopping the production of prostaglandins that protect the stomach and intestines. It therefore reduces pain and inflammation, but is less likely than traditional NSAIDs to cause side effects on the stomach and intestines.

What is it used for?

Inflammatory disease of the joints

Osteoarthritis

Warning!

This medicine can sometimes cause liver problems. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms.

The use of any medicines known to inhibit COX-2 (eg rofecoxib) is not recommended in women attempting to conceive. This is because COX-2 plays a role in ovulation and implantation.

This medicine may cause fatigue and dizziness. If affected, caution is required when driving or operating machinery due to the possible reduction in physical and/or mental ability.

People with impaired kidney, liver or heart function who are taking this medicine should have their kidney function monitored.

Use with caution in

Decreased kidney function

Decreased liver function

Dehydration

Elderly people

Excess fluid retention causing swelling (oedema) due to any cause

History of heart failure

History of high blood pressure

History of perforation, ulceration or bleeding in the stomach or intestines

History of poor functioning of one chamber of the heart (left ventricular dysfunction)

Liver cirrhosis

Not to be used in

3rd trimester of pregnancy

Active peptic ulcer

Bleeding from the stomach or intestines

Breastfeeding

Children

Inflammatory bowel disease such as ulcerative colitis or Crohn's disease

Moderate to severely decreased kidney function

Moderate to severely decreased liver function

People who have developed asthma, nasal inflammation (rhinitis), nasal polyps, swelling of the face, lips and tongue (angioedema) or itchy rash (urticaria) following the use of aspirin or other NSAIDs

Severe heart failure

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used in the third trimester of pregnancy as it may be harmful to the foetus. It should only be used in the first or second trimesters if the potential benefit to the mother outweighs any potential risk to the foetus. Discuss this with your doctor. In addition, this medicine is not recommended for women trying to conceive.

It is not known whether this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Headache

Disturbed sleep

Depression

Muscle cramps

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Weight gain

Indigestion (dyspepsia)

Retention of water in the body tissues (fluid retention), resulting in swelling (oedema)

Dizziness

Sensation of ringing, or other noise in the ears (tinnitus)

Difficulty in breathing (dyspnoea)

Sleepiness (somnolence)

High blood pressure (hypertension)

Chest pain

Skin reactions such as rash and itch

Liver or kidney disorders

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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