ARCOXIA is used for the following:
Osteoarthritis is a joint disease. It results from the gradual breakdown of the cartilage that covers the joints and cushions the ends of bones.
Symptoms of osteoarthritis include pain, tenderness, stiffness of one or more joints, and physical disability. The hips and knees are the most commonly affected joints, but other joints, such as those of the hands and spine, may also be affected.
Osteoarthritis is more common in women than in men. Many factors can lead to the development of osteoarthritis, including obesity and joint injury (eg. from sport).
Gout is a disease that causes attacks of arthritis, usually in a single joint. The affected joint is red, swollen, painful and extremely tender. A gout attack usually lasts a few days and it may recur.
For more information about osteoarthritis or gout, contact the Arthritis Foundation in the capital city of your state.
ARCOXIA belongs to a group of medicines called Coxibs. It works in a similar way to traditional anti-inflammatory medicines, known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), by blocking the production of substances that cause pain and inflammation. In clinical trials, ARCOXIA has been shown to have a lower risk of serious side effects on the stomach (for example, bleeding stomach ulcers) than NSAIDs. However taking aspirin with ARCOXIA may reverse this benefit.
Your doctor may have prescribed ARCOXIA for another reason. Ask your doctor if you have any questions about why ARCOXIA has been prescribed for you.
The safety and effectiveness of ARCOXIA in children and teenagers under the age of 18 years have not been established.
ARCOXIA is not addictive.
Do not take ARCOXIA if:
Do not take ARCOXIA if:
If you are not sure whether you should start taking ARCOXIA, talk to your doctor.
Tell your doctor if:
1. you are pregnant or intend to become pregnant
2. you are breast-feeding or plan to breast-feed
3. you have or have had any medical conditions, especially the following:
4. you have a history of ulcers or bleeding in your stomach or intestines
5. you have an infection
6. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you take any ARCOXIA.
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and ARCOXIA may interfere with each other. These include:
These medicines may be affected by ARCOXIA or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.
If you are taking low-dose aspirin to help prevent a heart attack or stroke, do not stop taking it unless your doctor tells you to because ARCOXIA cannot replace the use of aspirin for this purpose.
Some medicines should not be taken with ARCOXIA. These include:
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking ARCOXIA.
Take ARCOXIA only when prescribed by your doctor.
For osteoarthritis, the recommended dose is 30mg once a day, increase to a maximum of 60mg once a day if needed.
For the relief of gout attacks and short term pain, including menstrual pain and dental pain, the recommended dose is 120 mg taken once a day, which should only be used during the painful period.
Doses greater than those recommended for each condition stated above have either not been shown to improve the effectiveness of ARCOXIA or have not been studied. Therefore, the daily doses stated above for each condition should not be exceeded.
If you have mild liver disease, do not take more than 60 mg once a day.
If you have moderate liver disease, do not take more than 60 mg every second day or 30mg once a day.
Swallow ARCOXIA with a glass of water.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
Take your ARCOXIA at about the same time each day.
Taking ARCOXIA at the same time each day will have the best effect. It will also help you remember when to take the dose.
It does not matter if you take ARCOXIA before, with or after food.
Depending on your condition, you may need to take ARCOXIA for a few days or for a longer period.
For arthritis ARCOXIA helps relieve your symptoms but it does not cure it. Continue taking ARCOXIA for as long as your doctor prescribes it.
For the relief of gout attacks and short term pain, including menstrual pain and dental pain, ARCOXIA should only be used during the painful period, limited to a maximum of 8 days treatment.
If you are not sure how long to take ARCOXIA, talk to your doctor.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablet(s) as you would normally.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
Immediately telephone your doctor or Poisons Information Centre (in Australia, telephone 131 126; in New Zealand, telephone 0800 POISON or 0800 764 766), or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much ARCOXIA.
Do this even if there are no signs of discomfort or poisoning.
If you become pregnant while taking ARCOXIA, tell your doctor immediately.
If you get an infection while taking ARCOXIA, tell your doctor.
ARCOXIA may hide fever and may make you think, mistakenly, that you are better or that that your infection is less serious than it might be.
If you notice any of the following, tell your doctor immediately:
These symptoms may occur at any time during use and without warning.
You may need urgent medical attention.
If any of the following symptoms: shortness of breath, chest pains or ankle swelling, appear or worsen, stop your treatment with ARCOXIA and consult a doctor, as soon as is practical.
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking ARCOXIA.
Additional things to be aware of while taking ARCOXIA:
ARCOXIA works equally well in older and younger adult patients. Adverse experiences may occur at a higher incidence in older patients compared to younger patients. If you are elderly (i.e., over 65 years of age), your doctor will want to keep a regular check on you. No dosage adjustment is necessary for older patients.
If you have kidney, liver or heart disease, your doctor will want to keep a regular check on you.
Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and you should not take ARCOXIA for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
ARCOXIA can increase blood pressure in some people, especially in high doses, and this could increase the risk of heart attacks and strokes. Your doctor will want to check your blood pressure from time to time, to make sure that it is safe to continue treatment.
Do not give ARCOXIA to anyone else, even if they have the same condition as you.
Be careful driving or operating machinery until you know how ARCOXIA affects you.
The effect of ARCOXIA on the ability to drive a car or operate machinery has not been studied, although it is thought to be unlikely to have any effect on these activities. However, as with many medicines, ARCOXIA may cause certain side effects in some people, including dizziness and tiredness. Make sure you know how you react to ARCOXIA before you drive a car or operate machinery.
Some self-help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ARCOXIA.
ARCOXIA helps most people with arthritis, menstrual pain, or other types of pain, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice or have any of the following and they worry you:
These are the more common side effects of ARCOXIA.
Tell your doctor immediately if you notice any of the following:
These may be serious side effects. Some of these may be symptoms of an allergic reaction to ARCOXIA. You may need urgent medical attention.
If any of the following happen, tell your doctor immediately or go to accident and emergency at your nearest hospital:
These may be serious side effects. You may need urgent medical attention.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the blister pack, they may not keep well.
Keep ARCOXIA in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking ARCOXIA or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
ARCOXIA comes as three strengths of tablets:
*Presentation not currently marketed in Australia.
#Availability in New Zealand differs from that described herein for Australia. Please refer to the New Zealand data sheet for Arcoxia for details.
ARCOXIA does not contain gluten, sucrose, tartrazine or any other azo dyes.
ARCOXIA is made/supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
A.C.N. 000 173 508
54-68 Ferndell Street
South Granville NSW 2142
ARCOXIA is supplied in New Zealand by:
Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Tel: 0800 500 673
Date of Preparation
This leaflet was last revised on
9 November 2011
Australian Register Numbers:
30mg tablet - AUST R 131797
60mg tablet - AUST R 81456
120mg tablet - AUST R 81458
This CMI leaflet was current at the time of printing. To check if it has been updated, please view our website www.msd-australia.com.au or ask your pharmacist.
ARCOXIA Tablet AU-CMI 111109 v3
Based on ARCOXIA Tablet PI 111109 v3
Copyright © 2011. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, U.S.A. All rights reserved.