Active ingredient
- etoricoxib
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00025/0644.
Arcoxia 30 60 90 120mg film-coated tablets
Package leaflet: Information for the user
ARCOXIA® 30 mg film-coated tablets
ARCOXIA® 60 mg film-coated tablets
ARCOXIA® 90 mg film-coated tablets
ARCOXIA® 120 mg film-coated tablets
Etoricoxib
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What ARCOXIA is and what it is used for
2. What you need to know before you take ARCOXIA
3. How to take ARCOXIA
4. Possible side effects
5. How to store ARCOXIA
6. Contents of the pack and other information
1. What ARCOXIA is and what it is used for
What is ARCOXIA?
What is ARCOXIA used for?
What is osteoarthritis?
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.
What is rheumatoid arthritis?
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.
What is gout?
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.
What is ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
2. What you need to know before you take ARCOXIA
Do not take ARCOXIA:
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:
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:
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 are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
3. How to take ARCOXIA
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Do not take more than the recommended dose for your condition. 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.
There are different strengths available for this medicinal product and depending on your disease your doctor will prescribe the tablet strength that is appropriate for you.
The recommended dose is:
Osteoarthritis
The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Rheumatoid arthritis
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
Ankylosing spondylitis
The recommended dose is 60 mg once a day, increased to a maximum of 90 mg once a day if needed.
Acute pain conditions
Etoricoxib should be used only for the acute painful period.
Gout
The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Postoperative dental surgery pain
The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.
People with liver problems
Use in children and adolescents
ARCOXIA tablets should not be taken by children or adolescents under 16 years of age.
Elderly
No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration
ARCOXIA is for oral use. Take the tablets once a day. ARCOXIA can be taken with or without food.
If you take more ARCOXIA than you should
You should never take more tablets than the doctor recommends. If you do take too many ARCOXIA tablets, you should seek medical attention immediately.
If you forget to take ARCOXIA
It is important to take ARCOXIA 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 the forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you develop any of these signs you should stop ARCOXIA and talk to your doctor immediately (see What you need to know before you take ARCOXIA section 2):
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000).
The following side effects can occur during treatment with ARCOXIA:
Very Common:
Common:
Uncommon:
Rare:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store ARCOXIA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Bottles: Keep the container tightly closed in order to protect from moisture.
Blisters: Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What ARCOXIA contains
What ARCOXIA looks like and contents of the pack
ARCOXIA tablets are available in four strengths:
30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ACX 30’ on one side and ‘101’ on the other.
60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60’ on one side and ‘200’ on the other.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90’ on one side and ‘202’ on the other.
120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120’ on one side and ‘204’ on the other.
30 mg:
Pack sizes of 2, 7, 14, 20, 28, 49, 98 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters.
60 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters; or 30 and 90 tablets in bottles with desiccant containers. The desiccant (one or two containers) in the bottle, used to keep the tablets dry, should not be swallowed.
90 and 120 mg:
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 100 tablets or multi-packs containing 98 (2 packs of 49) tablets in blisters; or 30 and 90 tablets in bottles with desiccant containers. The desiccant (one or two containers) in the bottle, used to keep the tablets dry, should not be swallowed.
60, 90 and 120 mg:
Aluminium/aluminium blisters (unit doses) in packs of 5, 50 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is
The Manufacturer of the 30 mg, 60 mg, 90 mg (packs of 28 tablets) and 120 mg tablets is
This medicinal product is authorized in the Member States of the EEA under the following names:
Belgium, Luxemburg Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
Denmark, Estonia, Iceland, Norway Arcoxia
Ireland, United Kingdom ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
Austria Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten
Czech Rep. ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg, potahované tablety
Cyprus, Malta ARCOXIA 30, 60, 90, 120 mg film-coated tablets
Finland Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
France ARCOXIA 30, 60 , 90 mg, comprimé pelliculé
Germany ARCOXIA 30/60/90/120 mg Filmtabletten
Greece ARCOXIA 30 mg, 60 mg, 90 mg,120 mg film-coated tablets
Hungary Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta
Italy ARCOXIA 30, 60, 90, 120 mg compresse rivestite con film
Latvia Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets
Lithuania Arcoxia 30, 60, 90, 120 mg plėvele dengtos tabletės
Netherlands Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, filmomhulde tabletten
Poland ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane
Portugal ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película
Slovakia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg
Slovenia Arcoxia 30/60/90/120 mg filmsko obložene tablete
Spain ARCOXIA 30, 60, 90 y 120 mg comprimidos recubiertos con película
Sweden Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter
This leaflet was last revised in July 2019.
© Merck Sharp & Dohme Limited 2019. All rights reserved.
PIL.ACX.19.UK.6890.MAH
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
+44 (0)1992 467 272
Call MSD customer services on 01992 452094