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 17780/0726 .
Etoricoxib 30 mg, 60 mg, 90 mg & 120 mg film-coated tablets
Package leaflet: Information for the patient
Etoricoxib 30 mg film-coated tablets
Etoricoxib 60 mg film-coated tablets
Etoricoxib 90 mg film-coated tablets
Etoricoxib 120 mg film-coated tablets
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 etoricoxib is and what it is used for
2. What you need to know before you take etoricoxib
3. How to take etoricoxib
4. Possible side effects
5. How to store etoricoxib
6. Contents of the pack and other information
1. What Etoricoxib is and what it is used for
The name of your medicine is Etoricoxib film-coated tablets (referred to as etoricoxib throughout this leaflet). The active substance etoricoxib belongs to a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Etoricoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Etoricoxib is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older.
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 etoricoxib
Do not take etoricoxib:
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:
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.
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:
Etoricoxib with food and drink
The onset of the effect of etoricoxib may be faster when taken without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Etoricoxib must not be taken during pregnancy. If you are pregnant or think you may be pregnant or are planning to have a baby, 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 taking 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 if you experience dizziness or sleepiness.
Do not use any tools or machines if you experience dizziness or sleepiness.
3. How to take etoricoxib
Always take this medicine exactly as your doctor has told you. 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 etoricoxib 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, increased 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
If you have mild liver disease, you should not take more than 60 mg a day.
If you have moderate liver disease, you should not take more than 30 mg a day.
Use in children and adolescents
Etoricoxib should not be taken by children or adolescents under 16 years of age.
Elderly
No dose adjustment is necessary for elderly patients.
Caution should be exercised in elderly patients.
Method of administration
Etoricoxib is for oral use. Take the tablets once a day.
Etoricoxib can be taken with or without food.
If you take more etoricoxib than you should
You should never take more tablets than the doctor recommends. If you do take too many etoricoxib tablets, you should seek medical attention immediately.
If you forget to take etoricoxib
It is important to take etoricoxib 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 a 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 etoricoxib and talk to your doctor immediately (see What you need to know before you take etoricoxib section 2):
The following side effects can occur during treatment with etoricoxib:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. 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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store etoricoxib
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 pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Etoricoxib film-coated tablets contain
The active substance is etoricoxib.
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
The other ingredients are:
Tablet core: Calcium hydrogen phosphate, anhydrous; Cellulose microcrystalline; Croscarmellose sodium; Silica colloidal anhydrous; Talc; Magnesium stearate
Film coat: Hypromellose; Hydroxypropylcellulose; Macrogol 6000; Talc; Titanium dioxide E171
The 60 mg tablets also contain brown ferric oxide E172, the 90 mg tablets also contain yellow ferric oxide E172 and 120 mg tablets also contain red ferric oxide E172.
What Etoricoxib film-coated tablets look like and contents of the pack
Etoricoxib 30 mg film-coated tablets:
White to off white round biconvex film-coated tablets, approx. 6 mm in diameter.
Etoricoxib 60 mg film-coated tablets:
Light brown round biconvex film-coated tablets, approx. 8 mm in diameter.
Etoricoxib 90 mg film-coated tablets:
Light yellow round biconvex film-coated tablets, approx. 9 mm in diameter.
Etoricoxib 120 mg film-coated tablets:
Light pink round biconvex film-coated tablets, approx. 10 mm in diameter.
Pack sizes:
Etoricoxib 30 mg film-coated tablets
7, 20, 28, 50, 98 and 100 film-coated tablets
Etoricoxib 60 and 90 mg film-coated tablets
7, 14, 20, 28, 50 and100 film-coated tablets
Etoricoxib 120 mg film-coated tablets
5, 7, 14, 20, 28, 50 and 100 film-coated tablets
Not all pack sizes may be marketed.
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This leaflet was last revised in February 2020
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