Patient Leaflet Updated 17-Apr-2023 | Ranbaxy (UK) Limited a Sun Pharmaceutical Company
Etopan XL 600 mg Film-coated prolonged release tablets
Etopan XL 600 mg tablets
etodolac
1. What Etopan XL is and what it is used for
2. What you need to know before you take Etopan XL
3. How to take Etopan XL
4. Possible side effects
5. How to store Etopan XL
6. Contents of the pack and other information
Etopan XL is used to treat the symptoms of rheumatoid arthritis and osteoarthritis by reducing inflammation, swelling, stiffness and joint pain. Each tablet contains 600mg of the active ingredient etodolac. This medicine is released slowly which means that you only have to take one tablet each day.
Etopan XL is one of a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs) which are usually taken to relieve pain, stiffness, inflammation and swelling which is often associated with arthritis.
Talk to your doctor or pharmacist before taking Etopan XL
Medicines such as Etopan XL may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions ( for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Serious gastrointestinal side effects such as bleeding, ulceration and perforation can occur at any time with or without warning symptoms in patients treated with NSAIDs. If any sign of gastrointestinal bleeding occurs, Etopan XL should be stopped immediately.
Etopan XL is not recommended for use in children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking:
If you have a blood or urine test, tell your doctor that you are taking Etopan XL, as the drug may affect the results.
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.
You should inform your doctor if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.
Do not take Etopan XL if you are pregnant or think you are pregnant. The safety of this medicine for use during pregnancy is not known. It is not recommended for use in pregnancy unless considered essential by your doctor.
Etopan XL should not be used if you are breast-feeding. It is not known if this medicine passes into breast milk. It is not recommended for use during breast-feeding unless considered essential by your doctor.
Etopan XL may cause dizziness, drowsiness or abnormal vision. If you find that you are affected in this way, you should not drive or operate machinery whilst taking.
Lactose is an ingredient in Etopan XL. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Etopan XL contains orange yellow S E110. This may cause allergic reactions.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Check the pharmacist's label for the dose recommended for you.
The recommended adult dose is one tablet taken daily. The tablet should be swallowed whole with a glass of water.
Take with or after food. Do not chew or crush the tablet.
Take with or after food. Swallow the tablet whole with water, do not crush or chew the tablets.
Etopan XL is not recommended for use in children.
If you take more tablets than you should (an overdose), seek medical attention immediately. Always take the bottle ( or packaging) with you, even if empty. Symptoms of overdose include headache, feeling sick, vomiting, stomach pain, passing blood in faeces or passing black tarry stools. On rare occasions diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ringing in the ears, fainting, and convulsive fitting may occur. In cases of significant overdose kidney failure and liver damage are possible.
Do not take a double dose to make up for the forgotten dose. Take your tablet as soon as you remember and continue to take your medicine as usual, but do not take more than one tablet a day.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects that may occur with Etopan are serious allergic or hypersensitivity reactions, heart failure, stroke, kidney failure, liver failure, inflammation of the pancreas and aseptic meningitis. If you suffer from any of the symptoms described below: stop taking Etopan and call a doctor straight away.
Allergic or hypersensitivity reactions may have the following symptoms:
Heart and blood circulatory disorders symptoms:
Stomach and bowel (gastrointestinal) problems: If you
Kidney failure symptoms:
Liver failure and inflammation of the pancreas symptoms:
Jaundice (yellowing of the eyes or skin), abdominal pain, abnormal liver function test results.
Aseptic Meningitis symptoms
A serious rare condition known as aseptic meningitis may occur in patients with other auto-immune conditions such as systemic lupus erythematosus or mixed connective tissue disease.
The symptoms of aseptic meningitis are:
Other reported side effects are:
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you get any side effects, talk to your doctor, 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.
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 label. The expiry date refers to the last date of that month.
Do not throw away any medicines via wastewater or house hold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help with the environment.
Etopan XL are grey, oval, convex shaped, tablets with “T600” debossed on one side and plain on the other side.
The tablets are supplied in blister packs of 30 or 100 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in 10/2022.
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