Active ingredient
- etodolac
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 can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0019.
Eccoxolac
PACKAGE LEAFLET: INFORMATION FOR THE USER
ECCOXOLAC®
Etodolac 300 mg CAPSULES
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Eccoxolac Capsules are and what they are used for
2. Before you take Eccoxolac Capsules
3. How to take Eccoxolac Capsules
4. Possible side effects
5. How to store Eccoxolac Capsules
6. Further information
1. WHAT ECCOXOLAC CAPSULES ARE AND WHAT THEY ARE USED FOR
Eccoxolac Capsules belong to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Eccoxolac Capsules are used to relieve some of the symptoms caused by arthritis (Osteoarthritis and Rheumatoid arthritis) such as inflammation, swelling, stiffness and joint pain.
2. BEFORE YOU TAKE ECCOXOLAC CAPSULES
Do not take Eccoxolac Capsules if you
Take special care with Eccoxolac Capsules Tell your doctor or pharmacist before taking Eccoxolac Capsules if you:
Important information about your medicine
Medicines such as Eccoxolac 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.
Please speak to your doctor if you have any factors that may put you at a greater risk of suffering a heart attack or stroke such as:
If you are told you need a blood test or urine test, tell your doctor you are taking Eccoxolac Capsules as the drug may affect the results.
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, Eccoxolac Capsules should be stopped immediately.
Serious skin reactions including allergic reactions such as extensive rash, peeling or blistering of the skin, continuous itching may appear during the early course of the therapy or within the first month of treatment. These reactions have been reported very rarely with the use of NSAIDs. If any sign of skin reactions occurs Eccoxolac Capsules should be stopped immediately.
Taking other medicines
Please inform your doctor pharmacist if you are taking, or have recently taken, any other medicines, including medicines/obtained without a prescription
Do not take Eccoxolac Capsules in combination with:
Care is needed if you are taking
Taking Eccoxolac Capsules with alcohol
Do not take alcohol while taking Eccoxolac. Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine.
Pregnancy and breast-feeding
Do not take Eccoxolac Capsules if you are pregnant, may be pregnant or are breast-feeding.
Eccoxolac Capsules may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Eccoxolac Capsules may cause dizziness, drowsiness or visual disturbances in some individuals. DO NOT drive or operate machines if you are affected.
Important information about some of the ingredients of Eccoxolac Capsules
This medicine contains a small amount of an inactive ingredient lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ECCOXOLAC CAPSULES
Always take Eccoxolac Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults and Elderly:
The elderly have an increased risk of having side effects. A lower dose with a lesser duration may be recommended in elderly patients.
Your doctor will monitor you regularly for gastrointestinal side effects like bleeding during the therapy.
Children:
Eccoxolac Capsules are not recommended for use in children.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you forget to take Eccoxolac Capsules at the right time, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.
If you have taken more Eccoxolac Capsules than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken.
Symptoms of overdose include headache, nausea, vomiting, epigastric pain, passage of black tarry stools, diarrhoea, disorientation, excitation, drowsiness, dizziness, ringing in the ear, fainting, occasionally fits and coma. Kidney failure and liver damage have also been reported.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Eccoxolac Capsules can cause side effects, although not everybody gets them.
These side effects may be temporary. However, you should tell your doctor if the side effects are troublesome, or last for more than a few days. Medicines such as Eccoxolac capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Very serious side effects
If any of the following happen, stop taking Eccoxolac Capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:
These side effects are very serious. You may need urgent medical attention.
Serious side effects
Tell your doctor as soon as possible or go to the casualty department at your nearest hospital if you notice any of the following:
Other side effects
Tell your doctor if you notice any of the following:
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ECCOXOLAC CAPSULES
Keep out of the reach and sight of children.
Store in the original package.
Do not use Eccoxolac Capsules after the expiry date that is stated on the outer packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Eccoxolac Capsules contain:
The hard gelatin capsules are coloured with sunset yellow (E110) , E129, E171 and iron oxide black (E172).
The black ink contains shellac, iron oxide black (E172), IMS 74 OP, n-butyl alcohol, soya lecithin MC thin and antifoam DC 1510.
What Eccoxolac Capsules look like and contents of the pack:
Eccoxolac 300 mg Capsules are grey/red hard gelatine capsules of size '0' imprinted with 'ELT300' on the cap and 'R' on the body in black ink, containing a white to off-white granular powder.
The capsules are available in blister strips of 10 or 15 capsules each in boxes of 60 capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised: July 2011
5083288
Sky Way House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU
0845 460 0002
+44 (0)1748 828 810
0845 460 0000
+44 (0)1748 828 810
+44 (0)1748 828 801