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ETODOLAC 300MG CAPSULES

Active substance(s): ETODOLAC

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Package leaflet: Information for the user

ECCOXOLAC® 300 MG CAPSULES
Etodolac
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Eccoxolac Capsules are and what they are used for
What you need to know before you take Eccoxolac Capsules
How to take Eccoxolac Capsules
Possible side effects
How to store Eccoxolac Capsules
Contents of the pack and other information.

What Eccoxolac Capsules are and what they are used for

Eccoxolac Capsules belong to a class of medicines called non-steroidal antiinflammatory 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.

What you need to know before you take Eccoxolac Capsules

Do not take Eccoxolac Capsules if you:
• are allergic to etodolac or any of the ingredients of Eccoxolac Capsules (listed in
section 6).
• have had an allergic reaction after taking aspirin, ibuprofen or other non-steroidal
anti-inflammatory drugs (NSAIDs). An allergic reaction may include swelling of
the face or throat, a nettle rash, asthma or itchy and runny nose.
• have a peptic ulcer (a hole in the stomach or duodenum) or bleeding in your
stomach, or have had two or more episodes of peptic ulcers, stomach bleeding.
• have had perforation related to previous non-steroidal anti-inflammatory drugs
therapy
• have a severe heart failure, liver or renal failure
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are in the last three months of pregnancy (last trimester)

Warnings and precautions
Talk to your doctor or pharmacist before taking Eccoxolac Capsules if you:







have any kidney or liver problems or heart problems, especially if you are also
taking diuretics (water tablets) and are elderly. The dose should be as low as
possible and you should have regular checks
have a blood disorder
have high blood pressure or heart failure
suffer from fluid retention (swelling of legs, ankles, or feet)
have or had bronchial asthma or breathing difficulties
suffer from auto-immune disorders such as mixed connective tissue disease,
systemic lupus erythematosus (a disease affecting the skin, joints and
kidneys).

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:
• you are a smoker
• you have any heart problems
• you have high cholesterol
• you have high blood pressure
• you have diabetes
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 signs of skin reaction occur, Eccoxolac
Capsules should be stopped immediately.
Other medicines and Eccoxolac Capsules
Tell your doctor or pharmacist if you are taking, or have recently taken, or might take
any other medicines, including medicines obtained without a prescription.
Do not take Eccoxolac Capsules in combination with:
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other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin or
ibuprofen

Care is needed if you are taking:

anti-coagulants such as warfarin (used to prevent blood clotting)

ciclosporin, tacrolimus (used to help with organ transplants)

cardiac glycosides such as digoxin (used to treat certain heart problems)

lithium (used to treat manic depression)

mifepristone (used to terminate pregnancy)

methotrexate (used to treat conditions such as cancer, or rheumatoid
arthritis)

anti-hypertensives such as diuretics, also called water tablets (medicines
used to treat high blood pressure)

antibiotics known as quinolone such as ciprofloxacin, ofloxacin or
levofloxacin

corticosteroids (used to treat skin rashes)

zidovudine (used to treat HIV infection)

anti-platelet medicines such as clopidogrel, ticlopidine (used to prevent
blood clots)

selective serotonin reuptake inhibitor such as sertraline, fluoxetine
(medicines used to treat certain brain disorders).
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 breastfeeding.
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.
Eccoxolac Capsules contain lactose.
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.

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3.

How to take Eccoxolac Capsules

Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.


Take Eccoxolac Capsules by mouth with water. Take with or after food.

Use in adults and elderly:
• The usual adult dose is one 300 mg capsule twice a day.
• Alternatively, two 300 mg capsules may be taken once a day.
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.
Use in 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 a
forgotten dose.
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 medicine, 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.
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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:


serious allergic reaction which causes
o swelling of the face, lips, mouth, tongue or throat which may cause
difficulty in swallowing or breathing
o aggravation of asthma, asthma like reaction comprising of
breathlessness, wheezing, feeling of tightness in the chest and
shortness of breath
o different kind of skin disorders such as rashes, itching, hives, unusual
bleeding or bruising under the skin, flaking or peeling of the skin



serious illness with blistering of the skin, mouth, eyes and genitals



gastrointestinal bleeding (rectal bleeding, passage of black stools, vomiting of
blood or material that looks like coffee grounds), severe abdominal or stomach
pain. Gastrointestinal problems can occur in some individuals at any time
following long-term treatment with this class of medicines (NSAIDs)

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:









increases risk of bleeding or bruising. These symptoms may be due to
reduction in blood platelets
frequent infections such as fever, severe chills, sore throat or mouth ulcers due
to lack of white blood cells
tiredness, headaches, being short of breath when exercising, dizziness and
looking pale
fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright
light. These symptoms may be due to infection around the brain or spinal cord
(meningitis). This side effect has been reported especially in patients having
systemic lupus erythematosus (allergic condition which causes joint pain, skin
rashes and fever) or mixed connective tissue disease.
visual disturbances ,sudden dimming or loss of vision
heart attack, heart problems which can cause shortness of breath or ankle
swelling
numbness or weakness of the arms or legs, headache, dizziness and confusion,
visual disturbance, difficulty swallowing, slurred speech and loss of speech.
These symptoms may be due to damage to part of the brain caused by an
interruption to its blood supply (stroke)
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worsening of symptoms of colitis [inflammation of the colon (large bowel)].
Symptoms are diarrhoea, usually with blood and mucus, stomach pain, fever
worsening of symptoms of Crohn’s disease (an inflammatory disease that can
affect any part of the gastrointestinal tract). Symptoms are pain, fever,
diarrhoea and loss of weight
severe pain in the abdomen and back often with nausea and vomiting. These
symptoms may be due to inflammation of the pancreas
liver problems such as jaundice ( yellowing of the skin or whites of the eyes),
liver function problems.
Urinary problems such as high blood pressure, feet swelling, passing little or
no urine or passing blood. These might be a sign of kidney failure or toxicity.

Other side effects
Tell your doctor if you notice any of the following:













mental depression, headache, dizziness, trouble in sleeping, confusion, seeing
or hearing things that are not real (hallucination), disorientation, nervousness,
drowsiness or light-headedness
sensation of numbness or tingling over the limbs
shakiness or tremor
swelling of legs, ankles or feet
high blood pressure, throbbing of heart (palpitation)
loose stool (diarrhoea), feeling or being sick (nausea or vomiting), indigestion,
stomach pain, heart burn, constipation, wind
mouth ulcers and cold sores
pain when passing urine, urinating more or less often than usual
inflammation of blood vessels, often with skin rash
increased sensitivity of the skin to sunlight
generally feeling unwell, tiredness, unusual weakness, chills and fever.

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 Eccoxolac capsules
Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not use this medicine after the expiry date which is stated on the outer packaging.

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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 Eccoxolac Capsules contain:




The active ingredient is etodolac.
Each capsule contains etodolac 300 mg.
The other inactive ingredients are: lactose, anhydrous silica, sodium lauryl
sulphate, sodium starch glycollate, povidone, magnesium stearate,
microcrystalline cellulose and talc.

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 offwhite 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:
Ranbaxy (UK) Limited,
Building 4, Chiswick Park, 566 Chiswick High Road,
London, W4 5YE, United Kingdom
Manufacturer:
Ranbaxy Ireland Ltd, Spafield, Cork Road,
Cashel, Co Tipperary, Ireland
This leaflet was last revised in May 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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