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ETOPAN XL 600 MG TABLETS

Active substance(s): ETODOLAC

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Driving and using machines
Etopan XL may cause drowsiness, tiredness, dizziness and abnormal vision. Do not drive or operate
machinery if you experience any of these symptoms.
Etopan XL contains lactose and sunset yellow

Etopan XL have not been established as safe for use in breast-feeding mothers.

Etopan XL 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.
Do not use Etopan XL in the last trimester of pregnancy.
Etopan XL should not be used during the first two trimesters of pregnancy unless your doctor advises you
otherwise.

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.

Etopan XL can react with some medicines, which can cause unwanted effects or prevent the medicines from
working properly
- drugs used to treat high blood pressure
- drugs used to thin the blood e.g. warfarin
- drugs called cardiac glycosides such as digoxin (used to treat heart problems)
- ciclosporin or tacrolimus (used after an organ transplant)
- methotrexate (used to treat rheumatoid arthritis or psoriasis)
- lithium (used to treat mental illness)
- mifepristone (used for the medical termination of pregnancy)
- other non-steroidal anti-inflammatory drugs e.g. aspirin, ibuprofen
- corticosteroids such as prednisolone
- quinolone antibiotics (e.g. ciprofloxacin, levofloxacin, ofloxacin)
- antidepressants called SSRIs
- drugs used to stop blood clotting called antiplatelet agents (e.g. aspirin, dipyridamole, clopidogrel)
- diuretics ('water-pills')
- zidovudine (used to treat HIV infection).

Other medicines and Etopan XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Children
Etopan XL is not recommended for use in children.

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Etopan XL
- if you have problems with your heart, liver or kidneys or suffer from a blood disorder
- if you have a mixed connective tissue disorder such as lupus (SLE)
- if you suffer from or have had asthma or breathing difficulties
- if you suffer from fluid retention, (swelling of legs ankles and feet)
- if you suffer from heart failure or high blood pressure
- if you are taking long term-therapy with a medicine other than Etopan XL, as your doctor will want to
arrange regular check-ups, especially if you are elderly
- if you have disease that affects your digestion such as ulcerative colitis or Crohn's disease
- 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)
- your doctor may carry out a number of blood, kidney function and liver function tests whilst you take
Etopan XL
- if you are currently taking "water-pills" (diuretics)
- if any signs of gastrointestinal bleeding.

Do not take Etopan XL
- if you are allergic to etodolac or any of the other ingredients of this medicine (listed in section 6)
- if you have had an allergic reaction to other non-steroidal anti-inflammatory drugs such as aspirin or
ibuprofen
- if you have experienced shortness of breath, rhinitis (blocked or runny nose) or urticaria (allergic skin
reaction) when taking aspirin, ibuprofen or another non-steroidal anti-inflammatory drug
- if you have experienced gastrointestinal bleeding or perforation due to another non-steroidal
anti-inflammatory drug
- if you have a peptic ulcer (ulcer in your stomach or duodenum) or have had two or more episodes of
peptic ulcers, stomach bleeding or perforation
- if you have severe heart failure, liver failure or kidney failure
- if you are in your last trimester of pregnancy.

2. What you need to know before you take Etopan XL

Etopan XL is one of a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs) which are
usually taken to relieve pain, inflammation and stiffness often caused by osteoarthritis or rheumatoid
arthritis.

Etopan XL is used to treat the symptoms of rheumatoid arthritis and osteoarthritis by reducing
inflammation, swelling, stiffness and joint pain. This medicine is released slowly which means that you only
have to take one tablet each day.

1. What Etopan XL is and what it is used for

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

07-07-2017

What is in this leaflet

1

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 your 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.

Package leaflet: Information for the user
Etopan XL 600 mg tablets
etodolac

Etopan XL 600mg Tablets PIL 07-07-17.pdf
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70621-0217-8 471

This leaflet was last revised in 07/2017.

Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Not all pack sizes may be marketed.

The tablets are supplied in blister packs of 30 or 100 tablets.

What Etopan XL looks like and contents of the pack
Etopan XL are grey, oval, convex shaped, tablets with “T600” debossed on one side and plain on the other
side.

What Etopan XL contains
- The active substance is etodolac
- The other ingredients are:
tablet core: microcrystalline cellulose, povidone, methyl hydroxypropyl cellulose, lactose anhydrous,
magnesium stearate
tablet coat: hypromellose 3cP, hypromellose 6cP, polydextrose, macrogol, triacetin, titanium dioxide,
indigo carmine lake E132, orange yellow S E110, allura red AC lake E129.

6. Contents of the pack and other information

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.

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.

Keep this medicine out of the sight and reach of children.

5. How to store Etopan XL

Reporting of side effects
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.

Other side effects
- feeling or being sick, vomiting, diarrhoea, flatulence, constipation, worsening of colitis or Crohn's disease
- less frequently, gastritis (inflammation of the stomach lining)
- very rarely, inflammation of the pancreas (pancreatitis)
- swelling, high blood pressure and heart failure
- fever, weakness, feeling unwell, shortness of breath, abnormal vision, headache, unusual sensations such
as burning or tingling in the hands or feet, depression, confusion hallucinations, ringing in the ears
(tinnitus), dizziness (including vertigo), tiredness, tremor, sleep difficulties (insomnia), drowsiness.
- anaemia, sore throat, fever, unexpected bleeding.
- yellowing of the skin or whites of the eyes
- increased need to urinate, difficulty passing urine or discolouration of urine
- changes in liver function and changes in the blood can only be detected by blood tests
- inflammation of blood vessels (vasculitis)
- feelings of having rapid, fluttering or pounding heart (palpitations)
- small increased risk of heart attack ("myocardial infarction") or stroke.

Stop taking and seek immediate medicinal attention if you experience any of the following
- epigastric pain (upper abdomen), vomiting blood, bloody stools, bleeding from the anus, inflammation of
the colon, ulcers of mouth
- heartburn, indigestion abdominal pain
- allergic reactions such as rash, itching, blistering of skin, discolouration, swelling, wheezing or shortness of
breath
- aseptic meningitis (stiff neck, headache, feeling or being sick, fever, disorientation) has been reported
particularly in patients with lupus (SLE) or other mixed connective tissue disease
- very rarely, Stevens-Johnson syndrome, inflammation or blistering of the skin, mouth or tongue and/or
inflammation of the eyes with increased sensitivity to sunlight. These may be severe and be accompanied
by feeling generally unwell.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

4. Possible side effects

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Etopan XL
Do not stop taking Etopan XL without your doctor’s permission.

If you forget to take Etopan XL
If you forget to take a dose at the right time, take it as soon as you remember, unless it is nearly time for the
next dose. Do not take a double dose to make up for a forgotten dose. Do not take more than one tablet in a
single day.

If you take more Etopan XL than you should
If you or anybody else take(s) too many tablets call your doctor or contact your nearest hospital
immediately. Symptoms of an overdose include headache, feeling and being sick, pain in the upper
abdomen (above the navel), vomiting blood, disorientation, excitation, coma, drowsiness, dizziness, ringing
in the ears (tinnitus), fainting and occasionally convulsions.

07-07-2017

Use in children
Etopan XL is not recommended for use in children.

2

The recommended dose is one tablet taken daily.
If you are elderly, your doctor will make sure you take the lowest dose for the shortest time, as you may be
more likely to have the serious side effects.
Take with or after food. Swallow the tablet whole with water, do not crush or chew the tablets.

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

3. How to take Etopan XL

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.

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