Lodine 600 mg SR Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. 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 you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Lodine is and what it is used for
2. What you need to know before you take Lodine
3. How to take Lodine
4. Possible side effects
5. How to store Lodine
6. Contents of the pack and other information

• are allergic to etodolac or any of the other ingredients of this medicine (listed in section 6)
• have severe heart failure
• have a peptic ulcer (a small erosion or hole in the stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
• have had an allergic reaction or asthmatic type reaction (e.g., wheezing, itching or skin rash) after taking aspirin, Lodine or another NSAID
• have hepatic failure and renal failure
• are pregnant, think you may be pregnant or are breast feeding
• have previously taken similar medicines classed as NSAIDs and suffered with bleeding from the stomach or bowel.

Talk to your doctor or pharmacist before taking Lodine.

• If you suffer from kidney, heart or liver disease, or a blood disorder, especially if you are also taking diuretics (water tablets). The dose should be as low as possible and you should have regular checks
• If you are already on long-term therapy with a medicine other than Lodine, since your doctor will want to arrange regular check-ups, especially if you are elderly
• If you suffer from fluid retention, (swelling of legs, ankles or feet)
• If you suffer from high blood pressure or heart failure
• If you suffer from, or have ever suffered from, asthma or breathing difficulties
• 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)

Medicines such as Lodine 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, Lodine should be stopped immediately.

Lodine is not recommended for use in children.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking:

• warfarin - for blood thinning
• ciclosporin - following transplantation
• digoxin - for heart problems
• lithium - for mental illness
• methotrexate - used to treat conditions such as psoriasis or rheumatoid arthritis
• corticosteroids (such as prednisolone)
• quinolone antibiotics e.g. ciprofloxacin
• aspirin
• other NSAIDs e.g., ibuprofen, naproxen, diclofenac
• drugs to control high blood pressure
• mifepristone (a drug to induce abortion) in the last 12 days

If you have a blood or urine test, tell your doctor that you are taking Lodine, 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 Lodine if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Lodine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Lodine can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Lodine 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.

Lodine 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 Lodine.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains 34 mg sodium per tablet. This is equivalent to 1.7 % of the recommended maximum daily dietary intake of sodium for an adult.

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.

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, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can also provide more information on the safety of this medicine.

The active ingredient is etodolac (600mg).

The other ingredients are: hypromellose, dibasic sodium phosphate, ethylcellulose, lactose, magnesium stearate, hydroxypropyl cellulose, macrogol 400, macrogol 6000 and colourings titanium dioxide (E171) and iron oxide (E172). See also end of Section 2 for lactose.

Lodine are oval shaped, light grey film coated tablets, and embossed on one side with “Lodine SR600”.

The tablets are supplied in blister packs of 2, 28 or 30 tablets or in plastic bottles of 28 or 30 tablets.

However, your doctor may prescribe a different number of tablets for you.

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