What is a Patient Information Leaflet and why is it useful?

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 16973/0021.

Lodine SR

Package Leaflet : Information for the patient

Lodine 600 mg SR Tablets

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, 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.

What is in this leaflet:

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

1. What Lodine is and what it is used for

Lodine 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. In this tablet, the medicine is released slowly which means that you only have to take one tablet each day.

Lodine is one of a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs) which are usually taken to relieve the pain, stiffness, inflammation and swelling which is often associated with arthritis.

2. What you need to know before you take Lodine

DO NOT take Lodine if you:

  • 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.

Warnings and precautions

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.

Children

Lodine is not recommended for use in children.

Other medicines and Lodine

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.

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.

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 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.

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.

Driving and using machines

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.

Lodine contains 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.

Lodine contains sodium

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.

3. How to take Lodine

Always take Lodine exactly as your doctor 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 Lodine 600mg SR tablet a day. The tablet should be swallowed whole with a glass of water. Take with or after food. Do not chew or crush the tablet.

Lodine is not recommended for use in children.

If you take more Lodine than you should

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.

If you forget to take Lodine

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.

4. Possible side effects

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

The most serious side effects that may occur with Lodine 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 Lodine and call a doctor straight away.

Allergic or hypersensitivity reactions may have the following symptoms:

  • wheezing, difficulty breathing or shortness of breath,
  • swelling of the face, lips, mouth or tongue,
  • extensive rash, peeling or blistering of the skin, continuous itching.

Heart and blood circulatory disorders symptoms:

  • Chest pain, high blood pressure, swelling of the ankles, palpitations (throbbing of heart), several types of anaemia or other blood disorders, unexpected bruising and bleeding.

Stomach and bowel (gastrointestinal) problems: If you

  • Pass blood in your faeces (stools/motions)
  • Pass black tarry stools
  • Vomit any blood or dark particles that look like coffee grounds

Kidney failure symptoms:

  • Difficulty or pain when passing urine, discolouration of urine or urinating more or less often than usual

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:

  • a very high temperature, being sick, a headache, a blotchy rash that does not fade when a glass is rolled over it (this may not develop), a stiff neck, a dislike of bright lights, drowsiness and fits.

Other reported side effects are:

  • Sensory disorders such as headache, ringing or buzzing in ears, dizziness, abnormal vision, hallucinations, tingling, pricking and burning of the skin (pins and needles) and vertigo (a sensation that objects are moving or spinning). .
  • Gastrointestinal problems such as mouth ulcers, sore mouth, nausea, vomiting, stomach upsets, diarrhoea, constipation, wind, heartburn, indigestion.
  • Skin disorders such as swelling of tissues, itching of the skin, rash, redness.
  • General disorders such as fever, drowsiness, tiredness, weakness, sleeplessness, shaking, nervousness, depression, confusion..

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.

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, 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.

5. How to store Lodine

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

Lodine should be kept at room temperature (below 25°C).

Do not use Lodine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

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 Lodine contains

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.

What Lodine looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almirall, S.A.
Ronda General Mitre, 151
08022 Barcelona
Spain

Manufacturer

Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca
Barcelona
Spain

This leaflet was last revised in September 2018.