Patient Information Leaflet: Information For The User
Patient Information Leaflet
Read all this information carefully before you start taking this medicine.
If you have any further questions, ask your doctor, pharmacist, or nurse.
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, pharmacist, or nurse.
What is there in this page
What Lacvia tablet is and what it is used for
What you need to know before you take Lacvia tablet
How to take Lacvia tablet
Possible side effects
How to store Lacvia tablet
Contents of pack and other information
1. What is Lacvia tablet and what it is used for
Lacvia 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.
Lacvia 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 Lacvia tablet
DO NOT take Lacvia if you:
are allergic to etodolac or any of the other ingredients of this medicine
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, Lacvia 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 Lacvia.
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 Lacvia, 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 Lacvia 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, Lacvia should be stopped immediately.
Children
Lacvia is not recommended for use in children.
Other medicines and Lacvia
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 Lacvia, 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 Lacvia 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 Lacvia during the first 6 months of pregnancy unless 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, Lacvia 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.
Lacvia 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
Lacvia 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 Lacvia
3. How to take Lacvia tablet?
Always take Lacvia 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 Lacvia 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.
Lacvia is not recommended for use in children.
If you take more Lacvia 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 Lacvia
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 Lacvia 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 Lacvia 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, healthcare provider or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How Lacvia tablets stored?
Lacvia should be kept at room temperature (below 30°C).
Protect from light & moisture.
Keep out of reach of children.
6. Contents of the pack and other information
What Lacvia tablet contains:
The active ingredient is etodolac (600mg).
Other ingredients:
Colours: Ferric Oxide USP-NF (Red) & Titanium Dioxide IP
