Lacvia-MR

1. What is Lacvia-MR tablet and what it is used for

Lacvia®-MR is a combination of 400 mg of Etodolac and 4 mg of Thiocolchicoside.

Etodolac 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. Etodolac has anti-inflammatory, analgesic, and antipyretic activities.

Thiocolchicoside is a sulfur-containing, semi-synthetic analog of colchicine, which behaves pharmacologically as a muscle relaxant, both in humans and in animals. It is a muscle relaxant with anti-inflammatory and analgesic effects. It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions. It is to be used for acute conditions related to spinal column.

Lacvia®-MR tablets is used for the treatment of patients with acute painful musculoskeletal conditions. Acute painful musculoskeletal conditions refer to sudden and often severe pain and discomfort affecting the muscles, bones, joints, ligaments, or tendons. These conditions can arise from various causes such as injury, overuse, inflammation, or infection. Common examples include Muscle sprains and strains, fractures, tendonitis, bursitis, muscle spasms, acute gout, Spondyloarthropathies.

2. What you need to know before you take Lacvia-MR tablet

DO NOT take Lacvia®-MR Tablets if you:

• If you are allergic to etodolac or thiocolchicoside
• If you are pregnant or are breast feeding.
• If you are women of childbearing potential who are not using effective contraception.
• If you have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
• If you have a peptic ulcer or history of recurrent peptic ulceration or a history of peptic ulcer disease.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Lacvia®-MR Tablets.

• If you have epilepsy or at risk for seizures.
• If you suffer from kidney, heart or liver disease (including alcoholic 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 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).
• If you suffer from chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks every day), anorexia, bulimia or cachexia; chronic malnutrition (low reserves of hepatic glutathione), dehydration, and hypovolemia.
• If you have coagulation disorders or are receiving anticoagulants, hemoglobin or haematocrit should be carefully monitored.
• If you suffer from G-6-PD deficiency (a hereditary condition leading to low red blood cell counts).
• If you have systemic lupus erythematosus (SLE) and mixed connective tissue disorders.

Medicines such as Lacvia®-MR Tablets 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.

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®-MR Tablets should be stopped immediately.

Children

Lacvia®-MR Tablets are not recommended for use in children.

Other medicines and Lacvia®-MR Tablets

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

Tell your doctor if you are taking:

• ACE inhibitors
• Aspirin
• Other analgesics including cyclooxygenase-2 selective inhibitor
• Anti-hypertensive
• Diuretics
• Cardiac glycosides
• Lithium
• Cyclosporin, Digoxin, Methotrexate
• Anti-coagulants
• Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs)
• Tacrolimus
• Zidovudine
• Mifepristone
• Corticosteroids
• Quinolone antibiotics
• Phenylbutazone
• Chloramphenicol

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®-MR Tablets if you are pregnant or women of childbearing potential who are not using effective contraception.

Lacvia®-MR Tablets should not be used if you are breast-feeding. It is known to pass into breast milk. It is not recommended for use during breast-feeding.

Geriatric use

If you are elderly, select the dose carefully, and monitor renal function.

Driving and using machines

Lacvia®-MR may cause dizziness or somnolence. So, you should not drive or operate heavy machinery if you feel dizzy or not fully alert.