Acepar Plus Tablets

Description

Therapeutic Area: NSAIDs Generic Name: Aceclofenac + Thiocolchicoside Available as: 100 + 4mg – Prescribing information:

Therapeutic indications:
Aceclofenac and Thiocolchicoside Tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, Adjuvant treatment of painful muscle contractures
in acute spinal pathology in adults 18 years and above.
Posology and method of administration:
Route of administration: Oral administration.
Dosing Adults: The recommended dose is one tablet twice daily. preferably with or after food..
Contraindications:
Hypersensitivity to Aceclofenac, Thiocolchicoside or to NSAIDs.
Severe heart failure, hepatic failure, and renal failure.
History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy.
Tablets should not be prescribed during pregnancy, lactation and in women of childbearing potential not using contraception.
Special warnings and precautions for use:
The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase – 2 selective inhibitors should be avoided. Respiratory disorders: Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. Cardiovascular, Renal and Hepatic Impairment: The administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Dermatological: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Impaired female fertility: The use of Aceclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac should be considered. Preclinical studies showed that one of the Thiocolchicoside metabolites induced aneuploidy (i.e. unequal number of chromosomes in dividing cells) at concentrations close to human exposure observed at doses 8 mg twice daily. Aneuploidy is considered as a risk factor for teratogenicity,
embryo/foeto-toxicity, spontaneous abortion, and impaired male fertility and a potential risk factor for cancer