Each Jefenac -TR capsule contains timed release Diclofenac Sodium pellets equivalent to 100 mg Diclofenac Sodium BP.
Diclofenac is a non-steroidal compound pronounced anti-rheumatic, anti-inflammatory & analgesic properties. Jefenac -TR is encapsulated timed release dosage from possesses small microencapsulated pellets which are coated usually with different thickness having a desired steady drug release pattern for prolong time.
Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive polyarthritis, ankylosing spondylarthitis, osteoarthritis, spondylarthroses, acute gout, peri-articular rtheumatic disorders.
Surgery and Traumatology: Sprain bruises, disiocations, fractures, soft-tissue injuries, surgical interventions.
Obsterics and Gynaecology : Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, mastitis.
Otorthinolaryngology: As pre-operative medication for the prevention of pain, inflammation and swelling.
Dentistry: post-operative and post-traumatic pain, inflammation and swelling.
Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract. Renal and biliary colic. Feverish conditions and as an adjuvant to chemotherapy of infectious diseases. Painful conditions not associated with rheumatic disease.
DOSAGE AND ADMINISTRATION
One capsule of Jefenac -TR daily. If necessary, the daily dose can be increased to 150 mg by prescribing in addition Neofenac-50 enteric coated tablet of 50 mg. Where the symptoms are most pronounced during the night or in the morning. Jefenac -TR should preferably be taken in the evening. They should be taken with a little liquid preferably at mealtimes.
Peptic ulcer, hypersensitivity to Diclofenac. Like other non-steroidal anti-inflammatory agents, Jefenac -TR is also contraindicated in asthmatic patients in whom attacks of asthma, urticaria of acute rhinitis are precipitated by acetylsalicylic or by other drugs with prostaglandin synthetase inhibiting activity.
In the rare instances where peptic ulceration or gastro-intestinal bleeding occurs in patients under treatment with Jefenac -TR the therapy should be discontinued in patients with advanced age, caution is indicated on basic medical grounds. During prolonged treatment with Jefenac -TR as with all highly active non-steroidal anti-inflammatory agents, blood counts and monitoring of hepatic and renal function are indicated as precautionary measures.
PREGNANCY AND LACTATION
During Pregnancy Jefenac-TR should be employed only for compelling reasons and only in the lowest doses that still prove necessary. As in the case of other prostaglandin-synthetase inhibitors, this applies particularly to the last 3 months of pregnancy (owing to the possibility of uterine inertia and/or premature closure of the ductus anteriosus).
Following oral dose of 150 mg daily, Diclofenac passes into the beast milk, but in quantities so small that no undesirable effects on the infant are to be expected.
Jefenac -TR is generally well tolerated. At the start of treatment, however, patients may sometimes complain of epigastric pain, erucatation, nausea and diarrhoea, or of dizziness or headache. These effects are usually of mild nature.
Peripheral oedema and skin reactions, such as rash and eczema have also been encountered.
The following unwanted effects, which have been observed in response to other non-steroidal anti-inflammatory drugs, have seldom been reported with Jefenac -TR i.e. central nervous side effects, such as tiredness, insomnia or irritability. There have been a few reports at gastro-intestinal ulceration or haemorrhage, hypersensitivity reactions (e.g. bronchospasm anaphylactic/anaphylactoid systemic reactions) elevated transaminase levels, jaundice, hepatitis, renal failure and nephrotic syndrome.
Box containing 10×10’s capsule in blister pack.