COMPOSITION: Each tablet contains chlorzoxazone 250 mg and paracetamol 300 mg
PHARMACOLOGICAL CLASSIFICATION: A2.8 Analgesic combinations and
A3 2 Non-hormonal preparations.
PHARMACOLOGICAL ACTION: Data available from animal experiments as well as human studies indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The analgesic action of paracetamol supplements that which results secondarily from muscle relaxation. Paracetamol possesses antipyretic action.
PARAFON FORTE tablets are indicated for the relief of severe skeletal muscle spasm and pain associated with such medical and orthopaedic problems as: sprains and strains, myalgias, torticollis, tension headaches, traumatic muscle injuries, low back pain, fibrositis, cervical root and disc syndromes.
PARAFON FORTE tablets are contra-indicated in patients sensitive to either component.
PARAFON FORTE is not recommended during pregnancy or lactation since safety in pregnant women or nursing mothers has not been established.
Dosages in excess of those recommended may cause severe liver damage.
DOSAGE AND DIRECTIONS FOR USE: The usual adult dosage is two PARAFON FORTE tablets four times daily.
Because safety and effectiveness of PARAFON FORTE in children have not been established, such use is not recommended
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
(a) Adverse Reactions Occasional patients may develop gastrointestinal disturbances. It is possible, in rare instances, that chlorzoxazone may have been associated withgastrointestinal bleeding. Dizziness, nausea, lightheadedness, malaise, or overstimulation may be noted by an occasional patient.
Drowsiness can occur with the use of PARAFON FORTE and may be additive to drowsiness from the concomitant use of alcohol or other central nervous system depressants. Rarely, petechiae or ecchymoses may develop during treatment. Sensitivity reactions resulting in reversible skin rash or blood disorders may occur, but these are rare. Angioneurotic oedema and anaphylactic reactions are extremely rare. Rarely, a patient may note discolouration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance. Infrequently, cases have been reported in which the administration of chlorzoxazone or chlorzoxazone containing products was suspected of causing liver damage. Several of these were subsequently determined to the due to underlying diseases rather than to chlorzoxazone (i.e. carcinoma of the head of the pancreas, carcinoma with hepatic metastases, cholelithiasis). The remaining cases had a clinical picture consistent with viral hepatitis or a medicine induced hepatitis. In all of the latter cases the medicine was stopped and the patients recovered. It is not possible to state that the hepatitis in these patients was or was not medicine-induced. (b) Precautions Store in a safe place out of reach of children. PARAFON FORTE tablets should be used with caution in patients with known allergies or with a history of allergic reactions to medicines. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the medicine should be stopped. If any signs or symptoms suggestive of liver dysfunction are observed the medicine should be discontinued. Patients suffering from liver or kidney disease should take this medicine under medical supervision.
Do not use continuously for longer than ten days without consulting your doctor.
Consult your doctor if no relief is obtained with the recommended dosage.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre. Symptoms Initially nausea, vomiting, diarrhoea and upper abdominal pain associated with drawn, pale faces. Central nervous stimulation, dizziness or headache may be noted, followed by somnolence, lethargy or stupor. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered.
Liver damage which may be fatal may only appear after a few days. The chief biochemical changes noted in the blood are gross elevation of liver enzymes, some elevation of the bilirubin level, prolongation of prothrombin time and possibly either hypoglycaemia or hyperglycaemia.
Kidney failure has been described following acute intoxication. Treatment Gastric lavage or the induction of emesis (ipecac or apomorphine) followed by 50 grams of activated charcoal given orally to decrease absorption is the best available treatment and should be carried out immediately. Treatment is symptomatic and supportive.
CONDITIONS OF REGISTRATION: None.
IDENTIFICATION: Light blue, flat faced tablet, 11 mm in diameter, bevel-edged and scored on one face, hex-bevelled and imprinted "McNeil" on the reverse.
PARAFON FORTE tablets are supplied in screw-cap glass bottles containing either 25 or 100 tablets per bottle.
STORAGE INSTRUCTIONS: Store below 25°C.
Keep out of reach of children
REGISTRATION NUMBER: B 1019 (Act 101/1965)
APPLICANT: Johnson & Johnson Professional Products (Pty) Ltd.
(Reg. No. 83/13283/07)
HALFWAY HOUSE, Transvaal.