INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PARAFLEX® Tablet

SCHEDULING STATUS:
Schedule 2.

PROPRIETARY NAME
(and dosage form):

PARAFLEX® Tablet

COMPOSITION:
Each tablet contains 250 mg of the active ingredient
chlorzoxazone.

PHARMACOLOGICAL CLASSIFICATION:
A.2.10 Central nervous system depressants. Centrally active muscle relaxants.

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.

INDICATION:
PARAFLEX tablets are indicated for the relief of painful skeletal muscle spasm associated with such medical or orthopaedic problems as:
arthritides, acute and chronic back pains, bursitis, fibrositis, myositis, contusions, disc syndromes, lumbosacral strain, lumbago, sacroiliac strain, sprains and strains, tendinitis and tenosynovitis, torticollis.

CONTRA-INDICATIONS:
PARAFLEX tablets are contra-indicated in patients hypersensitive to the medicine.
PARAFLEX is not recommended during pregnancy or lactation since safely in pregnant women or nursing mothers has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Usual Adult Dosage
For muscle spasm: one tablet 3 or 4 times daily. The initial dosage for severe muscle spasm should be 2 tablets three or four times daily. If adequate response is not obtained with this dose it may be increased three or four times daily. As the condition improves the dosage can usually be reduced.

Usual Child's Dosage
One-half to two tablets (125 mg to 500 mg) three or four times daily given according to age and weight. The tablets may be crushed and mixed with food or a suitable vehicle for administration to children.

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 with gastrointestinal bleeding.
Drowsiness, nausea, dizziness, lightheadedness, malaise or overstimulation may be noted by an occasional patient.
Rarely, allergic-type skin rashes, petechiae or ecchymoses may develop during treatment. 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 clinical significance.
Infrequent 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 be due to underlying diseases rather than to chlorzoxazone (e.g. carcinoma of the head of the pancreas, carcinoma with hepatic metastases, cholelithiasis). The remaining cases had a clinical picture consistent with viral hepatitis or medicine-induced hepatitis. In all of the latter cases the medicine was stopped and the patient recovered. It is not possible to state that the hepatitis in these patients was or was not medicine-induced.

(b) Precautions
PARAFLEX 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 medicines should be stopped.
If any signs or symptoms suggestive of liver dysfunction are observed the medicine should be discontinued.
Drowsiness can occur with the use of PARAFLEX and may be additive to drownsiness from the concomitant use of alcohol or other central nervous system depressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms:
Initially gastrointestinal disturbances such as nausea, vomiting or diarrhoea together with drowsiness, dizziness, lightheadedness or headache may occur. 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. The sensorium remains intact and there is no peripheral loss of sensation. Respiratory depression may occur with rapid irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment:
Gastric lavage or induction of emesis should be carried out, followed by administration of the universal antidote. Thereafter treatment is entirely supportive. If respiration is depressed, oxygen and artificial respiration should be employed and a patent airway assured by the use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by the use of dextran plasma, concentrated albumin or a vasopressor agent such as noradrenaline. Cholinergic medicines or analeptic medicines are of no value and should not be used.

IDENTIFICATION:
Orange flat-faced tablet, 10,3 mm in diameter, bevel-edged and scored on one face, hex-bevelled and imprinted "McNeil" on second face.

PRESENTATION:
PARAFLEX tablets are available in bottles containing either 25 or 100 tablets per bottle.

STORAGE INSTRUCTIONS:
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER (OR REFERENCE NUMBER):
B1018 (Act 101/1965)

APPLICANT
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 80/11122/07)
15th Road, Halfway House. 1685

DATE OF PUBLICATION:
28 July 1983

Cilag
a division of
JANSSEN
PHARMACEUTICA

® Trademark
Code No.: 022139
90D
Britepak

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