INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
MYOFLEX® TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

MYOFLEX^® TABLETS

COMPOSITION:
Each tablet contains:

Paracetamol	500 mg
Chlormezanone	100 mg
Preservative: Nipastat 0,0195% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
The tablets have analgesic, antipyretic and mild tranquilising properties.

INDICATIONS:
Relief of generalised pain associated with tension.

CONTRA-INDICATIONS:
Sensitivity to Paracetamol. Safety in pregnancy and lactation has not been established.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor.
Dosages in excess of those recommended may cause severe liver damage.
Consult your doctor if no relief is obtained with the recommended dosage.
Patients suffering from liver or kidney disease should take only under medical supervision.

DOSAGE AND DIRECTIONS FOR USE:

Adults:	1 tablet 3 - 4 times daily as required.
Children 9 - 12 years:	½ tablet 3 - 4 times daily as required.

Not for children under 9 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Do not exceed the recommended dosage.
Store in a safe place out of reach of children.
Side Effects
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur.
Other side-effects include drowsiness, weakness, nausea, dizziness, flushing of the skin, excitement, depression, skin rash, confusion, dryness of the mouth and difficulty in micturition.
Cholestatic jaundice may occur.
Myoflex tablets should not be administered concomitantly with other tranquilisers or antidepressant medication. The patient should not drive a vehicle or operate machinery, if dizziness or drowsiness occurs.
The dosage should be reduced in case of renal functional impairment.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Drowsiness, weakness, nausea, dizziness, abdominal pain, cerebral oedema and renal tubular necrosis, hyperglycaemia and hypoglycaemia, liver damage, encephalopathy, coma and death. Treatment should be strongly supportive and symptomatic.
Since a serious side-effects of acute overdosage is dose-related potentially fatal liver necrosis, procedures to prevent further absorption should be instituted immediately.
Induction of vomiting or gastric lavage should be performed in all cases where the patient has ingested 7,5 g in the preceding 4 hours. Specific therapy with an antidote such as acetylcysteine or methionine is generally needed when the blood paracetamol concentration, lies above a line that is drawn between the 2 points, 200 mg/litre at 4 hours, and 30 mg/litre at 15 hours after the overdose is taken. Treatment is as follows:       

Acetylcysteine:	can be given either intravenously, or by mouth.
IV:	An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1 litre over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally:	140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is very effective if administered within 8 hours of overdosage.
Methionine:	The usual dose is 2,5 g by mouth every 4 hours for 4 doses, but must be started within 10 hours of the overdosage. It has also been given intravenously.

As little as 10 g paracetamol can lead to fatal liver necrosis in the adult, especially in the malnourished.

IDENTIFICATION:
White, biconvex, bisected tablets engraved with mortar and pestle.

PRESENTATION:
Packs of 20, 100, 250 and 500.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
L/2.8/388.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21:04:1980
                                G388B
                KOHLER C&P P.E.
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