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

Logo GAMBEX® SHAMPOO
SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

GAMBEX® SHAMPOO

COMPOSITION:
Each 100 mL contains:
        Gamma Benzene Hexachloride        1 g

PHARMACOLOGICAL CLASSIFICATION:
A.13 Dermatological preparations.

PHARMACOLOGICAL ACTION:
Gamma Benzene Hexachloride is a chlorinated insecticide active as a contact poison. It acts as a stimulant to the central nervous system and produces hyperirritability, lack of muscular co-ordination, convulsions and eventual death. It is absorbed in the respiratory tract, gastro-intestinal tract and through the skin.

INDICATIONS:
For the treatment of infestations with head lice (pediculosis capitis), crab lice (phthirus pubis).

CONTRA-INDICATIONS:
Pregnant and lactating women, very young infants, patients with extensively excoriated skin. Patients hypersensitive to Gamma Benzene Hexachloride.

WARNING:
Total body application can be dangerous.

Gamma Benzene Hexachloride should be used with caution, especially in children.

DOSAGE AND DIRECTIONS FOR USE:
FOR EXTERNAL USE ONLY.

Wet hair thoroughly with warm water. Apply about 30 mL
(2 tablespoonfuls) to the affected area and work into a luxuriant lather. Rub vigorously for a few minutes making sure that all hairy areas have been covered by the shampoo and wash off completely. If necessary, repeat treatment in 24 hours.

Contaminated articles such as hats, towels, etc. should be boiled or drycleaned to prevent re-infestation.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Seizures have been reported after the use of Gamma Benzene Hexachloride, but a cause and effect relationship has not been established.

Potent inducer of microsomal enzymes.

Eczematous eruptions due to sensitization may occur in some patients.

Avoid contact with eyes, nose, mouth and other mucous membranes. If accidental contact with the eye occurs, flush with water.

If irritation or sensitization occurs, discontinue use and consult a physician.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Vomiting and diarrhoea, paraesthesia, giddiness, and fatigue, followed by tremors, convulsions, coma possibly pulmonary oedema, and cardiac arrhythmias.

Immediate gastric lavage (not emesis) followed by saline purgatives. Aspiration may cause chemical pneumonitis. Treatment must be symptomatic. Anti-convulsants should be given when indicated.

Epinephrine should not be used because ventricular fibrillation may result.

Treatment of accidental contact with eyes:
Flush with plenty of water.

IDENTIFICATION:
Yellow free flowing liquid.

PRESENTATION:
Pack of 100 mL.

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

REGISTRATION NUMBERS:
M/13/13

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
09 December 1978


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