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

Logo QUELLADA® LOTION
SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

QUELLADA® LOTION

COMPOSITION:
Contains 1% (m/m) gamma benzene hexachloride in a pleasantly-scented water-dispersible base.
Preservatives: methylparaben 0,25% (m/m) and butylparaben 0,02% (m/m).

PHARMACOLOGICAL CLASSIFICATION:
A 13.2 Antiscabies medicines.

PHARMACOLOGICAL ACTION:
Gamma benzene hexachloride is a powerful inducer of microsomal enzymes. This property makes it an effective insecticide, larvicide and acaricide.

INDICATIONS:
QUELLADA LOTION is used for the treatment of scabies and pediculosis (lice). It rapidly eliminates the parasites.

DOSAGE AND DIRECTIONS FOR USE:
For external use only.
Adults and children over 6 months:
In the treatment of scabies or body lice: A thin layer of QUELLADA LOTION is applied to the whole body except for the face and scalp. It is left on for 24 hours and then washed off. If the hands or any part of the body are washed in the course of 24 hours the lotion should be reapplied to that area for the remainder of the 24 hours.
If evidence of viable mites or lice are present seven days after treatment, the dosage schedule should be repeated.

Children under 6 months:
QUELLADA LOTION is not recommended for children under 1 month of age.
Children of 1 - 6 months should be treated (under appropriate supervision) as adults, but the lotion should be washed off after 8 - 12 hours.
Children over 6 months should be treated as adults.
All Children should be under supervision, constant or as required, to ensure that they do not lick the lotion off and ingest it.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gamma benzene hexachloride is a chlorinated insecticide and can produce symptoms consistent with central nervous system stimulation. It may be absorbed through the respiratory and gastro-intestinal tracts and through the skin. Do not use on broken or infected skin. Whatever its route, this absorption is facilitated by oily substances. Skin irritation may occur.

QUELLADA LOTION should not be allowed to come into contact with the eyes, nose, mouth or other delicate membranes. Should the lotion accidentally get into the eyes, it should be flushed out immediately with water.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Poisoning could occur through accidental ingestion, inhalation or percutaneous absorption.

Symptoms:
Symptoms of acute poisoning include nausea and vomiting, diarrhoea, paraesthesia, respiratory failure, giddiness and fatigue, followed by tremors, convulsions and coma. Liver, kidney and myocardial toxicity have also been reported with chlorinated pesticides, while effects on the blood include agranulocytosis and aplastic anaemia. Early symptoms are loss of appetite, muscular weakness, fine tremors and apprehensive mental state.

Treatment of overdosage:
Acute poisoning (ingestion): Emesis should be induced with syrup of ipecac unless the patient is comatose or has lost the gag reflex when gastric lavage should be performed, followed by activated charcoal and then sodium or magnesium sulphate carthartics. Do not administer sympathomimetics, atropine or oils. Artificial respiration may be indicated to counteract pulmonary failure. Convulsions may be treated with i.v. diazepam.

Chronic poisoning(topical) may occur when patients use the product regularly (misuse). The patient should be withdrawn from the product.

IDENTIFICATION:
A pearly white smooth lotion with a rose boquet.

PRESENTATION:
QUELLADA LOTION is supplied in amber glass bottles containing 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 30°C). Do not refrigerate. Keep out of reach of children.

REGISTRATION NUMBER:
G/13.2/229

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
G.D. Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven
Johannesburg.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 September 1974.

Manufactured under license from: Stafford-Miller Ltd., Welwyn Garden City, Herts. England.

© 1994 G.D. Searle (South Africa) (Pty) Ltd.
Code 4355-7-10/93

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