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

Logo GAMBEX SHAMPOO (shampoo)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

GAMBEX SHAMPOO (shampoo)

Patients should be instructed on the proper use of GAMBEX SHAMPOO, especially the amount to apply, how long to leave shampoo on, and the need to avoid retreatment (See DOSAGE AND DIRECTIONS FOR USE).

COMPOSITION:
Each 50 mL contains:

Gamma Benzene Hexachloride0,5 g
Acetone 3 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), pubic lice (Pediculosis pubis), body lice (Pediculosis corporis), and crab lice (Phthirus pubis) in patients who cannot tolerate any other approved therapies, or who have failed to respond to other approved therapies.

CONTRA-INDICATIONS:
Pregnant and breastfeeding women (See PREGNANCY AND LACTATION).
Infants.
Patients with extensively excoriated skin.
Patients hypersensitive to gamma benzene hexachloride or any other ingredients of GAMBEX SHAMPOO.
Patients with known uncontrolled seizure disorders (See WARNINGS).
Blood disorders or blood diseases or medicines associated with bone marrow suppression.

WARNINGS:
Total body application can be dangerous (See DOSAGE AND DIRECTIONS FOR USE).
Seizures and deaths have been reported following GAMBEX SHAMPOO use with repeat or prolonged application, but also in rare cases following a single application according to directions (See CONTRA-INDICATIONS).
Infants, children, the elderly, and individuals with other skin conditions and those who weigh < 50 kg may be at a greater risk of serious neurotoxicity.
Careful consideration should be given before prescribing GAMBEX SHAMPOO to patients with conditions that may increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use of medications known to lower seizure threshold (See INTERACTIONS).
Patients should be informed that itching may occur after the successful killing of lice and repeat treatment may not be necessary.

INTERACTIONS:
Oils may enhance absorption of GAMBEX SHAMPOO, therefore, patients and caregivers applying the shampoo to others should avoid using oil treatments, or oil-based hair dressings or conditioners immediately before and after applying GAMBEX SHAMPOO.
In addition, there are many medicines that may lower the seizure threshold, and GAMBEX SHAMPOO should be prescribed with caution in patients taking these medications. Medication that may lower the seizure threshold include, but are not limited to the following:
Antipsychotics.
Antidepressants.
Theophylline.
Cyclosporin, mycophenolate mofetil, tacrolimus.
Penicillins, imipenem, quinolone antibiotics.
Chloroquine sulfate, pyrimethamine.
Isoniazid.
Pethidine.
Radiographic contrast agents.
Centrally active anticholinesterases.
Methocarbamol.

PREGNANCY AND LACTATION:
Safety in preganancy and lactation has not been established (see CONTRA-INDICATIONS).
Breastfeeding mothers, who require treatment with GAMBEX SHAMPOO, should be counselled to interrupt breastfeeding, with expression and discarding of breast milk, for at least 24 hours following use.

DOSAGE AND DIRECTIONS FOR USE:
FOR EXTERNAL USE ONLY.
Information for use:
Head lice:
Shake GAMBEX SHAMPOO well.
Hair should be completely dry prior to application of GAMBEX SHAMPOO.
Apply about 30 mL (2 tablespoonfuls) to lightly coat the hair and scalp. Most patients will require only 30 mL of GAMBEX SHAMPOO. Based on the length and density of hair, some patients may require 60 mL of GAMBEX SHAMPOO.
Use only enough GAMBEX SHAMPOO to lightly coat the hair and scalp.
Apply GAMBEX SHAMPOO directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the hairs along the neck and behind the ears.
After 4 minutes, add small quantities of water to hair until a good lather forms.
Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces.
Towel briskly and then remove nits with a comb or tweezers.
There may be some GAMBEX SHAMPOO left in the bottle. Close the bottle with the leftover GAMBEX SHAMPOO and immediately throw away the bottle in a trash can out of the reach of children.
Do not cover the hair with anything that does not breathe, like a shower cap or towel.
Do not ingest. Keep away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if open wounds, cuts or sores are present, unless specifically directed by your doctor.
Wash all recently worn clothing, underwear and pajamas, hats, and used sheets, pillow cases, and towels in very hot water or dry-clean.
Patients may still itch after using GAMBEX SHAMPOO. This does not mean the medicine did not work. GAMBEX SHAMPOO sometimes makes this itch even worse. Other medication can be used to sooth the itch. Do not use more GAMBEX SHAMPOO.
Do not retreat.
If there are any questions or concerns about the condition or use of GAMBEX SHAMPOO, contact your doctor.
Body or Pubic Lice:
Apply to affected area. A single application is usually effective to eradicate the ectoparasite.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Side-effects are consistent with central nervous system stimulation and GAMBEX SHAMPOO may be absorbed through the respiratory and gastro-intestinal tracts and through the skin.
Haematological disorders:
Less frequent: Aplastic anaemia may occur after prolonged repeated topical exposure (daily application for 3 weeks).
Nervous system disorders:
Headache, pain, paraesthesia.
Less frequent: Seizures have been reported after the use of GAMBEX SHAMPOO. However, most of the reported cases were associated with ingestion or excessive use.
Skin and subcutaneous tissue disorders:
Less frequent: Skin reactions such as itching, burning, dry skin, rash, alopecia, dermatitis, pruritis and urticaria may occur.
Hepatic disorders:
Frequency Unknown: Enhances microsomal hepatic enzyme activity.

Special Precautions:
Gamma benzene hexachloride as in GAMBEX SHAMPOO may have carcinogenic potential in combined exposure to co-carcinogens.
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 medical practitioner. Application to broken skin or large areas should be avoided as absorption may occur. It may give rise to skin reactions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Contact the closest Poison Control Centre.
Nausea and vomiting, paraesthesia, giddiness, tremors, convulsions, coma and respiratory failure. Liver, kidney and myocardial activity have been reported. Effects on the blood include agranulocytosis and aplastic anaemia. Symptoms may be complicated by the effects of the solvent (acetone).
Treatment:
If ingested, the stomach should be emptied by gastric lavage. Contaminated clothing should be removed and the skin washed with soap and water. Treatment is largely symptomatic and supportive with treatment of central nervous system stimulations such as hyperactivity and convulsions.

IDENTIFICATION:
Bright, clear yellow, slightly viscous liquid.

PRESENTATION:
Bottles of 50 mL.

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

REGISTRATION NUMBER:
M/13/13

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 2009

Code 308713 090504    Harry’s Printers K

New addition to this site: February 2010
Source: Pharmaceutical Industry

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