Numark Head Lice Treatment 1% W/W Cutaneous Emulsion
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Numark Head Lice Treatment 1% w/w Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Permethrin 1% w/w
‘For full list of excipients, see section 6.1’
3 PHARMACEUTICAL FORM
Cutaneous Emulsion.
Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is a smooth white liquid preparation for cutaneous application.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is intended for the treatment of head lice infestations.
4.2 Posology and method of administration
Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is applied topically and is for external use only.
Adults and children over 6 months:
The lotion should be used after the hair has been washed with a mild nonconditioning and non-medicated shampoo and then towel dried. The bottle should be shaken thoroughly and the hair and scalp should be saturated with the lotion, with particular attention given to the areas at the back of the neck and behind the ears.
The lotion should be left on for 10 minutes. Thereafter, the hair should be rinsed thoroughly with water and combed with an ordinary comb. The hair
should then be rinsed again, combed with a fine toothed comb (provided with the pack) to remove dead lice and eggs, and dried in the usual way.
One bottle of Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is usually sufficient to treat one person with shoulder length hair of average thickness, a little more may be required if the person’s hair is especially thick or long. It is very unlikely that more than two bottles will be required per application.
Children: Not recommended for children under 6 months of age, except on advice of a doctor.
Elderly: As for adults.
4.3 Contraindications
Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is contraindicated in patients with a known sensitivity to the product, its components and other pyrethroids or pyrethrins.
4.4 Special warnings and precautions for use
The active ingredient and the product are not known to be irritating to the eyes. However, if the product comes into contact with the eyes, rinse immediately with plenty of water.
Nursing or care staff who routinely use the product should wear gloves in order to avoid potential irritation to the hands.
The effect of this product on artificial hair dyes and perms has not been determined. Although complaints are extremely rare, it is recommended to apply the product to a small section of hair first, before treating the entire scalp.
Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is for external use only and is suitable for use in adults and children over 6 months of age. The use of Head Lice Numark Head Lice Treatment 1% w/w Cutaneous Emulsion in children below the age of 6 months should only be on the advice of a doctor.
Not to be used by persons known to be sensitive to the ingredients.
4.5 Interaction with other medicinal products and other forms of interaction
No adverse effects reported.
4.6
Pregnancy and lactation
Reproduction studies have been performed in mice, rats and rabbits (200 - 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are however, only very limited data on the use of permethrin in pregnant women.
Because animal studies are not always predictive of the human response, treatment should be considered during pregnancy only if clearly needed.
Studies following oral administration of permethrin in cattle have indicated that very low concentrations of permethrin are excreted in milk. However, it is not known whether permethrin is excreted in human milk. Whilst it is unlikely that the concentrations of permethrin in the milk will present any risk to the infant, consideration should be given to withholding treatment during nursing or temporarily discontinuing nursing.
4.7 Effects on ability to drive and use machines
No adverse effects reported.
4.8 Undesirable effects
Side effects are not common with Numark Head Lice Treatment 1% w/w Cutaneous Emulsion and if they occur they are usually mild and indistinguishable from the head lice infestation itself. Occasionally, skin irritation, redness or rash may occur.
4.9 Overdose
When applied topically, systemic overdosage with the product is unlikely due to minimal percutaneous absorption.
Indeed, there have been no reports of overdosage associated with the use of the product or other topical permethrin products. On the basis of a review of publically available animal and human-volunteer studies, it is extremely unlikely (even with intended misuse or excessive application) that the amount of permethrin or any of the other constituents, required to produce clinically-relevant toxic effects would be reached. The most likely symptoms and signs following repeated, excessive application are hypersensitivity-type reactions.
Following accidental ingestion, dizziness, nausea, vomiting, diarrhoea, CNS depression or hypotension could potentially occur. In the event of accidental ingestion of the contents of a bottle by a child a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion.
Symptomatic treatment is indicated if any of these reactions occur.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The ATC code for Numark Head Lice Treatment 1% w/w Cutaneous Emulsion is P03 A C 04 (Group: Ectoparasiticides, incl. Scabicides, insecticides and repellents). Permethrin may be classified as a Pyrethroid Pesticide. They are highly effective insecticidal neurotoxins, and are effective against head lice and their eggs.
5.2 Pharmacokinetic properties
Permethrin is practically insoluble in water and is readily metabolised in humans. Hydrolysis of the ester bond, hydroxylation and elimination as glucoside conjugate is the main route of metabolism. Permethrin may persist in the fatty tissues with halflives of 4 to 5 days in brain and fat. Permethrin does not block or inhibit cholinesterase enzymes.
Permethrin is rapidly metabolised by ester hydrolysis to inactive metabolites which are excreted primarily in the urine.
In vitro studies have shown that permethrin levels on hair are not affected by chlorine in concentrations used in swimming pools.
5.3 Preclinical safety data
Published acute toxicity data indicate that permethrin is of low acute toxicity in a range of mammalian species by common routes of exposure. In radiolabel experiments, no accumulation of the parent compounds or of their metabolites was observed.
The lowest NOEL identified was 20 mg/kg/day following dietary administration in the rat for periods from 90 days to 6 months in duration. Assuming a worst case scenario in which a child of six months of age (approximately 6 kg body weight) was treated with the maximum dose topically, the total absorption would be 1,200 mg x 1% = 12 mg i.e. 12/6 = 2 mg/kg. The safety margin in this extreme scenario is, therefore, ten-fold compared to the lowest reported NOEL for repeated dietary administration.
In vitro mutagenicity studies indicate that permethrin is universally negative in the Ames test with Salmonella typhimurium and Escherichia coli. The reported test in Chinese hamster V79 cells was conducted at a very low maximum dose level and the negative result in this assay must be approached with caution. The excipient hydroxycetyl hydroxethyl dimonium chloride has not been subjected to a full battery of genotoxicity tests. There was no evidence of mutagenicity in an Ames test with Salmonella typhimurium but an in vitro cytogenicity test in mammalian cells and an in vivo micronucleus test have not been conducted.
The available published data indicate that permethrin has the potential to induce numerical chromosome aberrations in both human lymphocytes and in CHO cells in the absence of S9. Perhaps of more importance are the data indicating that exposure of Wistar rats to permethrin in the dose range 12.6 to 125.7mg/kg induced numerical chromosome aberrations in bone marrow. The lowest reported dose to show this effect is approximately six times the worst case topical exposure calculated for Numark Head Lice Treatment 1% w/w Cutaneous Emulsion.
None of the reported studies demonstrated evidence of carcinogenicity.
There are sufficient published data to confirm that permethrin does not represent a reproductive risk in the intended pharmaceutical application as Numark Head Lice Treatment 1% w/w Cutaneous Emulsion.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl Alcohol Propylene Glycol
Hydroxycetyl Hydroxyethyl Dimonium Chloride
Cetostearyl Alcohol
Ceteareth-20
Light Liquid Paraffin
Carbomer
Sodium Hydroxide Solution Purified Water
6.2 Incompatibilities
None reported.
6.3 Shelf life
2 years.
6.4
Special precautions for storage
Do not store above 25oC.
Keep container in the outer carton in order to protect from light.
Keep out of the sight and reach of children.
Do not use after the expiry date on the label and carton.
Do not use Numark Head Lice Treatment 1% w/w Cutaneous Emulsion if there is any visible sign of deterioration of the lotion.
6.5 Nature and contents of container
White 59ml HDPE bottle with LDPE screw cap incorporating flip up applicator. A comb is also provided.
There are 2 pack sizes: 1 x 59ml pack and 2 x 59ml pack.
6.6 Special precautions for disposal
Shake bottle thoroughly before use.
Nursing staff routinely using Numark Head Lice Treatment 1% w/w Cutaneous Emulsion should wear gloves to avoid any irritation to the hands.
7 MARKETING AUTHORISATION HOLDER
Ovelle Ltd.,
Industrial Estate,
Coe’s Rd,
Dundalk,
Co. Louth,
Ireland.
8 MARKETING AUTHORISATION NUMBER(S)
PL 04149/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 12/06/2007
10 DATE OF REVISION OF THE TEXT
03/09/2014