PERMETHRIN CREME RINSE 1% W/W - Summary of medicine characteristics

Permethrin Crème Rinse 1% w/w

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains permethrin 1% w/w.

For Excipients, see 6.1

3 PHARMACEUTICAL FORM

Shampoo

A thick white lotion

4.1 Therapeutic indications

Permethrin Crème Rinse 1% w/w is indicated for the treatment of head lice and their nits, Pediculus humanus capitis.

4.2 Posology and method of administration

Adults, elderly and children over 6 months of age:

For topical administration.

Permethrin Crème Rinse 1% w/w should be shaken before use.

Permethrin Crème Rinse 1% w/w should be used after the hair has been washed with a non-medicated shampoo and towel-dried. The Crème Rinse should be applied in a sufficient quantity to saturate the hair, paying particular attention to the nape of the neck and behind the ears. Once the Crème Rinse has been on the hair for 10 minutes, it should be thoroughly rinsed off, and the hair dried in the normal way.

If after 7–10 days of treatment with permethrin living lice are found, treatment with permethrin should be repeated. If after 14–20 days infestation is still active treatment with an alternative product should be considered

One bottle of Crème Rinse should be sufficient to cover shoulder-length hair of average thickness. More may be used if required, although it is most unlikely that more than two bottles will be required for any one course of treatment.

Residual activity may persist for up to six weeks.

The dead nits need not be combed out unless desired for cosmetic reasons.

Permethrin Crème Rinse 1% w/w is not suitable for application to children under six months of age, unless on the advice of a physician.

4.3 Contraindications

The use of Permethrin Crème Rinse 1% w/w is contraindicated in people with hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, or to chrysanthemums.

4.4 Special warnings and precautions for use

Keep out of the sight and reach of children. For external use only. Gloves may be worn to avoid possible irritation to the hands of nursing staff who routinely use Permethrin Crème Rinse 1% w/w. Avoid contact with eyes. In case of contact, rinse immediately with water. If a reaction occurs, discontinue use and consult your doctor.

In the case of hypersensitivity to chrysanthemums or other compositae, treatment should only be given if strictly indicated. In such cases treatment should be switched to a chemically different agent.

Paediatric population

Only limited experience is available with X in children aged over 6 months up to 3 years. Therefore, treatment must be performed only under close specialist supervision in this age group.

Shake thoroughly before using.

As with all medicines, if you are currently taking any other medicines, consult your doctor or pharmacist before using this product.

If symptoms persist, consult your doctor.

This product may be used as normal in asthmatics.

Treatment failure and resistance development

Varying clinical success rates to permethrin in the treatment of head lice have been observed geographically and over time. Factors associated with treatment failure include incorrect dosing or administration errors, lack of concurrent treatment of household members, and re-infestation from community contacts. Furthermore, resistance to permethrin has been detected. However, no clear correlation could be established between lack of efficacy and mutations known to confer pyrethroid resistance. Official guidance on the appropriate use of pediculicide agents should be considered.

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Fertility, pregnancy and lactation

For precautionary reasons, the use of Permethrin Crème Rinse 1% w/w during pregnancy should be avoided unless physically acting treatment alternatives were ineffective and/or treatment with permethrin is required due to the woman's clinical condition.

There is inadequate evidence of the safety in human pregnancy. Permethrin Crème Rinse 1% w/w should only be used when the expected benefits outweigh the potential risks. It is not known if permethrin is excreted in human milk, although it is unlikely that concentrations would present any risk to the infant. It is recommended that nursing be discontinued or withholding treatment if it is not possible to discontinue nursing.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Nervous system disorders

Not known: Paraesthesia

Skin and subcutaneous tissue disorders

Permethrin Crème Rinse 1% w/w is generally well tolerated. In a few individuals erythema, rash and/or irritation of the scalp have been reported following its application, but as an infestation with head lice is often associated with scalp irritation, it is difficult in most instances to determine the underlying cause.

If severe or prolonged signs or symptoms of scalp irritation, skin discomfort or other undesirable effects occur, these should be brought to the attention of a doctor or pharmacist.

4.9 Overdose

On the basis of animal and human-volunteer studies, it is extremely unlikely, even with misuse or excessive application, that the amount of permethrin required to produce clinically relevant toxic effects would be reached. The most likely symptoms and signs following repeated, excessive application would be hypersensitivity-type reactions, for which symptomatic treatment would be indicated.

Theoretically, if swallowed by a small child, alcoholic intoxication could occur due to the isopropyl alcohol content of Permethrin Crème Rinse 1% w/w.

In the event of accidental ingestion by a child, a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion and management should be aimed at treatment of any possible alcoholic intoxication.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: P03AC04

Pharmacotherapeutic group- delousing agent-Pyrethroid

Permethrin is rapidly absorbed across the insect cuticle. The principle physiological lesion is the induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, incoordination and prostration. When presented in an aqueous base, the ovicidal activity of permethrin is increased by the addition of an alcohol.

5.2 Pharmacokinetic properties

Permethrin is rapidly metabolised by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. The application of cream rinse to the hair of volunteers for the recommended application time resulted in extremely low or undetectable levels of permethrin metabolites in plasma and urine samples. In vitro studies have shown that permethrin levels on hair were not affected by chlorine in concentrations used in swimming pools.

5.3 Preclinical safety data

In-vitro and in-vivo genetic toxicity studies on permethrin have all been negative, with no potential to induce mutagenic change.

Permethrin has been shown to have very low acute toxicity in animals, likely to be due to its rapid metabolic degradation to inactive constituents and incomplete absorption from the gastrointestinal tract. Overall, there is little evidence of chronic toxicity with permethrin use. The findings of repeated long-term bioassays in mice and rats do not indicate a significant oncogenic potential for permethrin in humans.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Carbomer

Isopropyl Alcohol

Lauryl Alcohol

Polyoxyethylene 4 Lauryl Ether

Polyquaternium-24

Propylene glycol

Stearalkonium Chloride

Triethanolamine

Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25°C.

Do not refrigerate or freeze.

Keep container in the outer carton

6.5 Nature and contents of container

High density polyethylene (HDPE) bottle used with a polypropylene screw cap containing 50 ml 55ml, 60ml 100ml or 200 ml of creme rinse

6.6 Special precautions for disposal

Shake the bottle before use. Avoid contact with eyes.

Permethrin is not affected by the chlorine in swimming pools.

The patient should be advised to not use hair mousses, gels, sprays or conditionsers immediately before or after treatment as these may reduce the effectiveness of Quellada P Crème Rinse.

It is possible that treatment could affect permed, bleached or coloured hair. To avoid this, it is advisable to test the product on a small area of hair before applying to the whole head.

7 MARKETING AUTHORISATION HOLDER

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 44673/0053

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

23/10/2006