LYCLEAR Creme rinse Ref.[27752] Active ingredients: Permethrin

Neither permethrin nor LYCLEAR Creme Rinse are irritants to the eyes. However, should LYCLEAR Creme Rinse be accidentally introduced into the eyes, rinse immediately with plenty of water.

Nursing staff who routinely use LYCLEAR Creme Rinse may wish to wear gloves to avoid any possible irritation to the hands.

The effect of this product on artificial hair colorants and perms has not formally been studied. Although complaints are extremely rare, it is good practice to apply to a small section of hair first, before treating the entire scalp.

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

For external use only.

If symptoms persist consult your doctor.

Lyclear Creme Rinse may be used as normal in asthmatics, however contact your doctor or pharmacist before commencing treatment if you have any particular concerns.

Permethrin is not affected by chlorine in swimming baths, so normal swimming activities may continue after use.

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.

As for other products used for the treatment of head lice, resistance can occur. After one week the result of the treatment should be checked. If living lice are still found, the treatment can be repeated with the same product. If, after 14 days, it is certain that the infestation is still active, it is best to switch to another active product.

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.

Excipients

Lyclear Crème Rinse contains:

• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
• Cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
• Stearalkonium chloride, a type of benzalkonium chloride, which may irritate the skin.
• Fragrance with amyl cinnamal, amylcinnamyl alcohol, anise alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, benzyl salicylate, cinnamal, cinnamyl alcohol, citral (neral + geranial), citronellol, coumarin, eugenol, farnesol, geraniol, hexyl cinnamal, hydroxycitronellal, isoeugenol, butylphenyl methylpropional D-limonene, linalool, hydroxyisohexyl 3-cyclohexene carboxaldehyde, methyl 2-octynoate, alpha-isomethyl ionone, evernia prunastri extract, evernia furfuracea extract. These allergens may cause allergic reactions.
• Benzyl alcohol which may cause mild local irritation.
• Sunset yellow which may cause allergic reactions.

None known.

Pregnancy

For precautionary reasons, the use of Lyclear Crème Rinse 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.

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 foetus 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.

Breast-feeding

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.

No special comment – unlikely to have an effect.

LYCLEAR Creme Rinse is generally well-tolerated with a low potential for inducing skin reactions. In a few individuals erythema, rash and/or irritation of the scalp have been reported following the application of the creme rinse, 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 and symptoms of scalp irritation, skin discomfort, or other undesirable effects occur in association with the use of LYCLEAR Creme Rinse it should be brought to the attention of a doctor or a pharmacist.

Frequency not known: Paraesthesia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None known.