Lyclear

LYCLEAR Creme Rinse

LYCLEAR Creme Rinse contains 1 % w/w permethrin.

For excipients, see 6.1.

Creme rinse for topical application

A light orange cream

LYCLEAR Creme Rinse is indicated for the treatment of infections with the head louse pediculus humanus capitis.

Adults and children 6 months and over:

Topical.

LYCLEAR Creme Rinse should be used after the hair has been washed with a mild proprietary shampoo and towelled dried. The bottle should be shaken thoroughly and enough LYCLEAR Creme Rinse applied to saturate the hair and scalp. Particular attention should be given to the areas behind the ears and at the nape of the neck.

LYCLEAR Creme Rinse should be left on the hair for ten minutes before rinsing the hair thoroughly with water. The hair should then be dried in the usual way.

One bottle of LYCLEAR Creme Rinse is sufficient for shoulder length hair of average thickness. More may be applied if required and although no maximum dose has been defined, it is most unlikely that more than two bottles will be required for any one course of treatment.

It is not necessary to remove dead eggs or nits except for cosmetic purposes. A fine toothed comb may be used if desired.

Children under 6 months:

LYCLEAR Creme Rinse is not suitable for application to children under six months of age, except on the advice of a physician.

The Elderly:

Normal adult dosage is appropriate.

LYCLEAR Creme Rinse is contra-indicated in individuals with known hypersensitivity to the product, it's components and other pyrethroids or pyrethrins.

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.

Lyclear Creme Rinse contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

Lyclear Creme Rinse contains propylene glycol which may cause skin irritation.

Lyclear Creme Rinse contains cetyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

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.

Children under 6 months of age should be treated on the advice of a doctor.

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.

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.

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.

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.

There are no reports of overdosage with LYCLEAR Creme Rinse. 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.

Symptomatic treatment is indicated should hypersensitivity-type reactions occur.

Theoretically if swallowed by a small child, alcoholic intoxication may occur due to the isopropanol content of LYCLEAR Creme Rinse.

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 and management should relate to treatment of alcoholic intoxication.

The active ingredient, permethrin, belongs to a group of medicines called pyrethroids which are anti-parasitic agents. Permethrin is rapidly absorbed across the insect cuticle. The principal physiological action is the induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, inco-ordination and prostration. When presented in aqueous base, the ovicidal activity of permethrin is increased by the addition of an alcohol.

Permethrin is rapidly metabolised by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. The application of creme rinse to the hair of the volunteers for the recommended application time resulted in extremely low or undetectable level 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.

The active ingredient of LYCLEAR Creme Rinse is a well-known constituent of medicinal products and its safety is well documented. The results of pre- clinical studies do not add anything of relevance for therapeutic purposes.

Isopropyl alcohol

Stearalkonium chloride

Cetyl alcohol

Ceteth-10 (polyoxyl 10 cetyl ether)

Hydroxyethylcellulose

Hydrolysed animal protein

Methyl parahydroxybenzoate (E218)

Balsm Fir Canada

Fragrance 06.070

Propyl parahydroxybenzoate (E216)

Propylene glycol

Sunset yellow (E110)

Anhydrous citric acid

Purified water

None known.

2 years

Do not store above 25°C. Keep container in the outer carton.

One or two 59 ml bottles consisting of low density polyethylene and high density polyethylene, fitted with a polypropylene disc-top cap. Included in the pack is a fine toothed comb which can be used to remove lice and eggs after treatment.

Shake well before use.

Omega Pharma Ltd.

1^st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

PL 02855/0013

12/12/2005

13 November 2017