This information is intended for use by health professionals

1. Name of the medicinal product

LYCLEAR Creme Rinse

2. Qualitative and quantitative composition

LYCLEAR Creme Rinse contains 1 % w/w permethrin.

For excipients, see 6.1.

3. Pharmaceutical form

Creme rinse for topical application

A light orange cream

4. Clinical particulars
4.1 Therapeutic indications

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

4.2 Posology and method of administration

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.

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.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

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.

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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

No special comment - unlikely to have an effect.

4.8 Undesirable effects

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.

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.

Symptoms of overdose may occur in case of accidental or voluntary oral ingestion, and in rare cases of skin absorption due to excessive local application. Some symptoms that have been reported are nausea, vomiting, dizziness and convulsions.

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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.

6. Pharmaceutical particulars
6.1 List of excipients

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

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

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.

6.6 Special precautions for disposal and other handling

Shake well before use.

7. Marketing authorisation holder

Omega Pharma Ltd.

1st Floor

32 Vauxhall Bridge Road

LONDON, SW1V 2SA

United Kingdom

8. Marketing authorisation number(s)

PL 02855/0013

9. Date of first authorisation/renewal of the authorisation

01/11/1988 / 12/12/2005

10. Date of revision of the text

10/2019