Lyclear Creme Rinse
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
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.
4.5 Interactions with other medicinal products and other forms of interaction
None known.
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 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.
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.
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
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.
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 preclinical 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 low density polyethylene bottles fitted with a 2-piece closure. The base of the closure is manufactured from either polypropylene or polyethylene and the spout from low density polyethylene vinyl acetate copolymer or polyethylene. Included in the pack is a fine toothed comb which can be used to remove lice and eggs after treatment.
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
PL 02855/0013
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/12/2005
10 DATE OF REVISION OF THE TEXT
30/11/2015