Lyclear Cream Rinse Twin Pack

Instructions for Lyclear Creme Rinse:

Please follow instructions carefully:

1. Shampoo the hair with a mild shampoo. Do not use combined shampoo-conditioner or a medicated shampoo.
2. After shaking the bottle thoroughly, apply sufficient Lyclear Creme Rinse to saturate the hair, root and scalp. Work methodically through the hair and remember to pay particular attention to the areas behind the ears and around the nape of the neck. For the majority of individuals all of the contents of this pack will be required to ensure that the hair and scalp are well saturated.
3. Leave Lyclear Creme Rinse on the hair for 10 minutes. An application for longer than 10 minutes will not give better result, but a full 10 minutes is required.
4. Rinse toughly with water. After the final rinse and while the hair is still wet, use the comb provided in the pack to remove the lice and eggs. Comb the hair in sections from the roots and work over the whole head in this way. Normal hair drying routines can then be followed.

Lyclear Creme Rinse should not irritate your eyes, although care should be taken when applying. If accidental contact does occur, rise immediately with plenty of water.

Lyclear Creme Rinse contains:

Permethrin 1 %w/w

Side effects of Lyclear Creme Rinse:

Like all medicines Lyclear Creme Rinse may have some possible side-effects. However with Lyclear Creme Rinse side-effects are not common and when they occur they are usually mild and cannot be distinguished from the head lice infection itself. Occasionally skin irritation, redness or rash may occur.
If you notice and side-effects not mentioned in this leaflet, or are worried about the above side-effects, contact your doctor or pharmacist.

Name of the product:

Lyclear Creme Rinse

Qualitative and quantitative Composition:

Lyclear Creme Rinse contains 1% w/w permethin

Pharmaceutical form:

Creme rinse for topical application

A light orange cream

Clinical particulars:

1. Therapeutic indications:

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

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 then be left on the hair for ten minutes before rinsing the hair thoroughly with water. The hair should then be dried 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 likely that more than two bottles will be required for any one course of treatment.

97-99% of individuals with head-lice are successfully treated with a single application of Lyclear Creme Rinse. Residual activity may persist for up to six weeks.

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.

3. Contraindications:

Lyclear Creme Rinse is contraindicated in individuals with known hypersensitivity to the product, its components and other pyrethroids or pyrethrins.

4. Special warnings and precautions for use:

Neither permethin 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.

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.

5. Interaction with other medicinal products and other forms of interaction:

            None known.

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.

7. Effects on abilityto drive and use machines:

            No special comment – unlikely to have an effect.

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.

9. Overdose:

There are no reports of overdose 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.

Pharmacological properties:

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.

2. Pharmacodynamic 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.

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.

Pharmaceutical particulars:

1. List of excipients:

Isopropyl alcohol

Stearalkonium chloride

Cetyl alcohol

Ceteth- 10 (polyoxyl 10 cetyl ether)

Hydroxyethcellulose

Hydrolysed animal protein

Methyl parahydroxybenzoate (E218)

Balsam fir Canada

Fragrance 06.070

Propyl parahyroxybenzoate (E216)

Propylene glycol

Sunset yellow (E110)

Anhydrous citric acid

Purified water

2. Incompatibilities:

            None known.

3. Shelf life:

            2 years.

4. Special precautions for storage:

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

5. Nature and contents of container:

One or two 59ml low density polyethylene bottles fitted with a 2-piece closure. The base of the closure is manufactured from polypropylene and the spout from low density polyethylene vinyl acetate copolymer. Included in the pack is a fine toothed comb which can be used to remove lice and eggs after treatment.

6. Special precautions for disposal and other handling:

Shake well before use.

Marketing authorisation holder:

Chefaro UK Limited,

3 Percy Road,

Huntingdon,

PE29 6SZ

United Kingdom

Marketing authorisation number:

PL 02855/0013

Date of first authorisation/renewal of the authorisation:

17/01/2005

Warnings when using Lyclear Creme Rinse:

• Do not store above 25°C
  
• Keep container in the outer carton
  
• Remember, as with all medicines, keep Lyclear Creme Rinse out of reach and sight of children
  
• Do not use after the last day of the month shown on the expiry date
  
• Return any out of date medicine to your pharmacist
  
• For any further information you should contact your doctor or pharmacist
  
• You should carefully read all product packaging and labels prior to use