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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom

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.

4.9. 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.

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.

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