LYCLEAR Cream Ref.[6432] Active ingredients: Permethrin

Posology

Treatment of scabies

Adults and adolescents over 12 years of age

Apply up to 30 g of cream (corresponding to one tube of 30 g).

Paediatric population

Children aged from 6-12 years: Apply up to 15 g of cream (corresponding to ½ tube of 30 g).

Children aged from 2 months – 5 years: Up to 7.5 g of cream (corresponding to ¼ tube of 30 g).

The safety and efficacy of Lyclear Dermal Cream in children under 2 months of age have not been established. No data are available.

Treatment of crab lice

Adults over 18 years of age

Apply up to 30 g of cream (corresponding to one tube of 30 g).

Method of administration

For cutaneous use only. The medicinal product must not be swallowed.

Carefully apply a thin layer of cream to the skin (cutaneous use).

For treatment of scabies

Adults should apply the cream uniformly to the whole body including the neck, palms of the hands and soles of the feet. The head and face can be spared unless scabies efflorescences are present in this region.

On application, the areas between the fingers and toes (also under the finger- and toe-nails), the wrists, elbows, armpits, external genitalia and the buttocks should be especially carefully treated.

Paediatric population

Children should apply the cream uniformly to the whole body, including the palms of the hands, soles of the feet, neck, face, ears, and scalp. Parts of the skin around the mouth (because the cream could be licked off) and the eyes should be spared. Children should be kept from licking the cream from the hands. If necessary, children should wear gloves.

Only limited experience is available with Lyclear Dermal Cream in children aged 2 months to 23 months. Therefore treatment must be given only under close medical supervision in this age group.

Elderly

Elderly patients (over 65 years) should use the cream in the same way as adults, but in addition, the face, ears and scalp should also be treated. Care should be taken to avoid applying the cream to areas of skin around the eyes.

Lyclear Dermal Cream should be applied to clean, dry, cool skin. If the patient has taken a warm bath prior to treatment the skin should be allowed to cool before the cream is applied.

Lyclear Dermal Cream is a vanishing cream and when rubbed gently into the skin it will disappear. Therefore, there is no need to continue to apply cream to the skin until it remains detectable on the surface.

Older children should be supervised by an adult when applying to ensure that a thorough treatment is administered.

The whole body should be washed thoroughly 8 – 12 hours after treatment.

Approximately 90% of individuals are cured with a single application of cream. If necessary, a second application may be given not less than 7 days after the initial application, if there are no signs of the original lesions healing or if new lesions are present.

For treatment of crab lice in adults

Sufficient cream should be applied to cover the pubic region, peri-anal (around the anus), inner thighs down to the knees and any hair that grows up from the pubic area to the chest/stomach.

For treatment of crab lice in adults, the cream should be left on the skin for 24 hours, after which the treatment areas should be washed thoroughly.

Any facial hair (beards, moustaches) and eyelashes should be checked for the presence of live lice and eggs. Cream should be applied to any facial hair, carefully avoiding eyes. If live lice or eggs are found on the eyelashes they should be removed carefully using tweezers. Cream should not be applied to the eyelashes because the cream can cause moderate eye irritation.

There are no reports of overdosage with Lyclear Dermal Cream.

Application of a full tube of cream to a 2 month old would result in a dose of approximately 350 mg/kg bodyweight to skin. It is unlikely that such a dose would cause overt signs of systemic toxicity even if 100% of the permethrin were absorbed.

It is possible that excessive application of Lyclear Dermal Cream might result in localised adverse reactions or more severe skin reactions.

Symptomatic treatment is indicated should hypersensitivity-type reactions occur.

In the event of accidental ingestion of the contents of a tube of Lyclear Dermal Cream by a child, gastric lavage should be considered if consultation is within 2 hours of ingestion.

60 months.

Do not store above 25°C.

Do not freeze.

Plastic foil laminate ointment tubes (30g) with Polyolefin screw caps.

Or

Internally lacquered membrane sealed collapsible aluminium tubes (30g) with high density polyethylene caps.

Not applicable.