LYCLEAR Cream Ref.[6432] Active ingredients: Permethrin

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.

When using Lyclear Dermal Cream 5%, care should be taken not to allow the cream to get into the eyes or come into contact with mucous membranes (e.g. nasopharyngeal space, genital area) or open wounds.

Paediatric population

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.

For cutaneous use only!

Lyclear Dermal Cream 5% is harmful to all types of insects and also for aquatic forms of life (fishes, daphnia, algae). Contamination of aquaria and terraria is to be avoided.

Note: The excipients of the cream (liquid paraffin, white soft paraffin) can reduce the functioning and hence the reliability of latex products (e.g. condoms, diaphragms) used at the same time.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

No interactions are known.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Lyclear Dermal Cream, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however, small.

There are limited data on the use of Lyclear Dermal Cream in pregnancy which provide no indication of any risk to the foetus. Furthermore the amount of permethrin absorbed systemically following a whole body application is extremely low. Some permethrin may cross the placental barrier. The negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with Lyclear Dermal Cream is minimal.

Studies, following oral administration of permethrin in cattle have indicated that very low concentrations of permethrin are excreted in milk. It is not known whether permethrin is excreted in human breast milk. However, because only extremely small amounts of permethrin are absorbed systemically following treatment with Lyclear Dermal Cream and in theory only a very small percentage of this systemic permethrin may pass into the breast milk, it is unlikely that the concentrations of permethrin in the milk will present any risk to the neonate/infant.

Reproduction studies in mice, rats and rabbits given oral dosage of 200 to 400 mg/kg bodyweight/day, revealed no evidence of impaired fertility. In addition, permethrin did not show any adverse effects on the reproductive function of rats given an oral dosage of 180 mg/kg bodyweight/day, in a three generation study.

There was no evidence of teratogenicity in reproduction studies in mice, rats and rabbits.

None known.

In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few individuals soon after Lyclear Dermal Cream is applied. This occurs more frequently in patients with severe scabies and is usually mild and transient.

Other transient signs and symptoms of irritation, including erythema, oedema, eczema, rash and pruritus which may follow treatment of scabies with Lyclear Dermal Cream are generally considered to be part of the natural history of scabies.

In patients treated for scabies, itching may persist for up to 4 weeks post-treatment. This is generally regarded as due to an allergic reaction to the dead mites under the skin and is not necessarily indicative of a treatment failure.

Common (≥1/100 to <1/10)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Nervous system disorders

Common: Paraesthesia, skin burning sensation

Rare: Headache

Respiratory, thoracic and mediastinal disorders

Very rare: Dyspnoea (in sensitive/allergic patients)

Gastrointestinal disorders

Not known: Nausea

Skin and subcutaneous tissue disorders

Common: Pruritus, erythematous rash, dry skin

Very rare: Excoriation, folliculitis, skin hypopigmentation

Not known: Contact dermatitis, urticaria

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.

None known.