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). The application should be repeated 7 – 14 days after the first treatment.

Paediatric population Children aged from 6 - 12 years:

Apply up to 15 g of cream (corresponding to ½ tube of 30 g). The application should be repeated 7 – 14 days after the first treatment. 5 g of cream (corresponding to ¼ tube of 30 g). The application should be repeated 7 – 14 days after the first treatment.

The safety and efficacy of Permethrin 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, adolescents and children over 2 years 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 under 2 years of age 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 Permethrin 5% w/w Cream in children aged 2 months to 23 months.

Therefore treatment must be given only under close medical supervision in this age group.

Elderly:

In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few individuals soon after Permethrin 5% w/w 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 Permethrin 5% w/w 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.

System Organ Class 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 Paraesthesia, skin burning sensation Headache Respiratory, thoracic and mediastinal disorders Dyspnoea (in sensitive/allergic patients) Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Pruritus, erythematous rash, dry skin Excoriation, folliculitis, skin hypopigmentation 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Nursing staff who routinely use Permethrin 5% w/w Dermal Cream may wish to wear gloves to avoid any possible irritation to the hands.

g. nasopharyngeal space, genital area) or open wounds. Permethrin is not an eye irritant but contact of Permethrin 5% w/w Dermal Cream with the eyes should be avoided because the cream itself may cause marked irritation. In the event of inadvertent eye contamination, the affected area should be rinsed immediately with plenty of water, or if readily available, normal saline.

Paediatric population Only limited experience is available with Permethrin 5% w/w 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.

Permethrin 5% w/w Cream 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. g. contact dermatitis), or irritation to the eyes and mucous membranes (lining of the nose, mouth and genital areas).

g. contact dermatitis). These 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. g. contact dermatitis).

Permethrin Cream contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate. These excipients of the cream can may cause allergic reactions (possibly delayed). The container of this medicinal product contains latex rubber.

May cause severe allergic reactions. 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.

1. In such cases treatment should be switched to a chemically different antiscabies agent.