- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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).
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 administrationFor 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 populationChildren 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.
Paediatric populationOnly 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.
|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)|
|Skin and subcutaneous tissue disorders||Pruritus, erythematous rash, dry skin||Excoriation, folliculitis, skin hypopigmentation||Contact dermatitis, urticaria|
Paediatric populationNewborns and infants:The safety and efficacy of permethrin in newborns and infants under 2 months of age have not been established since no data are available from prospective trials or larger case series. A limited number of case reports in the treatment of children under 2 months of age presenting with scabies do not suggest specific safety concerns for the use of topical permethrin in this age group, but no definite conclusion can be drawn.
Omega Pharma Ltd
1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
+44 (0)203 598 9603
+44 (0)1748 828 860