Lyclear Creme Rinse

  • Name:

    Lyclear Creme Rinse

  • Company:
    info
  • Active Ingredients:

    Permethrin

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/08/19

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Summary of Product Characteristics last updated on medicines.ie: 5/7/2019

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Chefaro Ireland Ltd

Chefaro Ireland Ltd

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Medicine Name Lyclear Creme Rinse Active Ingredients Permethrin
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1 - 0 of 33 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12 August 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 4 - possible side effects

Updated on 5 July 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 4 - possible side effects

Updated on 5 July 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Updated on 1 August 2018 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Updated on 17 November 2017 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.5 has been changed to: "...bottle consisting of low density polyethylene and high density polyethylene, fitted with a polypropylene disc-top".

Updated on 17 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 16 June 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7, Address updated to:

Chefaro Ireland DAC,
Treasury Building,

Lower Grand Canal Street,
Dublin 2

Ireland

Updated on 14 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 19 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

4.2 Posology and method of administration

 

Topical preparation – applied to scalp and hair.

Adults and Children over 6 months of age

Lyclear Crème Rinse should be used after hair has been washed with a mild non conditioning shampoo and towelled dry. The bottle should be shaken thoroughly and enough Lyclear Crème Rinse applied to saturate the hair and scalp. Particular attention should be given to areas behind the ears and at the nape of the neck.

Lyclear Crème Rinse should be left on the hair for 10 minutes before rinsing the hair thoroughly with water. The hair should then be dried in the usual way.

One bottle of Lyclear Crème 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 unlikely that two bottles will be required for any one course of treatment.

 

If necessary, a second application can be done 7 or 14 days afterwards.

 

Residual activity may persist for up to six weeks.

It is not necessary to remove dead eggs or nits except for cosmetic purposes. A fine toothed comb may be used if desired.

Use in the Elderly

          Lyclear Crème Rinse is suitable for use in the elderly.

 

4.4 Special warnings and precautions for use

 

Lyclear Crème Rinse may be used as normal in asthmatics, however, contact your doctor or pharmacist before commencing treatment if you have any particular concerns.

Neither Permethrin nor Lyclear Crème Rinse are irritants to the eyes. However, should Lyclear Crème Rinse be accidentally introduced into the eyes, rinse immediately with plenty of water.

Children under 6 months of age should be treated on the advice of a doctor.

Nursing staff who routinely use Lyclear Crème Rinse may wish to wear gloves and avoid any possible irritation to the hands.

Permethrin is not affected by the chlorine in swimming baths, so normal swimming activities may continue after use.

 

 

As for other products used for the treatment of head lice, resistance can occur. After one week the result of the treatment is checked. If one finds still living lice, one can repeat the treatment with the same product. If after 14 days it is certain that the infestation is still active, it is best to switch to another active product.

 

 

 

4.8 Undesirable effects

 

General Summary of the Most Important Side Effects

 

Lyclear Crème Rinse is generally well tolerated with a low potential for inducing skin reactions. In a few individuals erythema, rash, pruritus and/or irritation of the scalp has been reported following application of the Crème Rinse, but as an infection with head lice is often associated with such scalp irritation, it is difficult in most instances to determine the underlying cause.

If severe or prolonged signs and symptoms of scalp irritation, skin discomfort, or other undesirable effects occur in association with the use of Lyclear Crème Rinse it should be brought to the attention of a doctor or pharmacist.

Very rarely cases of alopecia have been reported.

Direct contacts should be checked for signs of head lice infection and treated if necessary.

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 HPRA Pharmacovigilance Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

 

 

10 DATE OF REVISION OF THE TEXT 

 
   November 2015

 

 

Updated on 18 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 August 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 7 (Marketing Authorisation Holder), the address of the MAH has been updated.

Updated on 20 August 2013 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 August 2012 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided