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Chefaro Ireland Ltd

Chefaro Ireland, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V2SA, UK
Telephone: +44 (0)203 598 9601
E-mail: omegaroi@professionalinformation.co.uk
WWW: www.omegapharma.ie
Medical Information Direct Line: +44 (0)1748 827 299
Summary of Product Characteristics last updated on medicines.ie: 16/06/2017
SPC Lyclear Creme Rinse

When a pharmaceutical company changes an SPC or PIL, 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 16/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2017
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 19/11/2015 and displayed until 16/06/2017
Reasons for adding or 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
Date of revision of text on the SPC:   18-Nov-2015
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 23/08/2013 and displayed until 19/11/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   21-Nov-2011
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 30/08/2012 and displayed until 23/08/2013
Reasons for adding or updating:
  • New SPC for medicines.ie
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Permethrin