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Lyclear Dermal Cream

*
Pharmacy Only: Non-prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Permethrin

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2021

File name

ie-spc-lyclear-issue5draft1-clean.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 21 June 2021

File name

ie-pl-lyclear-issue5draft1-clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 September 2020

File name

ie-spc-lyclear-issue4draft1-clean.pdf

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

Updated on 28 September 2020

File name

ie-pl-lyclear-issue4draft1-clean.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 January 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 14 January 2016

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3 - to contraindicate the use of permethrin in those with a previous history of hypersensitivity reactions to chrysanthemums due to the potentially serious nature of hypersensitivity reactions.

All other sections - editorial updates for consistency with Global Data Sheet.

Updated on 13 January 2016

File name

PIL_9084_996.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 January 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability

Updated on 17 July 2015

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

Change to address of the MA Holder

Updated on 17 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 28 November 2014

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Sections 2, 4.3, 4.6, 4.9, 6.6: Administrative changes only
Section 4.1: Clarification on who should use Lyclear Dermal cream.
Section 4.2: Clarification of posology and additional information has been provided on the method of administration.
Section 4.4 Additional warnings and precautions have been added including use in the paediatric population.
Section 4.8 Undesirable effects have been put into a table to provide clarity. Reporting information added.
Section 5.1 Administrative changes and the addition of pharmacodynamic properties in the paediatric population.
Section 5.2 Additional pharmacokinetic properties were added.
Section 5.3 simplification of pre clinical safety data and additional information on the environmental risk or premethrin.

Updated on 28 November 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 03 September 2013

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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Summary of Changes for the SPC for Lyclear 5% w/w Dermal Cream

Type II variation project edge findings

 

 

Addition of the following statement to section 4.2 Posology and Method of Administration:

 

Keep this medicine out of sight and reach of children.

 

 

Addition of the following information to section 4.2 Posology and Method of Administration, Treatment of Scabies:

 

Use in adults and children over 2 months of age: -

In view of the great individual variability in body area and skin types precise recommendations are not possible. Children under 2 years: Do not use the product without medical supervision.

 

The product should not be applied to the head and face.

 

Use in the Elderly:

In the elderly Lyclear Dermal Cream should be used as directed for adults and children over 12 years but should also include the head, neck, scalp and ears.  Care must be taken to avoid applying Lyclear Dermal Cream to areas close to the eyes. Patients over 70 years should be treated under medical supervision.

 

 

Addition of the following statements to section 4.2 Posology and Method of Administration, treatment of Crab Lice:

 

Children under 18 should seek medical advice before using the product.

 

Patients over 70 years should be treated under medical supervision.

 

 

Addition of the following information to section 4.4 Special Warnings and Precautions for Use:

 

Lyclear Dermal Cream is for external use only and should be kept out of the sight and reach of children.

 

Permethrin is not an eye irritant, but contact of Lyclear Dermal Cream with the eyes should be avoided because other components of the product can 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.

 

In the event of accidental ingestion of permethrin, please seek immediate medical attention.

 

It is important to ensure that the course of treatment is followed as directed because treatment failure has been reported when this has not occurred.

 

 

Addition of the following statements to section 4.6 Fertility, pregnancy and lactation:

 

Pregnancy

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, less than 0.5% of the applied dose is absorbed. These data together with 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. Women who are pregnant should use permethrin only after prior consultation with a healthcare professional.

 

Lactation

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, although there are very limited data, which suggest that suckling infants are unaffected following maternal use of permethrin containing products.  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. Women who are breastfeeding should only use permethrin containing products after consultation with a healthcare professional.

 

 

Update the following section 4.7 Effect on ability to Drive and Use Machines:

 

Not applicable.Permethrin is unlikely to have any effects on the ability to drive and use machines.

 

 

Update the following section 4.9 Overdose:

 

On the basis of animal and human volunteer studies, it is unlikely, even with misuse or excessive topical application that the amount of permethrin required to produce clinically relevant toxic effects would be reached.

 

In the event of accidental ingestion of permethrin, please seek immediate medical attention.

 

Symptoms and Signs

There are no reports of overdosage with Lyclear Dermal Cream.

Symptoms of overdose are generally likely to occur primarily because of accidental or

deliberate oral ingestion due to swallowing and in rare cases because of skin absorption following excessive topical application and may include dizziness, loss of appetite,

 nausea, vomiting, headache, weakness, seizures, and loss of consciousness.

Application of a full tube of cream to a 2 month-old child would result in a dose of approximately 350 mg/kg bodyweight to the skin.  It is unlikely that such a dose would cause overt signs of systemic toxicity even if 100% of the permethrin was absorbed.

 

Updated on 02 September 2013

Reasons for updating

  • Change to, or new use for medicine
  • Change to storage instructions

Updated on 30 July 2012

Reasons for updating

  • Change of inactive ingredient

Updated on 27 July 2012

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

1.                  NAME OF THE MEDICINAL PRODUCT

 

Lyclear 5% w/w Dermal Cream

 

6.         PHARMACEUTICAL PARTICULARS

 

6.1       List of Excipients

 

Fractionated Coconut OilTriglycerides, medium chain

Glyceryol Monostearate, 90%

Macrogol (2) cetyl ether

Glycerol

Isopropyl Myristate

Liquid paraffin

Wool alcohols

Amerchol L-101

Cetomacrogol 1000

Carbomer 974P-NF

Formaldehyde Solution

Butylhydroxytoluene (E321)

Sodium Hydroxide

Purified Water

 

7.         MARKETING AUTHORISATION HOLDER

 

GlaxoSmithKline (Ireland) Limited,

Stonemasons Way,

Rathfarnham,

Dublin 16,

Ireland..

 

 

10.       DATE OF (PARTIAL) REVISION OF THE TEXT

 

MarchJuly 2012

Updated on 01 June 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to:

 

 

Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Updated on 30 October 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 09 November 2005

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Legal category:Supply through pharmacy only

Updated on 09 November 2005

Reasons for updating

  • Change to date of revision

Updated on 26 August 2005

Reasons for updating

  • Change of manufacturer

Updated on 06 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 03 July 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only