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Acnecide Gel 5%

  • Name:

    Acnecide Gel 5%

  • Company:
    info
  • Active Ingredients:

    Benzoyl Peroxide, hydrous

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/09/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 21/9/2017
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Galderma International S.A.S. c/o Galderma (U.K) Ltd.

Galderma (U

Company Products

Medicine NameActive Ingredients
Medicine Name Acnecide Gel 5% Active Ingredients Benzoyl Peroxide, hydrous
Medicine Name Azzalure Active Ingredients Botulinum Toxin Type A
Medicine Name Calmurid Cream Active Ingredients Lactic Acid, Urea
Medicine Name Calmurid HC Cream Active Ingredients Hydrocortisone, Lactic Acid, Urea
Medicine Name Curanail 5% w/v Medicated Nail Lacquer Active Ingredients Amorolfine Hydrochloride
Medicine Name Differin Cream 0.1% w/w Active Ingredients Adapalene
Medicine Name Differin Gel Active Ingredients Adapalene
Medicine Name Efracea capsules Active Ingredients Doxycycline monohydrate
Medicine Name Epiduo 0.1%/2.5% Gel Active Ingredients Adapalene, Benzoyl Peroxide
Medicine Name Etrivex 500 micrograms/g Shampoo Active Ingredients Clobetasol Propionate
Medicine Name Loceryl Nail Lacquer Active Ingredients Amorolfine Hydrochloride
Medicine Name Metvix Cream Active Ingredients Methyl Aminolevulinate Hydrochloride
Medicine Name Mirvaso 3mg/g Gel Active Ingredients brimonidine tartrate
Medicine Name Rozex Cream Active Ingredients Metronidazole
Medicine Name Rozex Gel Active Ingredients Metronidazole
Medicine Name Silkis Ointment Active Ingredients Calcitriol
Medicine Name Soolantra 10 mg/g Cream Active Ingredients Ivermectin
Medicine Name Tetralysal 300 Capsules Active Ingredients Lymecycline
1 - 0 of 18 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 21 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 21 September 2017 SmPC

Reasons for updating

  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • 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 4.2 - Update to method of administration
Section 4.3 - QRD change
Section 4.4 - Addition of warning regarding swelling/blistering of the skin
Section 4.6 - Restructuring/Rewording of the section 
Section 4.8 - Addition of ADRs regarding allergic reactions
Section 4.9 - Restructuring/rewording of the section
Section 5.3 - Restructuring/Rewording of the section
Section 10 - Updated revision date

Updated on 20 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 September 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • 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 8 April 2015 PIL

Reasons for updating

  • Product/presentation re-marketed

Updated on 10 October 2013 PIL

Reasons for updating

  • Change to further information section

Updated on 9 September 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

In section 3 (pharmaceutical form), off-white has been added to the apprearance of the gel.

Updated on 13 June 2011 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 3 June 2011 SmPC

Reasons for updating

  • 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

Addition of 30g pack size.

Updated on 1 April 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 4 March 2011 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The shelf life of the product has been reduced from 36 months to 24 months.

Updated on 2 February 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

The adverse events listed in section 4.8 have been presented in a table accroding to system organ class and frequency of occurence. Some additional adverse events have also been added to the table in section 4.8.

Updated on 9 July 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 25 February 2008 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to section 4.4 - Special Warnings and Special Precautions for Use

Updated on 19 March 2007 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 30 August 2006 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 Change of office address from Galderma House, Church Lane, Kings Langley, Herts, WD4 8 JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS

Updated on 16 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only