E45 Cream

Summary of Product Characteristics last updated on medicines.ie: 6/12/2016
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Bonjela Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Bonjela Teething Gel Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution Active Ingredients Chloroxylenol
Medicine Name Disprin Active Ingredients Acetylsalicylic acid (Aspirin)
Medicine Name Disprin Direct 300mg Orodispersible Tablets Active Ingredients Aspirin
Medicine Name Disprin Extra Strength Active Ingredients Acetylsalicylic Acid
Medicine Name E45 Cream Active Ingredients Anhydrous Lanolin, Light Liquid Paraffin, White Soft Paraffin
Medicine Name Fybogel Citrus Active Ingredients Ispaghula Husk
Medicine Name Fybogel Mebeverine Active Ingredients Ispaghula Husk, Mebeverine Hydochloride
Medicine Name Fybogel Orange 3.5g Granules Active Ingredients Ispaghula Husk
Medicine Name Gaviscon Advance Oral Suspension Active Ingredients Potassium hydrogen carbonate, Sodium Alginate
Medicine Name Gaviscon Advance Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
Medicine Name Gaviscon Extra Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension 300ml Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Capsules with Caffeine Active Ingredients Caffeine, Paracetamol
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
Medicine Name Lemsip Cold & Flu Hot Lemon 500mg Powder for Oral Solution Active Ingredients Paracetamol
1 - 0 of 64 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 6 December 2016 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines

Free text change information supplied by the pharmaceutical company

Section4.4:
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"

Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin.  This could potentiate the hypotensive effects of vasodilators"

Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"

Updated on 6 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 6 December 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section4.4:
Addition of "Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard"

Section 4.5:
Addition of "The absorption of topical minoxidil can be increased by concurrent topical soft paraffin.  This could potentiate the hypotensive effects of vasodilators"

Section 4.7:
Text amended to read "This product has no or negligible influence on the ability to drive and use machines"

Updated on 14 April 2016 PIL

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Updated in line with CCDS

Updated on 14 April 2016 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Updated in line with CCDS

Updated on 17 December 2014 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Free text change information supplied by the pharmaceutical company

Addition of babies to section 4.2

Updated on 17 December 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Addition of babies to section 4.2

Updated on 30 March 2011 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.

In section 10, revison of text date changed to March 2011

Updated on 30 March 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 4.1 (therapeutic indication), "use as emollient adjunctive therapy in the treatment of dry cases of psoriasis" has been added.

In section 10, revison of text date changed to March 2011

Updated on 5 February 2010 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

All changes as a result of license renwal

Updated on 5 February 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

All changes as a result of license renwal

Updated on 21 August 2008 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Update to section 6.5 Nature and Contents of Containers

Updated on 21 August 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Update to section 6.5 Nature and Contents of Containers

Updated on 24 April 2008 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.

Updated on 24 April 2008 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Change to section 6.5 addition of 500g pump pack with pump piston airless dispenser.

Updated on 21 August 2007 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd

Updated on 21 August 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Change of MA holder and PA numer to Reckitt Benckiser Irelang Ltd

Updated on 9 June 2005 PIL

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Updated on 9 June 2005 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 27 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie