E45 Cream
- Name:
E45 Cream
- Company:
Reckitt Benckiser Ireland Limited
- Active Ingredients:
Anhydrous Lanolin, Light Liquid Paraffin, White Soft Paraffin
- Legal Category:
Supply through general sale
Summary of Product Characteristics last updated on medicines.ie: 6/12/2016
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Reckitt Benckiser Ireland Limited
Company Products
Items Per Page :
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"
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"
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
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
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