Zineryt powder and solvent for cutaneous solution

  • Name:

    Zineryt powder and solvent for cutaneous solution

  • Company:
    info
  • Active Ingredients:

    Erythromycin, Zinc acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/07/19

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Summary of Product Characteristics last updated on medicines.ie: 9/1/2019

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LEO Pharma

LEO Pharma

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26 - 40 of 40 items.Total: 2 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 10 July 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 28 June 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 9 January 2019 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Date of revision of the text has been updated - no other changes are made to the document.

Updated on 18 September 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer

Updated on 18 September 2018 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

1: The product name has been updated to Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution.

2: the active substance name has been updated to zinc acetate dehydrate

4.4: The following PRAC warning has been added:

As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

 

4.8: AGEP (acute generalised exanthematous pustulosis) has been added.

Updated on 24 July 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 July 2017 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 20 July 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 July 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Added street name and number to address of MAH

Updated on 29 June 2017 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 Change of MA Holder, from LEO Pharma A/S Denmark to LEO Laboratories, Dublin
Section 8 Change of MA Number - is now PA 0046/065/001
Section 10 Change of date of revision of text

Updated on 23 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 3 February 2017 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 31 October 2016 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 25 October 2016 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 2 July 2015 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8
Include HPRA e-mail address 'medsafety@hpra.ie' in Reporting of Suspected Adverse Reactions section.

Updated on 26 May 2015 SmPC

Reasons for updating

  • 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: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The HPRA contact details for side-effect reporting have been updated to reflect the name change from IMB to HPRA
The date of revision is updated to May 2015

Updated on 21 May 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 3 July 2013 SmPC

Reasons for updating

  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

correction of spacing errors

Updated on 25 February 2013 PIL

Reasons for updating

  • Change of manufacturer

Updated on 12 October 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 12 September 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 16 August 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 25 July 2012 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change Detail

 

7              Marketing Authorisation Holder

 

Astellas Pharma Co Ltd

5 Waterside

Citywest Business Campus

Naas Road

Dublin 24

Ireland

Updated on 10 April 2012 PIL

Reasons for updating

  • Change to information about pregnancy or lactation
  • Improved electronic presentation

Updated on 7 December 2011 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.6       Pregnancy and lactation

 

 

 

Human experience with oral erythromycin suggests that erythromycin can cause congenital malformations, such as cardiovascular malformations and pyloric stenosis, when administered during pregnancy.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

Zineryt® should not be used during pregnancy unless the clinical condition of the woman requires treatment with erythromycin.

It is recommended that the preparation should only be used with caution in lactating women who are breast feeding, and on areas away from the chest.

Updated on 20 August 2008 PIL

Reasons for updating

  • Change to improve clarity and readability
  • Change to date of revision

Updated on 15 February 2008 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section 2: (QUALITATIVE AND QUANTITATIVE COMPOSITION) “For excipients, see 6.1” was changed to read “For a full list of excipients, see section 6.1”

 

Section 6.3: (Shelf life) “2 years; 5 weeks after constitution” updated to read “Unopened: 2 years. Upon reconstitution: Use within 5 weeks “

 

Section 6.6: heading changed to read “Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product.”

 

 

Section 9: (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION) date of last renewal updated to 17th Dec 2007.

 

Section 10: (DATE OF REVISION OF THE TEXT) updated to December 2007.

 

 

Updated on 28 June 2006 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: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7: Marketing Authorisation Holder changed from Yamanouchi to Astellas Pharma Co. Ltd

 

Section 8: Marketing Authorisation Number changed to 1241/10/1

 

Section 10: Date of Revision of the Text changed to September 2005

Updated on 26 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)