Zineryt powder and solvent for cutaneous solution
- Name:
Zineryt powder and solvent for cutaneous solution
- Company:
LEO Pharma
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/07/20
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LEO Pharma
Company Products
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 7 July 2020 PIL
Reasons for updating
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Reconstituted product described as a clear to hazy solution
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
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 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
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 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
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)
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)