Mogadon 5mg Tablets
- Name:
Mogadon 5mg Tablets
- Company:
Mylan IRE Healthcare Limited
- 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: 28/09/18
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 28/9/2018
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Mylan IRE Healthcare Limited
Company Products
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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 28 September 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 28 September 2018 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)
Updated on 14 August 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 14 August 2018 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 4.8 – 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)
Updated on 16 April 2014 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
In section 4.2: There has been changes to the posology regarding insomnia with an additional warning for the elderly or debilitated patients. There has been an entry for other populations such as patients with chronic pulmonary insufficiency and patients with chronic renal and hepatic disease.
In section 4.3: There has been addition to the contraindications: namely the addition of hypersensitivity to the excipients, acute pulmonary insufficiency and in the short-term treatment of children
In section 4.4: Additional information has been added to the subsection dependence and the subsection amnesia.
In section 4.5: There has been additional information added to the interaction with other medicinal products and other forms of interaction
In section 4.6: Pregnancy, fertility and lactation have been divided into subsections and text has been amended.
In section 4.7: Warnings have been added to advise patients that performance at skilled tasks may be modified and that alcohol may intensify any impairment and there fore should be avoided
In section 4.8: the structure of the section for undesirable effects has been modified under the headings of frequency and the reporting of suspected adverse reactions has been added
In section 4.9: Additional information has been added regarding overdose.
In section 5.1: the ATC code has been added
In section 10: the date of revision has been added
In section 4.3: There has been addition to the contraindications: namely the addition of hypersensitivity to the excipients, acute pulmonary insufficiency and in the short-term treatment of children
In section 4.4: Additional information has been added to the subsection dependence and the subsection amnesia.
In section 4.5: There has been additional information added to the interaction with other medicinal products and other forms of interaction
In section 4.6: Pregnancy, fertility and lactation have been divided into subsections and text has been amended.
In section 4.7: Warnings have been added to advise patients that performance at skilled tasks may be modified and that alcohol may intensify any impairment and there fore should be avoided
In section 4.8: the structure of the section for undesirable effects has been modified under the headings of frequency and the reporting of suspected adverse reactions has been added
In section 4.9: Additional information has been added regarding overdose.
In section 5.1: the ATC code has been added
In section 10: the date of revision has been added
Updated on 16 April 2014 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 April 2014 PIL
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: There has been changes to the posology regarding insomnia with an additional warning for the elderly or debilitated patients. There has been an entry for other populations such as patients with chronic pulmonary insufficiency and patients with chronic renal and hepatic disease.
In section 4.3: There has been addition to the contraindications: namely the addition of hypersensitivity to the excipients, acute pulmonary insufficiency and in the short-term treatment of children
In section 4.4: Additional information has been added to the subsection dependence and the subsection amnesia.
In section 4.5: There has been additional information added to the interaction with other medicinal products and other forms of interaction
In section 4.6: Pregnancy, fertility and lactation have been divided into subsections and text has been amended.
In section 4.7: Warnings have been added to advise patients that performance at skilled tasks may be modified and that alcohol may intensify any impairment and there fore should be avoided
In section 4.8: the structure of the section for undesirable effects has been modified under the headings of frequency and the reporting of suspected adverse reactions has been added
In section 4.9: Additional information has been added regarding overdose.
In section 5.1: the ATC code has been added
In section 10: the date of revision has been added
In section 4.3: There has been addition to the contraindications: namely the addition of hypersensitivity to the excipients, acute pulmonary insufficiency and in the short-term treatment of children
In section 4.4: Additional information has been added to the subsection dependence and the subsection amnesia.
In section 4.5: There has been additional information added to the interaction with other medicinal products and other forms of interaction
In section 4.6: Pregnancy, fertility and lactation have been divided into subsections and text has been amended.
In section 4.7: Warnings have been added to advise patients that performance at skilled tasks may be modified and that alcohol may intensify any impairment and there fore should be avoided
In section 4.8: the structure of the section for undesirable effects has been modified under the headings of frequency and the reporting of suspected adverse reactions has been added
In section 4.9: Additional information has been added regarding overdose.
In section 5.1: the ATC code has been added
In section 10: the date of revision has been added
Updated on 9 March 2011 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011
In section 10: the date of revision has changed to Feb 2011
Updated on 9 March 2011 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
In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011
In section 10: the date of revision has changed to Feb 2011
Updated on 4 September 2009 PIL
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
None provided
Updated on 4 September 2009 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided