Cytotec 200 mcg Tablets
- Name:
Cytotec 200 mcg Tablets
- Company:
Pfizer Healthcare Ireland
- 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: 08/11/19

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Pfizer Healthcare Ireland

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 8 November 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 2 January 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 2 January 2019 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- 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
Variation Type IB EU PRAC Updates to SPC 4.3, 4.6 & 4.8)
Updated on 24 November 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 24 November 2016 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 21 January 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 January 2015 SPC
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 9 - Date of renewal of authorisation
- 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 SPC has been updated as follows.
Section 4.8 – New HPRA contact details added
Section 9 – Date of last renewal added
Section 10 – Date of last revision updated.Updated on 19 January 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 17 October 2013 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 September 2013 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
· 2 Qualitative and Quantitative composition
· 3 Pharmaceutical form
· 4.2 Posology and method of administration
· 4.3 Contraindications
· 4.4 Special warnings and precautions for use
· 4.5 Interactions with other medicinal product and other forms of interaction
· 4.6 Fertility, pregnancy and lactation
· 4.7 Effects on ability to drive and use machines
· 4.8 Undesirable effects
· 4.9 Overdose
· 5.1 Pharmacological properties
· 5.2 Pharmacokinetic properties
· 5.3 Preclinical safety data
· 6.1 List of excipients
· 6.6 Special precautions for disposal
· 7 Marketing Authorisation Holder
· 10 Date of revision of the text
Updated on 27 September 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
- Change of special precautions for disposal
- Improved electronic presentation
Updated on 21 February 2012 SPC
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
Updated on 20 December 2011 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 17 November 2011 SPC
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Updated on 20 October 2011 SPC
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
Updated on 19 October 2011 PIL
Reasons for updating
- Change to marketing authorisation holder
Updated on 6 January 2010 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 4 November 2009 SPC
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
SmPC - The date of renewal of the authorisation has been amended
Updated on 3 August 2009 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
Section 4.3
- Amendment of the wording of the contraindication in pregnancy to state that Cytotec is contraindicated in pregnant women and in women planning a pregnancy or in women whom pregnancy has not been exclude
- Addition of the contraindication; hypersensitivity to the active substance (misoprostol) any other prostaglandins or any of the excipients of Cytotec.
Section 4.4
- Addition of the following warnings for use in pregnancy
- Women of childbearing potential should not be started on misoprostol until pregnancy is excluded, and should be fully counselled on the importance of adequate contraception while undergoing treatment.
- If pregnancy is suspected the product should be discontinued.
Section 4.6
- Addition of information of the contraindication in pregnancy as well as an explanation of the effects of misoprostol in pregnancy.
Section 4.8
- Addition of side effects associated with the use of misoprostol for non-approved indications
Updated on 29 July 2009 PIL
Reasons for updating
- Change to date of revision
- Change to warnings or special precautions for use
- Change to side-effects
- Change due to user-testing of patient information
Updated on 14 November 2007 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 3 August 2007 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder address
Updated on 12 July 2006 PIL
Reasons for updating
- Change of licence holder
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 8 August 2005 SPC
Reasons for updating
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 10 November 2004 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 November 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 24 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)