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: 18/02/21

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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 18 February 2021 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
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)