Cytotec 200 mcg Tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 16 October 2024
File name
Reg SPC CZ 14_0 IE clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 October 2024
File name
Reg PIL CZ 200mcg 17_0 IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 07 June 2024
File name
Reg PIL CZ 200mcg 16_0 IE clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 February 2023
File name
DEC202126733_Reg SPC CZ 13_0 IE clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 April 2021
File name
DEC202126733_Reg SPC CZ 13_0 IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
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 4.4 update to excipient warning for sodium |
Updated on 21 April 2021
File name
DEC202126733_Reg PIL CZ 200mcg 15_0 IE clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 18 February 2021
File name
DEC202105528_Reg PIL CZ 200mcg 15_0 IE clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 November 2019
File name
DEC201961941_Reg PIL CZ 200mcg 14_0 IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 02 January 2019
File name
DEC201900049_Reg PIL CZ 200mcg 13_0 IE.Clean.pdf
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 02 January 2019
File name
DEC201900049_Reg SPC CZ 12_2 IE _1.Clean.pdf
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
File name
PIL_9204_875.pdf
Reasons for updating
- New PIL for new product
Updated on 24 November 2016
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
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
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
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 17 October 2013
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
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
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
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
Reasons for updating
- Correction of spelling/typing errors
Updated on 17 November 2011
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
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
Reasons for updating
- Change to marketing authorisation holder
Updated on 06 January 2010
Reasons for updating
- Change to name of manufacturer
Updated on 04 November 2009
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 03 August 2009
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
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
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 03 August 2007
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder address
Updated on 12 July 2006
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 08 August 2005
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
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
Reasons for updating
- New PIL for medicines.ie
Updated on 24 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)