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Cytotec 200 mcg Tablets

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Pharmacy Only: Prescription

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

Improved electronic presentation

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

Changes to amend a typo and also to align two headings.

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

Updates to sections 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction), 4.6 (Pregnancy and lactation), 4.8 (Undesirable effects), 4.9 (overdose) and 10.0 (Date of partial revision of the text) of the SPC

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

SmPC Updates to sections:  7 (Marketing Authorization holder); 10 (Date of partial revision of the text) 

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)