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Rifater Tablets

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    IsoniazidPyrazinamideRifampicin

    *Additional information is available within the SPC or upon request to the company

Updated on 21 March 2024

File name

1.3.1 SmPC Rifater _ IES23.346 CCDS 13_clean_EOP texts.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 March 2024

File name

1.3.1 Rifater PIL_IES23.346 CCDS 13_clean_EOP texts.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 03 October 2022

File name

1.3.1 Rifater PIL-IES22 077_CCDS 12 FRHxxxxWS283 - clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 03 October 2022

File name

1.3.1 SmPC Rifater IES22 077_CCDS 12 FRHxxxxWS283 - photosensitivity_clean (1).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 July 2022

File name

1.3.1 Rifater PIL-IES21 143 CCDS 10 WS NL-H-xxxx-WS-529 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 05 July 2022

File name

1.3.1 SmPC Rifater IES21 143 CCDS 10 WS NL-H-xxxx-WS-529 Clean.pdf

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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 May 2022

File name

1.3.1 Rifater PIL Agnani SRL site name change_clean-.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 20 December 2021

File name

1.3.1 Rifater PIL IE 1304 Sodium excipient update 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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 17 December 2021

File name

1.3.1 SmPC Rifater IE1304 Sodium excipient wave 3 clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 December 2021

File name

1.3.1 SmPC Rifater IE 1261 CCDS 9.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 09 December 2021

File name

1.3.1 Rifater PIL IE 1261 CCDS 14.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 01 April 2021

File name

1.3.1 SmPC Rifater clean IE 1190 CCDS 8.pdf

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 April 2021

File name

crop Rifater 803061.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 06 July 2020

File name

Rifater 50mg 300mg 120mg Tablets Leaflet.pdf

Reasons for updating

  • XPIL Removed

Updated on 03 April 2020

File name

Rifater 50mg 300mg 120mg Tablets Leaflet.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 31 March 2020

File name

1.3.1 SmPC Rifater clean.pdf

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
  • 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 11 July 2019

File name

1.3.2 IE 668 PIL CCDS v5.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 July 2019

File name

1.3.1 SPC Rifater CCDS 5 IE 668.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The nature of the update concerns the revision of the following sections of the SPCs:

 

  • Section 4.3 Contra-indications & 4.5 Interactions with other Medicaments and other forms of Interaction -updated with the information on rifampicin interactions with hepatitis C therapy

 

  • Section 4.5 Interactions with other Medicaments and other forms of Interaction - is reorganized and updated to reflect a review which assessed rifampicin regarding its potential as a perpetrator of drug interactions, primarily via induction of drug metabolizing enzymes and transporters   (note a table outlining this has been added to the SmPC)

 

  • Section 4.5 of SPC updated regarding the analgesic effect of morphine accordance with  CMD guidance for Rifampicin containing products which states the following :

 

For medicinal products containing rifampicin, whose product information does not already have information on the topic, the following text should be included in section 4.5 of the SPC:

 

“Plasma concentrations of morphine may be reduced by rifampicin. The analgesic effect of morphine should be monitored and doses of morphine adjusted during and after treatment with rifampicin.”

Updated on 11 December 2018

File name

1.2.2 IE current approved PIL 89033354.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 05 September 2018

File name

Rifater PIL 89033354.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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings

Updated on 30 July 2018

File name

Rifater 50mg 300mg & 120mg Tablets SPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

 

  • Section 4.4 Special Warnings and Precautions for Use to include reference to severe bullous reactions

 

  • Section 4.8 Undesirable Effects to include adverse event acute generalized exanthematous pustulosis (AGEP)

Updated on 06 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 March 2018

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.4

Added:- produce discolouration (yellow, orange, red, brown) of the teeth

Removed:-reddish

Section 4.8

Gastrointestinal disorders:-

Added:-tooth discolouration(which may be permanent)

Investigations:-

Added:-(yellow, orange, red, brown) teeth.

Removed:-reddish

Added:-Endocrine disorders - Gynecomastia

Updated on 05 March 2018

File name

PIL_13413_157.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 March 2018

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 12 April 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Type II.C.1.4 Alignment of SmPC/Labelling with CCDSv2

Updated on 10 April 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 January 2016

Reasons for updating

  • 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

 

4.8.      Undesirable Effects

 

            The following CIOMS frequency rating is used, when applicable:

Very common (≥ 1/10); Common (≥ 1/100 to < 1/ 10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very rare (<1/10,000), not known (cannot be estimated from available data).

Updated on 20 January 2016

Reasons for updating

  • Change to side-effects

Updated on 07 January 2016

Reasons for updating

  • Change to side-effects

Updated on 27 June 2013

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 December 2012

Reasons for updating

  • Change to name of manufacturer

Updated on 13 May 2011

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to Sections 4.3, 4.5, 4.7, 4.8, 5.1 and 6.4 of the SPC

Updated on 12 May 2011

Reasons for updating

  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery

Updated on 20 January 2011

Reasons for updating

  • Improved electronic presentation

Updated on 25 July 2008

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 May 2008

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Update
Section 4.8 Undesirable Effects
Section 10 Date of Revision

Updated on 14 February 2007

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 November 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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

Update Section
1 - Change name to Rifater 50mg/300mg/120mg Tablets
2 - Addition of sucrose statement
7 - Change MAH to sanofi-aventis Ireland Ltd.
10 -  Date of revision

Updated on 02 August 2006

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Update sections -
4.3 - addition of contraindication when used with concurrently with ritonavir/saquinavir.
4.5 - addition of interaction when used with ritonavir/saquinavir.
4.8 - update skin reactions to include urticaria, pemphigoid reactions, erythema mulitforme including Stevens Johnson syndrome, toxic epidermal necrolysis, vasculitis and agranulocytosis.
4.9 - additional information on symptoms of overdose and supportive measures.
10 - change in date of revision of SPC.

Updated on 10 May 2005

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 April 2005

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 04 August 2004

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 4.8 - 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)

Updated on 17 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)