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Rifinah 300/150mg film-coated 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):

    IsoniazidRifampicin

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

Updated on 21 March 2024

File name

IE 1.3.1 Rifinah 300mg SmPC _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

IE 1.3.1 Rifinah 300mg 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 March 2023

File name

IE 1.3.1 Rifinah 300mg SmPC Clean IE S21.617.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 03 March 2023

File name

1.3.1 Rifinah 300mg PIL.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 05 July 2022

File name

1.3.1 Rifinah 300mg 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 Rifinah 300mg SmPC - 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 Rifinah 300mg 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 09 December 2021

File name

Rifinah 300mg SmPC IE 1261- CCDS 9- updated to reflect HPRA approval date.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 Rifinah 300mg PIL- IE 1261 PIL text CCDS9.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 06 April 2021

File name

1.3.1 - Rifinah SPC - 300mg 150mg - clean CCDS 8 IE1190.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 06 April 2021

File name

crop Rifinah 300mg 150mg 802992.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 01 April 2021

File name

crop Rifinah 300mg 150mg 802992.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 Rifinah 300mg 150mg 802992.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

Rifinah PIL 300mg 150mg 749483 Rifinah PIL - CCDS 5 6 7 IE 669, IE719 IE917 clean PIL.pdf

Reasons for updating

  • XPIL Removed

Updated on 31 March 2020

File name

1.3.1 Full SPC - Rifinah SPC - 300mg 150mg - CCDS 5 6 7 IE 669, IE719 IE917 clean 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)

Updated on 31 March 2020

File name

Rifinah PIL 300mg 150mg 749483 Rifinah PIL - CCDS 5 6 7 IE 669, IE719 IE917 clean PIL.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 February 2020

File name

1.2.2 Full SPC (PDF) - SPC - 300mg 150mg - clean includes ccds 5, 6 only .pdf

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 4.8 - 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)

Free text change information supplied by the pharmaceutical company

For variation:

 

This VAN relates to the approval of CCDS 5 & 6 and SmPC alignment DDI Morphine- PRAC recommendation, details for which are outlined below:  

 

TII C.1.4. variation - CCDS V5 -impacts section 4.3 & 4.5  

 

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  

 

 

TII C.1.4. variation - CCDS V6 - section 4.4,4.5 & 4.8.

 

The nature of the update concerns the revision of the SPCs to include reference to the adverse biological effect of rifampicin and cefazolin when administered concurrently, which may lead to severe coagulation disorders including those with fatal outcome.

 

As a direct result the following sections of the SPCs have been updated as outlined below:

 

  • Section 4.4 Special Warnings and Special Precautions for Use

Updated to include reference to vitamin K dependent coagulopathy and severe bleeding.

  • Section 4.5 Interactions with other Medicaments and other forms of Interaction Updated to include reference to concomitant use of rifampicin and other antibiotics causing vitamin K dependent coagulopathy such as cefazolin should be avoided as it may lead to severe coagulation disorders, which may result in fatal outcome.
  • Section 4.8 Undesirable effects

Updated to include references to AEs Vitamin K dependent coagulation disorders, bleeding.  

 

DDI Morphine- alignment with PRAC recommendation: (submitted as part of CCDS 5)

 

Update to section 4.5 of the SmPCs to reference the analgesic effect of morphine.  The proposed update is aligned 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.”

 

 

In addition to the above the Malta reporting details have been added to the PIL to support shared supply

Updated on 12 September 2018

File name

Rifinah 300mg 89033355.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 August 2018

File name

Rifinah 300150mg Film-coated Tablets - SPC - 300mg 150mg - CCDS V4 clean.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)

Free text change information supplied by the pharmaceutical company

Approval of a type II C.1.4 variation for the above mentioned product to update the SPC in accordance with CCDS V4.  The nature of the update concerns the revision of the following sections of the SPC:

 

  • 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 04 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 04 April 2018

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3 Shelf Life reduced from 4 years to 3 years.

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

File name

PIL_8407_936.pdf

Reasons for updating

  • New PIL for new product

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

Removed:-reddish

Section 4.8

Gastrointestinal disorders

Added  Unknown:-tooth discolouration(which may be permanent)

Added Endocrine disorders - Gynecomastia

Updated on 06 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 - date of revision

Updated on 18 April 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

Updated on 21 December 2015

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 18 December 2015

Reasons for updating

  • Change to side-effects

Updated on 08 December 2015

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

Section 4.8

 

            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).


 

Gastrointestinal disorders

frequency not known: Pancreatitis ,

nausea, vomiting, epigastric distress.

 

Hepatobiliary disorders

Severe and sometimes fatal hepatitis

Uncommon: hepatitis

 

Skin and subcutaneous tissue disorders

Rash, acne, Stevens-Johnson syndrome, exfoliative dermatitis, pemphigus.

Rare: toxic epiderman necrolysis, eosinophilia systemic symptoms

Updated on 16 May 2014

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

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 11 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 16 May 2008

Reasons for updating

  • Improved electronic presentation
  • Change due to harmonisation of patient information leaflet

Updated on 19 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 10 November 2006

Reasons for updating

  • Change of licence holder

Updated on 10 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 02 February 2005

Reasons for updating

  • Improved electronic presentation

Updated on 18 November 2004

Reasons for updating

  • Change of active ingredient
  • Improved electronic presentation

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie