Rifater Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/20

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Summary of Product Characteristics last updated on medicines.ie: 31/3/2020

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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 3 April 2020 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 11 July 2019 SmPC

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 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 5 September 2018 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 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 SmPC

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 6 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 March 2018 SmPC

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 5 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 March 2018 PIL

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 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 7 January 2016 PIL

Reasons for updating

  • Change to side-effects

Updated on 27 June 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 December 2012 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 13 May 2011 SmPC

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 PIL

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 July 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 May 2008 SmPC

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 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 8 November 2006 SmPC

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 2 August 2006 SmPC

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 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 15 April 2005 SmPC

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 4 August 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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