Rifadin 300mg Capsules
*Company:
SANOFIStatus:
No Recent UpdateLegal 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 25 September 2024
File name
1.3.1 Rifadin 300mg Capsules SmPC IE (1).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 25 September 2024
File name
1.3.1 Rifadin 300mg Capsules PIL Text IE (1).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 12 September 2024
File name
1.3.1 Rifadin 300mg Capsules SmPC IE.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)
Updated on 12 September 2024
File name
1.3.1 Rifadin 300mg Capsules PIL Text IE.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 21 March 2024
File name
1.3.1 Rifadin 300mg Capsules PIL- IES23.346 CCDS 18_clean_EOP texts.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 March 2024
File name
1.3.1 - Rifadin 300mg Capsules Full SPC - IES23.346 CCDS 18_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 05 July 2022
File name
1.3.1 Rifadin 300mg Capsules PIL- IES21 143 CCDS 15 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 - Rifadin 300mg Capsules Full SPC - IES21 143 CCDS 15 WS NLHxxxxWS529_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 Rifadin 300mg Capsules 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 Rifadin 300mg Capsules PIL- IE1304 Sodium Excipient wave 3 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 - Rifadin 300mg Capsules Full SPC - 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 - Rifadin 300mg Capsules Full SPC - CCDS 14 IE 1261.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 Rifadin 300mg Capsules PIL- IE1261-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
crop EG09088 Rifadin 300 Leaflet Ireland 801043 vs1.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 01 April 2021
File name
1.3.1 - Rifadin 300mg Capsules Full SPC clean - CCDS 13 IE 1190.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 March 2020
File name
Rifinah PIL 300mg 150mg 749483.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 02 December 2019
File name
Rifadin 300mg SmPC.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 December 2019
File name
Rifadin 300mg PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
Updated on 21 June 2019
File name
PIL Rifadin 300 IE667.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
Updated on 21 June 2019
File name
SPC Rifadin 300mg capsules IE667.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
- 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 :
Updated on 05 September 2018
File name
PIL_8403_846.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
Updated on 23 August 2018
File name
Rifadin 300mg Capsules Full SPC (PDF) - SPC - 300mg - CCDS v9 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
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 03 August 2018
File name
Rifinah 300150mg Film-coated Tablets SPC (2).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
Severe and sometimes fatal hepatitis associated with isoniazid therapy may occur and may develop even after many months of treatment. The risk of developing hepatitis is age related. Therefore, patients should be monitored for the prodromal symptoms of hepatitis, such as fatigue, weakness, malaise, anorexia, nausea or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage.
Severe cutaneous reactions:
Cases of severe cutaneous reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some with a fatal outcome, have been reported with the use of isoniazid (See section 4.8). Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs or symptoms of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) develops, the patient should be advised to consult immediately their physician. Isoniazid should be permanently discontinued if an alternative etiology for the signs and symptoms cannot be established
Cases of severe bullous skin reactions such as Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) have been reported with rifampicin (See section 4.8). If symptoms or signs of AGEP, SJS or TEN are present, rifampicin treatment must immediately be discontinued.
Skin and subcutaneous tissue disorders
Unknown: Erythema multiforme, including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome (See section 4.4), skin
Updated on 30 July 2018
File name
Rifadin 300mg Capsules 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_8403_846.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 30 March 2017
Reasons for updating
- 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 15 March 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- 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 - CCDSv7 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet due to new quality, pre-clinical, clinical or pharmacovigilance data |
Updated on 08 March 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 01 July 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Type 1B No. C.I.3.a bulk variation to update SPC section 4.2 to reflect the dosing recommendations of the above mentioned products in line with the conclusion of the European Medicines Agency (EMA) review of World Health Organisation dosing recommendations for anti-tuberculosis medicines used in children.
Updated on 26 June 2014
Reasons for updating
- Change to dosage and administration
Updated on 27 March 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 July 2011
Reasons for updating
- Improved electronic presentation
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 28 January 2005
Reasons for updating
- Improved electronic presentation
Updated on 19 August 2004
Reasons for updating
- New PIL for medicines.ie