Fybogel Orange 3.5g Granules
*Company:
Reckitt Benckiser Ireland LimitedStatus:
UpdatedLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 April 2024
File name
Fybogel Orange PIL Medicines.ie.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 06 August 2021
File name
PIL Fybogel Orange.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 06 August 2021
File name
SPC Fybogel Orange.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 06 August 2021
File name
PIL Fybogel Orange.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 15 January 2020
File name
Fybogel Orange.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 15 January 2020
File name
Fybogel Orange.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 March 2017
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 07 March 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updates to the following sections:
Section 2 - Qualitative and Quantitative composition
Addition of (E951)
Section 6.1 List of excipients
Change to Potassium bicarbonate to Potassium hydrogen carbonate
Section 6.5 Nature and contents of container
Addition of Not all pack sizes may be marketed.
Section 10 Date of Revision of the text
Change to date from February 2016 to February 2017
Section 2 - Qualitative and Quantitative composition
Addition of (E951)
Section 6.1 List of excipients
Change to Potassium bicarbonate to Potassium hydrogen carbonate
Section 6.5 Nature and contents of container
Addition of Not all pack sizes may be marketed.
Section 10 Date of Revision of the text
Change to date from February 2016 to February 2017
Updated on 18 April 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 2- Administrative corrections
Section 3- Minor change to pharmaceutical form
Section 4.1 - Indication has been updated to a constipation indication
Section 4.2 - Fybogel Orange should be stirred into a minimum of 240mL of water. It is not recommended for children under 6. Addtional precauationary statement included.
Section 4.3- Additional contraindication warnings have been added.
Section 4.4 - This section has been subtantially updated to align with company current safety information
Section 4.5 - addition of statement for diabetic patients and patients on thyroid hormones
section 4.6 - Administrative updates
Section 4. 8 - updated for easier readability
section 4.9 - Addition of managment of overdose
section 5.1 - updated to align with current company information
section 5.2 - updated to align with current company information
section 5.3 - updated to align with current company information
Section 3- Minor change to pharmaceutical form
Section 4.1 - Indication has been updated to a constipation indication
Section 4.2 - Fybogel Orange should be stirred into a minimum of 240mL of water. It is not recommended for children under 6. Addtional precauationary statement included.
Section 4.3- Additional contraindication warnings have been added.
Section 4.4 - This section has been subtantially updated to align with company current safety information
Section 4.5 - addition of statement for diabetic patients and patients on thyroid hormones
section 4.6 - Administrative updates
Section 4. 8 - updated for easier readability
section 4.9 - Addition of managment of overdose
section 5.1 - updated to align with current company information
section 5.2 - updated to align with current company information
section 5.3 - updated to align with current company information
Updated on 04 August 2015
File name
PIL_14615_929.pdf
Reasons for updating
- New PIL for new product
Updated on 04 August 2015
Reasons for updating
- Change of trade or active ingredient name
Updated on 24 July 2015
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Removal of effervescent from pharmacetical form. Thus, product name was also updated to Fybogel Orange 3.5g Granules.
Updated on 14 March 2012
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 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.2:
Included the following text: When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimize the risk of sensitization to the active ingredient
Section 4.3:
Included the following text: Hypersensitivity to the active substance ispaghula husk, or to any of the excipients listed on section 6.1 (see 4.4 Special warnings and precautions for use)
Section 4.4:
Included the following text: Warning on hypersensitivity reactions In individuals with continued occupational contact to powder of Plantago ovata seeds (i.e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals. This sensitization usually leads to hypersensitivity reactions which could be serious (see 4.8 Undesirable effects).It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests.In case of proven sensitization leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (see 4.3 Contraindications).”
Included the following text: When preparing the product for administration, it is important to try to avoid inhaling any of the powder in order to minimize the risk of sensitization to the active ingredient
Section 4.3:
Included the following text: Hypersensitivity to the active substance ispaghula husk, or to any of the excipients listed on section 6.1 (see 4.4 Special warnings and precautions for use)
Section 4.4:
Included the following text: Warning on hypersensitivity reactions In individuals with continued occupational contact to powder of Plantago ovata seeds (i.e. healthcare workers, caregivers) allergic sensitization may occur due to inhalation, this is more frequent in atopic individuals. This sensitization usually leads to hypersensitivity reactions which could be serious (see 4.8 Undesirable effects).It is recommended to assess clinically the possible sensitization of individuals at risk and, if justified, to perform specific diagnostic tests.In case of proven sensitization leading to hypersensitivity reactions, exposure to the product should be stopped immediately and avoided in the future (see 4.3 Contraindications).”
Section 4.8
Included the following text: Ispaghula/psyllium husk contains potent allergens. The exposure to these allergens is possible through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation.
As a consequence to this allergic potential, individuals exposed to the product can develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxia. Cutaneous symptoms as exanthema and/or pruritus have also been reported. Special attention should be given to individuals manipulating the powder formulations routinely (see 4.4 Special warnings and precautions for use).
Section 6.6:
Included the followint text: See section 4.2
Updated on 13 March 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 25 March 2010
Reasons for updating
- New PIL for medicines.ie
Updated on 20 October 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 1 - strength added to name
Section 9 - date of renewal updated
Section 9 - date of renewal updated
Updated on 10 May 2007
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 6.1 - List of excipients
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
SECTION 1: Deletion of contraindication in patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase isomaltase insufficiency. Deletion of contraindication in patients allergic to peanut or soya.
SECTION 6.1: Change to beta-carotene content to 10% CWS/S and change to beta-carotene content to include - beta carotene, All-rac-alpha-tocopherol, Maize oil refined, Maize starch and Modified food starch. Addition of excipient, riboflavin sodium phosphate. Change of excipient 'colloidal silica' to 'Silica, colloidal anhydrous'.
SECTION 7: Change of address of Marketing Authorisation Holder to - 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.
SECTION 9: Update of renewal date to 8 April 2003.
Updated on 04 August 2006
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 4.3: Addition of : Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Patients allergic to peanut or soya should not take this medicine.
Updated on 01 July 2005
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 10 August 2004
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 24 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 16 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale