Fybogel Orange 3.5g Granules
- Name:
Fybogel Orange 3.5g Granules
- Company:
Reckitt Benckiser Ireland Limited
- Active Ingredients:
- Legal Category:
Supply through general sale
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/20


Print ViewKeyword Search SPC
1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Reckitt Benckiser Ireland Limited

Company Products
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 15 January 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 15 January 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 7 March 2017 SPC
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
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 7 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale
Updated on 18 April 2016 SPC
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 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 4 August 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 4 August 2015 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 24 July 2015 SPC
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
Updated on 14 March 2012 SPC
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
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 25 March 2010 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 20 October 2009 SPC
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 9 - date of renewal updated
Updated on 10 May 2007 SPC
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
Updated on 4 August 2006 SPC
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 1 July 2005 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through general sale
Updated on 10 August 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through general sale
Updated on 24 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale
Updated on 16 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale