Fybogel Citrus
- Name:
Fybogel Citrus
- Company:
Reckitt Benckiser Ireland Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
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 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 31 July 2015 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 4.5 - 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
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 31 July 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 13 July 2015 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 30 August 2013 SPC
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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
In section 4.4 added: If symptoms persist, consult a doctor. Added: Adequate fluid intake should be maintained. Therefore, they should always be taken with at least 150ml of water or other liquid.
In section 4.5, added: Ispaghula and other bulk-forming laxatives may delay or reduce the gastrointestinal absorption of other drugs such as cardiac glycosides, coumarin derivatives, lithium, or vitamins (such as vitamin B12) and minerals (such as calcium, iron, or zinc).
In section 4.8, added: A small amount of flatulence and abdominal distension may sometimes occur.
In section 5.1 added ATC code.
In section 10, updated date of revision of the text.
Updated on 27 August 2013 PIL
Reasons for updating
- Change to drug interactions
- Change to dosage and administration
Updated on 4 June 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 26 April 2012 PIL
Reasons for updating
- New PIL for medicines.ie
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 pharmacy only
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).”
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 following text: See section 4.2
Updated on 8 April 2011 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 28 March 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Inclusion of the statement "each sachet contains 0.016g aspartame" and "for a full list of excipients see section 6.1"
6.2. Incompatibilities
replace "none known" with "not applicable"
6.4. Special Precautions for Storage
amended text from Store below 30°C. Store in the original package to "Do not store above 30°C. Store in the original package in order to protect from moisture."
6.5. Nature and Contents of Containers
inclusion of "not all pack sizes may be marketed"
6.6. Special precautions for disposal and other handling
inclusion of "The granules are semi-transparent and buff-coloured with an odour of orange which when added to water form an effervescent suspension"
Updated on 22 August 2008 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Supply through pharmacy only
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
Legal category: Supply through pharmacy only
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 pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.3 updated to add: 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 16 May 2005 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Updated on 10 August 2004 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Supply through pharmacy only
Updated on 16 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only