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Fybogel Orange 3.5g Granules

  • Name:

    Fybogel Orange 3.5g Granules

  • Company:
    info
  • Active Ingredients:

    Ispaghula Husk

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/20

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Summary of Product Characteristics last updated on medicines.ie: 7/3/2017
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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1 - 0 of 64 items.Total: Infinity pages

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 SmPC

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

Updated on 7 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 18 April 2016 SmPC

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

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 SmPC

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 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 4.8 - 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).”

 

 

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 SmPC

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

Updated on 10 May 2007 SmPC

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 4 August 2006 SmPC

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 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 10 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale