Fybogel Citrus *

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 05 August 2021

File name

SPC Fybogel Citrus_1628164037.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

Updated on 05 August 2021

File name

IE SPC Fybogel Citrus (clean Jan21) - CRN009ZSF_1628163838.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through pharmacy only

Updated on 05 August 2021

File name

Fybogel Citrus_1628163615.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 August 2015

File name

PIL_15354_222.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 31 July 2015

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

Updates have been made to the SmPC to align with current company safety information

Updated on 31 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 13 July 2015

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

Name and pharaceutical form updated to remove "Effervescent"

Updated on 30 August 2013

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 4.3 added: Natural or drug-induced reduction of gut motility.

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

Reasons for updating

  • Change to drug interactions
  • Change to dosage and administration

Updated on 04 June 2013

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

In section 4.2, changed "Children under 12 years" to "Children under 6 years: To be taken only when prescribed by a doctor."

Updated on 26 April 2012

Reasons for updating

  • New PIL for medicines.ie

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 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 08 April 2011

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

Section 10 updated to revise date of revision of text from March 2011 to April 2011 (due to schedule correction)

Updated on 28 March 2011

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

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3: Removal of contraindications of patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption  or sucrase isomaltase insufficiency and patients allergic to peanut or soya.
 
Section 6.1: Correction of beta-carotene level to 10% CWS/S and contents to include beta carotene, all-rac-alpha-tocopherol, maize oil refined, maize starch and modified food starch.  Addition of excipient of riboflavin sodium phosphate.
 
Section 7:  Change of address of Marketing Authorisation Holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Updated on 04 August 2006

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

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only