go to medicines.ie homepage
  • Home  |  
  • About  |  
  • Links  |  
  • Help
Font Size
Search for:  
select
select
  • SPCs and PILs
  • SPCs Only
  • PILs Only
  Advanced Search
  • What's
    New
      
  • Browse
    Medicines
      
  • Browse
    Active Ingredients
      
  • Browse
    Companies
      
  • Codes
    of Practice
      
  • Adverse
    Reaction Reporting

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299


Summary of Product Characteristics last updated on medicines.ie: 20/10/2009
SPC Fybogel Orange 3.5g Effervescent Granules

Table of Contents

  • 1. NAME OF THE MEDICINAL PRODUCT
  • 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
  • 3. PHARMACEUTICAL FORM
  • 4. CLINICAL PARTICULARS
  • 4.1 Therapeutic indications
  • 4.2 Posology and method of administration
  • 4.3 Contraindications
  • 4.4 Special warnings and precautions for use
  • 4.5 Interaction with other medicinal products and other forms of interaction
  • 4.6 Pregnancy and lactation
  • 4.7 Effects on ability to drive and use machines
  • 4.8 Undesirable effects
  • 4.9 Overdose
  • 5. PHARMACOLOGICAL PROPERTIES
  • 5.1 Pharmacodynamic properties
  • 5.2 Pharmacokinetic properties
  • 5.3 Preclinical safety data
  • 6. PHARMACEUTICAL PARTICULARS
  • 6.1 List of excipients
  • 6.2 Incompatibilities
  • 6.3 Shelf life
  • 6.4 Special precautions for storage
  • 6.5 Nature and contents of container
  • 6.6 Special precautions for disposal and other handling
  • 7. MARKETING AUTHORISATION HOLDER
  • 8. MARKETING AUTHORISATION NUMBER(S)
  • 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
  • 10. DATE OF REVISION OF THE TEXT


Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Fybogel Orange 3.5g Effervescent Granules


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

A unit dose (one sachet or two level 5 ml spoonfuls) contains 3.5g ispaghula husk.

Excipients: Also includes Aspartame (E951) 0.016g per unit dose.

For a full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Effervescent granules.

Orange flavoured flaky granules of orange to buff colour which after dispersion in water forms an effervescent suspension.


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

In the management of patients requiring a high-fibre regimen.


Go to top of the page
4.2 Posology and method of administration

Fybogel Orange is intended for oral use after suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as the effervescence subsides. Concentrated fruit juices or natural juice may be added to taste.

Adults and children over 12 years: One sachet or two level 5 ml spoonfuls each morning and evening, preferably after meals.

Elderly: There is no indication that dosage needs to be modified for the elderly.

Children 6 to 12 years: Half to one level 5 ml spoonful, depending on age and size, morning and evening.

Children under 6 years: To be taken only when prescribed by a doctor, half to one level 5ml spoonful, depending on age and size, morning and evening.


Go to top of the page
4.3 Contraindications

Fybogel Orange is contraindicated in cases of intestinal obstruction and colonic atony.


Go to top of the page
4.4 Special warnings and precautions for use

Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.

Adequate fluid intake should be maintained.


Go to top of the page
4.5 Interaction with other medicinal products and other forms of interaction

None known.


Go to top of the page
4.6 Pregnancy and lactation

Fybogel Orange may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.


Go to top of the page
4.7 Effects on ability to drive and use machines

None.


Go to top of the page
4.8 Undesirable effects

Flatulence and bloating may be experienced during the first few days of treatment, but diminish during continued treatment.


Go to top of the page
4.9 Overdose

In the event of overdosage conservative measures should be taken. The patient may notice abdominal discomfort and flatulence, and attention should be paid to maintaining an adequate fluid intake, particularly if the granules have been taken without water contrary to administration instructions.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

Ispaghula husk is capable of absorbing up to 40 times its own weight in water in vitro, and part of its activity can be attributed to its action as a simple bulking agent. In addition, colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass and consequent softening of the faeces.


Go to top of the page
5.2 Pharmacokinetic properties

The mode of action of Fybogel Orange is physical and does not depend on absorption into the systemic circulation.


Go to top of the page
5.3 Preclinical safety data

No relevant preclinical findings relevant to the prescriber have been reported.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipients

Potassium bicarbonate

Sodium bicarbonate

Citric acid anhydrous

Beta-carotene 10% CWS/S (E160a) (contains: Beta carotene, All-rac-alpha-tocopherol, Maize oil refined, Maize Starch and Modified food starch)

Riboflavin sodium phosphate

Aspartame E951

Orange Flavour

Saccharin Sodium

colloidal anhydrous silica

Polysorbate 80


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

2 years.


Go to top of the page
6.4 Special precautions for storage

Store below 30° C.

Multidose containers: Keep container tightly closed to protect from moisture.

Sachets: Store in the original package to protect from moisture.


Go to top of the page
6.5 Nature and contents of container

Sachets of paper/aluminium foil/polythene/surlyn laminate enclosed in a cardboard outer carton.

Carton containing 10 and 30 sachets.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 979/9/2


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 8th April, 1993

Date of last renewal: 8th April, 2008


Go to top of the page
10. DATE OF REVISION OF THE TEXT

May, 2009.



Link to this document from your website:
http://www.medicines.ie/medicine/1156/SPC/Fybogel+Orange+3.5g+Effervescent+Granules/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Legal Categories

 
   Product subject to medical
prescription which may not
be renewed (A)
   Product subject to medical
prescription which may
be renewed (B)
   Product subject to
restricted prescription
(C)
   Supply through
general sale
   Supply through
pharmacy only

Active Ingredients

 
   Ispaghula Husk

  • Terms & Conditions | 
  • Accessibility | 
  • Privacy Statement | 
  • Contact Us

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

This website is certified by Health On the Net Foundation. Click to verify.

This site complies with the HONcode standard for trustworthy health information: verify here.

logo