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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: 08/04/2011
SPC Fybogel Citrus

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


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1. NAME OF THE MEDICINAL PRODUCT

Fybogel Citrus 3.5 g Effervescent Granules


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each single dose sachet contains 3.5 g ispaghula husk.

Excipients: each sachet contains 0.016g aspartame.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Effervescent granules.

Semi-transparent buff coloured granules with an odour of orange.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

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


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4.2 Posology and method of administration

Fybogel Citrus is intended for oral use after suspension in 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 5 ml spoonfuls each morning and evening, preferably after meals.

Elderly: There is no indication that dosage need 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 12 years: To be taken only when prescribed by a doctor. The usual dose is half to one level 5 ml spoonful, depending on age and size, morning and evening.


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4.3 Contraindications

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


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4.4 Special warnings and precautions for use

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

Adequate fluid intake should be maintained.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

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


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4.7 Effects on ability to drive and use machines

None.


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4.8 Undesirable effects

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


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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.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Ispaghula husk is capable of absorbing up to 40 times its own weight of 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.


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5.2 Pharmacokinetic properties

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


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5.3 Preclinical safety data

No preclinical findings relevant to the prescriber have been reported.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Citric acid anhydrous

Potassium hydrogen carbonate

Sodium hydrogen carbonate

Orange flavour

Aspartame E951

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

Riboflavin sodium phosphate

Saccharin sodium E954

Silica colloidal anhydrous

Polysorbate 80


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

2 years.


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6.4 Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.


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6.5 Nature and contents of container

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

Carton containing 2, 10 and 30 sachets.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special instructions.

The granules are semi-transparent and buff-coloured with an odour of orange which when added to water form an effervescent suspension.


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7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Limited

7 Riverwalk

Citywest Business Campus

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/9/1.


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 27th January 1975

Date of last renewal: 27th January 2010


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10. DATE OF REVISION OF THE TEXT

April 2011



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   Ispaghula Husk

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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

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