FYBOGEL
Active substance: ISPAGHULA HUSK
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fybogel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose sachet contains 3.5g ispaghula husk BP.
3
PHARMACEUTICAL FORM
Effervescent granules for preparation of an oral suspension
4
4.1
CLINICAL PARTICULARS
Therapeutic indications The treatment of patients requiring a high fibre regimen: for example, for the relief of constipation including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.
4.2
Posology and method of administration Fybogel should be stirred into a glass of water and taken as soon as effervescent subsides, preferably after meals. Adults and children over 12 years: Elderly: One sachet morning and evening. There is no indication the dosage need be modified for the elderly. Half to one level 5ml spoonful depending on size and age morning and evening.
Children 6-12 years:
Children under 6 years:
To be taken only when prescribed by a doctor. Half to one level 5ml spoonful depending on size and age morning and evening.
4.3
Contraindications Fybogel is contra-indicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile mega-colon.
4.4
Special warnings and precautions for use Due to its aspartame content, Fybogel should not be given to patients with phenylketonuria.
4.5
Interaction with other medicinal products and other forms of interaction None known
4.6
Pregnancy and lactation Fybogel may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.
4.7
Effects on ability to drive and use machines Not applicable in view of physical mode of action.
4.8
Undesirable effects None known
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.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Ispaghula husk is capable of absorbing up to 40 times it 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 with a consequent softening of the faeces.
5.2
Pharmacokinetic properties The mode of action of Fybogel is physical and does not depend on absorption into the systemic circulation.
5.3
Preclinical safety data No preclinical findings relevant to the prescriber have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Potassium bicarbonate Sodium bicarbonate Citric acid Riboflavin sodium phosphate Beta-carotene 10% (E160a) Aspartame Saccharin sodium Polysorbate 80 Silica, colloidal anhydrous USP Ph Eur Ph Eur Ph Eur HSE Ph Eur Ph Eur Ph Eur Ph. Eur
6.2
Incompatibilities None known
6.3
Shelf life Three years
6.4
Special precautions for storage Store below 30C in a dry place.
6.5
Nature and contents of container Sachets of paper/aluminium foil/polythene laminate enclosed in a cardboard outer carton. Pack size(s): Ten or thirty sachets (pack size printed in bold is currently sold).
6.6
Special precautions for disposal No special instructions.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0023
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/01/1990 / 09/06/2003
10
DATE OF REVISION OF THE TEXT
17/01/2007
1
NAME OF THE MEDICINAL PRODUCT
Fybogel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose sachet contains 3.5g ispaghula husk BP.
3
PHARMACEUTICAL FORM
Effervescent granules for preparation of an oral suspension
4
4.1
CLINICAL PARTICULARS
Therapeutic indications The treatment of patients requiring a high fibre regimen: for example, for the relief of constipation including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.
4.2
Posology and method of administration Fybogel should be stirred into a glass of water and taken as soon as effervescent subsides, preferably after meals. Adults and children over 12 years: Elderly: One sachet morning and evening. There is no indication the dosage need be modified for the elderly. Half to one level 5ml spoonful depending on size and age morning and evening.
Children 6-12 years:
Children under 6 years:
To be taken only when prescribed by a doctor. Half to one level 5ml spoonful depending on size and age morning and evening.
4.3
Contraindications Fybogel is contra-indicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile mega-colon.
4.4
Special warnings and precautions for use Due to its aspartame content, Fybogel should not be given to patients with phenylketonuria.
4.5
Interaction with other medicinal products and other forms of interaction None known
4.6
Pregnancy and lactation Fybogel may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.
4.7
Effects on ability to drive and use machines Not applicable in view of physical mode of action.
4.8
Undesirable effects None known
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.
5
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Ispaghula husk is capable of absorbing up to 40 times it 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 with a consequent softening of the faeces.
5.2
Pharmacokinetic properties The mode of action of Fybogel is physical and does not depend on absorption into the systemic circulation.
5.3
Preclinical safety data No preclinical findings relevant to the prescriber have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Potassium bicarbonate Sodium bicarbonate Citric acid Riboflavin sodium phosphate Beta-carotene 10% (E160a) Aspartame Saccharin sodium Polysorbate 80 Silica, colloidal anhydrous USP Ph Eur Ph Eur Ph Eur HSE Ph Eur Ph Eur Ph Eur Ph. Eur
6.2
Incompatibilities None known
6.3
Shelf life Three years
6.4
Special precautions for storage Store below 30C in a dry place.
6.5
Nature and contents of container Sachets of paper/aluminium foil/polythene laminate enclosed in a cardboard outer carton. Pack size(s): Ten or thirty sachets (pack size printed in bold is currently sold).
6.6
Special precautions for disposal No special instructions.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited Dansom Lane Hull HU8 7DS United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0023
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/01/1990 / 09/06/2003
10
DATE OF REVISION OF THE TEXT
17/01/2007
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
