Fybogel
Out of date information, search another1. NAME OF THE MEDICINAL PRODUCT
Fybogel Orange.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
A unit dose (one sachet or two level 5 ml spoonfuls) contains 3.5 g ispaghula husk BP.
3. PHARMACEUTICAL FORM
Effervescent granules.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
The treatment of patients requiring a high fibre regime: 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 Orange is intended for oral use as a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as the effervescence subsides, preferably after meals.
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.
Adults and children over 12 years: One sachet or two level 5ml spoonfuls morning and
evening
Elderly: There is no indication that dosage needs to be modified
for the elderly.
Children aged 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 5 ml spoonful depending on age and size, morning and evening
The last dose should not be taken immediately before going to sleep
If there has been no bowel movement after three days of treatment the doctor should be
consulted.
4.3 Contraindications
Fybogel Orange is contra-indicated in cases of intestinal obstruction, faecal impaction. Natural or drug-induced reduction of gut motility and colonic atony such as senile megacolon.
Hypersensitivity to the active substance or to any of the excipients in the product (See Section 4.4 Special warnings and precautions for use),
4.4. Special Warnings and Special Precautions for Use
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).
Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.
If symptoms persist consult a doctor.
Adequate fluid intake should be maintained. Therefore, they should always be taken with at least 150 mL of water or other liquid. The last dose should not be taken immediately before going to sleep since impaired or reduced gastric motility may impair the intestinal passage and then cause sub-obstruction.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
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).
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.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable effects
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).
A small amount of flatulence and abdominal distension may sometimes occur.
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. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: A06AC01
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 Orange is physical and does not depend on absorption into the systemic circulation.
Pre-clinical Safety Data
5.3.
No preclinical findings relevant to the prescriber have been reported.
6.1. List of Excipients
|
Potassium bicarbonate |
USP |
|
Sodium bicarbonate |
Ph Eur |
|
Citric acid |
Ph Eur |
|
Riboflavin sodium phosphate |
Ph Eur |
|
Beta-carotene 10% (E160a) |
HSE |
|
Aspartame |
Ph Eur |
|
Orange flavour |
HSE |
|
Saccharin sodium |
Ph Eur |
|
Polysorbate 80 |
Ph Eur |
|
Silica, colloidal anhydrous |
Ph. Eur |
|
Incompatibilities | |
|
None known. | |
|
Shelf-Life | |
|
Three years. | |
|
Special Precautions for Storage | |
|
Store below 30°C in a dry place. |
6.5. Nature and Content of Container
Sachets, one, seven, ten or thirty sachets enclosed in a carton. Tub containing 100-300 g Fybogel Orange.
6.6.
Instructions for Use, Handling and Disposal
Fybogel Orange granules are to be dispersed in water forming a drink.
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS.
8. MARKETING AUTHORISATION NUMBER(S)
PL 00063/0026
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
24th April 1995 / 26th June 1997.
10 DATE OF REVISION OF THE TEXT
11/03/14