FYBOGEL ORANGE

Active substance: ISPAGHULA HUSK

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1.

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.

5.3.

Pre-clinical Safety Data
No preclinical findings relevant to the prescriber have been reported.

6.1.

List of Excipients
Potassium bicarbonate
Sodium bicarbonate
Citric acid
Riboflavin sodium phosphate
Beta-carotene 10% (E160a)
Aspartame
Orange flavour
Saccharin sodium
Polysorbate 80
Silica, colloidal anhydrous

6.2.

USP
Ph Eur
Ph Eur
Ph Eur
HSE
Ph Eur
HSE
Ph Eur
Ph Eur
Ph. Eur

Incompatibilities
None known.

6.3.

Shelf-Life
Three years.

6.4.

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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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