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FYBOGEL ORANGE

Active substance(s): ISPAGHULA HUSK / 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. For
the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

4.

Granules
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
If there has been no bowel movement after three days of treatment a doctor or healthcare
professional should be consulted. (See section 4.4 ‘Special warnings and precautions for
use’)
Posology
Adults: One sachet, morning and evening
Elderly: There is no indication that dosage needs to be modified for the elderly.
Paediatric Population
Children over 12 years: One sachet, morning and evening
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: The use in children under 6 years of age is not recommended (See
section 4.4 ‘Special warnings and precautions for use’).
The effects start 12-24 hours later.
Method of administration

Fybogel Orange is intended for oral use as a suspension in a full drink of water (See section
4.4). The granules should be stirred into a glass of water and taken as soon as possible,
preferably after meals.
The product should be taken during the day at least ½ to 1 hour before or after intake of
other medicine and should not be taken immediately before going to sleep
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 sensitisation to the active ingredient.
4.3

Contraindications
Hypersensitivity to ispaghula husk or to any of the excipients listed in Section 6.1 (See
Section 4.4 Special warnings and precautions for use),
Patients with a sudden change in bowel habit that has persisted more than two weeks.
Undiagnosed rectal bleeding and failure to defecate following the use of a laxative.
Fybogel Orange is contra-indicated in patients suffering from abnormal constrictions in the
gastro-intestinal tract, with diseases of the oesophagus and cardia, intestinal obstruction,
faecal impaction, natural or drug-induced reduction of gut motility and colonic atony such as
senile mega-colon.
Patients who have difficulty in swallowing or any throat problems.

4.4.

Special Warnings and Special Precautions for Use
The product should not be taken dry and should always be taken mixed with fluid (5 fluid ounces or
150 mL of water or other liquid per sachet).
Ispaghula husk should not be used by patients with faecal impaction and symptoms such as
abdominal pain, nausea and vomiting unless advised by a doctor because these symptoms can be
signs of potential or existing intestinal blockage (ileus).
If abdominal pain occurs or in cases of any irregularity of faeces, the use of psyllium seed should be
discontinued and medical advice must be sought.
When taken with inadequate fluid amounts, bulk forming agents can cause obstruction of the throat
and oesophagus with choking and intestinal obstruction. Symptoms can be chest pain, vomiting, or
difficulty in swallowing or breathing.
The treatment of debilitated patients and / or elderly patients requires medical
supervision.
In order to decrease the risk of gastrointestinal obstruction ispaghula husk should not be used
together with medicinal products known to inhibit peristaltic movement (e.g. opioids) and then only
under medical supervision.

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.

Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.
If symptoms persist longer than 3 days, the patient should consult a doctor or healthcare
professional.
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 sensitisation leading to hypersensitivity reactions, exposure to the product should
be stopped immediately and avoided in the future (see 4.3 Contraindications).

Paediatric Population
Use is not recommended in children below 6 years of age due to insufficient data on safety and
efficacy. Laxative bulk producers should be used before using other purgatives if change of nutrition
is not successful.

4.5.

Interactions with other Medicinal Products and other Forms of Interaction
Enteral absorption of concomitantly administered medicines such as minerals, vitamins
(B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium may be
delayed. For this reason the product should not be taken ½ to 1 hour before or after intake of
other medicinal products.
Diabetic patients should take ispaghula husk only under medical supervision because
adjustment of anti-diabetic therapy may be necessary.
Use of ispaghula husk concomitantly with thyroid hormones requires medical supervision
because the dose of the thyroid hormones may have to be adjusted.

4.6

Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data (less than 300 pregnancy outcomes) from the use of
ispaghula husk in pregnant women. Animal studies are insufficient with respect to
reproductive toxicity (see section 5.3 Preclinical safety data).
Breast-feeding
The use of ispaghula husk may be considered during pregnancy and lactation, if necessary
and if change of nutrition is not successful. Laxative bulk producers should be used before
using other purgatives
Fertility
No known effects

4.7.

Effects on Ability to Drive and Use Machines

Fybogel Orange has no or negligible influence on the ability to drive and use machines.
4.8

Undesirable effects
Special attention should be given to individuals manipulating the powder formulations routinely (see
4.4 Special warnings and precautions for use).
Adverse events which have been associated with ispaghula husk are given below, tabulated by
system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common
(≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<
1/10,000); Not known (cannot be estimated from the available data). Within each frequency
grouping, adverse events are presented in order of decreasing seriousness
System Organ Class
Immune System Disorders
Eye Disorders
Respiratory, Thoracic and Mediastinal
Disorders
Gastrointestinal Disorders

Frequency
Not known
Not known
Not known

Adverse Events
Hypersensitivity disorders1,2
Conjunctivitis2
Rhinitis2

Not known

Skin and Subcutaneous Tissue Disorders

Not known

Flatulence, abdominal
distension, intestinal
obstruction, oesophageal
obstruction, faecal impaction3
Skin Rash2

Description of Selected Adverse Reactions
1
Including rash, anaphylaxis, pruritus, and bronchospasm
2

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, anaphylaxis. Cutaneous symptoms such as
exanthema and/or pruritus have also been reported.

3

A small amount of flatulence and abdominal distension may sometimes occur during the first few
days of treatment, but should diminish during continued treatment. Abdominal distension and risk of
intestinal or oesophageal obstruction and faecal impaction may occur, particularly if swallowed with
insufficient fluid.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:
http://www.mhra.gov.uk/yellowcard.

4.9.

Overdose
Symptoms
Overdose with ispaghula husk may cause abdominal discomfort, flatulence and intestinal
obstruction.
Management

Adequate fluid intake should be maintained, particularly if the granules have been taken
without water contrary to administration instructions, and management should be
symptomatic.
5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic Group: Ispaghula (psylla seeds); ATC Code: A06AC01 Bulk
producer
The active ingredient ispaghula husk consists of the episperm and collapsed adjacent layers
removed from the seeds of Plantago ovata Forssk (Plantago ispaghula Roxb.). Ispaghula
husk is particularly rich in alimentary fibres and mucilages, its mucilage content being
higher than that of other Plantago species. Ispaghula husk is capable of absorbing up to 40
times its own weight in water. Ispaghula husk consists of 85% water-soluble fibre; it is
partly fermentable (in vitro 72 % unfermentable residue) and acts by hydration in the bowel.
Gut motility and transit rate can be modified by ispaghula husk through mechanical
stimulation of the gut wall as a result of the increase in intestinal bulk by water and the
decrease in viscosity of the luminal contents. When taken with a sufficient amount of liquid
(at least 30 ml per 1 g of herbal substance) ispaghula husk produces an increased volume of
intestinal contents due to its highly bulking properties and hence a stretch stimulus, which
triggers defecation; at the same time the swollen mass of mucilage forms a lubricating layer,
which makes the transit of intestinal contents easier.
Progress of action: ispaghula husk usually acts within 12 to 24 hours after single
administration. Sometimes the maximum effect is reached after 2 to 3 days.

5.2.

Pharmacokinetic Properties
The material hydrates and swells to form amucilage because it is only partially solubilised.
Polysaccharides, such as those which dietary fibres are made of, must be hydrolysed to
monosaccharides before intestinal uptake can occur. The sugar residues of the xylan
backbone and the side chains are joined by ß-linkages, which cannot be broken by human
digestive enzymes.
Less than 10% of the mucilage gets hydrolysed in the stomach, with formation of free
arabinose. Intestinal absorption of the free arabinose is approximately 85% to 93%.
To varying degrees, dietary fibre is fermented by bacteria in the colon, resulting in
production of carbon dioxide, hydrogen, methane, water, and short-chain fatty acids, which
are absorbed and brought into the hepatic circulation. In humans, such fibre reaches the
large bowel in a highly polymerised form that is fermented to a limited extent, resulting in
increased faecal concentration and excretion of short-chain fatty acids.

5.3.

Pre-clinical Safety Data

In a study on fertility, embryo-foetal development and pre- and postnatal development
(multigeneration study) ispaghula husk (0, 1, 2.5, or 5% (w/w) of the diet) was administered to rats
continuously through two generations. For fertility and foetal development and teratogenesis the noobserved-adverse-effects-limit (NOAEL) was 5% of the diet, while for offspring growth and
development the NOAEL was given with 1% of the diet based on reductions in pup weights.

The study on embryo-foetal development in rabbits (ispaghula husk as 0, 2.5, 5 or 10% (w/w) of
diet) has to be considered as preliminary. Conclusions cannot be drawn.
The non-clinical data on toxicology of ispaghula husk preparations are incomplete, but available data
indicate no signals of toxicological concern. Adequate tests on reproductive toxicity, genotoxicity
and carcinogenicity have not been performed.

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.

Ph Eur
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
17/07/2017

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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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