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FYBOGEL HI-FIBRE ORANGE

Active substance(s): ISPAGHULA HUSK / ISPAGHULA HUSK / ISPAGHULA HUSK

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Senokot Hi-Fibre Orange
or
Fybogel Hi-Fibre Orange

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
A sachet contains 3.5g ispaghula husk BP. For the full list of excipients, see
section 6.1.

3

PHARMACEUTICAL FORM
Granules

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For 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 haemorrhoids.

4.2

Posology and Method of Administration

If there have been no bowel movements after 3 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
The medicine 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 medicines and should not be taken immediately before going to
sleep.

4.3.

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.
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.
This medicine 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 subobstruction.
Due to its aspartame content this medicine
phenylketonuria.

should not be given to patients with

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

The product 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 qbelow,
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

Frequency
Not known

Eye Disorders
Respiratory, Thoracic and
Mediastinal Disorders
Gastrointestinal Disorders

Not known
Not known

Skin and Subcutaneous
Tissue Disorders

Not known

Not known

Description of Selected Adverse Reactions
1

Including rash, anaphylaxis, pruritus, and bronchospasm

Adverse Events
Hypersensitivity
disorders1,2
Conjunctivitis2
Rhinitis2
Flatulence, abdominal
distension, intestinal
obstruction, oesophageal
obstruction, faecal
impaction3
Skin Rash2

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.

5.
5.1

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.
PHARMACOLOGICAL PROPERTIES
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 a mucilage 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

Preclinical 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 no-observed-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

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Potassium bicarbonate
Sodium bicarbonate
Citric acid
Riboflavin sodium phosphate
Aspartame
Orange flavour
Beta-carotene 10% CWS/S(E160a)
Saccharin Sodium
Polysorbate 80

Silica colloidal anhydrous

6.2

Incompatibilities
None known

6.3

Shelf life
3 years

6.4

Special precautions for storage
Store below 30ºC in a dry place.

6.5

Nature and contents of container
7, 8, 10, 12, 14, 20, 24, 28 or 30 sachets enclosed in a cardboard outer.
Polypropylene tubs with polyethylene lid containing 150 g of product.

6.6

Special precautions for disposal
Senokot Hi-Fibre 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
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0064

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/07/1992

10

DATE OF REVISION OF THE TEXT
17/07/2017

Expand Transcript

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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