Each single dose sachet contains 3.5 g ispaghula husk. Excipients: Each sachet contains 0.016 g Aspartame (E951).
Indication: For a high-fibre regime indicated for use in the relief of constipation.
Pharmacotherapeutic Group: Ispaghula Husk (Psylla seeds);
ATC Code: A06AC01 “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 as a laxative within 12 to 24 hours after single administration.
Sometimes the maximum effect is reached after 2 to 3 days.”
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 update can occur. The sugar residues of the xylan backbone and the side chains are joined by β-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.
Fybogel Orange is intended for oral administration as a suspension in a full glass of water. The granules should be stirred into a glass of water and taken as soon as possible. Concentrated fruit juices or natural juice may be added to taste.
Adults and children over 12 years: One sachet or two level 5 ml spoonfuls of granules to be reconstituted as above each morning and evening, preferably after meals.
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 of granules, depending on age and size, to be reconstituted as above, morning and evening.
Children under 6 years: The use in children under 6 years of age is not recommended
If there have been no bowel movements after 3 days of treatment a doctor should be consulted. 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.
The effects start 12-24 hours later. 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.
• Hypersensitivity to the active substance, or to any of the excipients
• Patients with a sudden change in bowel habit that has persisted more than two weeks.
• Undiagnosed rectal bleeding and failure to defecate follow ing the use of a laxative.
• 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.
Special warnings and precautions for use
• Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.
• Use is not recommended in children below 6 years of age due to insufficient data on efficacy. Laxative bulk producers should be used before using other purgatives if change of nutrition is not successful.
• The product should not be taken dry and should always be taken mixed with fluid (8 fluid ounces or 240mL of water or other liquid per sachet). 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.
• 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.
• If abdominal pain occurs or in cases of any irregularity of faeces, the use of ispaghula husk should be discontinued and medical advice must be sought.
• 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.
• This 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.
• If symptoms persist longer than 3 days, the patient should consult a doctor.
In individuals with continued occupational contact to powder of Plantago ovate seeds (e.g. healthcare workers, caregivers) allergic sensitisation may occur due to inhalation; this is more frequent in atopic individuals. This sensitisation usually leads to hypersensitivity reactions which could be serious. It is recommended to assess clinically the possible sensitisation 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. Fybogel Orange contains aspartame (E951) which is a source of phenylalanine. This may be harmful to patients with phenylketonuria.
Interaction with other medicinal products and other forms of interaction
Ispagula 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). 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 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.
Fertility, pregnancy and lactation
Pregnancy: There are no data from the use of psyllium seed, and limited data (less than 300 pregnancy outcomes) from the use of ispaghula husk, in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. The use of ispaghula husk may be considered during pregnancy if necessary and if change of nutrition is not successful.
Laxative bulk producers should be used before using other purgatives. Patients should consult a doctor or pharmacist before taking Fybogel Orange during pregnancy.
Breast-feeding: The use of ispaghula husk may be considered during lactation, if necessary and if change of nutrition is not successful
Fertility: There is no evidence of an effect on the fertility in the rat following oral application
Effects on ability to drive and use machines: None.
• Hypersensitivity reactions with pruritus, bronchospasm and anaphylaxis
• Flatulence, abdominal distension, intestinal obstruction, oesophageal obstruction, faecal impaction
• Skin rash