Fiberlax Ultra3.5 gm/sachet

This is indicated for the treatment of irritable bowel syndrome

Bulk-forming laxatives

Ispaghula husk: The active ingredient ispaghula husk consists of th episperm and collapsed adjacent layers removed from the seeds of Plantago ovate 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 absorping up to forty times its own weight of water in vitro and part of its activity can be attributed to its action as a simple bulking agent.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 transit of intestinal contents easier.Progress of action: Ispaghula husk ususally acts as a laxative within 12 to 24 hours after single administration. Sometimes the maximum effect is reached after 2 to 3 days. 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 consequential softening of the faeces.Mebeverine hydrochloride: Mebeverine hydrochloride is a musculotropic antispasmodic agent which exerts a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility. It is rapidly absorbed with peak concentrations achieved between 1-3 hours after ingestion.

Adults and children over 12: One sachet morning and evening, taken half an hour before meals. A third dose may be taken before the midday meal if necessary.Elderly: There is no indication that the dose needs to be modified for the elderly.Children below 12: The product is not recommended in children under 12 years of age.

The product is intended for oral administration as a suspension in water. The product should be stirred into a glass of cold water (approx. 240 mls) and taken immediately. The product should be taken during the day at least ½ to 1 hour before or after intake of other medicines and the product should not be taken immediately before going to sleep. Effects may take several hours. 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.

Ispaghula and other bulk-forming laxatives may delay or reduce the gastrointestinal absorption of other drugs such as cardiac glycosides, coumarin derivatives, lithium, carbamazepine 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 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. Ispaghula husk should not be used together with medicinal products known to inhibit peristaltic movement (e.g. opioids). Ispaghula husk increases the water content of stools thus promoting peristalsis. If the peristaltic action of the gut is reduced, there is potential for intestinal obstruction.

Patients suffering from abnormal constrictions in the gastrointestinal tract, with diseases of the oesophagus and cardia, cases of intestinal obstruction, natural or drug-induced reduction in gut motility, paralytic ileus, or faecal impaction and colonic atony such as senile megacolon. Patients with a sudden change in bowel habit that has persisted more than two weeks. Undiagnosed rectal bleeding following the use of a laxative. Failure to defecate following the use of a laxative. Patients who have difficulty in swallowing or any throat problems

Common side effects are Hypersensitivity disorders, Conjunctivitis, Rhinitis, Flatulence, abdominal distension, intestinal obstruction, oesophageal obstruction, faecal impaction, Skin rash

Pregnancy: The product should not be used during pregnancy unless considered essential by the physician. There are 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. There are no or limited amounts of data from the use of mebeverine in pregnant women. Animal studies are insufficient with respect to reproductive toxicityBreast-feeding: This product should not be used in breast-feeding. Mebeverine is excreted in human milk. The excretion of mebeverine in milk has not been studied in animals.Fertility: There are no clinical data on male or female fertility.

Symptoms: The patient may notice abdominal discomfort and flatulence and intestinal obstruction.Management: In the event of overdosage conservative measures should be taken. Attention should be paid to maintaining an adequate fluid intake, particularly if the product has been taken without water contrary to the administration instructions. Management should be symptomatic.

Store below 30º C. Store in the original package.