SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Manx Ispaghula Husk Granules Orange for Oral Suspension 3.5g

Boots Natural Fibre Drink

Ispaghula Husk Granules for Oral Suspension 3.5g

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ispaghula husk 3.5g For excipients, see 6.1.

3    PHARMACEUTICAL FORM

Granules for oral suspension.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Fibrelief Orange is used for the treatment of habitual constipation; conditions in which easy defecation with soft stools is desirable, for example, in cases of anal fissures, haemorrhoids, after rectal or anal surgery as well as in pregnancy; adjuvant symptomatic therapy in cases of diarrhoea from various causes; conditions which need an increased daily fibre intake, for example, irritable bowel syndrome.

4.2    Posology and method of administration

Unless otherwise prescribed:

Daily dose:

Adults, elderly, children over 12 years of age: 4 - 20 g in 1 -3 doses.

Method of administration: Mix approximately 5 g in 150 ml (¹/₄ pint) cool water, stir briskly and swallow as quickly as possible. Then maintain adequate fluid intake. The product should be taken during the day at least ¹/2 to 1 hour before and after intake of food or other medicines.

Warning: not to be taken immediately prior to going to bed.

Duration of administration: Medical advice should be sought if the symptoms persist more than 3 days in order to make a definitive diagnosis as to the cause of constipation

4.3 Contraindications

Ispaghula husk is not to be used by patients with faecal impaction, and undiagnosed abdominal symptoms, abdominal pain, nausea and vomiting unless advised by a doctor, a sudden change in bowel habit that persists for more than 2 weeks, rectal bleeding and failure to defecate following the use of a laxative. Ispaghula husk is also not to be used by patients suffering from abnormal constrictions in the gastrointestinal tract, with diseases of the oesophagus and cardia, potential or existing intestinal blockage (ileus), or megacolon, diabetes mellitus which is difficult to regulate; by patients with known hypersensitivity to ispaghula or any of the other constituents of the product, children aged less than 12 years.

4.4 Special warnings and precautions for use

A sufficient amount of liquid should always be taken e.g. 150 ml of water per 5 g of drug.

Warning: Take this product with at least 150 ml of water or other fluid. Taking this product without adequate fluid may cause it to swell and block your throat or oesophagus and may cause choking should an adequate fluid intake not be maintained. Intestinal obstruction may occur should an adequate fluid intake not be maintained. Do not take this product if you have ever had difficulty in swallowing or breathing or have any throat problems. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. The treatment of elderly and the debilitated patient requires medical supervision.

Fibrelief Orange contains aspartame. It should not be given to patients with phenylketonuria.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Enteral absorption of concomitantly administered medicines such as minerals (e.g. calcium, iron, lithium, zinc), vitamins (B12 ), cardiac glycosides and coumarin derivatives may be delayed. For this reason the product should not be taken 0.5 to 1 hour before and after the intake of food or other medicines.

In the case of insulin dependent diabetes it may be necessary to reduce the insulin dose.

4.6 Pregnancy and lactation

Controlled studies in pregnant and lactating women are not available, but ispaghula husk granules have been in wide spread use for many years without apparent ill consequence and animal studies have shown no hazard. Ispaghula is not thought to enter breast milk.

4.7 Effects on ability to drive and use machines

There should be no effect on the ability of the patient to drive and use machinery.

4.8 Undesirable effects

Flatulence may occur with the absorption of the product, which generally disappears in the course of the treatment. Abdominal distension and risk of intestinal or oesophageal obstruction and faecal impaction, particularly if swallowed with insufficient fluid.

Due to occupational exposure, risk of allergic reaction possible through inhalation of the powder.

Due to the allergic potential of ispaghula, patients must be aware of reactions of hypersensitivity including anaphylaxis-like reactions in single cases.

4.9 Overdose

Overdose with ispaghula husk may cause abdominal discomfort and flatulence and even intestinal obstruction. An adequate fluid intake should be maintained and management should be symptomatic.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The active ingredient ispaghula husk consists of the epidermis and adjacent layers of the dried, ripe seeds of Plantago ovata FORSSK. Ispaghula husk seed is particularly rich in alimentary fibres and mucilages; with it’s content of mucilage being higher than other Plantago species, absorbency of water is more than 40 times its weight. Psyllium fibres are partly fermentable (72% unfermentable residue) and act by hydration in the bowel. The pharmacological effects, gut motility and transit rate can be modified by ispaghula husk through mechanical stimulation of the gut wall depending on the increase in intestinal bulk by water and in viscosity of the luminal contents or by contact with rough fibre particles. When taken with a sufficient amount of liquid, ispaghula husk produces an increased volume of intestinal contents due to it’s 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

5.2 Pharmacokinetic properties

No experimental data is available.

Absorption: mucilage swells without being dissolved. About 10% of the mucilage is hydrolysed in the stomach; mainly free arabinose is well absorbed.

Onset of action: action sets in 12 to 24 hours after a single administration. Sometimes the maximum effect is not reached for 2 or 3 days.

Elimination:    human intestinal flora in the large intestine degrades the

polysaccharides.

5.3 Preclinical safety data

No data are available in the literature on mutagenicity and carcinogenicity. There are no preclinical concerns based on extensive human experience.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Natural orange flavour (maltodextrin, acacia gum, natural tocopherol extracts), aspartame, beta-carotene (maltodextrin, acacia [E414], hydrogentated vegetable oil, sucrose, beta-carotene [E 160a], sodium ascorbate [E 1301], dl-a-tocopherol [E 307]), citric acid monohydrate and pregelatinised starch.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Two years.

6.4 Special precautions for storage

Do not store above 25 °C. Store in the original package.

6.5 Nature and contents of container

Sachet containing 4.16 g. Sachets (white paper outer, then polyethylene, then aluminium, then polyethylene) are packed in boxes of 7, 10, 30 or 60.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 14251/0015

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/08/2003 / 26/03/2009

10 DATE OF REVISION OF THE TEXT

11/03/2011