FYBOGEL - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Fybogel.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each single dose sachet contains 3.5g ispaghula husk EP.

Excipients with known effect:

Aspartame (E 951) 16 mg/sachet

Potassium 9.76 mg/Sachet

For the full list of excipients see section 6.1

3 PHARMACEUTICAL FORM

Granules

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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 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 have been no bowel movements after 3 days of treatment a doctor or health care professional should be consulted. (See section 4.4 ‘Special warnings and precautions for use’)

Adults:

One sachet, morning and evening.

Elderly:

Paediatric Population

Children over 12 years:

Children aged 6 to12 years:

Children under 6 years:

The effects start 12–24 hours later.

Method of Administration

There is no indication the dosage need be modified for the elderly.

One sachet, morning and evening.

Half to one level 5ml spoonful depending on size and age, morning and evening.

The use in children under 6 years of age is not recommended (See section 4.4 ‘Special warnings and precautions for use’)

The product is intended for oral administration as a suspension in a full glass of water (See section 4.4). Fybogel 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 ^ to 1 hour before or after intake of other medicines 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 sensitization to the active ingredient.

4.3

Hypersensitivity to the 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 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 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 ispaghula husk 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.

This medicine contains 16mg aspartame in each sachet.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

This medicine contains less than 1 mmol sodium (23 mg) in each sachet, that is to say essentially ‘sodium-free’.

This medicine contains 0.25 mmol (or 9.76 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

If symptoms persist longer than 3 days, the patient should call a doctor or health care 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 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 (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 Interaction 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 ^ 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 lactationPregnancy

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).

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.

There is no evidence of an effect on the fertility in the rat following oral application (see section 5.3 ‘Preclinical safety data’)

4.7 Effects on ability to drive and use machines

Fybogel 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.

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.

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

5.   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Drugs for constipation; Bulk-forming laxatives; Ispaghula (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 within 12 to 24 hours after a 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.

6.1 List of excipients

Potassium bicarbonate

Ph Eur

Ph Eur

Ph Eur

Ph Eur HSE Ph Eur Ph Eur Ph Eur Ph. Eur

Sodium bicarbonate

Citric acid

Riboflavin sodium phosphate

Beta-carotene 10% (E160a)

Aspartame

Saccharin sodium

Polysorbate 80

Silica, colloidal anhydrous

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 contents of container

Sachets of paper/aluminium foil/polythene laminate enclosed in a cardboard outer carton.

Pack size(s): Ten or thirty sachets (pack size printed in bold is currently sold).

6.6 Special precautions for disposal No special instructions.

7 MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom