FYBOGEL Granules Ref.[27564] Active ingredients: Ispaghula

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom

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’)

Posology

Adults

One sachet, morning and evening.

Elderly

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

Paediatric Population

Children over 12 years: One sachet, morning and evening.

Children aged 6 to12 years: Half to one level 5ml spoonful depending on size and age, 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 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 ½ 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.

4.9. Overdose

Symptoms

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

Management

Attention should be paid to maintaining an adequate fluid intake, particularly if the granules have been taken without water, contrary to administration instructions and management should be symptomatic.

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 and other handling

No special instructions.

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