NORMACOL Granules Ref.[49824] Active ingredients:

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

4.1. Therapeutic indications

The treatment of constipation (including pregnancy and lactation).

Management of colostomies and ileostomies.

The ‘High Residue Diet’ management of diverticular disease of the colon and other conditions requiring a high fibre regimen.

The initiation and maintenance of bowel action after rectal and anal surgery.

Administration after ingestion of sharp foreign bodies to provide a coating and reduce the possibility of intestinal damage during transit.

4.2. Posology and method of administration

Adults

1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.

Older People

As adult dose.

Paediatric population

Children (6-12 years): one half the above amount or as directed by the physician.

NORMACOL is not recommended for children under 6 years of age.

The granules should be placed dry on the tongue and without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled onto and taken with soft food such as yoghurt.

4.9. Overdose

Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes. Oesophageal obstruction is possible if the product is taken in overdosage. If there is profound diarrhoea, dehydration and electrolyte depletion may occur.

6.3. Shelf life

Sachet and carton: 2 years.

6.4. Special precautions for storage

Sachet: Do not store above 25°C. Store in the original package in a dry place.

Carton: Do not store above 25°C. Store in the original package in a dry place. Keep the carton tightly closed.

6.5. Nature and contents of container

Sachet: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper. Each sachet contains 7g of white granules supplied in boxes of 2,7 or 60 sachets.

Carton lining: laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper. Lined carton of 500g of white granules.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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