NORMACOL Granules (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Normacol 62% w/w Granules.

2. Qualitative and quantitative composition

Each gram of NORMACOL Granules contains 0.62g of Sterculia BP (62% w/w). Each sachet contains 4.34g of Sterculia BP. Excipient(s) with know effect: Contains 1.7g of sucrose and 28.7mg of sodium ...

3. Pharmaceutical form

Granules. White irregular shaped granules.

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 ...

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 ...

4.3. Contraindications

Intestinal obstruction, faecal impaction, and colonic atony. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Known hypersensitivity ...

4.4. Special warnings and precautions for use

Adequate fluid intake should be maintained. Caution should be exercised in cases of ulcerative colitis. Patients should be advised: of possible fluid and electrolyte depletion in association with diarrhoea. ...

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

NORMACOL may be used during pregnancy or lactation.

4.7. Effects on ability to drive and use machines

NORMACOL has no influence on the ability to drive or use machines.

4.8. Undesirable effects

System Order Class Adverse Drug Reaction Immune system disorders Allergic reactions Gastrointestinal disorders Oesophageal obstruction, intestinal obstruction or impaction, abdominal ...

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 ...

5.1. Pharmacodynamic properties

NORMACOL is a laxative which contains sterculia. Sterculia is a bulking agent which stimulates the motility of the colon by increasing faecal volume, and reduces intraluminal recto-sigmoid pressure. Sterculia ...

5.2. Pharmacokinetic properties

Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.

5.3. Preclinical safety data

There is no evidence that Sterculia has a significant systemic toxicity potential.

6.1. List of excipients

Sucrose Talc Sodium hydrogen carbonate Hard paraffin Titanium dioxide (E171) Vanillin

6.2. Incompatibilities

None known.

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. ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

8. Marketing authorization number(s)

PA1336/007/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 25 September 1984 Date of last renewal: 25 September 2009

10. Date of revision of the text

January 2021

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