Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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Each gram of Normacol Plus Granules contains 0.62g (62% w/w) of Sterculia and 0.08g (8% w/e) of Frangula.
Each sachet contains 4.34g of Sterculia and 0.56g of Frangula
For excipients, see 6.1
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Granules.
Brown irregular shaped granules with a slight odour and taste of peppermint.
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The treatment of constipation.
The initiation and maintenance of bowel action after rectal surgery and after haemorrhoidectomy.
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Adults (including the elderly): 1 or 2 sachets or 1-2 heaped 5ml
spoonfuls, once or twice daily after meals.
Children (6-12 years): A reduced amount may be given at the discretion of the physician.
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 on, and taken with soft food such as yoghurt.
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Intestinal obstruction, faecal impaction, and total atony of the colon.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Use in patients with a sensitivity to sterculia or frangula.
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Caution should be exercised in the use of NORMACOL PLUS in cases of ulcerative colitis. Patients should be advised to maintain an adequate fluid intake, to avoid taking NORMACOL PLUS immediately before going to bed (especially if they are elderly), and to suspend treatment of bowel movements do not occur within four days.
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Pregnancy: No teratogenic effects have been reported, but caution should be exercised during the first trimester.
Lactation: There is no evidence to suggest that NORMACOL PLUS is unsuitable for use.
NORMACOL (Sterculia alone) is available if required in pregnancy and lactation.
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Abdominal distension may occur. Oesophageal obstruction is possible if the product is not adequately washed down with fluid.
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Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes.
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Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect. Frangula acts as a mild peristaltic stimulant and aids the evacuation of the softened faecal mass.
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Sterculia is not absorbed in the gastrointestinal tract; Frangula acts locally on the wall of the intestinal tract. The laxative action of NORMACOL PLUS is normally effective within 12 hours of oral administration.
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There are no preclinical data of relevance to the prescribed except as already included in the SPC.
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Sucrose
Talc
Sodium hydrogen carbonate
Paraffin wax
Peppermint flavouring
Indigo carmine (E132)
Erythrosine (E127)
Sunset yellow (E110)
Sodium chloride
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Sachet and lined carton: 2 years.
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Sachet: Do not store above 25°C. Store in original package in a dry place.
Carton: Do not store above 25°C. Store in original package in a dry place. Keep the carton tightly closed.
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Sachet: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.
Each sachet contains 7 g of brown granules in boxes of 2, 7, or 60 sachets.
Lined carton: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.
Lined carton of 200 g or 500 g of brown granules.
Not all pack sizes may be marketed
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Norgine Limited
Chaplin House
Widewater Place
Moorhall Road
Harefield
UXBRIDGE
Middlesex UB9 6NS
United Kingdom
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PA 102/12/1
9. DATE OF FIRST AUTHORISATION/RENEWAL/RENEWAL OF AUTHORISATION
25 September 1984/ 25th September 2004
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Date revised: November 2006
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