Normafibe

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sterculia 62%{relative}

Available from:

CARSL Consulting

INN (International Name):

Sterculia 62% w/w

Dosage:

62% w/w

Pharmaceutical form:

Oral granules

Composition:

Active: Sterculia 62%{relative} Excipient: Hard Paraffin Purified talc Sodium bicarbonate Sucrose Titanium dioxide Vanillin

Units in package:

Bag, 500 g

Class:

General sale

Prescription type:

General sale

Manufactured by:

Norgine Pharma

Product summary:

Package - Contents - Shelf Life: Bag, - 500 g - 24 months from date of manufacture stored at or below 25°C - Sachet, 7g - 7 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Summary of Product characteristics

NORMAFIBE NZ Datasheet – September 2020
Page 1 of 5
NEW ZEALAND DATASHEET
1 PRODUCT NAME
NORMAFIBE
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterculia 62% w/w
3 PHARMACEUTICAL FORM
NORMAFIBE are white irregular shaped granules with a sweet taste.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
The treatment of constipation, particularly simple or idiopathic
constipation and constipation
during pregnancy.
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
Dose and method of administration
ADULTS: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice
daily after meals.
ELDERLY: As per the adult dose.
CHILDREN: (6-12 years): one half the above amount.
NORMAFIBE 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, and then immediately
drinking plenty of water or a cool
drink.
4.3
Contraindications
Intestinal obstruction, faecal impaction, and total atony of the
colon.
Known hypersensitivity to any of the ingredients.
NORMAFIBE NZ Datasheet – September 2020
Page 2 of 5
4.4
Special warnings and precautions for use
Not to be taken immediately before going to bed or in a recumbent
position especially in the
elderly. Adequate fluid should be maintained. Caution should be
exercised in cases of ulcerative
colitis. Not to be taken for more than 4 days if there has been no
movement of the bowels. Take
with plenty of water to reduce the risk of oesophageal obstruction.
Patients with rare hereditary problems of fructose intolerance,
glucose–galactose m