Gaviscon Instants Tropical Fruit Flavour oral powder sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

A02BX

INN (International Name):

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Dosage:

500mg ; 267mg ; 160mg

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01010201; GTIN: 5000158103726

Summary of Product characteristics

OBJECT 1
GAVISCON INSTANTS TROPICAL FRUIT ORAL POWDER
Summary of Product Characteristics Updated 20-Jan-2015 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Gaviscon Instants Tropical Fruit Flavour Oral Powder
2. Qualitative and quantitative composition
Each sachet contains sodium alginate 500mg, sodium hydrogen carbonate
267mg and calcium carbonate
160mg.
Excipients: Aspartame E951.
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Oral powder in sachet
Cream coloured powder
4. Clinical particulars
4.1 Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion
(related to reflux), for example, following meals, or during
pregnancy, or in patients with symptoms
related to reflux oesophagitis.
4.2 Posology and method of administration
Oral administration.
Adults and children 12 years and over: One to two single dose
containers after meals and at bedtime. The
product is taken orally without water.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No modifications necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary.
No data available for children under 12.
4.3 Contraindications
This medicinal product is contraindicated in patients with known or
suspected hypersensitivity to the
active substances or to any of the excipients.
4.4 Special warnings and precautions for use
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
The sodium content of a single dose container is 123 mg (5.3 mmol).
This should be taken into account
when a highly restricted salt diet is recommended. e.g. in some cases
of congestive cardiac failure and
renal impairment.
Each single dose container contains 160 mg (1.6 mmol) of calcium
carbonate. Care needs to be taken in
treating patients with hypercalcaemia, nephrocalcinosis and recurrent
calcium containing renal calculi.
Due to its aspartame content this product should not be given to
p