Gaviscon Instants Oral Powder
Gaviscon Instants Oral Powder.
Each sachet contains sodium alginate 500 mg, sodium hydrogen carbonate 267 mg and calcium carbonate 160 mg.
Excipients: Aspartame E951.
For a full list of excipients, see Section 6.1.
Oral powder in sachet.
Cream coloured powder.
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.
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.
Children below 12 years: Should be given only on medical advice
Duration of treatment: If symptoms do not improve after seven days, the clinical situation should be reviewed.
Special patient groups
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No modifications necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
Method of administration
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium bicarbonate and calcium carbonate or to any of the excipients listed in section 6.1.
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 medicinal product should not be given to patients with phenylketonuria.
Consult your doctor if you are over 40 years and have never suffered with heartburn and acid indigestion before.
For children below 12 years, please see section 4.2.
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol,metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and bisphosphonates (diphosphonates). See section 4.4.
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.
Gaviscon has no or negligible influence on the ability to drive and use machines.
Adverse reactions have been ranked under headings of frequency using the following convention:
Very rare: <1/10,000
System Organ Class
Immune System Disorders
Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and Mediastinal Disorders
Respiratory effects such as bronchospasm.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard.
In the event of overdose symptomatic treatment should be given. The patient may notice abdominal distension.
Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD) ATC code: A02BX.
On ingestion the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
No pre-clinical findings of any relevance to the prescriber have been reported.
Macrogol 400 Aspartame (E951)
Citric acid anhydrous Acesulfame potassium (E950) Xylitol
Do not store above 25°C.
4, 6, 12, 16, 20, 24 or 32 unit dose sachets will be packed in either a cardboard box or in a blister pack comprising of a cardboard backing card and a styrene thermoform front.
The sachets are composed of printed polyester/polyethylene/ aluminium foil/polyethylene.
Not all pack sizes / types may be marketed.
No special requirements.
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First Approved: 10/10/2007 Renewed: 09/10/2012
10 DATE OF REVISION OF THE TEXT