This information is intended for use by health professionals
Gaviscon Liquid Sachets Mint Flavour
Gaviscon contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate per 10 ml dose.
Excipients: methyl parahydroxybenzoate (E218) 40 mg/10 ml and propyl parahydroxybenzoate (E216) 6 mg/10 ml.
For a full list of excipients, see Section 6.1.
Oral suspension in sachets.
An off-white suspension with the odour and flavour of peppermint.
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.
For oral administration.
Adults and children 12 years and over: One to two sachets after meals and at bedtime (up to four times a day).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Sodium content of a 10 ml, one sachet dose is 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is required, e.g. in some cases of congestive cardiac failure and renal impairment.
Each 10 ml, one sachet dose 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.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
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, biphosphonates (diphosphonates) and estramustine. See also 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.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
| System Organ Class
|| Adverse Event
| Immune System Disorders
|| Very rare
|| Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria.
| Respiratory, Thoracic and Mediastinal Disorders
|| Very rare
|| 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: www.mhra.gov.uk/yellowcard.
In the event of overdosage, symptomatic treatment should be given. The patient may notice abdominal distension.
Pharmacotherapeutic classification: A02BX13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease.
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 quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.
The mode 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.
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Natural mint flavour
Do not store above 25°C and store in the original package. Do not freeze or refrigerate.
A cardboard outer carton containing unit dose stick pack style sachets.
Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.
Not all pack sizes may be marketed.
The sachets are composed of polyester, aluminium and polyethylene.
Each sachet contains 10 ml of Gaviscon.
Reckitt Benckiser Healthcare (UK) Limited,