This information is intended for use by health professionals
Gaviscon Peppermint Flavour Tablets.
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg and calcium carbonate 80 mg.
Excipients: Aspartame (E951) 3.75 mg per tablet.
For excipients, see Section 6.1.
An off-white to cream, slightly mottled tablet.
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 use, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime.
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.
If symptoms do not improve after seven days, the clinical situation should be reviewed.
The sodium content of a four-tablet dose is 246 mg (10.6 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 four-tablet dose contains 320 mg (3.2 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 patients with phenylketonuria.
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.
There is a lack of robust pre-clinical data available regarding the effects of alginate on fertility; limited studies have not reported any negative effects 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 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, 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 mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
Non-clinical data reveal no special hazard for humans.
Acesulfame potassium (E950)
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister pack containing 4, 6 or 8 individually sealed tablets.
Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above units and packed into cartons.
Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets
Polypropylene container containing 8, 12, 16, 18, 20, 22 or 24 tablets.
Multiple packs (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) will be packed into cartons.
Pack sizes 8, 12, 16, 18, 20, 22, 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24 tablets.
Not all pack sizes may be marketed.
Reckitt Benckiser Healthcare (UK) Limited,