Gaviscon Double Action Liquid Sachets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Double Action Liquid Sachets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.
Excipients: methyl parahydroxybenzoate (E218) and propyl parahydroxyb enzoate (E216).
For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension in sachets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2 Posology and method of administration
For oral administration.
Adults and children 12 years and over: One to two sachets (10-20ml) after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
4.3 Contraindications
Hypersensitivity to any of the ingredients, including the esters of hydroxybenzoates (parabens).
4.4 Special warnings and precautions for use
Each 10ml (single sachet) dose has a sodium content of 127.25mg (5.53mmol). 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 10ml (single sachet) dose contains 130mg (3.25mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
4.5. Interactions with other medicaments and other forms of interaction
Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake an the administration of other medicinal products, especially H2-antihistaminics tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates.
4.6 Pregnancy and lactation
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
Ingestion of large quantities of calcium carbonate may cause alkalosis, hypercalcaemia, acid rebound, milk alkali syndrome or constipation. These usually occur following larger than recommended dosages.
4.9 Overdose
In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic classification: A02BX, other drugs for peptic ulcer and gastro-oesophageal reflux disease.
The medicinal product is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate.
On ingestion, the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and studies have shown that the raft interacts with and caps the acid pocket in the stomach, reducing oesophageal acid exposure. The raft floats on the stomach contents effectively impeding gastro-oesophageal reflux, for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within it structure, further protecting the oesophagus from these gastric components
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn. This effect is increased by the addition of sodium bicarbonate which also has a neutralising action. The total neutralising capacity of the product at the lowest dose of two tablets is approximately 10mEqH+.
5.2 Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3 Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbomer 974P, methyl (E218) and propyl (E216) parahydroxybenzoate, saccharin sodium, peppermint flavour no. 2, sodium hydroxide and purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Two years.
6.4 Special precautions for storage
Do not store above 25°C and store in the original package. Do not refrigerate or freeze.
6.5
Nature and contents of container
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 10ml of Gaviscon Double Action Liquid.
6.6 Special precautions for disposal
None required.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0524.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/07/2008
10 DATE OF REVISION OF THE TEXT
18/04/2016