Summary of Product Characteristics (SmPC) - Gaviscon Double Action Mint Flavour chewable tablets
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Double Action Mint Flavour Chewable Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg.
Excipient(s) with known effect:
Aspartame
Carmoisine Lake (E122)
For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and slightly mottled, and the other white.
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, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets 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.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3 Contraindications
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4 tablet dose, equivalent to 11.18 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 44.71% of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Each 4 tablet dose contains 300 mg (7.5 mmol) 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 persist, or treatment is required for more than 7 days |
| continuously, medical advice should be sought. |
| As with other antacid products, taking this product can mask the symptoms of |
| other more serious, underlying medical conditions. |
This medicinal product contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.
This medicine contains Carmoisine lake (E122). This may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
4.6 Fertility, pregnancy and lactation
Pregnancy
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, if clinically needed.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding if clinically needed.
Fertility:
Clinical data do not suggest that this product has an effect on human fertility.
4.7 Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: 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); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Events |
| Immune System Disorders | Very Rarely | Anaphylactic reaction, |
| System Organ Class | Frequency | Adverse Events |
| anaphylactoid reaction. Hypersensitivity reactions such as urticaria. | ||
| Metabolism and Nutritional Disorders | Not Known | Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1 |
| Respiratory, Thoracic and Mediastinal Disorders | Very Rarely | Respiratory effects such as bronchospasm. |
| Gastrointestinal Disorders | Not Known | Constipation1 |
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension
| may be | ||
| noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium | ||
| carbonate per day for prolonged periods. | ||
Management
In the event of overdosage symptomatic treatment should be given.
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
Macrogol 20,000
Mannitol (E421)
Copovidone
Acesulfame K
Aspartame (E951)
Mint flavour
Carmoisine Lake (E122)
Magnesium stearate
Xylitol DC
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Two years.
Polypropylene container: Use within 3 months of opening.
6.4 Special precautions for storage
Blister trays: Do not store above 30°C. Store in the original package.
Flip-top lid containers: Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Unprinted, glass, clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister tray containing two, four, six or eight sealed tablets. Pack sizes: 4, 6, 8, 12, 16, 24, 32, 48, 60, 62, 64 and 80 chewable tablets.
Coloured, opaque, injection-moulded, polypropylene flip-top lid containers containing 8, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special instructions.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0525
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/11/2009 / 07/08/2019
10 DATE OF REVISION OF THE TEXT
07/08/2019