GAVISCON DOUBLE ACTION

1. Winkle Report. 2019. 5 Key objectives to be answered for Gaviscon

2. Talley NJ, Irani MZ. J Intern Med. 2021;289:162-178

3. https://www.nhs.uk/conditions/heartburn-and-acid-reflux/

4. Exploring Gaviscon Double Action positioning among HB&I consumers in the UK, Terrier Research, December 2021

5. Gaviscon Funnel Research November 2022

6. https://www.nice.org.uk/guidance/cg184/chapter/1-Recommendations

7. https://www.nhs.uk/conditions/indigestion/

8. Dettmar PW, et al. Drug Develop Indust Pharmacy. 2018;44(1):30-39

9. Gaviscon Double Action Aniseed Oral Suspension SmPC https://www.medicines.org.uk/emc/product/685

10. Gaviscon Double Action Mint Flavour Chewable Tablets SmPC https://www.medicines.org.uk/emc/product/5329

11. Gaviscon Double Action Liquid Sachets SmPC https://www.medicines.org.uk/emc/product/3959

12. Decktor DL, et al. Am J Ther. 1995;2:546-552

Online sources last accessed May 2023

Gaviscon Double Action Mint Flavour Chewable Tablets - PL 00063/0525

Active substances: Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg.

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.

Dosage and 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

Contraindications: Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate or to any of the excipients

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.

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.

Side 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.

Licence Number: PL 00063/0525

Legal Classification: GSL.

Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, UK.

Price: 12s: £3.79, 24s: £5.99, 48s: £9.79

Last Revised: 07-08-2019

 

Gaviscon Double Action Liquid Sachets - PL 00063/0524

Active substances: Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.

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.

Dosage and administration: For oral administration. •Adults and children 12 years and over: One to two sachets (10-20 ml) 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.

Contraindications: Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients

Special warnings and precautions for use: •This medicinal product contains 127.88 mg sodium per 1 sachet (10ml) dose, equivalent to 6.4% of the WHO recommended maximum daily intake for sodium. •The maximum daily dose of this product is equivalent to 51.15% 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 2 sachets (20 ml) dose contains 260 mg (6.5 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. •Contains methyl parahydroxybenzoate (E218) 40 mg/ 10ml and propyl parahydroxybenzoate (E216) 6 mg/10ml which may cause allergic reactions (possibly delayed).

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.

Side 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.

Licence Number: PL 00063/0524

Legal Classification: GSL.

Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, UK.

Price: 12 x 10ml: £6.49, 24 x 10ml: £10.79, 4 x 10ml: £2.69

Last Revised: 22-01-2021

 

Gaviscon Double Action Aniseed – PL 00063/0543

Active substances: Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213mg and calcium carbonate 325 mg.

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.

Dosage and administration: For oral administration •Adults and children 12 years and over: 10-20 ml 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

Contraindications: Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients.

Special warnings and precautions for use: •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. •Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
Excipint warnings: •This medicinal product contains 127.88 mg sodium per dose, equivalent to 6.4 % of the WHO recommended maximum daily intake for sodium. •The maximum daily dose of this product is equivalent to 51.15% 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 20 ml contains 260 mg (6.5mmol) of calcium. 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). •This medicine contains 1.05 mg benzyl alcohol (from Fennel flavour) per 10 ml . Benzyl alcohol may cause allergic reactions. Large amounts of benzyl alcohol can build up in the body and may cause side effects (called "metabolic acidosis"). This should be taken into consideration by patients who have a liver or kidney disease or are pregnant or breast-feeding.

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.

Side 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.

Licence Number: PL 00063/0524

Legal Classification: GSL.

Licence Holder: Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, UK.

Price: 300ml: £9.69, 150ml: £5.99, 500ml: £10.79, 600ml: £15.09

Last Revised: 12-12-2022