Sodium Alginate/ Sodium Bicarbonate/ Calcium Carbonate

Registered South African indications:

• Gastro-oesophageal reflux 
• Reflux oesophagitis 
• Hiatus hernia 

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product 

Cautions 

• Pregnancy
• Renal impairment 
• Hepatic impairment
• Sodium controlled diet 
• Congestive cardiac failure 
• Hypercalcaemia 
• Nephrocalcinosis
• Calcium containing renal calculi
• Phenylketonuria (tab)

Forms avail. in SA and covered in this monograph: sus, tab 

Gastro-oesophageal reflux
- Heartburn
- Pregnancy-associated heartburn
- Flatulence
- Epigastric and retrosternal distress
- Indigestion
- Reflux oesophagitis - mild to moderate
- Hiatus hernia

Sodium Alginate/ Sodium Bicarbonate/ Calcium Carbonate
500/267/160 (mg/10ml)
500/213/325 (mg/10ml)

• Oral (sus): 10-20ml, after meals and at bedtime; Max: 80ml/24hrs

250/133.5/80 (mg)

• Oral (tab): 2-4 tabs, at meals and at bedtime

250/106.5/187.5 (mg)

• Oral (tab): 2-4 tabs, after meals and at bedtime; Max: 16 tab/24hrs

If symptoms do not improve after seven days, the clinical situation should be reviewed

Paed. forms avail. in SA and covered in this monograph: sus, tab 

Gastro-oesophageal reflux
- Heartburn
- Pregnancy-associated heartburn
- Flatulence
- Epigastric and retrosternal distress
- Indigestion
- Reflux oesophagitis - mild to moderate
- Hiatus hernia

Sodium Alginate/ Sodium Bicarbonate/ Calcium Carbonate
500/267/160 (mg/10ml)

• Younger than 6 years: Not established for use 
• Between 6-12 years: Oral (sus): 5-10ml, after meals and at bedtime; Max: 40ml/24hrs
• Older than 12 years: See adult dosage

250/133.5/80 (mg)
250/106.5/187.5 (mg)
500/213/325 (mg/10ml)

• Younger than 12 years: Not established for use 
• Older than 12 years: See adult dosage

If symptoms do not improve after seven days, the clinical situation should be reviewed

Pregnancy

• Safe
• Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of sodium alginate/ sodium bicarbonate/ calcium carbonate 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

• Compatible
• No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breastfeeding if clinically needed

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended 

Porphyria

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Respiratory Disorders

• Bronchospasm 

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions 
• Hypersensitivity

• Tetracyclines
• Digoxin
• Fluoroquinolone
• Iron salt
• Ketoconazole
• Neuroleptics
• Thyroid hormones
• Penicillamine
• Atenolol
• Metoprolol
• Propanolol
• Glucocorticoid
• Chloroquine
• Biphosphonates
• Diphosphonates
• Estramustine

None routine 

Sodium alginate
Sodium alginate is a salt of alginic acid. It combines with gastric acid to form a viscous gel, which acts as a physical barrier to the reflux of gastric contents. 

Sodium bicarbonate
Sodium bicarbonate has antacid properties and neutralises gastric acid with the production of carbon dioxide.

Calcium carbonate
Calcium carbonate reacts chemically to neutralise or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in an increased pH of the stomach contents, thus providing relief of hyperacidity symptoms. It also reduces acid concentrations within the lumen of the oesophagus, thus causing an increase in intra-oesophageal pH and a decrease in pepsin activity, which aids the control of gastro-oesophageal reflux.

Sodium alginate/ Sodium bicarbonate/ Calcium carbonate is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

COMBINATION PREPARATIONS

Sodium alginate/ Sodium bicarbonate/ Calcium carbonate

Suspension (per 10ml) 500mg/267mg/160mg

• Gaviscon Aniseed (Reckitt Benckiser)
• Gaviscon Peppermint (Reckitt Benckiser)
• Gelacid (Cipla)
• Gelusil Plus (Pharma Dynamics)

Suspension (per 10ml) 500mg/213mg/325mg

• Gaviscon Double Action Liquid (Reckitt Benckiser)
• Gaviscon Plus Liquid (Reckitt benckiser)

Tablet 250mg/133.5mg/ 80mg

• Gaviscon (Reckitt Benckiser)

Tablet 250mg/106.5mg/187.5mg

• Gaviscon Plus (Reckitt Benckiser)