SODIUM ALGINATE/SODIUM BICARBONATE ZENTIVA 500 mg/267 mg Oral suspension sachet 24Sachet/10ml

Sodium alginate...................................................................................................................................... 500,00 mg

Sodium bicarbonate................................................................................................................................267,00 mg

Per sachet of 10 ml.

Excipients with known effect: methyl parahydroxybenzoate (40 mg/sachet), propyl parahydroxybenzoate (6 mg/sachet), sodium (6 mmol or 138 mg/sachet).

Symptomatic treatment of gastro-oesophageal reflux.

Adults and children over 12 years:

1 sachet 3 times a day after the 3 main meals and possibly at bedtime in the evening.

This dosage may be doubled in cases of severe reflux or oesophageal inflammation.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

This medicine contains 138 mg (i.e. 6 mmol) of sodium per 10 ml sachet, which is equivalent to 7% of the maximum daily dietary intake of sodium recommended by the WHO.

The maximum daily dose of this medicine is equivalent to 56% of the maximum daily dietary intake of sodium recommended by the WHO.

SODIUM ALGINATE/SODIUM BICARBONATE ZENTIVA is considered a medicine with a high sodium content. This should be taken into particular consideration in patients following a low-sodium diet, for example in cases of congestive heart failure or renal failure.

This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).

This medicine contains calcium. Each sachet contains 160 mg of calcium carbonate. Precautions must be taken in patients with hypercalcaemia, nephrocalcinosis and renal calculi.

Associations requiring precautions for use

As a precaution, an interval of 2 hours (if possible) should be considered between taking SODIUM ALGINATE/SODIUM BICARBONATE and other medicines, such as acetylsalicylic acid, H2 antihistamines, lansoprazole, bisphosphonates, cationic resins, certain antibiotics (fluoroquinolones, tetracyclines, lincosamides), digitalis glycosides, glucocorticoids, thyroid hormones, thiazide and related diuretics, phenothiazine neuroleptics, sulpiride, certain beta-blockers, penicillamine, ions (iron, phosphorus, fluoride), zinc, strontium, chloroquine, dolutegravir, elvitegravir, fexofenadine, ledipasvir, rosuvastatin, teriflunomide, ulipristal, estramustine.

Pregnancy

Clinical studies conducted in more than 500 pregnant women, as well as a large amount of data from post-marketing experience, have not revealed any malformative or toxic effect of the active substances on the foetus or newborn.

SODIUM ALGINATE/SODIUM BICARBONATE may be used during pregnancy if necessary.

Breast-feeding

No effect of the active substances has been demonstrated in newborns/infants breastfed by a treated woman. SODIUM ALGINATE/SODIUM BICARBONATE may be used during breastfeeding.

Fertility

Clinical data do not suggest that SODIUM ALGINATE/SODIUM BICARBONATE has an effect on human fertility at therapeutic doses.

SODIUM ALGINATE/SODIUM BICARBONATE has no effect or negligible effect on the ability to drive vehicles and use machines.

Adverse effects are classified below by frequency, using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), frequency not known (cannot be estimated from the available data).

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 national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr..

Symptoms

The possible symptoms of an overdose are minor; gastrointestinal discomfort may be felt.

Treatment

In case of overdose, treatment is symptomatic.

Pharmacotherapeutic class: other medicines for peptic ulcer and gastro-oesophageal reflux disease (GORD) - ATC code: A02BX.

The physico-chemical characteristics of the SODIUM ALGINATE/SODIUM BICARBONATE gel, formed on contact with acidic gastric fluid, give it the following 3 properties:

• its lightness allows it to float above the gastric contents at the level of the gastro-oesophageal junction,

• its viscosity and cohesiveness form a physical barrier that opposes reflux (reduction in the number of reflux episodes). In cases of severe reflux, the gel regurgitates first into the oesophagus and interposes itself between the oesophageal wall and the irritating gastric fluid,

• its alkaline pH replaces the acidic pH of the refluxed fluid. Gastric pH-metry shows that administration of SODIUM ALGINATE/SODIUM BICARBONATE increases the pH by 2 units at the cardia but does not modify the pH in the rest of the stomach.

Its pharmacological efficacy is confirmed by oesophageal pH-metry studies which show that SODIUM ALGINATE/SODIUM BICARBONATE significantly reduces the overall percentage of time spent at acidic pH in the oesophagus (pH < 4), as well as the number and average duration of reflux episodes.

The efficacy of SODIUM ALGINATE/SODIUM BICARBONATE on reflux symptoms has notably been established in patients who previously had grade I or II oesophagitis that had healed.

SODIUM ALGINATE/SODIUM BICARBONATE immediately transforms in the stomach on contact with acidic fluid into a light, foamy (release of carbon dioxide bubbles), viscous gel (alginate precipitate), with a pH close to neutral.

This gel persists for a prolonged period (2 to 4 hours) in the upper part of the stomach and is evacuated progressively as gastric emptying occurs. It does not modify transit.

Alginates (non-absorbable polysaccharides) are completely eliminated via the digestive tract.

No significant pre-clinical data have been reported. The patient may experience abdominal distension.

3 years.

Store at a temperature not exceeding 25°C.

No special requirements.

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree