1. NAME OF THE MEDICINAL PRODUCT
MAALOX REFLUX SODIUM ALGINATE / SODIUM BICARBONATE MINT 500 mg/267 mg SUGENT-FREE, drinkable suspension in sachet, sweetened with sodium saccharin.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium alginate ............................ 500.00 mg
Sodium bicarbonate ...................... 267.00 mg For a 10 ml sachet.
Notable excipients: sodium (6 mmol or 138 mg per sachet), methyl parahydroxybenzoate (E218) (40 mg per sachet), propyl parahydroxybenzoate (E216) (6 mg per sachet). For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension in sachet. Whitish, viscous drinkable suspension.
4. CLINICAL DATA
4.1 Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux disease (GERD) such as acid regurgitation, pyrosis and difficult digestion (reflux-related), for example, after meals or during pregnancy, or during oesophagitis.
4.2. Dosage and administration
Dosage
Adults and children over 12: 1 sachet 3 times a day after the 3 main meals and possibly in the evening at bedtime. This dose may be doubled in cases of severe reflux or oesophageal inflammation.
Elderly: no dose adjustment is required for this population. 4
4.3. Contraindications
This medicinal product must never be used in the event of known or suspected hypersensitivity to the active substances or to one of the excipients.
4.4 Special warnings and precautions for use
Efficacy may be reduced in patients with low gastric acidity. If there is no improvement in symptoms after seven days, the clinical situation should be reconsidered. Treatment of children under 12 years of age is not generally recommended, except on medical advice. This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions (which may be delayed). This medicine contains sodium. This medicine contains 6 mmol (or 138 mg) of sodium per sachet. To be taken into account in patients on a strict low-salt diet.
4.5. Interactions with other medicinal products and other forms of interaction
Antacids interact with certain other orally absorbed medicinal products. Due to the presence of calcium carbonate, which acts as an antacid, a two-hour delay should be considered between taking this medicine and the administration of other medicines, in particular H2 antihistamines, tetracyclines, digoxin, fluoroquinolones, iron salts, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propranolol), glucocorticoids, chloroquine and diphosphonates.
4.6. Pregnancy and breast-feeding
Pregnancy There are no reliable studies of teratogenesis in animals. Clinically, analysis of a large number of exposed pregnancies has apparently not revealed any particular malformative or foetotoxic effect of this medicinal product. However, the absence of risk can only be verified by epidemiological studies. Consequently, this medicine may be prescribed during pregnancy, if necessary. Breast-feeding This medicinal product may be prescribed during breast-feeding, if necessary.
4.7. Effects on ability to drive vehicles and use machines
Not applicable.
4.8. Undesirable effects Linked to calcium carbonate:
- possible constipation, which is exceptional due to the presence of alginate,
- with prolonged use, hypercalcaemia may occur, with a risk of nephrolithiasis and renal failure. Allergic manifestations such as urticaria, bronchospasm, anaphylactic or anaphylactoid reactions have been reported.
4.9. Overdose In the event of overdose,
treatment is symptomatic. The patient may experience abdominal distension.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
The physicochemical characteristics of MAALOX REFLUX SODIUM ALGINATE / SODIUM BICARBONATE MENTH Suspension, 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 gastro-oesophageal junction,
- its viscosity and consistency form a physical barrier to reflux (reducing the number of refluxes). In the event of severe reflux, the suspension regurgitates first into the oesophagus, interposing itself between the oesophageal wall and the irritating gastric fluid.
- Its alkaline pH replaces the acidic pH of the reflux fluid. Gastric pH-metry shows that administration of MAALOX REFLUX SODIUM ALGINATE / SODIUM BICARBONATE SWEET increases the pH by 2 units in the cardia but does not alter the pH in the rest of the stomach.
Its pharmacological efficacy is confirmed by oesophageal pH-metry studies, which show that it significantly reduces the percentage of time spent at acid pH in the oesophagus (pH <4), as well as the number and average duration of reflux episodes. The efficacy of MAALOX REFLUX SODIUM ALGINATE / SODIUM BICARBONATE MINT on reflux symptoms has been demonstrated in patients with previously healed Grade I or II oesophagitis.
5.2. Pharmacokinetic properties
MAALOX REFLUX SODIUM ALGINATE / SODIUM BICARBONATE MENTH is immediately transformed in the stomach on contact with the acidic liquid into a light foaming gel (release of carbon dioxide bubbles), viscous (alginate precipitate), with a pH close to neutral.
This gel persists for a long time (2 to 4 hours) in the upper part of the stomach and is evacuated as the stomach empties. It does not affect transit. The alginates (non-absorbable polysaccharides) are completely eliminated via the digestive tract. The action of this medicine is mechanical and does not depend on its systemic absorption.
5.3. Preclinical safety data In animals,
delayed calcification of the foetal skeleton and ossification abnormalities have been described following administration of calcium carbonate.
6. PHARMACEUTICAL DATA
6.1. List of excipients Calcium carbonate, carbomer (974P), sodium saccharin, peppermint essential oil, sodium hydroxide (for pH adjustment), sodium methyl parahydroxybenzoate (E218), sodium propyl parahydroxybenzoate (E216), purified water.
6.2 Incompatibilities Not applicable.
6.3. Shelf life 2 years.
6.4. Special precautions for storage Store at a temperature not exceeding 25°C.
6.5. Nature and contents of packaging 10 ml in sachet (PET/Aluminium/PE). Box of 12 or 24 sachets. Not all presentations may be marketed.
6.6. Special precautions for disposal and handling No special requirements.
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