Symptomatic treatment of gastro-oesophageal reflux disease.
Directions for use Sodium alginate/Sodium bicarbonate
Dosage 1 sachet 3 times a day after the 3 main meals and possibly in the evening at bedtime.
This dosage may be doubled in cases of severe reflux or esophageal inflammation.
Pediatric population Not applicable.
Method of administration Oral use.
Precautions for use Sodium alginate/Sodium bicarbonate
Contraindications:
Hypersensitivity to the active ingredients or to any of the excipients listed in the Composition section.
Warnings and other special precautions for use:
This medicine contains sodium.
It contains 6 mmol (or 138 mg) per 10 ml sachet. To be taken into account in patients on a strict low-salt diet.
This medicine contains propyl parahydroxybenzoate and methyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).
This medicine contains calcium. Each sachet contains 160 mg [SY1] calcium carbonate. Precautions should be taken in patients with hypercalcemia, nephrocalcinosis and kidney stones.
Pregnancy and lactation :
- Pregnancy
Clinical studies in over 500 pregnant women, together with a large body of post-marketing experience, have shown no evidence of malformative or toxic effects of the active substances on the foetus or the newborn. MYLAN SODIUM ALGINATE/BICARBONATE can be used during pregnancy if necessary.
- Lactation
No effect of the active substances has been demonstrated in neonates/infants breast-fed by a woman receiving treatment. SODIUM ALGINATE/BICARBONATE MYLAN may be used during breast-feeding.
- Fertility
Clinical data do not suggest that SODIUM ALGINATE/BICARBONATE MYLAN has an effect on human fertility at therapeutic doses.
Effects on ability to drive and use machines :
SODIUM ALGINATE/BICARBONATE MYLAN has no or only a negligible effect on the ability to drive and use machines.
Composition Sodium alginate/sodium bicarbonate
oral suspension (whitish, viscous) : Sodium alginate 500 mg, Sodium bicarbonate 267 mg.
Excipients : Calcium carbonate, Carbomer (974P), Sodium saccharin, Sodium methyl parahydroxybenzoate (E218), Sodium propyl parahydroxybenzoate (E216), Peppermint essential oil, Sodium hydroxide, Purified water, qsp 1 sachet.
Notable excipients: methyl parahydroxybenzoate (40 mg/bag), propyl parahydroxybenzoate (6 mg/bag), sodium (6 mmol or 138 mg/bag).
Français
English
