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4.4 Special warnings and precautions for use
Due to the presence of lactose, and sucrose patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Care should be taken if used by patients with diabetes mellitus or low sugar diet because of the sugar content: sucrose 880 mg, lactose 220 mg.
This product contains 11 mg sodium per tablet: take into account for patients with strict low sodium diet.
Aluminium hydroxide may:
- cause constipation due to its astringent action; this effect may be balanced by the cathartic effect of the magnesium salts,
- may lead to phosphate depletion, particularly in patients on a low phosphate diet, e.g. malnutrition.
- cause delayed or decrease the absorption of certain drugs used in combination; see section 4.5.
Use with caution in chronic dialysed patients because of risk of encephalopathy due to aluminium.
In the presence of renal insufficiency magnesium salts may cause central nervous depression
- Each tablet contains 40 mg sodium bicarbonate.
- TOPAL is not recommended in patients who are severely debilitated or on low phosphorus diets and in patients with severe renal insufficiency alkalosis or hypermagnesaemia.
4.5 Interaction with other medicinal products and other forms of interaction
Antacids may interfere with and cause delayed or decreased absorption of certain drugs, e.g. acetylsalicylic acid, indometacin, antituberculosis drugs (ethambutol, isoniazide), tetracyclines, quinolones (ciprofloxacin), penicillamine, chloroquine, ketoconazole, antihistaminics H2, difluinsal, digoxin, bisphosphonates, glucocorticoids, phenothiazinic neuroleptics, sulpiride, iron salts, thyroid hormones.
It is recommended that antacids are not administered at the same time as these medicines but taken at least 2 hours later.
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