MAALOX PLUS

Route of administration:

Oral Adults (including elderly persons): 1-2 tablets well chewed, four times a day, taken twenty minutes to one hour after meals and at bedtime, or as required.

Children:

Not recommended

The following CIOMS frequency rating is used, when applicable:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data). Immune system disorders Frequency not known: hypersensitivity reactions, such as pruritus, urticaria, angioedema and anaphylactic reactions.

Gastrointestinal disorders Gastrointestinal side effects are uncommon. 4) Frequency not known: Abdominal pain Injury, poisoning and procedural complications: Frequency not known: Hyperaluminemia (related to Aluminum component).

Metabolism and nutrition disorders Very rare:

Hypermagnesemia, including observations after prolonged administration of magnesium hydroxide to patients with renal impairment. 4). 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Aluminium hydroxide may cause constipation and magnesium salts overdose may cause hypomotility of the bowel; large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at higher risk such as those with renal impairment, or the elderly.

Aluminium hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low- phosphorus diets, may lead to phosphate depletion (due to aluminium-phosphate binding) accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia.

Medical advice is recommended in case of long-term use or in patients at risk of phosphate depletion. In patients with renal impairment, plasma levels of both aluminium and magnesium increase. In these patients, a long-term exposure to high doses of aluminium and magnesium salts may lead to encephalopathy, dementia, microcytic anaemia, or worsen dialysis-induced osteomalacia, Aluminium hydroxide may be unsafe in patients with porphyria undergoing haemodialysis.

The prolonged use of antacids in patients with renal failure should be avoided. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

Should not be used in patients who are severely debilitated or suffering from kidney failure. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Hypersensitivity to the active ingredients or to any of the excipients.