MAGALTAB® (YELLOW)

Composition: Each tablet contains:
Dried aluminium hydroxide gel . . . . . . . . . . . . .522,88 mg
(As Aluminium hydroxide. . . . . . . . . . . . . . . . . . . 400 mg)
Magnesium hydroxide. . . . . . . . . . . . . . . . . . . . . .400 mg
Presentation:
HD plastic bottle containing 50 or 100 chewable tablets in a carton box.
50 blisters of 10 chewable tablets in a carton box.
Indications:
The symptomatic relief of gastric hyperacidity (heartburn, acid reflux, flatulence, dyspepsia due to increased acid).
Increased gastric acid due to gastric and duodenal ulcers.
Prevention and treatment of gastroduodenal ulcers or bleeding due to stress.
The symptomatic treatment of gastroesophageal reflux.

Additional information

Dosage and administration

The usual dose for:
Adults:
1 – 2 tablets, 4 times daily. Do not take more than 8 tablets in a day. Magaltab should not be used continuously for more than 2 weeks unless indicated by a doctor.
Children:
Magaltab tablets are not recommended for children. If an antacid with similar components is required for use in children, other dosage form and content appropriate to them should be used (e.g. suspension).

Contraindications

Hypersensitivity to aluminium hydroxide, magnesium hydroxide or any of the excipients.
Reduction of blood phosphate (hypophosphatemia).
Kidney failure.
Magaltab should not be used in children. In case of necessity, other appropriate drug forms for children are recommended.
Magaltab should not be used in children. Other products with dosage forms and contents appropriate to children should be used if an antacid is required.

Warnings and precautions for use

Caution should be exercised in patients with congestive heart failure, renal failure, edema, cirrhosis and low sodium diet and patients who have recently experienced GI bleeding.
Elderly patients may have constipation and solid feces due to illness or treatment with Magaltab. Drug interactions should be considered cautiously.
Phosphate levels should be regularly monitored during long-term treatment.
In patients with severe renal impairment, hypermagnesemia has been reported (causing hypotension, mental decline, coma), so Magaltab should not be used in patients with kidney failure.

Recommendation for pregnancy and breastfeeding

Pregnancy:
Magaltab is considered safe; however, prolonged use and high doses of Magaltab should be avoided in pregnant women.
Lactation:
Although aluminium and magnesium are excreted in human milk but in small amount not enough to cause harm to breastfed infants.

Effects on ability to drive and use machines

There have been no reports on the effects of this product on the ability to drive and use machines.

Interactions, incompatibilities of medicine

Magaltab containing aluminium hydroxide and magnesium hydroxide should not be taken simultaneously with medicines such as tetracycline, digoxin, indomethacin, iron salts, isoniazid, allopurinol, benzodiazepine, corticosteroid, penicillamine, phenothiazine, ranitidine, ketoconazole, itraconazole as it may reduce the absorption of these drugs.
If the treatment with these drugs is required, they must be used at least 2 hours apart from Magaltab.

Undesirable effects (ADRs)

At the recommended dose, side effects are uncommon (≥ 1/1, 000 to < 1/100).
Immune system disorders:
Frequency not known: Hypersensitivity reactions such as pruritus, urticaria, angioedema and anaphylactic reaction.
Gastrointestinal disorders:
Uncommon: Diarrhea or constipation.
Metabolic and nutritional disorders:
Frequency not known:
– Hypermagnesemia.
– Elevated plasma aluminium levels.
– Aluminium hydroxide binds to phosphate in the gastrointestinal tract to form insoluble complexes and reduces phosphate absorption.
– Hypophosphatemia occurs in long-term use or at high-dose or even with normal dosage in patients on a low phosphate diet or in children under 2 years of age, which may lead to bone resorption, hypercalciuria, osteomalacia.

Overdose and management

Information about overdose has not been reported.

Pharmacodynamic properties

Gastric-peptic disease results from an imbalance between protective factors, such as gastric mucosal barrier, bicarbonate secretion, and prostaglandin secretion, and aggressive gastric factors such as hydrochloric acid, pepsin, and Helicobacter pylori. Antacids work by restoring acid-base balance, attenuating the pepsin activity and increasing bicarbonate and prostaglandin secretion.
Magaltab is a balanced mixture of two antacids: Aluminium hydroxide is a slow-acting antacid and magnesium hydroxide is a quick-acting one.
Aluminium hydroxide is slowly solubilized in the stomach and reacts with hydrochloric acid to form soluble aluminium chloride, a small amount is absorbed into the body. Aluminium hydroxide also inhibits the action of pepsin by increasing the pH and via adsorption. An increase in bicarbonate ions and prostaglandins may also confer cytoprotective effects.
Magnesium hydroxide neutralizes stomach acid by reacting with hydrochloric acid in the stomach to form magnesium chloride and water. Magnesium hydroxide is practically insoluble in water and has no effect until it reacts with hydrochloric acid in the stomach. At there, magnesium hydroxide reduces direct irritiation of acid and increases pH leading to inactivation of pepsin. Magnesium hydroxide increases the integrity of gastric mucosal.
Approximately 30% of the magnesium ions are absorbed from the small intestine, in the form of magnesium salts.
Aluminium hydroxide and magnesium hydroxide are usually combined in antacid mixture.
Aluminium hydroxide has astringent property and may cause constipation. This effect is balanced by the effects of magnesium hydroxide. Usually, like other magnesium salts, magnesium hydroxide can cause diarrhea.

Pharmacokinetic properties

The absorption of aluminium hydroxide and magnesium hydroxide from antacids is negligible, aluminium hydroxide is slowly converted to aluminium chloride in the stomach. Some absorption of soluble aluminium salts occurs in the gastro-intestinal tract with urinary excretion. Therefore, patients with renal impairment have high risk of aluminium accumulation (especially in the bone and central nervous system) and aluminium toxicity. Absorbed aluminium will bind to serum proteins (eg, albumin, transferrin) and thus it is difficult to remove aluminium by dialysis.
The aluminium compounds which account for most of a dose remains in the gastrointestinal tract to form insoluble and poorly absorbed aluminium salts in the intestine, including hydroxide salts, which are excreted in the faeces.
Absorbed magnesium salts are also excreted in the urine.

Storage conditions, shelf-life, quality specification of the medicine

Storage conditions: Protect from humidity and light, below 30 degrees C.
Shelf – life: 24 months from the manufacture date.
Quality specification: In house specification.