MAALOX PLUS

Maalox Plus Chewable Tablets 200mg/200mg/25mg.

Each tablet contains:

200 mg of Magnesium Hydroxide (as magnesium hydroxide paste)

200mg of Hydrated Aluminium Oxide

25mg of Dimeticone (as simeticone)

Excipients with known effect: Sorbitol (E420) 45 mg

Glucose 500.5 mg

Sucrose 75 mg

Ethanol 0.00004 mg

Sulphur dioxide (E220) 13 ppm

For a full list of excipients, see section 6.1.

Chewable Tablet.

Bi-layered, white/yellow tablets engraved with “Maalox” on one side.

In the treatment of heartburn, indigestion, flatulence and dyspepsia.

The route of administration is oral.

Recommended Dosage

Adults: One to two tablets four times a day (after meals and at bedtime) or as required.

Use in severely debilitated patients or in those suffering from kidney failure.

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, infants less than 2 years, 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 or in infants less than 2 years, 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.

Magnesium salts may cause central nervous depression in the presence of renal insufficiency and should be used with extreme caution in patients with kidney disease.

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 anemia or worsen dialysis-induced osteomalacia.

The prolonged use of antacids in patients with renal failure should be avoided.

Care should be observed if used by diabetics because of the sugar content in the tablet.

Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis because it has been shown that aluminium may be involved in porphyrin metabolism abnormalities.

Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase –isomaltase insufficiency should not take this medicine.

Sulphur dioxide may rarely cause hypersensitivity reactions and bronchospasm.

Maalox Plus contains small amounts of ethanol (alcohol), less than 100mg per dose.

Pronlonged use with antacids may mask symptoms of more serious diseases, such as gastrointestinal ulceration or cancer.

Aluminium hydroxide may form complexes with certain drugs, e.g. tetracyclines, digoxin and vitamins, resulting in decreased absorption. This should be borne in mind when concomitant administration is considered.

Concomitant use with quinidines may increase the serum levels of quinidine and lead to quinidine and lead to quinidine overdosage.

Aluminium-containing antacids may prevent the proper absorption of H2 antagonists, atenolol, cefdinir, cefpodoxime chloroquine, cyclines, diflunisal, digoxin, diphosphonates, ethambutol, fluoroquinolones, sodium fluorure, glucorticoids, indometacine, isoniazide, kayexalate, ketoconazole, lincosamides, metoprolol, neuroleptics phenothiazines, penicillamine, propranolol, iron salts.

Staggering the administration times of the interacting drug and the antacid by at least 2 hours (4 hours for the fluoroquinolones) will often help avoid undesirable drug interactions.

Polystyrene sulfonate (Kayexalate)

Caution is advised when used concomitantly with polystyrene sulfonate (Kayexalate) due to the potential risks of reduced effectiveness of the resin in binding potassium, of metabolic alkalosis in patients with renal failure (reported with aluminium hydroxide and magnesium hydroxide), and of intestinal obstruction (reported with aluminium hydroxide).

Aluminium hydroxide and citrates may result in increased aluminium levels, especially in patients with renal impairment.

The use of Maalox Plus should be avoided during the first trimester of pregnancy.

Because of the limited maternal absorption when used as recommended, aluminium hydroxide and magnesium salts combinations are considered as compatible with lactation.

Side effects are uncommon at recommended doses

Immune system disorders

frequency unknown: hypersensitivity reactions, such as pruritus, urticaria, angioedema and anaphylactic reactions 1

Gastrointestinal disorders

Uncommon: diarrhea or constipation (see Section 4.4 Special warnings and precautions for use)

Metabolism and nutrition disorders

frequency unknown:

- hypermagnesemia,

- hyperaluminemia,

- hypophosphatemia, in prolonged use or at high doses or even normal doses of the product in patients with low-phosphorus diets or in infants less than 2 years, which may result in increased bone resorption, hypercalciuria, osteomalacia (see Section 4.4 Special warnings and precautions for use).

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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: http://www.hpra.ie/; E-mail: medsafety@hpra.ie.

SIGNS AND SYMPTOMS

Reported symptoms of acute overdose with aluminium hydroxide and magnesium salts combination include diarrhea, abdominal pain, vomiting. Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see Section 4.4 Special warnings and precautions for use)

MANAGEMENT

Aluminium and magnesium are eliminated through urinary route; treatment of acute overdose consists of rehydration, forced diuresis. In case of renal function deficiency, haemodialysis or peritoneal dialysis is necessary.

Serious symptoms are unlikely following overdosage.

Maalox Plus is a balanced mixture of two antacids and simethicone: aluminium hydroxide is a slow-acting antacid and magnesium hydroxide is a fast-acting one. The two are frequently combined in antacids mixtures. Aluminium hydroxide on its own is astringent and may cause constipation. This effect is balanced by the effect of magnesium hydroxide, which, in common with other magnesium salts, may cause diarrhoea. Simethicone is a surface-active agent included to disperse form. This reduces gastrooesophageal reflux. It does not have antacid properties.

The absorption of aluminium and magnesium from antacids is small. 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. Any absorbed magnesium is likewise excreted in the urine.

Not relevant.

Sucrose

Mannitol

Sorbitol liquid non-crystallising

Sorbitol

Saccharin sodium

Magnesium stearate

Talc

Pregelatinised maize starch

Maize starch

Citric acid, anhydrous

Glucose, anhydrous

Lemon flavour (contains sulphur dioxide)

Swiss cream flavour (contains sulphur dioxide and ethanol)

Iron oxide yellow (E172)

Not applicable.

3 years.

Do not store above 25°C. Store in the original package in order to protect from moisture.

PVC/aluminium blister packs in outer carton: 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 80, 84, 90, 96 and 100 tablets.

Not all pack sizes are marketed.

No special requirements.

Sanofi-Aventis Ireland Ltd. T/A SANOFI

Citywest Business Campus

Dublin 24

Ireland.

PA0540/109/002

Date of first authorisation: 10 November 1975

Date of last renewal: 01 October 2009

August2014