Maalox Plus Tablets

Tablet

Bi-layered white and yellow tablets, 16mm in diameter, with 'Maalox' embossed on one side.

The symptomatic relief of:

1. Dyspepsia

2. Heartburn

3. Flatulence

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

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.

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 dementia, microcytic anemia.

Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.

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

Maalox Plus should not be taken simultaneously with other medicines as they may interfere with their absorption if taken within 1 hour.

Aluminium-containing antacids may prevent the proper absorption of drugs such as tetracyclines, vitamins, ciprofloxacin, ketoconazole, hydroxychloroquine, chloroquine, chlorpromazine, rifampicin, cefdinir, cefpodoxime, levothyroxine, rosuvastatin.

Levothyroxine may also bind to simeticone which may delay or reduce the absorption of levothyroxine.

Polystyrene sulphonate

Caution is advised when used concomitantly with polystyrene sulphonate due to the potential risk 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.

Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.

The safety of Maalox Plus Tablets in pregnancy has not been established.

Because of the limited maternal absorption, when used as recommended, minimal amounts, if any, of aluminium hydroxide and magnesium salt combinations are expected to be excreted into breast milk.

Simeticone is not absorbed from the gastrointestinal tract.

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to aluminium hydroxide, magnesium hydroxide and simeticone is negligible.

None stated.

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.

Uncommon: diarrhoea or constipation (see section 4.4)

Frequency not known: Abdominal pain

Metabolism and nutrition disorders

Very rare: Hypermagnesemia, including observations after prolonged administration of magnesium hydroxide to patients with renal impairment.

Frequency not known:

Hyperaluminemia

Hypophosphatemia, in prolonged use or at high doses or even normal doses of the product in patients with low-phosphorus diets, which may result in increased bone resorption, hypercalciuria, osteomalacia (see section 4.4).

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Serious symptoms are unlikely following overdosage.

Reported symptoms of acute overdose with aluminium hydroxide and magnesium salts combination include diarrhoea, abdominal pain, vomiting.

Large doses of this product may trigger or aggravate intestinal obstruction and ileus in patients at risk (see section 4.4)

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

Dried aluminium hydroxide gel - antacid

Magnesium hydroxide - antacid

Simeticone - Antifoaming agent/antiflatulent

The antacids are balanced such that gastrointestinal side effects (constipation and diarrhoea) are minimal.

None stated

None stated

Swiss Cream flavour

Lemon flavour

Magnesium stearate

Talc

Citric acid, anhydrous

Glucose, anhydrous

Saccharin sodium

Sorbitol (E420)

Sorbitol liquid non-crystallising (E420)

Iron oxide yellow (E172)

Pregelatinised starch (Maize starch)

Maize starch

Sucrose

Mannitol (E421)

None stated.

Store below 25°C

Strip packs

Plastic/aluminium strip packs packed in cardboard boxes

Packs of 10,12,20,24,30,36,40,48,50,60,70,72,80,84,90,96,100 tablets are available

Tubes

Paper/foil roll tubes of 12 tablets sold individually or packed in cellophane pillow packs or cardboard cartons

Packs of 12, 24, 36, 48, 72, 144 tablets are available

None stated

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

or Trading as

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0177

23 January 2009

21 December 2017

LEGAL STATUS

GSL