Maalox Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Maalox Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dried aluminium hydroxide gel BP 220 mg, and Magnesium hydroxide BP 195 mg per 5 ml.
3 PHARMACEUTICAL FORM
Suspension.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Antacid therapy in gastric and duodenal ulcer, gastritis, heartburn and gastric hyperacidity.
4.2 Posology and method of administration Adults (including the elderly):
10 - 20 ml taken 20 minutes to one hour after meals and at bedtime or as required. Maalox can be taken with water or milk if required.
Children:
Not recommended for children under 14 years.
Oral administration.
4.3 Contraindications
Maalox should not be used in patients who are severely debilitated or suffering from renal insufficiency, or if there is severe abdominal pain and/or the possibility of bowel obstruction.
Hypersensitivity to the active ingredients or to any of the excipients.
4.4 Special warnings and precautions for use
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 anaemia.
Aluminium hydroxide may be unsafe in patients with porphyria undergoing haemodialysis.
This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This product contains methyl paraben (E218) and propyl paraben (E216); these may cause allergic reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
Antacids are known to interfere with the absorption of drugs such as tetracyclines, vitamins, ciprofloxacin, ketoconazole, levothyroxine, hydroxychloroquine, chloroquine, chlorpromazine, rifampicin, cefdinir, cefpodoxime, rosuvastatin.
Polystyrene sulphonate
Caution is advised when used concomitantly with polystyrene sulphonate 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.
4.6 Fertility, pregnancy and lactation
The safety of Maalox Suspension 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.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
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 (>1/10,000 to <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)
Metabolism and nutrition disorders Frequency not known:
Hypermagnesemia
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
4.9 Overdose
Serious symptoms are unlikely following overdose. Discontinue medication and correct fluid deficiency if necessary.
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Maalox is a balanced mixture of two antacids; aluminium hydroxide is a slow-acting antacid and magnesium hydroxide is a quick-acting one. The two are frequently. combined in antacid mixtures. Aluminium hydroxide on its own is an 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. Gastro-intestinal side effects are thus rare with Maalox and this makes it especially suitable when long term therapy is necessary.
5.2 Pharmacokinetic 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. Aluminium containing antacids should not be administered to patients with renal impairment where increased plasma concentration may occur.
5.3 Preclinical safety data
No relevant data.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methylparaben (E218), propylparaben (E216), citric acid (anhydrous), sodium saccharin (granular), sorbitol solution 70% (E420), mannitol powder (E421), hydrogen peroxide solution 35%, hydrochloric acid, peppermint oil and purified water.
6.2 Incompatibilities
None stated.
6.3 Shelf life
Unopened: 24 months. After opening: 28 days.
6.4 Special precautions for storage
Protect from freezing. Store away from direct sunlight.
6.5 Nature and contents of container
White plastic bottles/alternative polypropylene closure containing 100, 180, 200, 250, 300 or 500 ml.
Glass bottles containing 180 or 300 ml.
Aluminium/polyethylene laminate/paper sachets containing 10ml.
6.6 Special precautions for disposal
Maalox can be taken with milk or water if required.
MARKETING AUTHORISATION HOLDER
7
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
8 MARKETING AUTHORISATION NUMBER(S)
PL 04425/0378
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/01/2009
10 DATE OF REVISION OF THE TEXT
10/03/2014