Israel - English - Ministry of Health
Maalox Plus Suspension SPC version 15.0 dated 09/2020
NAME OF THE MEDICINAL PRODUCT
Maalox Plus Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
5ml of the suspension contains: 175 mg of Aluminum Hydroxide (as aluminium hydroxide
gel), 25 mg of simethicone and 200mg of Magnesium Hydroxide
Also contains 320 mg of sorbitol liquid 70% per 5 ml
For a full list of excipients, see section 6.1.
White suspension, homogenous after shaking, with the odour and taste of lemon
Antacid, antiflatulent, relief of sensation of heartburn
Posology and method of administration
For oral administration.
5-10ml, four times a day, taken 20 minutes to 1 hour after meals and at bedtime or as
Child 6–12 years 5 mL 3–4 times daily
Child 12–18 years 5–10 mL 4 times daily,
taken 20 minutes to 1 hour after meals and at bedtime when required
The normal adult dose is appropriate.
Should not be used in patients who are hypersensitive to any of the active substances or
excipients, are severely debilitated or suffering from kidney failure, or hypophosphataemia or
if there is severe abdominal pain and/or the possibility of bowel obstruction.
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
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.
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 dementia, microcytic anemia..
Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.
This product contains sorbitol (E420). Patients with rare hereditary problems of fructose
intolerance should not take this medicine.
In young children the use of magnesium hydroxide can produce a hypermagnesemia,
especially if they present renal impairment or dehydration.
Interaction with other medicinal products and other forms of interaction
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, ketoconalzole, hydroxychloroquine ,chloroquine,
chlorpromazine, rifampicin, cefdinir, cefpodoxime, levothyroxine, rosuvastatin, H
antagonists, atenolol, cyclines, diflunisal, digoxin, bisphosphonates, ethambutol,
fluoroquinolones, sodium fluorure, glucocorticoids, indometacine, isoniazide, lincosamides,
metoprolol, neuroleptics phenothiazines, pencillamine, propranolol, iron salts.
Concomitant use with quinidines may increase the serum levels of quinidine and lead to
Staggering the administration times of the interacting drug and the antacid by at least 2 hours
(4 hours of the fluoroquinolones) will often help avoid undesirable drug interactions.
Levothyroxine may also bind to simeticone which may delay or reduce the absorption of
Polystyrene sulphonate (Kayexalate):
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.
Urine alkalinisation secondary to administration of magnesium hydroxide may modify
excretion of some drugs; thus, increased excretion of salicylates has been seen.
Fertility, Pregnancy and lactation
The safety of Maalox Plus Suspension in pregnancy has not been established.
The use of Maalox Plus should be avoided during the first trimester of pregnancy.
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 effect on the breastfed newborn/infant are anticipated since the systemic exposure of the
breast-feeding woman to aluminium hydroxide, magnesium hydroxide and simeticone is
Effects on ability to drive and use machines
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
Immune system disorders
Frequency not known: hypersensitivity reactions, such as pruritus, urticaria, angioedema and
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:
Hypophosphataemia, 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.
Any suspected adverse events should be reported to the Ministry of Health according to the
National Regulation by using an online form: https://sideeffects.health.gov.il/
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.
Pharmacotherapeutic group: Drugs for acid related disorders; Antacids with antiflatulents,
ATC Code: A02AF02
Dried aluminium hydroxide gel
- antifoaming agent/antiflatulent
Maalox Plus is a balanced mixture of two antacids and an antiflatulent/antifoaming agent
The two antacids are aluminium hydroxide which is a slow acting antacid and magnesium
hydroxide which is a fast acting one. The combination produces a fast onset of action and an
increase in total buffering time. Aluminium hydroxide on its own is an astringent and may
cause constipation. This effect is balanced by the effect of the magnesium hydroxide which
is in common with other magnesium salts, may cause diarrhoea.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that
already included in other sections of the SmPC
List of Excipients
Sobitol liquid 70% (non crystallizing) 320mg/5ml, Hydroxypropylcellulose, Microcrystalline
cellulose and Carmellose Sodium, lemon flavour, Citric Acid monohydrate, Hydrogen
peroxide solution 30%, Swiss Cream flavor, Methylcellulose, Sodium saccharin, Domiphen
bromide 0.42mg/5ml, Purified water.
The expiry date is indicated on the packaging materials.
After first opening: 6 months
Special precautions for storage
Store below 30
C. Do not freeze.
Shake well before using. Keep bottle tightly closed.
Nature and contents of container
polyethylene (PE/LDPE) liner : 250ml and 355ml.
Not all pack sizes may be marketed.
Sanofi S.P.A., Italy
MARKETING AUTHORISATION HOLDER
Sanofi-aventis Israel ltd.
Revised in September 2020
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