MAALOX PLUS SUSPENSION

Israel - English - Ministry of Health

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Active ingredient:
ALUMINIUM HYDROXIDE; MAGNESIUM HYDROXIDE; SIMETHICONE
Available from:
SANOFI - AVENTIS ISRAEL LTD
ATC code:
A02AF
Pharmaceutical form:
SUSPENSION
Composition:
ALUMINIUM HYDROXIDE 175 MG / 5 ML; MAGNESIUM HYDROXIDE 200 MG / 5 ML; SIMETHICONE 25 MG / 5 ML
Administration route:
PER OS
Prescription type:
Not required
Manufactured by:
A.NATTERMANN & CIE GMBH, GERMANY
Therapeutic group:
ANTACIDS WITH ANTIFLATULENTS
Therapeutic indications:
Antacid, antiflatulent, relief of sensation of heatburn.
Authorization number:
107 65 20354 00
Authorization date:
2012-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

21-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

01-10-2020

Maalox Plus Suspension SPC version 15.0 dated 09/2020

1.

NAME OF THE MEDICINAL PRODUCT

Maalox Plus Suspension

2.

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.

3.

PHARMACEUTICAL FORM

Oral suspension

White suspension, homogenous after shaking, with the odour and taste of lemon

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Antacid, antiflatulent, relief of sensation of heartburn

4.2

Posology and method of administration

For oral administration.

Adults

5-10ml, four times a day, taken 20 minutes to 1 hour after meals and at bedtime or as

required.

Children

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

Elderly

The normal adult dose is appropriate.

4.3

Contraindications

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.

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.

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.

Paediatric population

In young children the use of magnesium hydroxide can produce a hypermagnesemia,

especially if they present renal impairment or dehydration.

4.5

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

quinidine overdosage.

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

levothyroxine.

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.

4.6

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

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).

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

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/

4.9

Overdose

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.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for acid related disorders; Antacids with antiflatulents,

ATC Code: A02AF02

Dried aluminium hydroxide gel

- antacid

Magnesium Hydroxide

- antacid

Simethicone

- antifoaming agent/antiflatulent

Maalox Plus is a balanced mixture of two antacids and an antiflatulent/antifoaming agent

simethicone.

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.

5.2

Pharmacokinetic properties

None stated

5.3

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

6.

PHARMACEUTICAL PARTICULARS

6.1

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.

6.2

Incompatibilities

Not applicable

6.3

Shelf life

The expiry date is indicated on the packaging materials.

After first opening: 6 months

6.4

Special precautions for storage

Store below 30

C. Do not freeze.

Shake well before using. Keep bottle tightly closed.

6.5

Nature and contents of container

White

polyethylene

terephthalate

(PET)

bottles

with

polypropylene

(PP)

closure

polyethylene (PE/LDPE) liner : 250ml and 355ml.

Not all pack sizes may be marketed.

7.

MANUFACTURER

Sanofi S.P.A., Italy

8.

MARKETING AUTHORISATION HOLDER

Sanofi-aventis Israel ltd.

Revised in September 2020

MAALPLUS-SUS-

.תשפיחש המ תא ונאצמ אל הנוכנ תנזהש תבותכה םא קודבל יאדכ תבותכב עייסל חמשנ

info@gov.il

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