MAALOX PLUS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Maalox Plus

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

The active components of Maalox Plus are:

Dried Aluminium Hydroxide Gel 230mg/5ml

Magnesium Hydroxide Simeticone

200mg/5ml

25mg/5ml

Also contains 320mg of sorbitol (E420), per 5ml.

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

The symptomatic relief of:

Dyspepsia

Heartburn

Flatulence

4.2 Posology and method of administration

For oral administration:

Adults

5–10ml taken 20 minutes to 1 hour after meals and at bedtime or as required.

Children

As an appropriate proportion of the adult dose.

Children under 5 years

Maximum of 5ml t.d.s.

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.

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-phosphorous 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 encephalopathy, dementia, microcytic anaemia, or worsen dialysis-induced osteomalacia.

Aluminium hydroxide may be unsafe in patients with porphyria undergoing haemodialysis. The prolonged use of antacids in patients with renal failure should be avoided.

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, ketoconazole, hydroxychloroquine, chloroquine, chlorpromazine, rifampicin, cefdinir, cefpodoxime, levothyroxine, rosuvastatin, H2 antagonists, atenolol, cyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, lincosamides, metoprolol, phenothiazine neuroleptics, penicillamine, propranolol, and iron salts.

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 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).

Quinidine:

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

Tetracycline:

Because of the aluminium content, Maalox Plus should not be concomitantly administered with tetracycline-containing antibiotics or any tetracycline salts.

Citrates:

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.

Pregnancy:

There are no available data on Maalox Plus use in pregnant women. No conclusions can be drawn regarding whether or not Maalox Plus is safe for use during pregnancy. Maalox Plus should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.

Lactation:

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

Injury, poisoning and procedural complications:

Frequency not known:

Hyperaluminemia (related to Aluminum component).

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.

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

Simeticone                    - antifoaming agent/antiflatulent

Maalox Plus is a balanced mixture of two antacids and an antiflatulent/an­tifoaming agent simeticone. The two antacids are magnesium hydroxide which is fast acting and aluminium hydroxide which is a slow acting antacid. 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

Domiphen bromide

Microcrystalline cellulose and carmellose sodium

Hydroxpropylce­llulose

Hydrogen peroxide 30%

Citric acid monohydrate

Sodium saccharin

Sorbitol liquid 70% (non-crystallising) (E420)

Methylcellulose

Lemon flavour

Swiss cream flavour

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

Unopened: 2 years

After opening: 6 months

6.4 Special precautions for storage

Store below 30°C.

Do not refrigerate or freeze.

6.5 Nature and contents of container

White polyethylene terephthalate (PET) bottles with polypropylene (PP) closure and polyethylene (PE/LDPE) liner: 250ml and 355ml.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Opella Healthcare UK Limited, trading as Sanofi

410 Thames Valley Park Drive,

Reading,

Berkshire,

RG6 1PT,

United Kingdom.

8 MARKETING AUTHORISATION NUMBER(S)

PL 53886/0041

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

08/09/1989