Maalox Plus
SUMMARY OF PRODUCT 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 200mg/5ml
Simeticone 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 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.
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.
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).
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 Plus (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 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 Magnesium Hydroxide Simeticone
- antacid
- antacid
- 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
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GUI 4YS
UK
Or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GUI 4YS
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 04425/0382
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/09/1989
10 DATE OF REVISION OF THE TEXT
07/11/2014