Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Simeticone, Magnesium hydroxide, Aluminium hydroxide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Maalox Plus contains three different medicines:
e Maalox Plus Do not take Maalox Plus if: X You are allergic (hypersensitive) to aluminium hydroxide, magnesium hydroxide, simeticone or any of the other ingredients in Maalox Plus (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue X You are feeling very weak and have no energy (debilitated) X You have kidney disease / kidney failure X You have low levels of phosphate (called 'hypophosphataemia'). This is shown up in blood tests. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Maalox Plus.
This includes medicines you buy without a prescription including herbal medicines. Maalox Plus should not be taken at the same time as other medicines. This is because some medicines may be affected by Maalox Plus or they may affect how well Maalox Plus will work. In particular:
Maalox Plus Taking this medicine
prolonged administration to patients with renal impairment. Not known (frequency cannot be estimated from the available data)
not listed in this leaflet: Uncommon (may affect up to 1 in 100 people)
Marketing Authorisation Holder Sanofi, 410 Thames Valley Park Drive Reading, Berkshire, RG6 1PT, UK Tel: 0800 035 2525 Email: [email protected] Manufacturer Opella Healthcare Italy S.r.l. Viale Europa, 11 Origgio Italy This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in May 2024 © Sanofi, 1990 – 2024
869985 418626-01.15-GB
Maalox Plus Keep this medicine in a safe place where children cannot see or reach it. Do not use Maalox Plus after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month. Do not refrigerate or freeze. Store below 30°C. Maalox Plus should be disposed of 6 months after opening the bottle. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
4. Possible side effects
What Maalox Plus contains
The following effects may happen; diarrhoea, stomach pain or you may get a bloated feeling and cramping pain in the abdomen (stomach), be sick (vomit), have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the bowel (ileus).
What Maalox Plus looks like and contents of the pack Maalox Plus is a white suspension, homogenous after shaking and is available in a plastic bottle. Each bottle contains 250ml or 355ml with polypropylene closure. Not all pack sizes may be available.
Like all medicines, Maalox Plus can cause side effects, although not everybody gets them.
Marketing Authorisation Holder and Manufacturer
If you take more Maalox Plus than you should Talk to your doctor or go to a hospital straight away. Remember to take any medicine that is left with you so the doctor knows what you have taken.
Stop taking Maalox Plus and see a doctor or go to a hospital straight away if: Not known (frequency cannot be estimated from the available data)
Maalox Plus suspension comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Maalox Plus suspension is simeticone, magnesium hydroxide, aluminium hydroxide.
This leaflet reproduces the patient information leaflet approved for Maalox Plus suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
The symptomatic relief of:
1. Dyspepsia.
2. Heartburn.
3. Flatulence.
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.
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.
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 anemiaor worsen dialysis-induced osteomalacia.
Aluminium hydroxide may be unsafe in patients with porphyria undergoing hemodialysis. 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.
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 notably H2 antagonists, atenolol, bisphosphonates, cefdinir, cefpodoxime, chloroquine, chlorpromazine, ciprofloxacin, cyclines, dasatinib monohydrate, dexamethasone, diflunisal, digoxin, eltrombopag olamine, elvitegravir, ethambutol, fluoroquinolones, glucocorticoids, hydroxychloroquine, indomethacin, iron salts, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, nilotinib, phenothiazine neuroleptics, penicillamine, propranolol, raltegravir potassium, rifampicin, rilpivirine, riociguat, rosuvastatin, sodium fluorure, antiviral treatment combination of tenofovir alafenamide fumarate/emtricitabine/bictegravir sodium, tetracyclines, and vitamins.
With the integrase inhibitors (dolutegravir, raltegravir, bictegravir) the combination should be avoided (please refer to their SmPC for dose recommendations).
As a precaution, staggering the administration times of any orally administered drug and the antacid by at least 2 hours (4 hours for the fluoroquinolones).
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.
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 feotus.
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.
None stated.
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 Aluminium 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.
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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Simeticone, Magnesium hydroxide, Aluminium hydroxide. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Maalox Plus suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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