Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint

Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint is an antacid in liquid format, ideal for the symptomatic treatment of gastric hyperacidity , heartburn , gastric reflux and associated disorders such as bloating , stomach pain and difficult digestion . Its formulation contains magnesium hydroxide (4%), aluminum hydroxide (3.5%) and simethicone (0.5%), active ingredients known for their effectiveness in neutralizing gastric acidity and reducing the formation of intestinal gas, offering rapid relief from the most common symptoms of dyspepsia and esophagitis .

The oral suspension, with a pleasant lemon and mint aroma , is packaged in a practical 250 ml bottle that guarantees easy administration and homogeneous distribution of the active ingredients. Maalox Plus is particularly suitable for those looking for an effective and fast-acting stomach medicine , capable of alleviating the discomforts associated with hyperacidity and gastrointestinal swelling. Thanks to the presence of simethicone, the product also helps to counteract the formation of air bubbles and gas, improving digestive comfort.

Maalox Plus oral suspension is a reliable solution for the symptomatic treatment of gastric disorders, suitable for those who want a practical and fresh-tasting remedy. Its balanced composition acts quickly, offering long-lasting relief and promoting a better quality of life in case of heartburn and digestive problems .

ACTIVE INGREDIENTS

Active ingredients contained in Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - What is the active ingredient in Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint?

100 ml of suspension contain : Active ingredients : magnesium hydroxide 4.0 g, aluminium hydroxide 3.5 g, equivalent to aluminium oxide 2.3 g, simethicone 0.50 g. Excipients with known effect : sorbitol (E420), ethanol, invert sugar, sucrose, sulphur dioxide (E220) (see section 4.4). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - What does Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint contain?

Domifene bromide, citric acid monohydrate, sodium saccharin, 70% non-crystallizing liquid sorbitol (E420), methylcellulose, hydroxypropylcellulose, microcrystalline cellulose and sodium carmellose, hydrogen peroxide solution 30%, lemon flavouring (containing ethanol), Swiss cream flavouring (containing ethanol, invert sugar, sucrose, sulphur dioxide (E220)) and purified water.

DIRECTIONS

Therapeutic indications Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - Why is Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint used? What is it used for?

Symptomatic treatment of hyperacidity (including burning and pain) including in cases of esophagitis, and of hyperacidity when accompanied by dyspepsia. Symptomatic treatment of gastrointestinal bloating when accompanied by hyperacidity.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - When should Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint not be used?

-Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; -Patients with porphyria (see section 4.4); -Severe forms of renal insufficiency (creatinine clearance less than 30 mL/min) (see section 4.4); -Contraindicated in paediatric age (see section 4.2); -State of cachexia.

DOSAGE

Quantity and method of taking Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - How to take Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint?

Dosage Ingest 2-4 teaspoons (10-20 ml) of oral suspension 4 times a day, 20-60 minutes after meals and at bedtime. It can be diluted in water or milk. Do not exceed the maximum indicated dose of 16 teaspoons. Paediatric population MAALOX PLUS is contraindicated in children and adolescents under 18 years of age (see section 4.3). Method of administration For oral use. Shake well before use.

CONSERVATION

Storage Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - How do you store Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint?

Store below 30°C. For storage conditions after first opening, see section 6.3.

WARNINGS

Warnings Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - About Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint it is important to know that:

Aluminium hydroxide may cause constipation and an overdose of magnesium salts may cause intestinal hypermotility (see section 4.8); high doses of this medicinal product may cause or aggravate intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, with underlying constipation, with impaired intestinal motility, in children (0 to 24 months), or the elderly (see section 4.9). 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 on low-phosphorus diets or in children (0 to 24 months), may lead to phosphate elimination (due to an aluminium-phosphate bond) accompanied by increased bone resorption and hypercalciuria with risk of osteomalacia (see section 4.8). Monitoring of patients with long-term use or patients at risk of hypophosphatemia is recommended. In patients with renal impairment, plasma levels of aluminium and magnesium tend to increase, causing hyperaluminemia and hypermagnesemia, respectively. In these patients, long-term exposure to high doses of aluminium and magnesium salts may lead to encephalopathy, dementia, microcytic anemia or worsening of dialysis-induced osteomalacia. In the presence of mild and moderate forms of renal impairment, the medicinal product should be taken under medical supervision and prolonged use of the medicinal product should be avoided. Administration of this medicinal product to patients with severe forms of renal insufficiency is contraindicated (see section 4.3). Aluminium hydroxide may not be safe in patients with porphyria undergoing haemodialysis; MAALOX PLUS is contraindicated in patients with porphyria (see section 4.3). MAALOX PLUS, due to its composition, does not tend to modify bowel habits. However, in some particularly sensitive subjects and for high doses, an acceleration of intestinal transit may occur. This medicinal product contains 448 mg of sorbitol (E420) in 10 ml (2 teaspoons). Patients with hereditary fructose intolerance should not be given this medicine. This medicinal product contains 8.2 mg of ethanol in 10 ml (2 teaspoons). 10 ml of this medicinal product is equivalent to 0.2 ml of beer or 0.1 ml of wine. The small amount of alcohol in this medicinal product will not produce relevant effects. This medicinal product contains invert sugar and sucrose : patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. This medicinal product contains sulphur dioxide (E220): may rarely cause severe hypersensitivity reactions and bronchospasm. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'. Paediatric population In young children, the use of magnesium hydroxide may lead to hypermagnesaemia, particularly if they have renal impairment or dehydration.

INTERACTIONS

Interactions Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - Which medicines or foods can modify the effect of Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint?

Since Al and Mg salts reduce the gastrointestinal absorption of tetracyclines, it is recommended to avoid taking MAALOX PLUS during oral tetracycline therapy. The use of aluminum-containing antacids may reduce the absorption of drugs, particularly H2-antagonists, atenolol, bisphosphonates, cefdinir, cefpodoxime, chloroquine, tetracyclines, dasatinib monohydrate, diflunisal, digoxin, dexamethasone, eltrombopag olamine, elvitegravir, ethambutol, fluoroquinolones, glucocorticoids, indomethacin, iron salts, isoniazid, ketoconazole, levothyroxine, lincosamides, metoprolol, nilotinib, phenothiazine neuroleptics, penicillamine, propranolol, raltegravir potassium, rilpivirine, riociguat, rosuvastatin, sodium fluoride and antiviral treatments in combination with tenofovir alafenamide fumarate/emtricitabine/ bictegravir sodium. Since the use of magnesium hydroxide causes alkalinization of the urine, increased excretion of salicylates has been observed when administered concomitantly. Caution is advised when the medicinal product is taken with polystyrene sulfonate (Kayexalate) due to the potential risk of reduced efficacy of the resin in binding potassium, metabolic alkalosis in patients with renal impairment (reported with aluminium hydroxide and magnesium hydroxide) and intestinal obstruction (reported with aluminium hydroxide). Aluminium hydroxide and citrates may cause hyperaluminemia, especially in patients with renal impairment. The combination with integrase inhibitors (dolutegravir, raltegravir, bictegravir) and MAALOX PLUS should be avoided (refer to their respective SmPCs for dose recommendations). As a precaution, allow at least 2 hours (4 hours for fluoroquinolones) to elapse between taking any oral medication and MAALOX PLUS. Concomitant use of quinidine may increase serum quinidine levels and lead to quinidine overdose. Concomitant use of aluminum hydroxide and citrates may lead to increased aluminum levels, particularly in patients with renal insufficiency. Alkalinization of urine following administration of magnesium hydroxide may alter the excretion of some drugs; therefore, increased excretion of salicylates has been observed.

SIDE EFFECTS

Like all medicines, Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint can cause side effects - What are the side effects of Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint?

The frequency of adverse reactions listed below is defined using the following conventions: common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Immune system disorders Frequency not known: angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus. Gastrointestinal disorders Uncommon : diarrhoea or constipation (see section 4.4); Frequency not known : abdominal pain. Metabolism and nutrition disorders Very rare: hypermagnesaemia, including observations after prolonged administration to patients with renal impairment ; Frequency not known : hyperaluminaemia, hypophosphatemia, during prolonged use or at high doses or even at normal doses of the medicinal product in patients with low phosphorus diets or in children (0 to 24 months), which may cause increased bone resorption, hypercalciuria, osteomalacia (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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 the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint - What are the risks of Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint in case of overdose?

Experience with deliberate overdose is very limited. Cases of overdose with aluminium salts are more likely to occur in patients with chronic severe renal impairment with the following symptoms: encephalopathy, convulsions and dementia, hypermagnesemia. The most frequently reported symptoms of acute overdose with aluminium hydroxide and in combination with magnesium salts include diarrhoea, abdominal pain and vomiting. High doses of this medicinal product may cause or aggravate intestinal obstruction and ileus in patients at risk (see section 4.4). Treatment should be symptomatic, with general supportive measures. Aluminium and magnesium are eliminated by urinary excretion; treatment of magnesium overdose includes rehydration and forced diuresis. In cases of renal insufficiency, haemodialysis or peritoneal dialysis is necessary.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint.

There are no data on the use of MAALOX PLUS in pregnant women. It is not possible to establish whether or not the use of MAALOX PLUS during pregnancy is safe . Pregnancy The medicine should be used only in case of need, under the direct supervision of a doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus or the infant. Breastfeeding Due to the limited maternal absorption when taken according to the indicated dosage regimen (see section 4.2), aluminium hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint before driving or using machines - Does Maalox Plus 4% + 3.5% + 0.5% 250 ml oral suspension lemon and mint affect driving or using machines?

MAALOX PLUS does not alter the ability to drive vehicles or use machinery.