MAALOX * OS SOSP 250ML 4% + 3.5%

  • Medifarm S.r.l.
  • 041417041

Maalox is a drug based on the active ingredient magnesium hydroxide + algeldrate - belonging to the category of Antacids and specifically Associations and complexes between aluminum compounds - calcium and magnesium. Maalox can be prescribed with OTC Recipe - self-medication. Symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

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MAALOX * OS SOSP 250ML 4% + 3.5%

Therapeutic indications

Symptomatic treatment of occasional heartburn and hyperacidity of the stomach.

Dosage and method of use

DosageSwallow 2 to 4 teaspoons (10-20 ml) of oral suspension 4 times a day, 20-60 minutes after meals and at bedtime. Do not exceed the maximum indicated dose of 16 tsp.Pediatric populationMAALOX is contraindicated in children and adolescents below 18 years of age (see section 4.3).Method of administrationFor oral use. Shake well before use.

Contraindications

- 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 failure (see section 4.4). - Contraindicated in pediatric age (see section 4.2). - State of cachexia.

Side effects

The frequency of the undesirable effects listed below is defined using the following conventions: common (≥1 / 100,Immune system disorders: Frequency not known: angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus. Gastrointestinal disorders: Uncommon: diarrhea or constipation (see section 4.4).Frequency not known: abdominal pain. Metabolism and nutrition disorders: Very rare: hypermagnesemia, including observations after prolonged administration to patients with renal impairment.Frequency not known:hyperalluminaemia, hypophosphataemia, during prolonged use or at high doses or even at normal doses of the drug in patients with low phosphorus diets or in children (0 to 24 months), which can cause increased bone resorption, hypercalciuria, osteomalacia (see section 4.4).Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. 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.

Special warnings

Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause hypomotility of the intestine (see section 4.8); high doses of this medicine may cause or aggravate intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, with underlying constipation, with impaired bowel motility, in children (0 to 24 months) , or the elderly (see section 4.9). Aluminum 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 or in children (0 to 24 months), can lead to phosphate elimination (due to an aluminum-phosphate bond) accompanied by an increase in bone resorption and hypercalciuria with risk of osteomalacia (see section 4.8). It is advisable to monitor patients for long-term use or patients at risk of hypophosphataemia. In patients with renal impairment, plasma levels of aluminum and magnesium tend to increase causing hyperalluminaemia and hypermagnesaemia, respectively. In these patients, long exposures to high doses of aluminum and magnesium salts can lead to encephalopathies, dementia, microcytic anemia or worsening of dialysis 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 subjects with severe renal insufficiency is contraindicated (see section 4.3). Aluminum hydroxide may be unsafe in patients with porphyria undergoing hemodialysis. MAALOX is contraindicated in patients with porphyria (see section 4.3). This medicine contains approximately 100 mg ofsorbitolin 10 ml (2 tsp). Patients with hereditary fructose intolerance should not be given this medicine. This medicinal product contains less than 1 mmol (23 mg) ofsodiumper dose, ie it is essentially “sodium-free”.Pediatric populationIn young children, the use of magnesium hydroxide can lead to hypermagnesemia, particularly if they have kidney damage or dehydration.

Pregnancy and breastfeeding

PregnancyThe medicine should only be used when needed, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.Feeding timeDue to limited maternal absorption when taken according to the indicated dosage regimen (see section 4.2), aluminum hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding.

Expiration and retention

Store below 25 ° C. For storage conditions after first opening see section 6.3.

Interactions with other drugs

Since Al and Mg salts reduce the gastrointestinal absorption of tetracyclines, it is recommended to avoid taking MAALOX during oral tetracycline therapy. The use of aluminum-containing antacids can reduce the absorption of drugs such as H.2- antagonists, atenolol, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacin, isoniazid, ketoconazole, levothyroxine, rosenotexine, methylaminol, propenoluvamine, propenol-methylenol, lincosamides iron salts. Caution is advised when the medicinal product is taken together with polystyrene sulphonate (Kayexalate) due to the potential risk of the resin's reduced efficacy in binding potassium, metabolic alkalosis in patients with renal impairment (reported with aluminum hydroxide and magnesium hydroxide) and intestinal obstruction (reported with aluminum hydroxide). Aluminum hydroxide and citrates can cause hyperalluminaemia, especially in patients with renal impairment. Allow at least two hours (4 for fluoroquinolones) before taking MAALOX to avoid interaction with other drugs. Simultaneous use of quinidine may result in increased serum quinidine levels and lead to quinidine overdose. The simultaneous use of aluminum hydroxide and citrates can lead to an increase in aluminum levels, particularly in patients with renal insufficiency. Alkalinization of urine following administration of magnesium hydroxide can modify the excretion of some drugs; therefore, increased excretion of salicylates was observed.

Overdose

Experience with deliberate overdose is very limited. Cases of overdose with aluminum salts can occur more easily in patients with chronic severe renal impairment with the following symptoms: encephalopathy, convulsions and dementia, hypermagnesaemia. The most frequently reported symptoms of acute overdose with aluminum hydroxide and in combination with magnesium salts include diarrhea, 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 generic supportive measures. Aluminum and magnesium are eliminated by urinary excretion; treatment of magnesium overdose involves rehydration and forced diuresis. In case of renal insufficiency, hemodialysis or peritoneal dialysis is required.

Active principles

100 ml of suspension contain:- Active principles:magnesium hydroxide 4.00 g aluminum hydroxide 3.5 g equivalent to aluminum oxide 2.3 g Excipients with known effects: 10 ml contain 0.31 mg of sodium and 100.03 mg of sorbitol. For the full list of excipients, see section 6.1.

Excipients

Hydrochloric acid (10%), citric acid (monohydrate), mint essence, mannitol (E421), domiphene bromide,sodium saccharin,sorbitol70% non-crystallizable liquid (E420), hydrogen peroxide solution 30% and purified water.

041417041

Data sheet

Packaging
4% + 3 -5% oral suspension mint flavor 250 ml bottle (imported from Poland)
4% + 3.5% oral suspension mint flavor 250 ml bottle (imported from Poland)
Product Type
HUMAN DRUG
ATC code
A02AD01
ATC description
Common salt associations
Therapeutic Group
Antacids
Active principle
magnesium hydroxide + algeldrate
Class
C.
Pharmaceutical form
Suspension
Type of Administration
oral
Container
vial / bottle / vial in box
Quantity
1 vial / vial / vial
Capacity
250 milliliters
Quantity of the Active Ingredient
3 -5G (algeldrate) + 4G (magnesium hydroxide)
3.5G (algeldrate) + 4G (magnesium hydroxide)
Recipe required
OTC - self-medication medicine
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