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Stomalox, chewable tablets

Drug formTablets

ATC categoryGastroenterology. Hepatology

ATC subcategoryGastric antisecretoric and acid neutralizing agents

Brand nameStomalox

Generic nameAluminum hydroxide/Magnesium hydroxide

Composition

Each chewable tablet contains:

active ingredients: Aluminum hydroxide 400 mg, Magnesium hydroxide 400 mg;
excipients: maize starch, xylitol, sodium starch glycolate, magnesium stearate, mint flavor.

Pharmacological group and ATC code
Antacid; A02AD01

Pharmacology

Stomalox is a well-balanced combination of magnesium hydroxide and aluminum hydroxide, which ensures its high neutralizing capacity and cytoprotective effect. Aluminum hydroxide inhibits the secretion of pepsin, neutralizes hydrochloric acid forming aluminum chloride, which turns to alkaline aluminum salts in an alkaline environment. Magnesium hydroxide also neutralizes the hydrochloric acid, turning into magnesium chloride, which has a small laxative action. Thus, the counteract effect of aluminum hydroxide carries out counteracts the effects of aluminum hydroxide, which causes constipation.Acid-neutralizing activity of 1 tablet of the preparation Stomalox is 18.5 meq of the hydrochloric acid. Preparation has antacid, absorbent and protective effect, soothes the pain in the upper digestive tract for several hours.

Pharmacokinetics

The active ingredients of the preparation practically don’t absorb from the gastrointestinal tract.

Uses
Symptomatic treatment of increased gastric acidity conditions in diseases:

– Acute gastritis,

– Chronic gastritis with increased secretory function in the exacerbation phase,

– Gastroesophageal disease,

– Hiatus hernia,

– Gastroduodenitis,

– Stomach ulcers and duodenal ulcer (prevention and symptomatic therapy),

Can be used in heartburn after errors in diet, after reception of medications and alcohol abuse, coffee, nicotine.

Dosage and administration

Dosage is set individually depending on the indications and the pH of gastric juice.

Adult should take preparation Stomalox 1-1.5 hours after a meal. Adults are administered 1-2 tablets 3 times during the day and at night. Preparation should be taken when pain or heartburn occur.

The tablets must be chewed or keep in the mouth to complete their resorption.

Attending doctor should set the dosage for children.

Adverse effects
Rare: hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagniemia, hyperaluminemia, encephalopathy, nephrocalcinosis, impairment of renal functions, constipation, dizziness, palpitations, mood changes, unmotivated weakness, stomach cramps, nausea, vomiting, changes in taste sensations, hypophosphatemia.

Contraindications
– Hypersensitivity to the ingredients of the preparation,

– Expressed impairments of renal functions,

– Hypophosphatemia,

– Alzheimer’s disease.

Precautions

Use of the preparation Stomalox in high doses is contraindicated in patients with renal insufficiency. During the period of application middle and low doses of the preparation in these patients the monitoring of the phosphorus content in the body is necessary. When the first symptoms of phosphorus depletion appear in the body the preparation should be canceled immediately. Stomalox should be used with special caution in appendicitis, weakening or reinforcement effects of the preparation may trigger perforation. Aluminum hydroxide is capable of forming insoluble complexes with phosphates, which are excreted with excrement. This can lead to a reduction in phosphorus concentration in plasma and its subsequent mobilization from the bones. In patients with bones diseases the use of aluminum-containing antacids background depleted inventory levels of phosphorus in the body (e.g malabsorption syndrome) can lead to osteoporosis development and an increased risk of fractures. In elderly patients with metabolic bone diseases prolonged use of aluminum-containing antacids can lead to the depletion of phosphorus inventory levels, hypercalciuria and delayed absorption of fluoride from the intestine.

Paediatric use

Stomalox should be applied to the children under 12 years only in those cases when the preparation is prescribed by a doctor. Admission of antacids should be preceded by detailed diagnosis, because usually children can not accurately describe their complaints. This will prevent the aggravation of the existing at the moment pathological state or occurrence of acute adverse effects.

Pregnancy and breastfeeding

The use of the preparation during pregnancy can be according to the indications.

Not recommended for use during breastfeeding because of the lack of data for the excretion of the active substances with the breast milk.

Identification

White or white off flat cylindrical tablets with a few small patches of yellow colour and specific odor.

Presentation

Stomalox, Chewable tablets N30
6 tablets are packed into PVC-Aluminum blister. 5 blisters with the leaflet inserted into cardboard box.

Stomalox, Chewable tablets N40
10 tablets are packed into PVC-Aluminum blister. 4 blisters with the leaflet inserted into cardboard box.

Expiry date

2 years. Do not use after the expiration date.

Prescription status

To be dispensed without prescription.

Storage conditions

Store at a room temperature (15-250C), in a dry place, out of the reach of children. Protect from light.