Instructions Almagel Neo suspension for oral use sachet 10 ml No. 20
Composition
active ingredients:
5 ml (1 measuring spoon) of suspension contains:
aluminum hydroxide gel in terms of aluminum hydroxide 340 mg, magnesium hydroxide paste in terms of magnesium hydroxide 395 mg, simethicone emulsion 30% in terms of polydimethylsiloxane 36 mg;
10 ml (1 sachet) of suspension contains:
aluminum hydroxide gel in terms of aluminum hydroxide 680 mg, magnesium hydroxide paste in terms of magnesium hydroxide 790 mg, simethicone emulsion 30% in terms of polydimethylsiloxane 72 mg;
Excipients: hydrogen peroxide solution (30%), sorbitol (E 420), sodium saccharin, hydroxyethylcellulose, citric acid monohydrate, ethyl parahydroxybenzoate (E 214), propyl parahydroxybenzoate (E 216), propylene glycol, macrogol 4000, orange flavoring, ethanol 96%, purified water.
Dosage form
Suspension for oral use.
Main physicochemical properties: white or almost white suspension with an orange odor.
Pharmacotherapeutic group
Antacids. Combinations of simple salts and carminatives (antiflatulents). ATX code A02A F02.
Pharmacological properties
Almagel® Neo is a balanced combination of aluminum hydroxide and magnesium hydroxide with a carminative component - simethicone. It has a long-lasting antacid effect, exhibits a mild laxative effect, successfully eliminates constipation and reduces flatulence in patients with stomach ulcers.
Its dual mechanism of action, combining acid-neutralizing ability and cytoprotective activity, provides protection of the gastric mucosa and its healing when damaged.
The alkaline active components of the drug are finely dispersed, which increases their active surface, ensures closer contact with the surface of the gastric and duodenal mucosa, slows down the evacuation of gastric contents, and prolongs the neutralizing effect.
Cytoprotective activity is associated with activation of prostaglandin synthesis, which stimulate mucus and bicarbonate secretion from the gastric mucosa. Given the ability of the drug to bind bile acids and lysolecithin, as well as to exert a gastroprotective effect, Almagel® Neo can be used for the treatment of duodenogastric reflux.
Simethicone helps eliminate flatulence, is a stable silicone compound that is not absorbed from the gastrointestinal tract (GI), causes natural release of gases and their absorption by the intestinal walls. Simethicone acts in the lumen of the small intestines and is excreted from the body unchanged. The components of the drug are not absorbed in the GI tract and, therefore, do not lead to clinically significant plasma concentrations when used in recommended doses and for the recommended duration of treatment. Aluminum hydroxide neutralizes the increased secretion of hydrochloric acid in the stomach, forming aluminum chloride. Under the influence of the alkaline environment of the intestine, the latter is converted into alkaline aluminum salts, which are poorly absorbed and excreted in the feces. With normal kidney function, the serum aluminum level practically does not change. Magnesium hydroxide also neutralizes hydrochloric acid in the stomach and is converted into magnesium chloride. In the intestines, it is converted into magnesium carbonate, which is poorly absorbed, so the concentration of magnesium ions in the blood practically does not change.
In patients with chronic renal failure (CKD), the level of aluminum and magnesium ions may increase to toxic levels due to impaired excretion.
Indication
Symptomatic treatment of digestive tract diseases accompanied by increased or normal acidity of gastric juice and increased gas formation.
The drug should be used alone or in combination with other medications for:
gastritis and duodenitis;
stomach and duodenal ulcers;
erosions of the stomach and duodenum;
gastroesophageal reflux disease;
duodenogastric reflux;
functional dyspepsia;
flatulence, discomfort due to increased gas formation.
Contraindication
Hypersensitivity to aluminum hydroxide, magnesium hydroxide or simethicone and/or excipients included in the medicinal product. Severe renal impairment, including in patients on hemodialysis, in whom there is a risk of increasing the concentration of aluminum and magnesium ions in the blood serum to toxic levels as a result of reduced renal excretion. Hypophosphatemia, severe osteoporosis, habitual constipation, chronic diarrhea, intestinal obstruction, suspected appendicitis, bleeding from the digestive tract of unknown origin, severe abdominal pain of unspecified genesis, ulcerative colitis, conditions that cause disturbances in water and electrolyte balance, severe exhaustion.
Interaction with other medicinal products and other types of interactions
Concomitant use with Almagel® Neo may lead to a decrease in the absorption of the following drugs: tetracycline antibiotics (tetracycline, doxycycline); quinolones (ciprofloxacin, norfloxacin, ofloxacin); bisphosphonate derivatives (cloronate, alendronate, risedronate); protease inhibitors (atazanavir, tipranavir, fosamprenavir); ketoconazole, itraconazole; rosuvastatin; allopurinol, diflunisal, gabapentin, iron, mycophenolate mofetil; levothyroxine; dasatinib; strontium ranelate.
Plasma concentrations of penicillamine, sotalol, propranolol, phenytoin, cefpodoxime, fexofenadine may decrease when used simultaneously with antacids.
Aluminum-containing antacids reduce the absorption of the following drugs: H2-antihistamines, antituberculosis drugs: ethambutol, isoniazid (oral), polystyrene sulfonate, atenolol, cefdinir, metoprolol, neuroleptics, chloroquine, cyclins, digoxin, sodium fluoride, glucocorticoid drugs (interaction with prednisolone and dexamethasone has been described), indomethacin, lansoprazole, lincosamides, phenothiazine neuroleptics, phosphorus (supplements), vitamins. Reduced absorption of these drugs is associated with the formation of insoluble complexes and/or alkalization of gastric contents. To avoid undesirable interactions, a 2-hour interval is recommended between taking these drugs (4 hours for fluoroquinolones) and the drug Almagel® Neo.
Caution should be exercised when using the drug concomitantly with polystyrene sulfonate, as effective potassium binding may be reduced due to the risk of metabolic alkalosis in patients with renal insufficiency (reported with aluminum hydroxide and magnesium hydroxide) and the risk of intestinal obstruction (reported with aluminum hydroxide).
Combinations to be considered. When used simultaneously with salicylates, the renal excretion of salicylates is increased due to alkalinization of the urine. The drug should not be used simultaneously with quinolines. The simultaneous use of this drug with quinidine may increase the concentration of quinidine in the blood plasma and lead to overdose. The elimination of quinidine may be impaired with manifestations of quinidine toxicity, especially in patients with NN. Simultaneous use with cholinergic drugs reduces their effectiveness. The simultaneous use of aluminum hydroxide and citrates may lead to increased aluminum levels, especially in patients with NN. The simultaneous use of simethicone with levothyroxine may lead to a delay or decrease in the absorption of levothyroxine. The use of the drug together with enteric-coated drugs may lead to more rapid dissolution of the coating and irritation of the stomach and duodenum. The drug may reduce the absorption of folic acid. Pirenzepine enhances and prolongs the effect of Almagel® Neo. The likelihood of drug interactions is lower when using antacids in low doses.
Application features
Before starting the drug, the presence of a malignant process should be excluded. Patients should consult a doctor in case of weight loss; difficulty swallowing or persistent abdominal discomfort; new or worsening digestive disorders; renal failure.
Aluminum hydroxide may cause constipation, and overdose of magnesium salts may cause intestinal hypokinesia. In patients at increased risk, especially patients with renal failure or the elderly, the use of the drug in high doses may cause or complicate intestinal obstruction and intestinal obstruction. Long-term use of antacids may mask the symptoms of more serious diseases, such as gastrointestinal ulcers or cancer.
Aluminum hydroxide is poorly absorbed from the gastrointestinal tract, so systemic effects in patients with normal renal function are rarely observed. However, prolonged use, use of very high doses or usual doses in the presence of insufficient dietary phosphate intake may lead to phosphate deficiency (due to binding of aluminum to phosphate), accompanied by increased bone resorption, hypercalciuria and the risk of osteomalacia. Long-term use or treatment of patients at risk of phosphate deficiency should be carried out under medical supervision.
In patients with impaired renal function, plasma levels of aluminum and/or magnesium may increase, so it should be borne in mind that prolonged use of high doses of the drug may lead to encephalopathy, dementia and microcytic anemia and worsen dialysis-induced osteomalacia. This drug should be used with caution in patients with NN: they need to reduce the dose or increase the interval between doses of the drug, depending on the severity of renal failure. During the treatment of patients with NN, it is necessary to monitor the dynamics of renal function, ulcer size, diarrhea, serum aluminum and magnesium levels. The use of aluminum hydroxide in patients with porphyria on hemodialysis can be dangerous, since aluminum can cause impaired porphyrin metabolism.
Long-term use of Almagel® Neo or taking high doses can cause phosphorus deficiency syndrome (loss of appetite, muscle weakness, weight loss). With long-term use of the drug, it is necessary to ensure that the body receives a sufficient amount of phosphorus, since aluminum hydroxide binds to phosphates and reduces their absorption from the digestive tract. In addition, urinary calcium excretion increases, which can lead to calcium-phosphate imbalance and create conditions for the development of osteomalacia (symptoms - complaints of weakness and pain in the bones). This drug is not suitable for patients suffering from hypophosphatemia, since with long-term use it can cause hypophosphatemia.
Children: Use of magnesium hydroxide in young children may cause hypermagnesemia, especially in the presence of renal insufficiency or dehydration.
One dose (10 ml) of the drug contains 0.226 g of ethanol, the presence of which may adversely affect the condition of patients with liver and brain diseases, people with alcohol dependence, epilepsy, pregnant women and children under 14 years of age; 0.95 g of sorbitol, which is contraindicated in patients with rare hereditary diseases such as fructose intolerance, and may cause stomach irritation and diarrhea.
Parabens, which are part of the medicinal product as excipients, may cause allergic reactions (possibly delayed), including urticaria and bronchospasm.
Use during pregnancy or breastfeeding
Due to the lack of adequate clinical studies, Almagel® Neo can be used during pregnancy only on medical advice if the expected benefit to the mother outweighs the potential risk to the fetus/child. The content of aluminum and magnesium ions, which can affect gastrointestinal transit, should be taken into account: magnesium hydroxide salts can cause diarrhea; aluminum salts can cause constipation and worsen constipation, which is often observed during pregnancy, so prolonged use and exceeding the dosage of this medicine should be avoided. When using Almagel® Neo in pregnant women, the drug may cause harm due to the content of ethyl alcohol (0.226 g in one dose).
Due to the lack of adequate clinical research data, Almagel® Neo can be used by women during breastfeeding only as prescribed by a doctor if the expected benefit to the mother outweighs the possible risk to the child.
The ability to influence the reaction speed when driving or working with other mechanisms
There is no data on the negative impact on the ability to drive vehicles or operate complex mechanisms.
Method of administration and doses
Adults and children over 14 years of age
For gastroesophageal reflux disease, the recommended dose is 10-15 ml (2-3 measuring spoons) or 1 sachet 4 times a day 1 hour after meals and before bedtime. After achieving the desired effect, the recommended dose is 10 ml (2 measuring spoons) or 1 sachet 4 times a day.
For gastritis, duodenitis, gastric and duodenal erosions, gastric and duodenal ulcers, duodenogastric reflux, functional dyspepsia, flatulence, the recommended dose is 10 ml (2 measuring spoons) or 1 sachet 4 times a day 1 hour after meals and before bedtime.
The duration of treatment is determined by the doctor. The maximum daily dose is 60 ml (12 measuring spoons or 6 sachets), the maximum duration of treatment is 4 weeks. If the symptoms persist, you should consult a doctor.
The drug should be taken undiluted. It is not recommended to drink liquids for 30 minutes after taking it. Before use, the suspension should be thoroughly homogenized by shaking the bottle.
Patients with impaired renal function. The drug should be taken after consulting a doctor. With prolonged use, the state of renal function should be taken into account.
Children
Use in children over 14 years of age. The safety and effectiveness of the drug in children under 14 years of age have not been established.
Overdose
Long-term use of Almagel® Neo can cause hypermagnesemia, despite the fact that the drug is almost not absorbed from the gastrointestinal tract. Symptoms of overdose are manifested by rapid fatigue, facial flushing, exhaustion, muscle weakness and inadequate behavior. Signs of metabolic alkalosis may also be observed: changes in mood or mental activity, numbness or pain in the muscles, nervousness and rapid fatigue, slowed breathing, unpleasant taste sensations. If an overdose is suspected or if clinical signs appear, the drug should be discontinued and measures should be taken to quickly remove it from the gastrointestinal tract (administer activated charcoal, perform gastric lavage and other procedures to reduce the absorption of aluminum and magnesium ions). Treatment of magnesium overdose: rehydration, forced diuresis. Calcium gluconate can be administered intravenously. In case of NN, hemodialysis or peritoneal dialysis is necessary.
Side effects
Immune system disorders: Frequency unknown: allergic reactions, including bronchospasm, pruritus, urticaria, angioedema, hypersensitivity and anaphylactic reactions.
Metabolism and nutrition disorders: Very rare: hypermagnesemia (observed after prolonged use of magnesium hydroxide in patients with renal insufficiency). Frequency unknown: hypophosphatemia, hyperaluminemia.
Nervous system: Rare: aluminum and/or magnesium intoxication, mainly in patients with renal failure. Very rare: dementia, worsening of Alzheimer's disease.
Gastrointestinal disorders: Uncommon: taste disturbance (chalky taste). Very rare: diarrhoea. Frequency unknown: constipation, abdominal pain.
Description of selected adverse reactions. Hypophosphatemia may occur with prolonged use or high doses, as well as with normal doses in the presence of insufficient dietary phosphate intake. Hypophosphatemia may lead to increased bone resorption, hypercalciuria, and osteomalacia.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C. Keep out of the reach of children. Do not freeze.
After first opening the bottle, the medicine can be stored for 30 days under the specified conditions.
Packaging
170 ml or 200 ml in a bottle with a measuring spoon; 1 bottle with a measuring spoon in a cardboard box.
10 ml in foil sachets. 10 or 20 sachets in a cardboard box.
Vacation category
Without a prescription.
Producer
Balkanfarma-Troyan JSC.
Location of the manufacturer and address of its place of business.
1 Krayrechna St., Troyan, 5600, Bulgaria.
