Instructions Almagel Neo suspension for oral use bottle 170 ml
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;
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
Pharmacodynamics
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 the activation of prostaglandin synthesis, which stimulate the secretion of mucus and bicarbonates from the gastric mucosa.
Given the drug's ability to bind bile acids and lysolecithin, as well as to exert a gastroprotective effect, Almagel Neo can be used to treat duodenogastric reflux.
Simethicone, which is part of the drug, helps eliminate flatulence.
Simethicone is a stable silicone compound that is not absorbed from the digestive tract, causing the natural release of gases and their absorption by the intestinal walls.
Simethicone exerts its effect in the lumen of the small intestines and is excreted from the body unchanged.
The components of the drug are not absorbed in the gastrointestinal 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 turns into magnesium chloride. In the intestines, it turns 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, 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; gastric and duodenal ulcers; gastric and duodenal erosions; 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 origin, ulcerative colitis, conditions that cause disturbances in water and electrolyte balance.
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 (e.g. tetracycline, doxycycline); quinolones (e.g. ciprofloxacin, norfloxacin, ofloxacin); bisphosphonate derivatives (e.g. cloranate, 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. The effect of calcium polystyrene sulfonate may be weakened when used simultaneously with antacids. A two-hour interval should also be observed between taking the following drugs: H2-antihistamines, antituberculosis drugs: ethambutol, isoniazid (oral), atenolol, metoprolol, chloroquine, cyclins, digoxin, sodium fluoride, glucocorticoids (interaction with prednisolone and dexamethasone has been described), indomethacin, lansoprazole, lincosamides, phenothiazine neuroleptics, phosphorus (supplements).
Combinations to consider.
When used simultaneously with salicylates, the excretion of salicylates by the kidneys is increased due to alkalinization of the urine.
The drug should not be used simultaneously with quinolines.
Quinidine excretion may be impaired with manifestations of quinidine toxicity, especially in patients with renal insufficiency.
Concomitant use with cholinergic agents reduces their effectiveness.
Concomitant use of aluminum hydroxide and citrates may lead to increased aluminum levels, especially in patients with renal insufficiency.
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 antacids are used in low doses.
Application features
Before starting the drug, the presence of a malignant process should be excluded.
Aluminum hydroxide may cause constipation, and magnesium hydroxide may cause intestinal hypokinesia. The use of this drug in high doses may cause or complicate intestinal obstruction and intestinal ileus, especially in patients at increased risk of such complications, such as patients with renal insufficiency or elderly patients.
Patients should consult a doctor if:
weight loss; difficulty swallowing or persistent abdominal discomfort; new or worsening digestive disorders; kidney failure.
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 the development of dementia and microcytic anemia.
The drug is not recommended for use in patients with Alzheimer's disease (aluminum concentrates in the nerve fibrils of brain tissue and can lead to complications).
With prolonged 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 prolonged use it can cause hypophosphatemia.
This drug should be used with caution in patients with renal insufficiency. During treatment of patients with renal insufficiency, it is necessary to monitor the dynamics of kidney function, ulcer size, diarrhea, serum aluminum and magnesium levels.
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 addiction, 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 included in the composition of the drug as excipients, can cause allergic reactions, including urticaria and bronchospasm.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the negative impact on the ability to drive vehicles or operate complex mechanisms.
Use during pregnancy or breastfeeding
Due to the lack of adequate clinical research data, Almagel Neo can be used in women during pregnancy only as prescribed by a doctor if the expected benefit to the mother outweighs the possible risk to the fetus/child.
It is necessary to take into account the content of aluminum and magnesium ions, which can affect transit in the gastrointestinal tract, namely:
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 doses of this medicine should be avoided.
When using Almagel Neo to 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.
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 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 for children over 14 years of age.
The safety and efficacy 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 in 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 fatigue, slowed breathing, unpleasant taste sensations.
If an overdose of the drug is suspected or clinical signs appear, it is necessary to cancel the drug and take measures to quickly remove the drug 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 IV may be administered. In case of renal failure, hemodialysis or peritoneal dialysis is necessary.
Adverse reactions
Prolonged use of Almagel® Neo or taking high doses may cause phosphorus deficiency syndrome (loss of appetite, muscle weakness, weight loss).
It should be borne in mind that even when using normal doses of the drug in patients whose diet is characterized by a low phosphorus content, a decrease in the phosphorus content in the body, increased resorption processes in bone tissue, hypercalciuria, osteomalacia, osteoporosis are possible, since this drug contains aluminum (see the section "Special instructions").
In patients with renal insufficiency, increased plasma concentrations of both aluminum and magnesium have been observed, therefore, prolonged use of high doses of aluminum and magnesium salts may lead to the development of encephalopathy, dementia, microcytic anemia or worsen the course of dialysis-induced osteomalacia. Patients with renal insufficiency should receive a reduced dose of the drug or increase the interval between doses of the drug, based on the severity of renal insufficiency. Patients in this group should monitor plasma concentrations of aluminum and magnesium.
Aluminum hydroxide may be dangerous for patients with porphyria who are receiving hemodialysis.
Adverse reactions are classified according to frequency as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated from the available data).
Immune system disorders: Frequency unknown: allergic reactions, including bronchospasm, pruritus, urticaria, angioedema and anaphylactic reactions.
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.
Storage conditions
In the original packaging at a temperature not exceeding 25 °C. Do not freeze! After first opening the primary packaging, the suspension can be stored for 30 days under the specified conditions.
Packaging
170 ml per bottle, 1 bottle per package.
Vacation category
Without a prescription.
Producer
Balkanfarma-Troyan JSC.
Location of the manufacturer and its business address
Bulgaria, 5600 Troyan, 1 Krayrechna St.
