Almagel Neo, 170 ml suspension

Pharmacotherapeutic group: antacidal agent + diuretic.

ATX code: A02AF02

Pharmacological properties

Pharmacodynamics

A combined remedy whose action is due to its constituent components. It has antacid, adsorptive, sedative and diarrheal action. Algeldrat (aluminum hydroxide) and magnesium hydroxide neutralize free hydrochloric acid in the stomach, decrease the acidity of gastric juice, bind bile acids. The relaxing effect of magnesium hydroxide balances the ability of algeldrate to slow intestinal motility. Simethicone impedes the formation of gas bubbles and promotes their destruction. The gases released are absorbed by the intestinal walls and eliminated through peristalsis.

Pharmacokinetics

absorption. Due to physiological and chemical inertness, simethicone and other active ingredients are not absorbed into organs and tissues and are excreted unchanged after passing through the gastrointestinal tract (GIT). Absorption of aluminum and magnesium ions in the intestine is low.

Distribution.In normal renal function, the concentration of aluminum and magnesium in the blood does not change. In patients with chronic renal insufficiency, the concentration of aluminum and magnesium in the blood may increase to toxic values as a result of impaired excretion.

Elimation.Extracted through the intestine.

Indications

Heartburn, Chronic pancreatitis, Peptic ulcer, Gastroduodenitis, Meteorism, Reflux esophagitis, Bloating, Gastritis- Heartburn (after excessive use of ethanol, nicotine, coffee, medications; improper diet).
– Pain in the stomach.
– Acute gastritis; chronic gastritis with increased and normal secretory function of the stomach (in the acute phase).
– Peptic ulcer and duodenal ulcer (in the acute phase).
– Symptomatic peptic ulcers of the gastrointestinal tract of various genesis.
– Erosions of the mucous membrane of the upper gastrointestinal tract.
– Gastroesophageal reflux, reflux-esophagitis.
– Acute duodenitis, duodenogastric reflux.
– Acute pancreatitis, exacerbation of chronic pancreatitis.
– Meteorism.
– Fermentation or putrefactive dyspepsia.

Active ingredient

Algeldrate, Magnesium hydroxide, Simethicone

Composition

5 ml (one scoop) of the suspension contains:

acting substances: aluminum hydroxide gel (in terms of aluminum hydroxide) 340.00 mg, magnesium hydroxide paste (in terms of magnesium hydroxide) 395.00 mg, simethicone (simethicone emulsion) (in terms of dimethicone) 36.00 mg;

auxiliary substances: Hydrogen peroxide solution 30% – 0.495 mg, sorbitol – 474.60 mg, sodium saccharinate – 1.13 mg, hyethylose – 5.65 mg, citric acid monohydrate – 5.65 mg, ethyl parahydroxybenzoate – 7,90 mg, propyl parahydroxybenzoate – 3.40 mg, propylene glycol – 113.00 mg, macrogol 4000 – 452.00 mg, orange flavoring – 2.26 mg, ethanol 96% – 113.00 mg, purified water to 5 ml.

10 ml (1 sachet) of the suspension contains:

acting substances: Aluminum hydroxide gel (in terms of aluminum hydroxide) 680.00 mg, magnesium hydroxide paste (in terms of magnesium hydroxide) 790.00 mg, simethicone (simethicone emulsion) (in terms of dimethicone) 72.00 mg;

auxiliary substances: Hydrogen peroxide solution 30% – 0.990 mg, sorbitol – 949.20 mg, sodium saccharinate – 2.26 mg, hyethylose – 11.30 mg, citric acid monohydrate – 11.30 mg, ethyl parahydroxybenzoate – 15,80 mg, propyl parahydroxybenzoate – 6.80 mg, propylene glycol – 226.00 mg, macrogol 4000 – 904.00 mg, orange flavoring – 4.52 mg, ethanol 96% – 226.00 mg, purified water to 10 ml.

How to take, the dosage

To be taken orally.

Adults and children over 14 years

Burn (after excessive use of ethanol, nicotine, coffee, medications; improper diet), pain in the stomach: The recommended dose is 10-15 ml (2-3 measuring spoons) or the contents of 1 – 1.5 sachets 4 times a day 1 hour after a meal and in the evening before bedtime.

Reflux esophagitis:The recommended dose is 10-15 ml (2-3 scoops) or the contents of 1 sachet 4 times daily 1 hour after a meal and in the evening before bedtime. After achieving the desired effect, the recommended dose is 10 ml (2 scoops) or the contents of 1 sachet 4 times daily.

Acute gastritis; Chronic gastritis with increased and normal secretory function of the stomach (in the acute phase), gastric ulcer and duodenal ulcer (in the acute phase), symptomatic gastrointestinal ulcers of various genesis, mucosal erosions of the upper gastrointestinal tract, gastroesophageal reflux, acute duodenitis, duodenogastric reflux, acute pancreatitis, exacerbation of chronic pancreatitis, flatulence, fermentative or putrefactive dyspepsia: the recommended dose is 10 ml (2 measuring spoons) or the contents of 1 sachet 4 times daily 1 hour after a meal and in the evening before bedtime.

The maximum daily dose is 60 ml (12 scoops) or 6 pouches; therapy has a maximum duration of 4 weeks.

Consult a physician if symptoms persist.

Application in children: b The safety and effectiveness in children under 14 years of age has not been evaluated.

Application in patients with acute renal failure: Application of the drug is possible only after consultation with the attending physician. In long-term therapy (more than 14 days) monitoring of renal function is required.

Before intake, the suspension should be homogenized by shaking the bottle or by kneading and shaking the bag. It is preferable to take Almagel^® Neo undiluted. It is not recommended to take liquids for half an hour after taking the drug.

Interaction

Almagel® Neo reduces and slows down absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H2-histamine receptor blockers, beta-adrenoblockers, diflunisal, ketoconazole and itraconazole, isoniazid, tetracycline antibiotics and quinolones, azithromycin, cefpodoxime, pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexophenadine, dipyridamole, zalcitabine, chenodeoxycholic and ursodeoxycholic acids, penicillamine and lansoprazole.
M-cholinoblockers, by slowing gastric emptying, enhance and prolong the effects of the drug.
Secondary to the use of magnesium hydroxide, increased urine pH may alter the excretion of certain drugs. For example, increased excretion of salicylates has been noted.
If you are taking other drugs, you should consult your doctor before taking Almagel® Neo.

Special Instructions

The interval between taking Almagel® Neo and other medicinal products should be 1-2 hours.

One scoop (5 ml) of the drug contains 0.113 g of ethyl alcohol (the content of 1 sachet (10 ml) contains 0.226 g of ethyl alcohol), therefore there may be complications in patients with liver and brain disease, in patients with alcoholism and epilepsy, in pregnant women and children under 18 years.

The daily dose of the drug (8 to 12 scoops or the contents of 4-6 sachets) contains 0.904 g to 1.356 g of ethyl alcohol, respectively.

The maximum daily dose of the suspension (12 scoops or 6 sachets) contains 1.356 grams of ethanol.

One scoop (5 ml) of Almagel ^® Neo contains 0.475 g sorbitol, which is contraindicated if the patient has an inborn intolerance to fructose and may cause stomach irritation and diarrhea.

When prolonged therapy with the drug, it is necessary to maintain sufficient intake of phosphorus with food, because aluminum hydroxide can bind phosphates and delay their absorption in the gastrointestinal tract. In addition, therapy is associated with increased calcium elimination and an imbalance of calcium and phosphorus, which may lead to osteomalacia, manifesting as general weakness and bone pain.

Influence on driving, operating machinery

It does not adversely affect the ability to drive vehicles and operate machinery requiring increased concentration and rapid psychomotor reactions.

Synopsis

White or almost white suspension, with a smell of orange.

Contraindications

– Hypersensitivity to the active substance or any excipient contained in the Prepart.
– Chronic renal insufficiency.
– Pregnancy.
– Hypophosphatemia.
– Congenital intolerance to fructose.
– Alzheimer’s disease.
– Children under 14 years of age due to the lack of data on the efficacy and safety.

With caution
Breast-feeding, liver cirrhosis, alcoholism, brain injury, epilepsy, encephalopathy, dementia, children (over 14 years) age. In patients with acute renal failure an increase in plasma aluminum and/or magnesium concentrations is possible. Therefore, 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. During the treatment of patients with acute renal failure it is necessary to monitor the dynamics of clinical symptoms, the size of the ulcer, the appearance of diarrhea, the concentration of aluminum and magnesium in blood serum.
In children (over 14 years) the use of magnesium hydroxide may lead to hypermagnesemia, especially in the concomitant presence of acute renal failure or dehydration.
Patients with the diseases specified in this section, before starting the drug is recommended to consult a physician.

Side effects

The adverse reactions are classified according to the World Health Organization (WHO) Classification: very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1000, < 1/100); rare (≥1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined based on available data).

Immune system disorders: frequency unknown-allergic reactions, including bronchospasm.

Disorders of the metabolism and nutrition: very rarely – hypermagnesemia¹.

Nervous system disorders: frequent – intoxication with aluminum and/or magnesium (mainly in renal failure); very rare – dementia, aggravation of the severity of Alzheimer’s disease.

Gastrointestinal tract disorders: infrequently: change in taste sensation; very rare – diarrhea; frequency unknown – constipation, abdominal pain¹.

Nausea, vomiting have also been observed. When long-term use in high doses – hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hy-permagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, renal dysfunction. In patients with concomitant renal failure – thirst, decreased blood pressure, hyporeflexia.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

1 Observed with long-term use of magnesium hydroxide in patients with renal impairment.

Overdose

Symptoms: Although Almagel^® Neo is partially absorbed, prolonged use of high doses may lead to the development of hypermagnesemia (increased blood magnesium levels), characterized by rapid fatigue, flushed face, exhaustion, muscle weakness and inadequate behavior.

There may also be signs of metabolic alkalosis: changes in mood or mental alertness, numbness or pain in muscles, nervousness and rapid fatigue, decreased respiratory rate, and unpleasant taste sensations.

Emergency measures:Instantaneous measures should be taken to quickly eliminate the drug – gastric lavage, inducing vomiting, taking activated charcoal.

In case of overdose, symptomatic therapy is required.

Pregnancy use

The drug is contraindicated in pregnancy (see section “Contraindications”).
Due to the lack of sufficient clinical data, women during breast-feeding should use the drug only after consultation with your doctor (see section “Caution”).