Almagel Neo, 10 ml suspension 10 pcs

A combined remedy, the action of which is due to its constituent components. It has antacidic, adsorptive, coating and diarrheal action.

Algeldrate (aluminum hydroxide) and magnesium hydroxide neutralize free hydrochloric acid in the stomach, decrease the acidity of gastric juice and bind bile acids.

The loosening effect of magnesium hydroxide balances the ability of algeldrate to slow intestinal motility.

Simethicone impedes the formation of gas bubbles and promotes their collapse. The gases released are absorbed by the intestinal walls and are expelled from the body through peristalsis.

Pharmacokinetics

Due to physiological and chemical inertness Simethicone is not absorbed into organs and tissues and after passing through the gastrointestinal tract (GIT) is eliminated unchanged.

The absorption of aluminum and magnesium ions in the intestine is low. With normal renal function the concentration of aluminum and magnesium in the blood does not change.

In patients with chronic renal insufficiency the level of aluminum and magnesium in the blood may increase to toxic values as a result of impaired excretion.

Indications

Heartburn, Gastroduodenitis, Gastritis, Bloating, Reflux esophagitis, Chronic pancreatitis, Meteorism, Peptic ulcer

• Burn (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).
• Gastric and duodenal ulcer (in the acute phase).
• Symptomatic gastrointestinal ulcers 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.
• Meterosis.
• Digestive or putrefactive dyspepsia.

.

Active ingredient

Algeldrate, Magnesium hydroxide, Simethicone

How to take, the dosage

For oral administration.

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 desirable 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 acid and efso-deoxycholic acid, penicillamine and lansoprazole. M-cholinoblockers, by slowing gastric emptying, enhance and prolong the effect of the drug.

Special Instructions

The interval between taking Almagel® Neo and other drugs should be 1-2 hours. In case of prolonged use it is necessary to ensure sufficient intake of phosphorus with food.

Because of lack of data of controlled clinical trials, Almagel® Neo should be taken by breastfeeding women only after consultation with a physician. One scoop (5 ml) of the drug contains 0.113 g of ethyl alcohol. One sachet (10 ml) of the drug contains 0.226 g of ethyl alcohol.

This can lead to complications in patients with liver and brain diseases, in patients with alcoholism and epilepsy, in pregnant women and children under 18 years.

The daily dose of the drug (8 measuring spoons or 4 sachets) contains 0.904 g of ethyl alcohol, the maximum daily dose of suspension (12 measuring spoons or 6 sachets) contains 1.356 g of ethyl alcohol. One scoop (5 ml) of Almagel® Neo contains 0.475 g of sorbitol.

One sachet (10 ml) of the suspension contains 0.950 g of sorbitol. Sorbitol is contraindicated if you have an innate intolerance to fructose and can cause stomach irritation and diarrhea.

Impact on the ability to operate vehicles and machinery:

Almagel® Neo has no adverse effect on the ability to drive vehicles and operate machinery requiring increased concentration and rapid psychomotor reactions.

Contraindications

Hypersensitivity, chronic renal failure, pregnancy, Alzheimer’s disease, hypophosphatemia, children under 10 years of age, congenital fructose intolerance.

With caution:

Lactation period, liver disease, alcoholism, brain injury, brain disease, epilepsy, childhood and adolescence from 10 to 18 years.

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: despite the fact that Almagel® Neo is partially absorbed, prolonged use of high doses may lead to hypermagnesemia (increased magnesium levels in blood), which is 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, unpleasant taste. Emergency measures: it is necessary to immediately take measures for rapid excretion of the drug – gastric lavage, stimulation of vomiting, taking activated charcoal. In case of overdose symptomatic therapy is required.

Pregnancy use

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