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 (after excessive consumption of ethanol, nicotine, coffee, taking medications; improper diet).
Stomach pain.
Acute gastritis; chronic gastritis with increased and normal secretory function of the stomach (in the acute phase).
Peptic ulcer of the stomach and duodenum (in the acute phase).
Symptomatic ulcers of the gastrointestinal tract of various origins.
Erosion of the mucous membrane of the upper gastrointestinal tract.
Gastroesophageal reflux, reflux esophagitis.
Acute duodenitis, duodenogastric reflux.
Acute pancreatitis, exacerbation of chronic pancreatitis.
Flatulence.
Fermentative or putrefactive dyspepsia.

Pharmacological effect

A combined product whose effect is determined by its constituent components. It has an antacid, adsorbent, enveloping, carminative effect.

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

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

Simethicone inhibits the formation of gas bubbles and promotes their destruction. The gases released during this process are absorbed by the intestinal walls and removed from the body due to peristalsis.

Pharmacokinetics

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

Absorption of aluminum and magnesium ions in the intestines is low. With normal kidney function, the concentration of aluminum and magnesium in the blood does not change.

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

Special instructions

The interval between taking Almagel® Neo and other medications should be 1-2 hours. With long-term use, sufficient intake of phosphorus from food should be ensured.

Due to the lack of data from controlled clinical trials, breastfeeding women should take Almagel® Neo only after consulting a doctor. One measuring spoon (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.

As a result, complications may occur in patients with liver and brain diseases, in those suffering from alcoholism and epilepsy, in pregnant women and children under 18 years of age.

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

One sachet (10 ml) of suspension contains 0.950 g of sorbitol. Sorbitol is contraindicated in people with congenital fructose intolerance and may cause stomach irritation and diarrhea.

Impact on the ability to drive vehicles and machinery:

Almagel® Neo does not have a negative effect on the ability to drive vehicles and operate mechanisms that require increased concentration and speed of psychomotor reactions.

Active ingredient

Algeldrat, Magnesium hydroxide, Simethicone

Composition

10 ml (1 sachet) suspension contains:

Pregnancy

The use of the drug during pregnancy is contraindicated (see Section “Contraindications”).
Due to the lack of sufficient clinical data, women during breastfeeding should use the drug only after consulting a doctor (see section “With caution”).

Contraindications

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

With caution:

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

Side Effects

Adverse reactions are systematized in accordance with the World Health Organization (WHO) Classification: very common (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data).

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

Metabolic and nutritional disorders: very rarely – hypermagnesemia1.

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

Gastrointestinal disorders: uncommon: changes in taste sensations; very rarely – diarrhea; frequency unknown – constipation, abdominal pain1.

Nausea and vomiting were also observed. With long-term use in high doses – hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, renal dysfunction. In patients with concomitant renal failure – thirst, decreased blood pressure, hyporeflexia.

If any of the side effects indicated in the instructions get worse or 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 failure.

Interaction

Almagel® Neo reduces and slows down the absorption of digoxin, indomethacin, salicylates, chlorpromazine, phenytoin, H2-histamine receptor blockers, beta-blockers, diflunisal, ketoconazole and itraconazole, isoniazid, tetracycline antibiotics and quinolones, azithromycin, cefpodoxime, pivampicillin, rifampicin, indirect anticoagulants, barbiturates, fexofenadine, dipyridamole, zalcitabine, chenodeoxycholic and efsodeoxycholic acids, penicillamine and lansoprazole. M-anticholinergic blockers, by slowing down gastric emptying, enhance and prolong the effect of the drug.

Overdose

Symptoms: despite the fact that Almagel® Neo is partially absorbed, prolonged use of high doses can lead to the development of hypermagnesemia (increased magnesium levels in the blood), which is characterized by fatigue, facial flushing, exhaustion, muscle weakness and inappropriate behavior.
Signs of metabolic alkalosis may also be observed: changes in mood or mental activity, numbness or muscle pain, nervousness and fatigue, decreased breathing rate, unpleasant taste sensations.
Urgent measures: it is necessary to immediately take measures to quickly remove the drug – gastric lavage, stimulation of vomiting, taking activated charcoal.
In case of overdose, symptomatic therapy is required.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C (do not freeze)

Shelf life

2 years

Manufacturer

Balkanpharma-Troyan AD, Bulgaria