Almagel^® NEO (Suspension) Instructions for Use

Marketing Authorization Holder

Balkanpharma-Troyan, AD (Bulgaria)

Contact Information

Actavis Group hf. (Iceland)

ATC Code

A02AF02 (Simple combinations of salts and carminatives)

Active Substances

Magnesium hydroxide (Ph.Eur.)

Simeticone (Rec.INN)

Algeldrate (Rec.INN)

Dosage Forms

	Almagel® NEO	Oral suspension 340 mg+395 mg+36 mg/5 ml: sachet 10 ml 10 or 20 pcs.
		Oral suspension 340 mg+395 mg+36 mg/5 ml: bottle 170 ml 1 pc. with measur. spoon

Dosage Form, Packaging, and Composition

Oral suspension white or almost white, with an orange odor.

Excipients: hydrogen peroxide (30% solution) – 0.495 mg, sorbitol – 474.6 mg, sodium saccharin – 1.13 mg, hydroxyethylcellulose – 5.65 mg, citric acid monohydrate – 5.65 mg, ethylparahydroxybenzoate – 7.9 mg, propylparahydroxybenzoate – 3.4 mg, propylene glycol – 113 mg, macrogol 4000 – 452 mg, orange flavor – 2.26 mg, ethanol 96% – 113 mg, purified water – up to 5 ml.

170 ml – glass bottles (1) in a cardboard box with a 5 ml measuring spoon.
170 ml – polyethylene terephthalate bottles (1) in a cardboard box with a 5 ml measuring spoon.

Clinical-Pharmacological Group

Antacid drug with an antiflatulent component

Pharmacotherapeutic Group

Antacid agent + carminative agent

Pharmacological Action

A combined agent whose action is due to its constituent components. It has antacid, adsorbent, enveloping, and carminative effects.

Algedrate (aluminium 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 hinders the formation of gas bubbles and promotes their destruction. The gases released in this process are absorbed by the intestinal walls and eliminated from the body due to peristalsis.

Pharmacokinetics

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

The absorption of aluminium and magnesium ions in the intestine is low. In patients with normal renal function, the concentration of aluminium and magnesium in the blood does not change.

In patients with chronic renal failure, the level of aluminium and magnesium in the blood may increase to toxic values due to impaired excretion.

Indications

• Acute gastritis;
• Chronic gastritis with increased and normal secretory function of the stomach (in the acute phase);
• Acute duodenitis, duodenogastric reflux;
• Gastric and duodenal ulcer (in the acute phase);
• Symptomatic gastrointestinal ulcers of various origins;
• Erosions of the mucous membrane of the upper gastrointestinal tract;
• Gastroesophageal reflux, reflux esophagitis;
• Acute pancreatitis, exacerbation of chronic pancreatitis;
• Gastralgia, heartburn (after excessive consumption of ethanol, nicotine, coffee, taking medications; incorrect diet that negatively affects the functioning of the gastrointestinal tract);
• Flatulence;
• Fermentative or putrefactive dyspepsia.

ICD codes

Dosage Regimen

Adults.

Orally, 2 measuring spoons of orange-flavored suspension 4 times/day 1 hour after meals and in the evening before bedtime. If necessary, the single dose can be increased to 4 measuring spoons, but the maximum daily dose should not exceed 12 measuring spoons.

Children over 10 years old.

The dosage is determined by the attending physician – usually 1/2 of the adult dose.

The course of treatment is no more than 4 weeks. Before use, the suspension must be homogenized by shaking the bottle. It is advisable to take Almagel^® Neo undiluted. It is not recommended to drink fluids for half an hour after taking the drug.

Adverse Reactions

Allergic reactions, nausea, vomiting, change in taste sensations, constipation, diarrhea. With long-term use in high doses – hypophosphatemia, hypocalcemia, hypercalciuria, osteomalacia, osteoporosis, hypermagnesemia, hyperaluminemia, encephalopathy, nephrocalcinosis, impaired renal function. In patients with concomitant renal failure – thirst, decreased blood pressure, hyporeflexia.

Contraindications

• Chronic renal failure;
• Pregnancy;
• Alzheimer’s disease;
• Hypophosphatemia;
• Children under 10 years of age;
• Congenital fructose intolerance;
• Hypersensitivity.

With caution lactation period, liver diseases, alcoholism, traumatic brain injury, brain diseases, epilepsy, children and adolescents from 10 to 18 years of age.

Special Precautions

The interval between taking Almagel Neo and other drugs should be 1-2 hours.

With long-term use, sufficient intake of phosphorus with 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, which may cause complications 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) contains 0.904 g of ethyl alcohol, the maximum daily dose of the suspension (12 measuring spoons) contains 1.356 g of ethyl alcohol.

One measuring spoon (5 ml) of Almagel^® Neo contains 0.475 g of sorbitol, which is contraindicated in congenital fructose intolerance and may cause stomach irritation and diarrhea.

Does not adversely affect the ability to drive vehicles and operate machinery requiring increased concentration and speed of psychomotor reactions.

Overdose

Symptoms. Prolonged use of high doses may lead to the development of hypermagnesemia, which is characterized by rapid fatigue, facial flushing, exhaustion, muscle weakness, and inappropriate behavior. Signs of metabolic alkalosis may also be observed: mood changes, impaired mental activity, numbness or muscle pain, nervousness and rapid fatigue, slow breathing, unpleasant taste sensations.

Emergency measures. It is necessary to immediately take measures for rapid elimination of the drug – gastric lavage, induction of vomiting, intake of activated charcoal.

Drug Interactions

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 and quinolone antibiotics, azithromycin, cefpodoxime, pivampicillin, rifampin, indirect anticoagulants, barbiturates, fexofenadine, dipyridamole, zalcitabine, chenodeoxycholic and ursodeoxycholic acids, penicillamine and lansoprazole.

M-cholinoblockers, by slowing gastric emptying, enhance and prolong the action of the drug.

Storage Conditions

Store in a light-protected place, out of reach of children, at a temperature not exceeding 25°C (77°F). Do not freeze!

Shelf Life

Shelf life – 2 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.