Almagel oral suspension, 170ml

Treatment

• Heartburn and epigastric pain after errors in nutrition, excessive consumption of ethanol, nicotine, coffee, taking medications that irritate the gastric mucosa.

• Acute gastritis; chronic gastritis with increased and normal gastric secretory function (in the acute phase); acute duodenitis, enteritis, colitis.

• Peptic ulcer of the stomach and duodenum (in the acute phase).

• Hernia of the esophageal opening of the diaphragm, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux.

• Symptomatic ulcers of the gastrointestinal tract of various origins; erosion of the mucous membrane of the upper gastrointestinal tract.

• Acute pancreatitis, exacerbation of chronic pancreatitis.

Prevention of gastric and duodenal disorders - reducing the irritating and ulcerogenic effect associated with taking medications that irritate the gastric mucosa.

For oral administration.

Treatment
Adults and children over 15 years old
5-10 ml (1-2 scoops) or 1 sachet 3-4 times a day.
If necessary, a single dose can be increased to 15 ml (3 scoops).
After reaching the therapeutic effect, the daily dose is reduced to 5 ml (1 scoop) 3-4 times a day or to 1 sachet 1-2 times a day for 15-20 days.

Children from 10 to 15 years old
Apply in a dose equal to half the dose for adults - 1 scoop 2-4 times a day or 2 scoops 1-2 times a day or 1 sachet 1-2 times a day.
The drug is taken 45-60 minutes after meals and in the evening before bedtime.
It is not recommended to take liquids within 15 minutes after taking AlmagelЃ.
Before each use, the suspension must be thoroughly homogenized by shaking the bottle or kneading and shaking the sachet.

Prophylaxis
5-15 ml (1-3 scoops) or 1 sachet 15 minutes before taking medications with irritating effect.

5 ml (one scoop) of the suspension contains:

active ingredients: aluminum hydroxide gel (in terms of aluminum oxide) 2.18 g (218 mg), magnesium hydroxide paste (in terms of magnesium oxide) 350 mg (75 mg);

auxiliary substances: hydrogen peroxide solution 30% - 0.41 mg, sorbitol -801.15 mg, hyetellose - 10.90 mg, methyl parahydroxybenzoate - 10.90 mg, propyl parahydroxybenzoate - 1.363 mg, butyl parahydroxybenzoate - 1.363 mg, sodium saccharinate dihydrate - 0.818 mg, propylene glycol - 327.00 mg, macrogol 4000 - 218.00 mg, lemon oil - 1.635 mg, ethanol 96% - 98.10 mg, purified water up to 5 ml.

• Hypersensitivity to the active substance or to any auxiliary substance that is part of the drug.

• Severe renal failure (creatinine clearance <30 ml / min) due to the risk of developing hypermagnesemia and aluminum intoxication.

• Pregnancy.

• Alzheimer's disease.

• Children under 10 years of age.

• Rare hereditary fructose intolerance (contains sorbitol).

• Severe hypophosphatemia.

With caution
In patients with renal insufficiency, prolonged use of a combination of algeldrate and magnesium hydroxide can lead to the development of hypermagnesemia.
In young children, the use of magnesium hydroxide can lead to the development of hypermagnesemia, especially with the concomitant presence of renal failure or dehydration.

Trade name of the drug:

AlmagelЃ

International non-proprietary or group name:

Algeldrate + Magnesium hydroxide

Dosage form:

oral suspension

Composition:

5 ml (one scoop) of the suspension contains:

active ingredients: aluminum hydroxide gel (in terms of aluminum oxide) 2.18 g (218 mg), magnesium hydroxide paste (in terms of magnesium oxide) 350 mg (75 mg);

auxiliary substances: hydrogen peroxide solution 30% - 0.41 mg, sorbitol -801.15 mg, hyetellose - 10.90 mg, methyl parahydroxybenzoate - 10.90 mg, propyl parahydroxybenzoate - 1.363 mg, butyl parahydroxybenzoate - 1.363 mg, sodium saccharinate dihydrate - 0.818 mg, propylene glycol - 327.00 mg, macrogol 4000 - 218.00 mg, lemon oil - 1.635 mg, ethanol 96% - 98.10 mg, purified water up to 5 ml.

Description

Suspension of white or almost white color with a characteristic lemon scent. During storage, a layer of clear liquid may precipitate on the surface.

With vigorous shaking of the contents of the vial, the homogeneity of the suspension is restored.

Pharmacotherapeutic group:

antacid agent.

ATX code:

A02AX

pharmachologic effect

Pharmacodynamics
AlmagelЃ is a balanced combination of algeldrate (aluminum hydroxide) and magnesium hydroxide. It neutralizes free hydrochloric acid in the stomach, reduces the activity of pepsin, which leads to a decrease in the digestive activity of gastric juice. It has an enveloping, adsorbing effect. Protects the gastric mucosa by stimulating the synthesis of prostaglandins (cytoprotective effect). This protects the mucous membrane from inflammatory and erosive-hemorrhagic lesions as a result of the use of irritating and ulcerogenic agents such as ethyl alcohol and non-steroidal anti-inflammatory drugs (for example, indomethacin, diclofenac, aspirin, acetylsalicylic acid, corticosteroid drugs). The therapeutic effect after taking the drug occurs in 3-5 minutes.The duration of action depends on the rate of gastric emptying. When taken on an empty stomach, the effect lasts up to 60 minutes. When taken one hour after a meal, the antacid effect may last up to 3 hours.

Does not cause secondary hypersecretion of gastric juice.

Pharmacokinetics
Algeldrat
Absorption - small amounts of AlmagelЃ are resorbed, which practically do not change the concentration of aluminum salts in the blood.
Distribution is not. Metabolism is not.
Excretion - excreted through the intestines.

Magnesium hydroxide
Absorption - magnesium ions are resorbed in an amount of about 10% of the dose taken and do not change the concentration of magnesium ions in the blood.
Distribution is usually local.
Metabolism is not.
Excretion - excreted through the intestines.

Indications for use

Treatment

• Heartburn and epigastric pain after errors in nutrition, excessive consumption of ethanol, nicotine, coffee, taking medications that irritate the gastric mucosa.

• Acute gastritis; chronic gastritis with increased and normal gastric secretory function (in the acute phase); acute duodenitis, enteritis, colitis.

• Peptic ulcer of the stomach and duodenum (in the acute phase).

• Hernia of the esophageal opening of the diaphragm, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux.

• Symptomatic ulcers of the gastrointestinal tract of various origins; erosion of the mucous membrane of the upper gastrointestinal tract.

• Acute pancreatitis, exacerbation of chronic pancreatitis.

Prevention of gastric and duodenal disorders - reducing the irritating and ulcerogenic effect associated with taking medications that irritate the gastric mucosa.

Contraindications

• Hypersensitivity to the active substance or to any auxiliary substance that is part of the drug.

• Severe renal failure (creatinine clearance <30 ml / min) due to the risk of developing hypermagnesemia and aluminum intoxication.

• Pregnancy.

• Alzheimer's disease.

• Children under 10 years of age.

• Rare hereditary fructose intolerance (contains sorbitol).

• Severe hypophosphatemia.

With caution
In patients with renal insufficiency, prolonged use of a combination of algeldrate and magnesium hydroxide can lead to the development of hypermagnesemia.
In young children, the use of magnesium hydroxide can lead to the development of hypermagnesemia, especially with the concomitant presence of renal failure or dehydration.

Application during pregnancy and during breastfeeding

Animal studies have shown no teratogenic potential or other undesirable effects on the embryo and / or fetus.

There are no clinical data on the use of AlmagelЃ by pregnant women. The drug AlmagelЃ is not recommended to be taken during pregnancy, but if the benefits of its use outweigh the potential risk to the fetus, then the duration of use should not exceed 5-6 days under medical supervision.

There is no data on the release of the active substances of the drug AlmagelЃ with breast milk. AlmagelЃ can be used during breastfeeding only after a careful assessment of the ratio of benefits to the mother and the potential risk to the newborn.

During lactation, the duration of use should not exceed 5-6 days under medical supervision.

Method of administration and dosage

For oral administration.

Treatment
Adults and children over 15 years old
5-10 ml (1-2 scoops) or 1 sachet 3-4 times a day.
If necessary, a single dose can be increased to 15 ml (3 scoops).
After reaching the therapeutic effect, the daily dose is reduced to 5 ml (1 scoop) 3-4 times a day or to 1 sachet 1-2 times a day for 15-20 days.

Children from 10 to 15 years old
Apply in a dose equal to half the dose for adults - 1 scoop 2-4 times a day or 2 scoops 1-2 times a day or 1 sachet 1-2 times a day.
The drug is taken 45-60 minutes after meals and in the evening before bedtime.
It is not recommended to take liquids within 15 minutes after taking AlmagelЃ.
Before each use, the suspension must be thoroughly homogenized by shaking the bottle or kneading and shaking the sachet.

Prophylaxis
5-15 ml (1-3 scoops) or 1 sachet 15 minutes before taking medications with irritating effect.

Side effect

Immune system disorders: rarely - allergic reactions.

Metabolic and nutritional disorders: very rarely - hypermagnesemia1 (with concomitant arterial hypotension); frequency unknown - hypophosphatemia, hypercalciuria.

Musculoskeletal and connective tissue disorders: frequency unknown - osteomalacia.

Disturbances from the gastrointestinal tract: rarely - nausea, vomiting, stomach cramps , changes in taste; frequency unknown - abdominal pain1; constipation (disappears after dose reduction).
1 Has been observed with prolonged use of magnesium hydroxide in patients with renal insufficiency.

With prolonged use of the drug by patients with renal failure and patients on hemodialysis, changes in mood and mental activity are possible.

With prolonged use of high doses of the drug and phosphorus deficiency in food, osteomalacia may occur.

Overdose

Symptoms: with a single dose of a dose exceeding the recommended one, there are usually no other signs of an overdose other than constipation, flatulence, a metallic taste in the mouth.

With prolonged use of high doses, the formation of kidney stones, the appearance of severe constipation, slight drowsiness, and hypermagnesemia are possible. Signs of metabolic alkalosis can also be observed: changes in mood or mental activity, numbness or muscle pain, irritability and fatigue, slow breathing, unpleasant taste sensations.

Urgent measures: in these cases, it is necessary to immediately take measures to quickly remove the drug from the body - gastric lavage, stimulation of vomiting, intake of activated carbon.

In case of overdose, symptomatic therapy is required.

Interaction with other medicinal products

It can absorb some drugs, thus reducing their absorption, therefore, with the simultaneous use of other drugs, they must be taken 1-2 hours before or after taking AlmagelЃ.

The drug AlmagelЃ reduces the acidity of gastric juice, and this can affect the action of a large number of drugs when used simultaneously.

The drug AlmagelЃ reduces the absorption of blockers of histamine H2-receptors (cimetidine, ranitidine, famotidine), digitalis cardiac glycosides, iron salts, lithium preparations, quinidine, mexiletine, phenothiazine drugs, tetracycline antibiotics and ciprofloxiazol.

With the simultaneous use of the drug AlmagelЃ and drugs coated with an enteric coating, an increased pH of gastric juice can lead to accelerated destruction of their membrane and cause irritation of the stomach and duodenum.

The drug AlmagelЃ can affect the results of some laboratory and functional studies and tests: it reduces the level of gastric secretion when determining its acidity; modifies test results using technetium (TC99), such as bone scintigraphy; moderately and briefly increases serum gastrin levels; increases serum phosphorus, serum and urine pH values.

An increase in urine pH secondary to the use of magnesium hydroxide can alter the elimination of certain drugs. For example, an increase in the excretion of salicylates has been noted.

special instructions

The use of the drug AlmagelЃ is not recommended for patients with severe constipation; with pain in the stomach of unknown origin and with suspicion of acute appendicitis; in the presence of ulcerative colitis, diverticulosis, colostomy or ileostomy (increased risk of imbalance in water and electrolyte balance); with chronic diarrhea; acute hemorrhoids; when the acid-base balance in the body changes, as well as in the presence of metabolic alkalosis; with cirrhosis of the liver; severe heart failure; with toxicosis of pregnant women; with impaired renal function (CC <30 ml / min due to the risk of developing hypermagnesemia and aluminum intoxication).

With prolonged use (more than 14 days) of AlmagelЃ by patients with impaired renal function, regular medical supervision and monitoring of serum magnesium levels are necessary.

The drug AlmagelЃ does not contain sugar, which allows patients with diabetes mellitus to take it.

AlmagelЃ contains sorbitol and is contraindicated in rare hereditary fructose intolerance.

The drug AlmagelЃ contains parahydroxybenzoates, which can cause an allergic reaction (possibly of a delayed type) and, very rarely, bronchospasm.

AlmagelЃ contains 98.1 mg of ethanol in a dose of 5 ml. Not recommended for people suffering from alcoholism. Ethanol can cause complications in pregnant and breastfeeding women, children, and patients with hepatic dysfunction and epilepsy.

Influence on the ability to drive vehicles, mechanisms

The drug AlmagelЃ does not affect the ability to drive vehicles and work with mechanisms. When taken in the recommended daily dose, the ethyl alcohol contained in the drug does not affect the ability to drive vehicles and work with mechanisms.

Release form

Suspension for oral administration.
170 ml of the drug in a dark glass or polyethylene terephthalate vial with a screw-on plastic cap. Each bottle together with instructions for use and a 5 ml measuring spoon in a cardboard box.
10 ml in a multilayer foil bag.
10 or 20 sachets together with instructions for use in a cardboard box.

Storage conditions

At a temperature not exceeding 25 ? C.
Do not freeze!
Keep out of the reach of children!

Shelf life

2 years.
Do not use after the expiration date.

Vacation conditions

Available without a prescription.