Almagel A oral suspension, 170 ml

• 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);

• hiatal hernia, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux;

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

• acute pancreatitis, exacerbation of chronic pancreatitis;

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

Inside. As prescribed by the doctor, 1-3 dosage (teaspoons) spoons, depending on the severity of the case, 3-4 times / day half an hour before meals and in the evening before bedtime.

In children, the drug is used strictly according to the doctor's prescription: children under 10 years old are prescribed 1/3 of the dose for adults, and children from 10 to 15 years old - 1/2 dose for adults.

For diseases accompanied by nausea, vomiting and abdominal pain, treatment begins with Almagel A, and after the disappearance of the listed symptoms, they switch to Almagel. Shake the bottle before taking.

Active substances:
Algeldrat (aluminum hydroxide gel 2.18 g, corresponding to 218 mg of aluminum oxide); magnesium hydroxide (magnesium hydroxide paste 350 mg, corresponding to 75 mg of magnesium oxide); benzocaine 109 mg.

Excipients: sorbitol 801.150 mg, hyetellose 15.260 mg, methyl parahydroxybenzoate 10.900 mg, propyl parahydroxybenzoate 1.363 mg, butyl parahydroxybenzoate 1.363 mg, sodium saccharinate dihydrate 0.818 mg, lemon oil 1.635 mg, purified ethanol 96% 98.100 ml.

• Hypersensitivity to any component of the drug.

• Severe renal failure (due to the risk of hypermagnesemia and aluminum intoxication).

• Not prescribed for children, since there is a risk of developing methemoglobinemia. Pregnancy and lactation.

TRADE NAME OF THE PREPARATION: ALMAGELЃ A

INTERNATIONAL NON-PATENTED OR GROUP NAME: Algeldrat + Benzocaine + Magnesium Hydroxide

DOSAGE FORM: Suspension for oral administration

COMPOSITION

1 scoop of suspension contains:

Active substances:
Algeldrat (aluminum hydroxide gel 2.18 g, corresponding to 218 mg of aluminum oxide); magnesium hydroxide (magnesium hydroxide paste 350 mg, corresponding to 75 mg of magnesium oxide); benzocaine 109 mg.

Excipients: sorbitol 801.150 mg, hyetellose 15.260 mg, methyl parahydroxybenzoate 10.900 mg, propyl parahydroxybenzoate 1.363 mg, butyl parahydroxybenzoate 1.363 mg, sodium saccharinate dihydrate 0.818 mg, lemon oil 1.635 mg, purified ethanol 96% 98.100 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 + local anesthetic

ATX code: ј02ј¬10

PHARMACHOLOGIC EFFECT

Pharmacodynamics
Almagel A is a drug that is a balanced combination of algeldrate (aluminum hydroxide), magnesium hydroxide and benzocaine. 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.

Benzocaine has a local analgesic effect in the presence of severe pain syndrome.

Pharmacokinetics

Algeldrat
Absorption - small amounts of the drug 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 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.

Benzocaine
Benzocaine is absorbed in minimal amounts and has practically no systemic effects on the body. Its local anesthetic effect occurs within 1-2 minutes after taking the suspension.

INDICATIONS FOR USE

• 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);

• hiatal hernia, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux;

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

• acute pancreatitis, exacerbation of chronic pancreatitis;

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

CONTRAINDICATIONS

• Hypersensitivity to any component of the drug.

• Severe renal failure (due to the risk of hypermagnesemia and aluminum intoxication).

• Not prescribed for children, since there is a risk of developing methemoglobinemia. Pregnancy and lactation.

Application during pregnancy and lactation

Almagel A is not prescribed during pregnancy and lactation, as it contains benzocaine.

DOSAGE AND APPLICATION

Adults
5-10 ml (1-2 scoops) 3-4 times a day 10-15 minutes before meals.

The maximum duration of treatment is 7 days, then they switch to treatment with Almagel.

Before use, the suspension must be thoroughly homogenized by shaking the bottle!

SIDE EFFECT

Almagel A can cause constipation, which disappears after dose reduction.
In rare cases, nausea, vomiting, stomach cramps, changes in taste, allergic reactions and hypermagnesemia are observed.

With prolonged use of the drug in patients with renal failure and those on dialysis, changes in mood and mental activity are possible. With prolonged use of high doses of the drug, along with a deficiency of phosphorus in food, osteomalacia may occur.

OVERDOSE

With a single excess of the dose, other signs of overdose are not observed except for constipation, flatulence, a feeling of a metallic taste.

With prolonged use of high doses, nephrocalcinosis, 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.

It is necessary to immediately take measures for the rapid elimination of the drug from the body through gastric lavage (induction of vomiting, intake of activated carbon).

INTERACTION WITH OTHER DRUGS

It can absorb some drugs, thus reducing their absorption, therefore, while taking other drugs, they must be taken 1-2 hours before or after taking Almagel A. Almagel A reduces the acidity of gastric juice, and this can affect the effect of a large number medicines while taking.

Almagel A reduces the absorption of reserpine, histamine H2 receptor blockers, cardiac glycosides, iron salts, lithium preparations, quinidine, mexiletine, phenothiazine drugs, tetracycline antibiotics, ciprofloxacin, isoniazid and ketoconazole.

With the simultaneous administration of enteric tablets, an increased pH of gastric juice can lead to an accelerated violation of their membrane and cause irritation of the stomach and duodenum. Almagel A should not be taken simultaneously with sulfonylamides, due to the presence of benzocaine in its composition.

Almagel A can affect the results of some laboratory and functional studies and tests: it reduces the level of gastric secretion when determining its acidity; violates the test for visualization of diverticula and bone scintigraphy using technetium (TC99); moderately and briefly increases serum gastrin, increases serum phosphorus, serum and urine pH.

SPECIAL INSTRUCTIONS

It is not recommended to use the drug in patients with severe habitual constipation; with symptoms of acute appendicitis; in the presence of metabolic alkalosis, liver cirrhosis, severe heart failure; in the presence of ulcerative colitis, diverticulosis, colostomy or ileostomy (increased risk of developing disorders of water and electrolyte balance); chronic diarrhea; acute hemorrhoids; impaired renal function (creatinine clearance During treatment with Almagel A, it is necessary to avoid the use of alcohol and acids (lemon juice, vinegar, etc.), due to the possibility of weakening the local anesthetic effect of benzocaine.

When taking the drug, numbness and anesthesia of the mucous membrane of the mouth and tongue occurs. This phenomenon is transient and does not require therapeutic measures. The drug does not contain sugar, which allows diabetics to take it. The drug contains sorbitol, which is contraindicated in congenital fructose intolerance.

Influence on the ability to drive and work with mechanisms

Almagel A 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 and work with mechanisms.

RELEASE FORM

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

STORAGE CONDITIONS

In a dark place 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 printed on the package.

TERMS OF RELEASE FROM PHARMACIES

Without recipe.

MANUFACTURER:

Balkanfarma-Troyan AD, Bulgaria
5600, Troyan, st. 'Krairechna' No. 1

Consumer claims should be sent to:

LLC
Actavis 127018, Moscow, st. Suschevsky Val, 18