Almagel - instructions for use, dose, side effects, contraindications

Hydrogen peroxide solution of 30% 0.41 mg, sorbitol 801.15 mg, gietellose 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, water purified to 5 ml.

10 ml (1 sachet) of the suspension contains:

Active substances:

Aluminum hydroxide gel - 4.36 g

in terms of Al₂ABOUT₃ - 436 mg

Magnesium hydroxide is 700 mg

in terms of MgO - 150 mg

Excipients:

Hydrogen peroxide solution 30% - 0.82 mg, sorbitol - 1602.300 mg, hyethellosis - 21.80 mg,methylparahydroxybenzoate 21,80 mg, propyl parahydroxybenzoate 2,726 mg, butyl parahydroxybenzoate 2.726 mg, sodium saccharinate dihydrate 1.636 mg, propylene glycol 654.00 mg macrogol 4000 436.00 mg lemon oil 3.27 mg ethanol 96% - 196.20 mg, water purified to 10 ml.

Description:

A suspension of white or almost white color with a characteristic smell of lemon. When stored on the surface, a clear liquid layer may be released. With vigorous agitation, the homogeneity of the suspension is restored.

Pharmacotherapeutic group:Antacid agent

ATX: & nbsp

A.02.A.X Antacids in combination with other drugs

Pharmacodynamics:

Almagel is a drug that is a balanced combination of an alginate (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 action). 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, corticosteroids). Therapeutic effect after taking the drug comes in 3-5 minutes. The duration of action depends on the rate of emptying the stomach. When taken on an empty stomach, the action lasts up to 60 minutes. At reception in an hour after reception of food antatsidnoe action can proceed till 3 o'clock.

Does not cause secondary hypersecretion of gastric juice.

Pharmacokinetics:

Algeldrat

Suction - Small amounts of the drug are resorbed, which practically do not change the concentration of aluminum salts in the blood.

Distribution - no.

Metabolism - no.

Excretion - is excreted through the intestine.

Magnesium hydroxide

Suction - magnesium ions are resorbed in about 10% of the dose and do not change the concentration of magnesium ions in the blood.

Distribution - usually locally.

Metabolism - no.

Excretion - is excreted through the intestine.

Indications:

Treatment

- Acute gastritis; chronic gastritis with increased and normal secretory function of the stomach (in the phase of exacerbation); acute duodenitis, enteritis, colitis;

- Stomach ulcer and duodenal ulcer (in the phase of exacerbation);

- hernia of the esophageal aperture of the diaphragm, gastroesophageal reflux, reflux esophagitis, duodenogastric reflux;

- symptomatic gastrointestinal ulcers of different genesis; erosion of the mucous membrane of the upper gastrointestinal tract;

- Acute pancreatitis, exacerbation of chronic pancreatitis;

- Heartburn and epigastric pain after inaccuracies in the diet, excessive consumption of ethanol, nicotine, coffee, taking medicines that irritate the mucous membrane of the stomach.

Prevention gastric and duodenal disorders - a decrease in the irritant and ulcerogenic effect associated with taking medications that irritate the gastric mucosa.

Contraindications:

- Hypersensitivity to the active or to any auxiliary substance included in the preparation.

- Severe form of renal failure (due to the danger of hypermagnesia and aluminum intoxication).

- Pregnancy.

- Alzheimer's disease.

- Hypophosphatemia.

- Children up to 10 years.

- Congenital fructose intolerance (contains sorbitol).

Pregnancy and lactation:

Animal studies have shown that there is no evidence of a teratogenic potential or other undesirable effects on the embryo and / or fetus. There are no clinical data on the use of Almagel by pregnant women. The drug is not recommended during pregnancy, but if the intended benefit from its use exceeds the potential risk to the fetus, the drug should be taken under the supervision of the doctor for no more than 5-6 days.

There is no data on the release of active substances of the drug with breast milk. Almagel can be used during the period of breastfeeding only after a thorough evaluation of the relationship between the benefits for the mother and the potential risk to the newborn.

During the period of breastfeeding it is recommended to apply no more than 5-6 days under the supervision of a doctor.

Dosing and Administration:

Treatment

Adults and children over 15 years of age

For 5-10 ml (1-2 scoops) or 1 sachet 3-4 times a day.

If necessary, single dose can be increased to 15 ml (3 scoops).

Children from 10 to 15 years

Apply in a dose equal to half the dose for adults - 1 measuring spoon 2-4 times a day or 2 measuring spoons 1-2 times a day or 1 packet 1-2 times a day.

The drug is taken 45-60 minutes after meals and in the evening before bedtime.

After reaching the therapeutic effect, the daily dose is reduced to 5 ml (1 measuring spoon) 3-4 times a day or 1 packet 1-2 times a day for 15-20 days.

It is not recommended to take liquids within 15 minutes after taking Almagel. Before use, the suspension must be thoroughly homogenized, shaking the bottle or mashing and shaking the bag.

For prevention

For 5-15 ml (1-3 scoops) or 1 sachet 15 minutes before taking drugs with irritant effect.

Side effects:

Almagel can cause constipation, which occurs after a dose reduction.

In rare cases, nausea, vomiting, gastric spasm, changes in taste sensations, allergic reactions and hypermagnesia (increased magnesium levels, blood) are observed. With prolonged use of the drug, patients with renal insufficiency and dialysis may experience changes in mood and mental activity; With prolonged intake of high doses of the drug along with a deficiency of phosphorus in food, it is possible - the occurrence of osteomalacia.

Overdose:

With a single dose excess, there are no other signs of an overdose other than constipation, flatulence, a sensation of metallic taste in the mouth.

With prolonged intake of high doses, the formation of kidney stones, the appearance of severe constipation, mild drowsiness, hypermagnia. There may also be signs of metabolic alkalosis: a change in mood or mental activity, numbness or pain in the muscles, irritability and fatigue, slowing of breathing, unpleasant gustatory sensations. In these cases, it is necessary to immediately take measures to rapidly remove the drug from the body - gastric lavage, stimulation of vomiting, reception of activated charcoal.

Interaction:

Can absorb some medicines, thereby reducing their absorption, so while taking other medicines, they must be taken 1-2 hours before or after taking Almagel.

Almagel reduces the acidity of gastric juice, and this can affect the effect of a large number of drugs with simultaneous intake.

Almagel reduces the effect of histamine blockers H₂-receptors (cimetidine, ranitidine, famotidine), cardiac glycosides, iron salts, lithium preparations, quinidine, mexiletine, phenothiazine preparations, tetracycline antibiotics, ciprofloxacin, isoniazid and ketoconazole.

With the simultaneous administration of enteric-soluble drugs, an elevated pH of the gastric juice can lead to an accelerated disruption of the shell and cause irritation of the stomach and duodenum.

Almagel can affect the results of some laboratory and functional studies and tests: it reduces the level of gastric secretion when determining its acidity; changes the results of tests using technetium (TS₉₉), such as bone scintigraphy and some esophagus tests, increases serum phosphorus levels, serum and urine pH values.

Special instructions:

It is not recommended to use the drug in patients with severe constipation; with pain in the stomach of unknown origin and with suspected acute appendicitis; in the presence of ulcerative colitis, diverticulosis, colostomy or ileostomy; with chronic diarrhea; acute hemorrhoids; with a change in acid-base balance in the body, as well as in the presence of metabolic alkalosis; with cirrhosis of the liver; severe heart failure; with toxicosis of pregnant women; with violations of kidney function (creatinine clearance <30 ml / min, due to the danger of hypermagnesia and aluminum intoxication).

With prolonged intake of the drug (more than 20 days), regular medical treatment is required, serum-magnesium level control in the treatment of patients with renal insufficiency.

The drug does not contain sugar, which allows you to take it to people with diabetes. The preparation contains sorbitol, which is contraindicated in congenital intolerance to fructose.

Effect on the ability to drive transp. cf. and fur:

Almagel does not affect the ability to drive and work with machinery. When taken in the recommended daily dose, the ethyl alcohol contained in the preparation does not affect the ability to drive and work with machinery.

Form release / dosage:Suspension for oral administration.

Packaging:

For 170 ml of the drug in a bottle of dark glass or polyethylene terephthalate with a screwed plastic cap.

Each vial with instructions for use and a measuring spoon for 5 ml in a cardboard bundle.

For 10 ml of the drug in a bag of multilayer foil.

10 or 20 bags together with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Do not freeze!

Keep out of the reach of children!

Shelf life:

2 years.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:Without recipe

Registration number:П N012742 / 01

Date of registration:26.02.2010 / 03.12.2015

Expiration Date:Unlimited

The owner of the registration certificate:AKTAVIS, LTD. AKTAVIS, LTD. Russia

Manufacturer: & nbsp

BALKANPHARMA-TROYAN, AD Bulgaria

Information update date: & nbsp11.07.2017

Illustrated instructions

Instructions

Almagel® (Almagel®)