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

Active substanceAlgealdrate + Benzocaine + Magnesium hydroxideAlgealdrate + Benzocaine + Magnesium hydroxide

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Almagel® A

suspension inwards

Balkanfarm - Troyan AD Bulgaria

Dosage form: & nbsporal suspension

Composition:

5 ml (one measuring spoon) of the suspension contains:

Active substances:

Aluminum hydroxide gel - 2.18 g

in terms of Al₂ABOUT₃ - 218 mg

Magnesium hydroxide paste 350 mg

in terms of MgO - 75 mg

Benzocaine-109 mg

Excipients:

Hydrogen peroxide solution of 30% 0.41 mg, sorbitol 801.15 mg, gietellose 15.26 mg, methyl parahydroxybenzoate 10,90 mg, propyl parahydroxybenzoate 1,363 mg, butyl parahydroxybenzoate 1,363 mg, sodium saccharinate dihydrate 0.818 mg, propyl 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 paste - 700 mg

in terms of MgO - 150 mg

Benzocaine -218 mg

Excipients:

Hydrogen peroxide solution of 30% - 0.82 mg, sorbitol - 1602.30 mg, gietellose - 30.52 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 + local anesthetic

ATX: & nbsp

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

Pharmacodynamics:

Almagel A is a drug that is a balanced combination of an alginate (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 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.

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

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.

Benzocaine

Benzocaine is absorbed in minimal amounts and has almost no effect systemic effects on the body. His local anesthetic effect comes 1-2 minutes after taking the suspension.

Indications:

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

- peptic ulcer of the stomach and duodenum (in the phase of exacerbation);

- hernia of the esophageal opening 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 gastric mucosa.

Contraindications:

- Hypersensitivity to any component that is part of the drug.

- Severe form of kidney failure (because of the danger of development hypermagnes and aluminum intoxication).

- Do not administer to children, as there is a risk of developing methaemoglobinaemia.

- Pregnancy and lactation.

Pregnancy and lactation:

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

Dosing and Administration:

Adults

For 5-10 ml (1-2 scoops or 1 sachet) 3-4 times a day for 10-15 minutes before meals. The maximum duration of treatment is 7 days, then switch to treatment with Almagel®.

It is not recommended to take liquids within 15 minutes after taking the drug.

Before use, the suspension must be thoroughly homogenized, shaking the bottle or mashing and shaking the bag.

Side effects:

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

In rare cases, nausea, vomiting, gastric spasm, changes in taste sensations, allergic reactions and hypermagnesia 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 intake of high doses of the drug, along with a deficiency of phosphorus in food, the occurrence of osteomalacia is possible.

Overdose:

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

With prolonged use of high doses of nephrocalcinosis, 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 taste sensations.

It is necessary to immediately take measures to rapidly remove the drug from the body by washing the stomach (induction of vomiting, reception of activated carbon).

Interaction:

It can absorb some drugs, thereby reducing their absorption, therefore, while taking other medicines at the same time, they should 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 of drugs with simultaneous intake.

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

With the simultaneous administration of enteric-soluble tablets, the increased pH of gastric juice can lead to an accelerated disruption of their envelope and cause irritation of the stomach and duodenum.

Almagel A should not be taken concomitantly with sulfonamides, because of 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 of visualization of diverticula and bone scintigraphy with the help of technetium (TS₉₉); moderately and for a short time increases the serum level of gastrin, increases serum phosphorus, pH of serum and urine.

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 development of violations of water-electrolyte balance); chronic diarrhea; acute hemorrhoids; disorders of kidney function (creatinine clearance <30 ml / min, the risk of hypermagnetism and aluminum intoxication).

During treatment with Almagel A it is necessary to avoid the use of alcohol and acids (lemon juice, vinegar, etc.)because of the possibility of weakening the local analgesic effect of benzocaine.

When taking the drug there is numbness and anesthesia of the mucous membrane of the mouth and tongue. This phenomenon is transitory and does not require therapeutic measures.

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

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

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 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:On prescription

Registration number:П N012741 / 01

Date of registration:26.02.2010 / 30.05.2017

Expiration Date:Unlimited

The owner of the registration certificate:Balkanfarm - Troyan ADBalkanfarm - Troyan AD Bulgaria

Manufacturer: & nbsp

BALKANPHARMA-TROYAN, AD Bulgaria

Representation: & nbspAktavis, Open Company Aktavis, Open Company

Information update date: & nbsp11.07.2017

Illustrated instructions

Instructions

Almagel® A (Almagel® A)