RAIGEL [Multicomponent preparation] 180 ml Suspension for oral administration

instructions for the medical use of the medicinal product

RAIGEL

Tradename: Raigel, Райгель

International non-proprietary name or generic name:

• aluminum hydroxide, алюминия гидроксид

• magnesium hydroxide, магния гидроксид

• simethicone, симетикон

Dosage form: suspension for oral administration.

Composition for 5 ml of suspension:

active substances: aluminum hydroxide gel 1530 mg equivalent to aluminum hydroxide 309.83 mg, magnesium hydroxide paste equivalent to magnesium hydroxide 100 mg, simethicone emulsion 416.7 mg equivalent to simethicone 125 mg;

excipients: anhydrous citric acid, hydroxypropyl methylcellulose, colloidal anhydrous silicon dioxide, mannitol, sodium methylparaben, sodium propylparaben, sodium saccharin, sorbitol, hydrogen peroxide, peppermint oil, propylene glycol, polysorbate 20, purified water.

Pharmacotherapeutic group: Antacids combined with carminatives. A simple combination of salts and carminatives.

Code АТХ: A02AF02

Pharmacological properties

Pharmacodynamics

A combination product whose action is determined by its constituent components. It has antacid, adsorbent, enveloping, and carminative effects. Aluminum hydroxide and magnesium hydroxide neutralize free hydrochloric acid in the stomach, reduce gastric acidity, and bind bile acids. The laxative effect of magnesium hydroxide counterbalances the ability of aluminum hydroxide to slow intestinal motility. Simethicone inhibits the formation of gas bubbles and promotes their destruction. The gases released are absorbed by the intestinal walls and eliminated from the body through peristalsis.

Pharmacokinetics

Rigel is virtually non-absorbable and does not disrupt electrolyte balance in the body.

Aluminum hydroxide neutralizes excess hydrochloric acid in the stomach, forming aluminum chloride. Under the influence of alkaline intestinal contents, aluminum chloride is converted into alkaline aluminum salts, which are poorly absorbed and excreted through the gastrointestinal tract (GIT). Serum aluminum levels remain virtually unchanged.

Magnesium hydroxide also neutralizes hydrochloric acid in the stomach, converting to magnesium chloride. In the intestine, this salt forms poorly absorbed magnesium carbonate and does not significantly alter blood magnesium ion concentrations.

In patients with chronic and renal failure, serum magnesium and aluminum ion levels may increase to toxic levels due to impaired excretion.

Simethicone acts throughout the gastrointestinal tract and is an inert compound. It does not affect the absorption of other substances, does not accumulate or promote accumulation, does not alter the pH or chemical environment of the gastrointestinal tract, and is excreted unchanged.

The drug takes effect within 3-5 minutes after oral administration, with the effect lasting up to 3 hours.

Indications for use

• Acute gastritis;

• Chronic gastritis with increased and normal gastric secretory function (in the acute phase);

• Acute duodenitis, duodenogastric reflux;

• Gastric ulcer and duodenal ulcer (in the acute phase);

• Symptomatic gastrointestinal ulcers of various origins;

• Mucosal erosions of the upper gastrointestinal tract;

• Gastroesophageal reflux, reflux esophagitis;

• Acute pancreatitis, exacerbation of chronic pancreatitis;

• Gastralgia, heartburn (after excessive consumption of ethanol, nicotine, coffee, medications, or an improper diet that negatively affects gastrointestinal function);

• Flatulence;

• Fermentative or putrefactive dyspepsia.

Contraindications

• Hypersensitivity to any of the drug's components;

• Renal impairment;

• Pregnancy and lactation;

• Liver disease;

• Alzheimer's disease;

• Intestinal obstruction, obstructive gastrointestinal diseases;

• Hypophosphatemia;

• Pregnancy and lactation;

• Children and adolescents under 18 years of age.

Method of administration and dosage

Oral suspension.

Shake the suspension bottle well before use.

Adults: Take 10 ml 4 times daily, 30-40 minutes before meals (unless otherwise directed by a doctor).

For reflux esophagitis, take the medication 1 hour after meals.

The course of treatment is 2-3 months.

Special instructions and precautions

Consult a doctor before using this medication.

When using Rigel concomitantly with other medications, the interval between doses should be at least 2 hours.

With prolonged use, monitoring of blood phosphorus and magnesium levels is recommended.

This medication contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medication.

Caution is advised when using this medication for long-term use in elderly patients.

Influence on the ability to drive vehicles and mechanisms

This medication does not affect the ability to drive or operate machinery.

Use during pregnancy and breastfeeding

The drug is not recommended for use during pregnancy.

During breastfeeding, it should be used with caution and for short periods.

Side effect

• nausea, vomiting, constipation, diarrhea, taste changes;

• arthralgia, osteomalacia, osteoporosis;

• exacerbation of Alzheimer's disease (in the elderly);

• allergic reactions: flushing, bronchospasm, itching, skin rash, urticaria;

• hyporeflexia (in chronic renal failure);

• impaired phosphorus, calcium, and magnesium metabolism (with long-term use);

• encephalopathy;

• nephrocalcinosis.

If any of the side effects listed in the instructions worsen, or you notice any other side effects not listed in the instructions, inform your doctor.

Interaction with other medicinal products

When taken concomitantly with tetracycline antibiotics, histamine H2 receptor antagonists, iron salts, ciprofloxacin, phenothiazine, isoniazid, beta-blockers, indomethacin, and ketoconazole, Rigel may reduce their therapeutic effect.

Rigel reduces the plasma concentration of captopril and its relative bioavailability. Captopril should be administered 2 hours before administration.

Rigel should not be administered concomitantly with quinolones. The drug should be administered 2 hours before or after digoxin and propranolol, as Rigel reduces their bioavailability.

Rigel may impair the elimination of quinidine, which may lead to quinidine intoxication, especially in patients with impaired renal function. Concomitant administration of antacids and salicylates leads to a significant decrease in serum salicylate levels.

Anticholinolytics, by slowing gastric emptying, enhance and prolong the drug's effect.

Overdose

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

Emergency measures. It is necessary to immediately take measures to quickly eliminate the drug, such as gastric lavage, inducing vomiting, and administering activated charcoal.

Storage conditions

Store at a temperature not exceeding 30°C. Keep out of reach of children.

Shelf life

3 years.

Do not use after the expiration date.

Vacation conditions

Without prescription.

Release form

180 ml of suspension in PET bottles with screw caps.

1 bottle and a measuring syringe along with instructions for use are packaged in a cardboard box.