Belladonna Leaf Extract + Benzocaine + Metamizol sodium + Sodium bicarbonate - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Included in the formulation

Bellalgin

pills inwards

DALHIMFARM, OJSC Russia

АТХ:

A.03.D Spasmolytics in combination with analgesics

Pharmacodynamics:

Combined drug, which has antacid, spasmolytic, hypoxecretory and analgesic effect.

The action is determined by the effects of the constituent components. Spasmolytic (lowering the tone of smooth muscle organs, including the gastrointestinal tract) and antisecretory effects (decreased secretion of the gastric, pancreatic, bronchial, salivary, sweat glands and bile secretion) are caused by alkaloids of the belladonna extract (hyoscyamine, scopolamine, apoatropin, etc.) ), analgesic - metamizole and anesthesin, antacid - sodium bicarbonate.

Pharmacokinetics:

No data.

Indications:

As a symptomatic means for eliminating the pain syndrome in diseases gastrointestinal tract, accompanied by increased secretion of gastric juice and spasms of smooth muscles:

- Hyperacid gastritis;

- Stomach ulcer and duodenal ulcer;

- Heartburn, eructation;

- gastralgia;

- Spastic colitis;

- spasm of smooth muscles of organs gastrointestinal tract.

ICD-10

XI.K20-K31.K25 Stomach ulcer

XI.K20-K31.K26 Duodenal ulcer

XI.K20-K31.K29 Gastritis and duodenitis

XI.K50-K52.K52 Other non-infectious gastroenteritis and colitis

XVIII.R10-R19.R10.4 Other and unspecified abdominal pain

XVIII.R10-R19.R12 Heartburn

Contraindications:

Hypersensitivity; angle-closure glaucoma; hyperplasia of the prostate; oppression hemopoiesis (granulocytopenia, leukopenia, agranulocytosis, cytostatic or infectious neutropenia); severe hepatic and / or renal insufficiency; hereditary hemolytic anemia associated with a deficiency of glucose-6-phosphate dehydrogenase; aspirin asthma; pregnancy (especially in the first trimester and in the last 6 weeks); lactation period.

Carefully:

Diseases of the kidneys (pyelonephritis, glomerulonephritis, including in the anamnesis), long-term abuse of ethanol.

Pregnancy and lactation:

Contraindications during pregnancy and during breastfeeding.

Dosing and Administration:

Inside, before meals, 1 tablet 2-3 times a day.

The highest single dose for adults - 3 tablets, daily - 10 tablets. The duration of treatment is determined by the doctor.

Side effects:

From the urinary system: renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

Allergic reactions: urticaria (including on the conjunctiva and mucous membranes of the nasopharynx), angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

From the hematopoiesis: agranulocytosis, leukopenia, thrombocytopenia.

Other: lowering blood pressure, dry mouth, thirst, constipation, mydriasis, paresis of accommodation, temporary visual impairment, dysuria, urinary retention, palpitation, drowsiness, dizziness, psychomotor agitation, convulsions.

Overdose:

Symptoms: nausea, vomiting, gastralgia, oliguria, hypothermia, lowering of arterial pressure, tachycardia, dyspnea, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal and / or hepatic insufficiency, convulsions, respiratory muscle paralysis.

Treatment: gastric lavage, saline laxatives, Activated carbon; carrying out forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous diazepam and high-speed barbiturates.

Interaction:

Enhances the effects of ethanol.

Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

Radiopaque drugs, colloidal blood substitutes and penicillin should not be used during treatment with metamizole.

With the simultaneous use of cyclosporine, the concentration of the latter in the blood decreases.

Metamizole, displacing from the connection with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity.

Phenylbutazone, barbiturates and other hepatoinductors with simultaneous administration reduce the effectiveness of metamizole.

Simultaneous reception with other non-narcotic analgesics, tricyclic antidepressants, hormonal contraceptives and allopurinol may lead to increased toxicity.

Sedative and anxiolytic drugs (tranquilizers) increase the analgesic effect of metamizole.

Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced codeine, histamine H blockers₂receptors and propranolol (slows inactivation).

Special instructions:

Avoid use of the drug for people whose activities require increased visual acuity.

In the treatment of patients receiving cytotoxic drugs, metamizole sodium should be administered only under medical supervision.

Patients with atopic bronchial asthma and pollinosis have an increased risk of developing allergic reactions.

Against the background of taking metamizole sodium, the development of agranulocytosis is possible, in connection with which, when an unmotivated rise in temperature, chills, sore throats, difficulty swallowing, stomatitis, as well as in the development of phenomena of vaginitis or proctitis, immediate withdrawal of the drug is necessary.

With prolonged use, it is necessary to monitor the picture of peripheral blood.

It is inadmissible to use to relieve acute pain in the abdomen (until the cause is clarified).

Against the backdrop of treatment, it is possible to stain urine in red due to the release of a metabolite (it does not matter).

Instructions

Belladonna Leaf Extract + Benzocaine + Metamizole Sodium + Sodium Hydrocarbonate (Extractum foliorum Belladonnae + Benzocainum + Methamizolum natrium + Natrii hydrocarbonas)