Becarbon

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BЕCARBON (BECARBON)

Composition:

Active substances: 1 tablet contains:
Belladonna extract, dry (Belladonnae extractum spissum) – aqueous-ethanolic ((4.8–5.2):1), extraction solvent 20% (v/v) ethanol, containing 1.5% of total alkaloids calculated as atropine – base (hyoscyamine) and dry matter – 10 mg;
sodium bicarbonate – 300 mg.

Excipients: maize starch, colloidal anhydrous silicon dioxide, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: round-shaped tablets, from light brown to yellowish-brown in color, with speckles, beveled edges and a score line, with a characteristic mild specific odor.

Pharmacotherapeutic group. Agents used in functional gastrointestinal disorders. Spasmolytics and anticholinergics in combination with other drugs. ATC code A03ED.

Pharmacological properties.

Pharmacodynamics.

Becarbon is a combination drug that exerts analgesic and spasmolytic effects, and also neutralizes free hydrochloric acid in gastric juice, thereby providing protective action on the gastric mucosa.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Functional gastrointestinal disorders (abdominal pain of functional origin);
• Spasms of smooth-muscle organs of the gastrointestinal tract;
• Biliary tract spasms.

Contraindications.

• Hypersensitivity to belladonna or to any component of the drug;
• Cardiovascular diseases in which an increase in heart rate may be undesirable: atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension;
• Gastrointestinal disorders associated with obstruction, hypochlorhydric gastritis;
• Urinary retention or predisposition to it, including in prostatic adenoma with impaired urine outflow;
• Glaucoma;
• Myasthenia gravis;
• Hyperthermic syndrome;
• Thyrotoxicosis;
• Acute bleeding.

Interaction with other medicinal products and other forms of interaction.

If the patient is taking any other medicinal products, it is essential to inform the physician!

When used concomitantly with other drugs having anticholinergic effects, the action of Becarbon may be enhanced. The inhibition of peristalsis caused by the drug may lead to altered absorption of other drugs.

When using Becarbon:

• with antiparkinsonian agents (amantadine), M-cholinoblockers (including tiotropium bromide, ipratropium bromide), antiarrhythmic anticholinergic drugs (including quinidine, disopyramide), tricyclic antidepressants, nefopam, glutethimide, spasmolytics – anticholinergic effects of the drugs are potentiated;
• with opioid analgesics and drugs that depress the central nervous system (including phenothiazines, clozapine) – dangerous CNS depression may occur; possible reduction in duration and depth of action of narcotic agents, weakening of opioid analgesic effect;
• with butyrophenones (haloperidol) and organic nitrates – intraocular pressure may increase;
• with systemic corticosteroids – reduced corticosteroid effect and possible increase in intraocular pressure;
• with parasympathomimetics – antagonism to the effects of parasympathomimetics may occur when used with anticholinergic drugs, e.g., reduced effect of pilocarpine in glaucoma treatment;
• with furosemide – orthostatic hypotension may occur;
• with reserpine, guanethidine, antacids, ascorbic acid, attapulgite – reduced effect of Becarbon;
• with levodopa – decreased systemic concentrations of levodopa, therefore dosage adjustment may be required;
• with certain antihistamines (including meclizine, dimenhydrinate, diprazine) – enhanced antihistaminic effect with risk of antimuscarinic side effects;
• with beta-adrenergic blockers – their effect may be reduced;
• with hormonal contraceptives – contraceptive effect may be reduced;
• with MAO inhibitors, including non-selective inhibitors of neuronal reuptake of monoamines – enhanced sedative effect of both drugs; possible development of cardiac arrhythmias;
• with nonsteroidal anti-inflammatory drugs, griseofulvin, digoxitin, doxycycline, metronidazole – reduced efficacy of these drugs;
• with penicillins – mutual potentiation of effects;
• with ketoconazole – increased gastric pH due to Becarbon reduces ketoconazole absorption; therefore, Becarbon should be taken no earlier than 2 hours after ketoconazole;
• with sulfonamides – increased risk of kidney damage and reduced antibacterial activity;
• with indapamide, nizatidine – their effects are enhanced;
• with spironolactone, minoxidil – their effects are reduced;
• with potassium chloride – possible damage to gastrointestinal mucosa;
• with domperidone, metoclopramide – anticholinergic drug effects antagonize the effects of these drugs on gastrointestinal motility;
• with ethanol – enhanced sedative effect of ethanol;
• with lithium – sodium bicarbonate component increases lithium excretion, thereby reducing its plasma concentration.

Since sodium bicarbonate contained in the drug has antacid properties, it is advisable not to take Becarbon simultaneously with other medicinal products (possible interference with their absorption).

Special precautions for use.

Before starting treatment with Becarbon, consult a physician.

If persistent or worsening abdominal pain of unknown origin occurs, especially when accompanied by such symptoms as fever, nausea, vomiting, changes in intestinal peristalsis, decreased arterial pressure, loss of consciousness, or blood in the stool, medical consultation is required.

Do not exceed the recommended dosage. Use the lowest effective dose necessary.

Treatment should be discontinued immediately upon the first appearance of skin rash and/or mucosal lesions. If these symptoms occur, seek immediate medical advice.

Alcoholic beverages should be avoided during treatment with this medication.

Use with caution in patients:

• with autonomic (vegetative) neuropathy;
• with marked arterial hypotension;
• with prostatic hypertrophy without urinary tract obstruction;
• with Down's syndrome, cerebral palsy, or brain injury;
• with hepatic or renal insufficiency;
• with chronic lung diseases associated with low production of difficult-to-expectorate mucus, especially in debilitated patients;
• with reflux esophagitis or hiatal hernia associated with reflux esophagitis;
• with inflammatory bowel diseases, including ulcerative colitis and Crohn's disease;
• with megacolon;
• with xerostomia (dry mouth);
• elderly patients: they are particularly sensitive to antimuscarinic effects (e.g., constipation, dry mouth, urinary retention, drowsiness, confusion, and/or psychomotor agitation), even at usual doses;
• debilitated patients;
• in high environmental temperatures (risk of heat stroke due to suppression of sweat gland activity).

Becarbon should be used with caution in patients on a low-sodium diet (the preparation contains sodium hydrocarbonate).

In patients with undiagnosed and therefore untreated angle-closure glaucoma, anticholinergic agents such as belladonna preparations may cause an increase in intraocular pressure. Therefore, if eye pain, redness of the eyes, or visual disturbances/loss occur, the patient must consult an ophthalmologist.

Belladonna alkaloids may affect the results of the following laboratory tests:

• gastric acidity test (may antagonize the action of pentagastrin and histamine; discontinue the drug at least 24 hours before the test);
• radionuclide gastric emptying study (may delay gastric emptying);
• phenolsulfonphthalein urinary secretion test (may delay excretion of phenolsulfonphthalein in urine).

Do not use the drug for longer than the recommended duration without consulting a physician!

If symptoms do not begin to improve, if the condition worsens, or if adverse reactions occur, discontinue use and consult a physician regarding further treatment.

Use during pregnancy or breastfeeding.

Use during pregnancy is permitted only if, in the physician’s opinion, the expected benefit to the mother outweighs the potential risk to the fetus.

If use of the drug is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Exercise caution when driving or operating machinery during treatment due to possible adverse effects on the nervous system and visual organs.

Method of Administration and Dosage

For oral use in adults. Take 1 tablet 2–3 times daily, 30–40 minutes before meals. Swallow the tablet whole without chewing, with an adequate amount of water.

The maximum single dose is 5 tablets.

Becarbon is intended for symptomatic short-term use; therefore, treatment duration should be individually determined.

If symptoms do not resolve within 3–5 days, consult a physician to reassess the treatment regimen and further use of the medication.

Children

Clinical data on efficacy and safety of Becarbon in children are lacking; therefore, the drug should not be used in this patient population.

Overdose

Symptoms: intensified adverse reactions, nausea, vomiting, tachycardia, decreased arterial pressure, accommodation disturbances, urinary retention, psychomotor agitation, irritability, tremor, seizures, insomnia, drowsiness, hallucinations, delirium, hyperthermia, tachypnea, hyperpnea, possible signs of dehydration, central nervous system depression, respiratory and vasomotor center depression.

Treatment: symptomatic. Gastric lavage, administration of activated charcoal, correction of water-electrolyte balance, parenteral administration of cholinomimetics and anticholinesterase agents. Do not use phenothiazines. In case of hyperthermia, wet sponging and antipyretic agents are indicated; for agitation, intravenous administration of sodium thiopental or sodium oxybutyrate; for mydriasis, topical application of eye drops containing phosphacol, physostigmine, or pilocarpine. In case of glaucoma attack, instill 2 drops of 1% pilocarpine solution into the conjunctival sac every hour and administer 1 ml of 0.05% proserine solution subcutaneously 3–4 times daily.

At the first signs of overdose, seek immediate medical assistance!

Adverse Reactions

Nervous system: headache, dizziness, nervousness, sleep disturbances, drowsiness/insomnia, weakness, ataxia (impaired coordination of movements), speech disorders, seizures.

Psychiatric disorders: confusion or psychomotor agitation (especially in elderly patients), psychotic disorders, delirium, hallucinations.

Urinary system: difficulty and retention of urination.

Gastrointestinal tract: dry mouth, sensation of thirst, taste disturbances, belching, dysphagia, flatulence, spasms/pain in the abdomen, decreased intestinal motility up to atony, constipation, reduced tone of bile ducts and gallbladder, nausea, vomiting; with short-term use of high doses of the drug, compensatory hypersecretion of gastric juice is possible.

Eyes: dilated pupils, photophobia, accommodation paralysis, transient visual disturbances (blurred vision), decreased lacrimation, increased intraocular pressure.

Cardiovascular system: facial flushing, hot flushes, palpitations, arrhythmias (including extrasystoles, transient bradycardia, tachycardia), myocardial ischemia, possible decrease/increase in blood pressure.

Respiratory system and mediastinal organs: reduced secretory activity and tone of bronchi, leading to formation of viscous sputum difficult to expectorate.

Immune system: possible manifestations of hypersensitivity reactions, including anaphylactic reactions, anaphylactic shock.

Skin and subcutaneous tissue: skin rashes, hyperemia, urticaria, pruritus, exfoliative dermatitis, dyshidrosis, decreased sweating, dry skin.

Other: dryness of mucous membranes, dysarthria, edema, worsening of existing hypokalemia.

If any adverse reactions occur, discontinue use of the drug and consult a physician immediately.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

In the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister, 2 blisters per carton.

Availability category. Over-the-counter (without prescription).

Manufacturer.

Public Joint-Stock Company "Scientific-Production Center "Borshchagovskiy Chemical and Pharmaceutical Plant".

Limited Liability Company "Agrofarm".

Manufacturer's address and place of business.

Ukraine, 03134, Kyiv, Miru St., 17.

Ukraine, 08200, Kyiv Oblast, Irpin, Centralna St., 113-A.