Instructions for Belastezin tablets blister No. 10
Composition
active ingredients: benzocaine, thick belladonna extract;
1 tablet contains benzocaine – 300 mg, thick belladonna extract (Belladonnae extractum spissum) – water-alcohol ((4.8-5.2):1) (extractant 20% (v/v) ethanol) with a content of 1.5% of the total alkaloids, calculated as atropine – base (hyoscyamine) and dry matter – 15 mg;
Excipients: microcrystalline cellulose, croscarmellose sodium, mannitol (E 421), calcium stearate, copovidone.
Dosage form
Pills.
Main physicochemical properties: round tablets of brown color with a marbled surface and inclusions of light and brown color of varying intensity, with beveled edges and a score, and with a characteristic weak specific odor.
Pharmacotherapeutic group
Drugs used in functional gastrointestinal disorders. Antispasmodics in combination with analgesics. Sum of belladonna alkaloids in combination with analgesics. ATX code A03D B.
Pharmacological properties
Belastezin is a combined drug that contains belladonna extract and benzocaine (anesthesin). It has analgesic and antispasmodic effects. The analgesic effect is due to the effect of benzocaine, a local anesthetic, and the antispasmodic effect is due to the effect of belladonna.
Indication
· Spasms of smooth muscle organs of the gastrointestinal tract;
· spasms of the biliary tract;
· hypersecretory gastritis;
· hypersalivation (increased salivation).
Contraindication
· Hypersensitivity to belladonna, benzocaine, other amide anesthetics or other components of the drug;
· diseases of the cardiovascular system in which an increase in heart rate may be undesirable: atrial fibrillation, tachycardia, chronic heart failure, ischemic heart disease, mitral stenosis, severe arterial hypertension;
glaucoma;
· urinary retention or tendency to it;
· diseases of the gastrointestinal tract accompanied by obstruction;
· myasthenia gravis;
· hyperthermic syndrome;
· thyrotoxicosis;
· acute bleeding;
· thromboembolic disease, granulocytopenia (the drug contains benzocaine).
Interaction with other medicinal products and other types of interactions
If the patient is using any other medications, it is imperative to inform the doctor!
When using Belastezin:
· with amantadine, antiarrhythmic anticholinergic drugs (including quinidine), tricyclic antidepressants, glutethimide - the anticholinergic effects of Belastezin are enhanced;
· with opioid analgesics and drugs that depress the central nervous system (including phenothiazines) - dangerous inhibition of the central nervous system occurs;
· with butyrophenones (haloperidol) and organic nitrates - intraocular pressure increases;
· with corticosteroids for systemic use - the effect of corticosteroids is reduced and an increase in intraocular pressure is possible;
· with pilocarpine - its effect in the treatment of glaucoma is reduced;
· with M-cholinoblockers - anticholinergic effects are enhanced;
· with furosemide - orthostatic hypotension is possible;
· with reserpine, MAO inhibitors, guanethidine, antacids, ascorbic acid, attapulgite - the effect of Belastezin is reduced;
· with levodopa - decreased systemic concentrations of levodopa, so its dosage should be adjusted;
· with some antihistamines (including meclizine) - the antihistamine effect is enhanced;
· with beta-adrenergic blockers - their effect is reduced;
· with hormonal contraceptives - the contraceptive effect is reduced;
· with non-selective inhibitors of neuronal reuptake of monoamines - the sedative effect is enhanced;
· with nonsteroidal anti-inflammatory drugs, griseofulvin, digitoxin, doxycycline, metoclopramide, metronidazole - the effect of these drugs is reduced;
· with ketoconazole - increasing the pH of gastric juice with Belastezin reduces the absorption of ketoconazole, therefore Belastezin should be taken no earlier than 2 hours after taking ketoconazole;
· with sulfonamides - their antibacterial activity decreases;
· with indapamide, nizatidine - their effect increases;
· with potassium chloride - possible damage to the mucous membrane of the gastrointestinal tract.
Application features
Before starting treatment with Belastezin, you should consult a doctor.
In case of persistent or worsening pain of unexplained origin in the abdominal area, accompanied by symptoms such as fever, nausea, vomiting, changes in intestinal motility, decreased blood pressure, fainting, or blood in the stool, a doctor's consultation is necessary.
Do not exceed the recommended dosage. Use the smallest amount of the drug necessary.
When using the drug, you should refrain from drinking alcoholic beverages.
It should be used with caution in patients:
with autonomic neuropathy;
· with Down syndrome, cerebral palsy, brain damage;
· with liver and kidney failure;
· with chronic lung diseases accompanied by low sputum production, which is difficult to separate, especially in weakened patients;
· with reflux esophagitis, hiatal hernia combined with reflux esophagitis;
· with inflammatory bowel diseases, including non-specific ulcerative colitis and Crohn's disease;
with megacolon;
· with xerostomia (dry mouth), elderly or debilitated patients;
· with hyperthermia, especially in elderly and weakened patients - hyperthermia may increase;
· at high ambient temperature (risk of heat stroke due to suppression of sweat gland activity).
In patients with undiagnosed and therefore untreated angle-closure glaucoma, anticholinergics such as belladonna may increase intraocular pressure. Therefore, if pain, redness of the eyes occurs, accompanied by deterioration/loss of vision, the patient should consult an ophthalmologist.
There is a risk of developing methemoglobinemia when using drugs containing benzocaine, mainly in patients with congenital defects such as, for example, glucose-6-phosphate dehydrogenase deficiency, NADH-methemoglobin reductase deficiency, pyruvate kinase deficiency, hemoglobinosis M. Symptoms such as cyanosis of the skin, lips and nail beds, headache, dizziness, difficulty breathing, weakness, tachycardia may indicate methemoglobinemia, which is potentially life-threatening and requires urgent medical intervention.
Belladonna alkaloids may affect the results of the following laboratory tests:
· gastric acidity test (may counteract the activity of pentagastrin and histamine; the drug should be discontinued 24 hours before the test);
· radioisotope study of gastric emptying (may slow gastric emptying);
· phenolsulfophthalein urine secretion test (may slow down the excretion of phenolsulfophthalein in the urine).
The drug contains benzocaine, which may cause a positive doping test result in athletes.
Do not use the drug for longer than the prescribed period without consulting a doctor!
If the signs of the disease do not disappear or, on the contrary, the state of health worsens, or undesirable phenomena begin, it is necessary to stop taking the drug and consult a doctor regarding further use of the drug.
Use during pregnancy or breastfeeding
Use during pregnancy is possible only if, in the opinion of the doctor, the expected benefit to the mother outweighs the potential risk to the fetus.
If necessary, use of the drug should be discontinued.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug, you should refrain from driving or working with other mechanisms due to possible side effects on the nervous system and organs of vision.
Method of administration and doses
Adults should take 1 tablet orally 3 times a day. Swallow the tablet without chewing and drink with plenty of water.
Belastezin is intended for short-term use. If symptoms of the disease do not disappear within 3-5 days, you should consult a doctor about further use of the drug.
Children
There are no clinical data on the efficacy and safety of use in children, therefore the drug should not be used in children.
Overdose
Symptoms: increased manifestations of adverse reactions, nausea, vomiting, tachycardia, decreased blood pressure, agitation, irritability, tremor, convulsions, insomnia, drowsiness, hallucinations, hyperthermia, depression of the central nervous system, depression of the activity of the respiratory and vasomotor centers.
There are reports that the use of products containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips and nail beds, headache, dizziness, shortness of breath, weakness, tachycardia may indicate methemoglobinemia, which is potentially life-threatening and requires immediate medical intervention.
Treatment: gastric lavage, parenteral administration of cholinomimetics and anticholinesterase agents. Do not use phenothiazines. In case of methemoglobinemia, intravenous administration of methylene blue. Treatment is symptomatic.
In case of overdose, seek medical attention immediately!
Adverse reactions
Digestive tract: dry mouth, thirst, taste disturbance, dysphagia, constipation, decreased intestinal motility up to atony, decreased tone of the biliary tract and gallbladder.
Urinary system: difficulty and delay in urination.
Cardiovascular system: facial flushing, hot flashes, palpitations, arrhythmia, including extrasystole, myocardial ischemia.
Nervous system: headache, dizziness.
Respiratory system and mediastinal organs: decreased secretory activity and bronchial tone, leading to the formation of viscous sputum that is difficult to cough up.
Skin and subcutaneous tissue: skin rash, itching, urticaria, hyperemia, exfoliative dermatitis.
Immune system: anaphylactic reactions, anaphylactic shock.
Other: decreased sweating, dry skin, dysarthria.
When using the drug, methemoglobinemia (cyanosis of the skin, lips and nail beds, headache, dizziness, shortness of breath, weakness, tachycardia) is possible (the drug contains benzocaine).
If any adverse reactions occur, you should stop taking the drug and be sure to consult a doctor.
Expiration date
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 in a blister, 1 blister in a pack.
Vacation category
Without a prescription.
Producer
Public Joint Stock Company "Research and Production Center "Borshchagov Chemical and Pharmaceutical Plant".
Limited Liability Company "AGROFARM".
Location of the manufacturer and its business address
Ukraine, 03134, Kyiv, Myru St., 17.
Ukraine, 08200, Kyiv region, Irpin city, Centralna st., 113-A.
