Dibazol-darnitsa

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT Dibazol-Darnitsia (Dibazol-Darnitsa)

Composition:

active substance: bendazol;

1 tablet contains bendazol hydrochloride 20 mg;

excipients: lactose monohydrate, potato starch, talc, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white, flat cylindrical tablets with a bevel.

Pharmacotherapeutic group. Peripheral vasodilators. ATC code C04AX.

Pharmacological properties.

Pharmacodynamics.

Bendazole is a vasodilatory and spasmolytic agent. It exerts hypotensive and vasodilatory effects, stimulates spinal cord function, and has a moderate immunostimulatory effect.

It exerts a direct spasmolytic action on smooth muscles of blood vessels and internal organs. The drug causes a short-term (2–3 hours) moderate hypotensive effect and is well tolerated. It induces transient dilation of cerebral vessels in chronic cerebral hypoxia caused by local circulatory disturbances (cerebral arterial sclerosis). It facilitates synaptic transmission in the spinal cord.

Dibazol stimulates antibody production, enhances phagocytic activity of leukocytes and macrophages, and improves interferon synthesis, although the immunomodulatory effect of dibazol develops slowly.

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Clinical characteristics.

Indications.

As an adjunctive therapy in arterial hypertension. Nervous system disorders – residual effects of poliomyelitis, peripheral facial nerve paralysis, polyneuritis, flaccid paralysis syndrome.

Contraindications.

Hypersensitivity to bendazole hydrochloride or to any of the excipients of the medicinal product. Conditions characterized by decreased muscle tone, seizure disorders, severe cardiac insufficiency. Hypotension. Chronic nephritis with edema and impaired renal nitrogen excretory function. Bleeding gastric or duodenal ulcer. Diabetes mellitus.

Interaction with other medicinal products and other forms of interaction.

If the patient is taking any other medicinal products, consultation with a physician is mandatory regarding the possibility of using this drug.

Papaverine hydrochloride, theobromine, salysolin – when used in combination with dibazol, the spectrum of pharmacological action of papaverine hydrochloride, theobromine, and salysolin is expanded.

Barbiturates – when used in combination with dibazol, the efficacy of long-acting barbiturates, particularly phenobarbital, is enhanced.

Phentolamine, antihypertensive agents (drugs affecting the renin-angiotensin system), saluretics – when used in combination with dibazol, the hypotensive effect is enhanced.

β-blockers – when used in combination with dibazol, the hypotensive effect of the latter remains unchanged; however, with prolonged use, dibazol prevents the increase in total peripheral resistance caused by β-blockers.

Special precautions for use.

Consult a physician before starting treatment!

Dibazol in tablet form is an auxiliary agent used in arterial hypertension when sensitive to other antihypertensive agents. In the treatment of arterial hypertension, it is recommended to use in combination with other antihypertensive drugs.

Prolonged use of Dibazol-Darnytsia as an antihypertensive agent is not advisable in elderly patients due to the potential for worsening ECG parameters and reduction in cardiac output.

Long-term treatment of arterial hypertension with Dibazol-Darnytsia is not recommended, especially in elderly patients.

Important information about excipients.

Dibazol-Darnytsia contains lactose; therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not use this medicinal product.

If you have been diagnosed with intolerance to certain sugars, consult your physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

Do not use this medicinal product during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

During treatment, caution should be exercised when driving vehicles or operating complex machinery. If dizziness occurs, avoid potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

Dosage and Administration.

For adults and children aged 12 years and older, administer the drug orally at a dose of 20–40 mg (1–2 tablets) 2–3 times daily. Take Dibazol-Darnytsia 2 hours before meals or 2 hours after meals.

Maximum oral doses for adults: single dose – 40 mg, daily dose – 120 mg.

Children.

The drug is contraindicated for children under 12 years of age.

Overdose.

Symptoms: hypotension, increased sweating, sensation of warmth, dizziness, nausea, mild headache, which rapidly resolve upon dose reduction or discontinuation of the drug.

Treatment: in case of the above symptoms, seek immediate medical attention. Prior to medical assistance, induce vomiting and perform gastric lavage using activated charcoal. Administer a saline laxative. In cases of hypotension, infusion therapy and symptomatic treatment are recommended (vasopressors, cardiac glycosides). There is no specific antidote.

Side effects.

Respiratory system: dry cough, nasal congestion, dyspnea.

Gastrointestinal tract: nausea, heartburn.

Nervous system: dizziness, headache.

Cardiovascular system: palpitations, chest pain; with prolonged use – worsening of ECG parameters due to decreased cardiac output, reduction in arterial blood pressure.

Immune system: itching, hyperemia, rash, urticaria.

General disorders: sensation of warmth, increased sweating, facial flushing.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization is an important procedure. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

10 tablets in a blister pack; 1 blister pack in a carton; 10 tablets in blister packs.

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

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of operations.

13, Boryspylska Street, Kyiv, 02093, Ukraine.