DIAZOLIN-DARNITSA

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIAZOLIN-DARNITSA (DIAZOLIN-DARNITSA)

Composition:

Active substance: mebhydrolin;

One tablet contains mebhydrolin 100 mg;

Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, povidone, colloidal anhydrous silicon dioxide, magnesium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical characteristics: flat cylindrical tablets with bevel and score line, white or white with yellowish tint.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC code R06AX15.

Pharmacological properties.

Pharmacodynamics.

The active substance of the medicinal product – mebhydrolin – belongs to antihistamine agents and is an H1-histamine receptor blocker. It reduces the spasmogenic effect of histamine on smooth muscles of the bronchi and intestines, as well as affects vascular permeability.

Pharmacokinetics.

Mebhydrolin is rapidly absorbed from the gastrointestinal tract. Bioavailability ranges from 40–60%. Therapeutic effect is achieved within 15–30 minutes, with maximum effect observed within 1–2 hours. The drug practically does not penetrate the blood-brain barrier. It is metabolized in the liver via methylation. Eliminated from the body by the kidneys.

Clinical characteristics.

Indications.

Prevention and treatment of seasonal and allergic rhinitis, pollinosis, urticaria, food and drug allergies, dermatoses accompanied by skin itching (eczema, neurodermatitis).

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product, peptic ulcer disease of the stomach and duodenum during the period of exacerbation, inflammatory diseases of the gastrointestinal tract, pylorostenosis, prostatic hyperplasia, closed-angle glaucoma, epilepsy, cardiac arrhythmias.

Interaction with other medicinal products and other forms of interaction.

The medicinal product potentiates the effect of hypnotics, sedatives, and other medicinal products that depress the central nervous system, as well as alcohol.

Special precautions for use.

Alcoholic beverages and medicinal products containing ethanol should not be used during treatment with this medicinal product.

This medicinal product should be used with caution in patients with severe hepatic and/or renal impairment (dose adjustment and prolonged dosing intervals may be required).

This medicinal product contains lactose; therefore, it should not be administered to patients with rare hereditary disorders of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

This medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Driving vehicles or operating machinery requiring high attention concentration and rapid psychomotor reactions is not recommended during treatment with this medicinal product.

Dosage and Administration

The medicinal product should be taken orally after meals.

Adults and children aged 12 years and older: administer the medicinal product at a dose of 100–200 mg 1–2 times daily. Maximum single dose – 300 mg, maximum daily dose – 600 mg.

Children aged 5 to 12 years: administer the medicinal product at a dose of 50 mg (1/2 tablet) 1–3 times daily.

The duration of treatment should be determined by a physician depending on the nature of the disease, therapeutic response, and tolerability of the medicinal product.

Children.

The medicinal product is indicated for children aged 5 years and older.

Overdose.

Symptoms: confusion, drowsiness, impaired coordination, dry mouth.

Treatment: gastric lavage until the washings are clear, oral administration of activated charcoal, forced diuresis. Further treatment is symptomatic.

Side effects.

Eye disorders: blurred vision.

Gastrointestinal disorders: dry mouth, dyspeptic symptoms (heartburn, nausea, epigastric pain), gastrointestinal mucosa irritation.

Renal and urinary disorders: impaired urination.

Nervous system disorders: headache, dizziness, paresthesia, increased fatigue, drowsiness, slowed reaction time, tremor, irritability, anxiety (at night).

Blood and lymphatic system disorders: granulocytopenia, agranulocytosis.

Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including itching, rash, urticaria, Quincke's edema.

Paradoxical reactions such as increased excitability, tremor, and sleep disturbances may occasionally occur in children.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C.

Packaging.

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

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

Manufacturer: JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.