Diazolin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIAZOLINE® (DIAZOLINE®)

Composition:

Active ingredient: mebhydrolin;

One dragee contains mebhydrolin, recalculated to 100% dry substance, 50 mg (0.05 g) or 100 mg (0.1 g);

Excipients: sucrose, starch syrup, talc, yellow wax, sunflower oil.

Pharmaceutical form. Dragees.

Main physico-chemical properties: white or almost white dragees. On cross-section, two layers are visible. The dragees must have a spherical shape.

Pharmacotherapeutic group.

Antihistamines for systemic use.

ATC code R06AX15.

Pharmacological properties.

Pharmacodynamics.

Mebhydrolin belongs to antihistamine agents and is an H1-histamine receptor blocker. Mebhydrolin reduces the spasmogenic effect of histamine on smooth muscles of bronchi and intestines, as well as its influence on vascular permeability. Unlike first-generation antihistamines (dimedrol, suprastin), it has a less pronounced sedative and hypnotic effect. It possesses weak M-cholinoblocking and anesthetic properties.

Pharmacokinetics.

Rapidly absorbed from the gastrointestinal tract. Bioavailability ranges between 40–60%. Therapeutic effect develops within 15–30 minutes; maximum effect is observed within 1–2 hours. Duration of action may last up to 2 days. The drug practically does not penetrate the blood-brain barrier, is metabolized in the liver via methylation, induces liver enzymes, and is excreted 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 components of the drug. Gastric and duodenal peptic ulcer in the period of exacerbation, inflammatory diseases of the gastrointestinal tract, pylorostenosis, prostate hyperplasia, closed-angle glaucoma, epilepsy, cardiac arrhythmias.

Interaction with other medicinal products and other types of interactions.

Diazolinâ potentiates the effect of hypnotics, sedatives, and other central nervous system depressants, as well as alcohol.

Special precautions for use.

Diazolin® should be administered with caution in severe hepatic and/or renal insufficiency (dose adjustment and increased intervals between doses may be required). During treatment with Diazolin®, consumption of alcoholic beverages and use of medications containing ethanol are not recommended.

If you have known intolerance to certain sugars, consult your doctor before taking this medicinal product.

Use during pregnancy or breastfeeding.

The use of this medication is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.
Driving vehicles and engaging in other potentially hazardous activities requiring concentration is not recommended during drug use.

Dosage and Administration

Diazolin® should be administered orally after meals. For adults and children aged 12 years and older: 100–200 mg 1–2 times daily. Maximum doses for adults: single dose – 300 mg, daily dose – 600 mg.

For children aged 5–12 years: 50 mg 1–3 times daily; for children aged 3–5 years: 50 mg 1–2 times daily.

The duration of treatment is determined by the physician depending on the nature of the disease, clinical response, and drug tolerability.

Children. The drug is indicated for children aged 3 years and older.

Overdose.

In case of overdose, the risk of adverse reactions described in the relevant section increases. In such cases, discontinue the drug and, if necessary, carry out general detoxification measures (gastric lavage, forced diuresis) and symptomatic therapy.

Adverse Reactions.

Gastrointestinal system: irritation of gastrointestinal mucosa, sometimes manifested by dyspeptic symptoms (heartburn, nausea, epigastric pain).

Central nervous system: dizziness, paresthesia, increased fatigue, drowsiness, blurred vision, slowed reaction time, tremor, anxiety (at night).

Other: dry mouth, urinary disturbances, allergic reactions. Granulocytopenia and agranulocytosis are possible, but extremely rare.

In children, paradoxical reactions may occasionally occur: increased excitability, tremor, sleep disturbances, irritability.

In isolated cases during the post-marketing period, the following adverse reactions were reported: headache, itching, rash, urticaria, Quincke's edema.

Shelf life.

3 years 6 months.

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

Storage conditions.

Store in a protected from light place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 dragees in a blister, without insertion into the carton.

10 dragees in a blister. 2 blisters per carton.

Availability category. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.