Diazolin-sb-farma

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIAZOLINE-SB-PHARMA

Composition:

Active substance: mebhydrolin;

1 tablet contains mebhydrolin, calculated as 100% substance, 50 mg or 100 mg;

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

Pharmaceutical form. Dragees.

Main physicochemical properties: white dragees or white with yellowish or greyish tinge. The dragees should have a regular spherical shape. The surface of the dragees should be smooth, even, and uniformly colored.

Pharmacotherapeutic group.

Antihistamines for systemic use.

ATC Code: R06AX15.

Pharmacological properties.

Pharmacodynamics.

Mebehydroline belongs to antihistamine agents and is an H1-histamine receptor blocker. Mebehydroline reduces the spasmogenic effect of histamine on smooth muscles of the bronchi and intestines, as well as its effect on vascular permeability. It has weakly expressed M-cholinoblocking and anesthetic properties.

Pharmacokinetics.

Rapidly absorbed from the gastrointestinal tract. Bioavailability ranges from 40–60 %. Therapeutic effect develops within 15–30 minutes, with maximum effect 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 from the body by the kidneys.

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

Diazolin-SB-FARMA potentiates the effects of hypnotics, sedatives, and other central nervous system depressants, as well as the effects of alcohol.

Special precautions for use.

Diazolin-SB-FARMA should be prescribed with caution in patients with severe hepatic and/or renal insufficiency (dose adjustment and prolonged dosing intervals may be required). During treatment with Diazolin-SB-FARMA, consumption of alcoholic beverages and use of medicinal products containing ethanol are not recommended.

If a patient has known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

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 and engaging in other potentially hazardous activities requiring high concentration of attention is not recommended during treatment with this medicinal product.

Dosage and Administration

Diazolin-SB-FARMA should be taken orally after meals. For adults and children aged 12 years and older, the recommended dose is 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, the recommended dose is 50 mg 1–3 times daily.

For children aged 3–5 years, the recommended dose is 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 patient's tolerance to the drug.

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

Overdose.

In case of overdose of mebhydrolin, the risk of adverse reactions described in the relevant section increases. In the event of overdose, administration of the drug should be discontinued; if necessary, general detoxification measures (gastric lavage, forced diuresis) and symptomatic therapy should be implemented.

Side effects.

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 sometimes occur: increased excitability, tremor, sleep disturbances, irritability.

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

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

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 dragees per blister, 2 blisters per cardboard pack.

Availability classification.

Over-the-counter.

Manufacturer.

JSC "Vitamins", Ukraine.

Manufacturer's address and location of business activity.

31 Uspenska Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

LLC "FORC-PHARMA DISTRIBUTION".

Address of the Marketing Authorization Holder.

132, Holosiivske Avenue, Kyiv, 03127, Ukraine.