Diazolin dragee 0.05 g blister No. 20

Instructions Diazolin dragee 0.05 g blister No. 20

Composition

active ingredient: mebhydrolin;

1 dragee contains mebhydrolin in terms of 100% dry matter 50 mg (0.05 g) or 100 mg (0.1 g);

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

Dosage form

Dragee.

Main physical and chemical properties: white or almost white dragees. Two layers are visible in cross section. Dragees should have a spherical shape.

Pharmacotherapeutic group

Antihistamines for systemic use. ATX code R06A X15.

Pharmacological properties

Pharmacodynamics

Mebhydrolin belongs to antihistamines, is a blocker of histamine H1 receptors. Mebhydrolin weakens the spasmogenic effect of histamine on the smooth muscles of the bronchi and intestines, as well as its effect on vascular permeability. Unlike first-generation antihistamines (diphenhydramine, suprastin), it has a less pronounced sedative and hypnotic effect. It has weakly expressed m-cholinoblocking and anesthetic properties.

Pharmacokinetics

Rapidly absorbed from the digestive tract. Bioavailability ranges from 40 to 60%. The therapeutic effect develops after 15 to 30 minutes, the maximum effect is observed after 1 to 2 hours. The duration of the effect can reach 2 days. The drug practically does not penetrate the blood-brain barrier, is metabolized in the liver by methylation, induces liver enzymes, and is excreted from the body by the kidneys.

Indication

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

Contraindication

Hypersensitivity to the components of the drug. Gastric and duodenal ulcer during exacerbation, inflammatory diseases of the digestive tract, pyloric stenosis, prostatic hyperplasia, angle-closure glaucoma, epilepsy, cardiac arrhythmias.

Interaction with other medicinal products and other types of interactions

Diazolin potentiates the effects of hypnotics, sedatives and other drugs that depress the central nervous system, as well as alcohol.

Application features

Diazolin is prescribed with caution in severe hepatic and/or renal insufficiency (dose adjustment and increase in the intervals between doses are possible). During treatment with Diazolin, drinking alcoholic beverages and taking medications containing ethanol is not recommended.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ability to influence reaction speed when driving vehicles or other mechanisms

When using the drug, it is not recommended to drive vehicles and engage in other potentially dangerous activities that require concentration.

Use during pregnancy or breastfeeding

The drug is contraindicated during pregnancy or breastfeeding.

Method of administration and doses

Diazolin is prescribed orally, after meals, to adults and children over 12 years of age, 100-200 mg 1-2 times a day. Maximum doses for adults: single dose - 300 mg, daily dose - 600 mg.

Children aged 5-12 years should be prescribed 50 mg 1-3 times a day; children aged 3-5 years - 50 mg 1-2 times a day.

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

Children

The drug should be used in children over 3 years of age.

Overdose

In case of overdose of the drug, the risk of adverse reactions described in the relevant section increases. In this case, the drug is canceled, if necessary, general detoxification measures (gastric lavage, forced diuresis) and symptomatic therapy are carried out.

Adverse reactions

On the part of the digestive system: irritation of the mucous membranes of the gastrointestinal tract, sometimes manifested by dyspeptic phenomena (heartburn, nausea, pain in the epigastric region).

From the side of the central nervous system: dizziness, paresthesia, increased fatigue, drowsiness, blurred vision, slowed reaction speed, tremor, anxiety (at night).

Others: dry mouth, urination disorders, allergic reactions. Granulocytopenia and agranulocytosis may occur extremely rarely.

Paradoxical reactions are sometimes observed in children: increased excitement, tremors, sleep disturbances, irritability.

In isolated cases, the following adverse reactions were observed in the post-marketing period: headache, itching, rash, urticaria, angioedema.

Expiration date

3 years 6 months.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

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

Keep out of reach of children.

Packaging

10 dragees in a blister without being placed in a pack.

10 tablets in a blister. 2 blisters in a pack.

Vacation category

Producer

PJSC "Farmak".

Location of the manufacturer and its business address

Ukraine, 04080, Kyiv, Frunze St., 74.