Instructions for use Diazolin-Darnitsa tablets 100 mg No. 10
Composition
active ingredient: mebhydrolin;
1 tablet contains mebhydrolin 100 mg;
Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, povidone, colloidal anhydrous silicon dioxide, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: flat-cylindrical tablets with a bevel and a score, white or white with a yellowish tinge.
Pharmacotherapeutic group
Antihistamines for systemic use.
ATX code R06A X15.
Pharmacological properties
Pharmacodynamics
The active ingredient of the drug - mebhydrolin - belongs to antihistamines, is a blocker of Hl-histamine receptors. It weakens the spasmogenic effect of histamine on the smooth muscles of the bronchi and intestines, and also affects vascular permeability.
Pharmacokinetics
Mebhydrolin is rapidly absorbed from the digestive tract. Bioavailability is 40–60%. The therapeutic effect is achieved after 15–30 minutes, the maximum effect is noted after 1–2 hours. The drug practically does not penetrate the blood-brain barrier. It is metabolized in the liver by methylation. It 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 active substance or to other 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
The drug potentiates the effects of hypnotics, sedatives and other drugs that depress the central nervous system, as well as alcohol.
Application features
It is not recommended to consume alcoholic beverages and medications containing ethanol while using the medicine.
The drug should be used with caution in patients with severe hepatic and/or renal insufficiency (dose adjustment and increased dosing intervals may be required).
The medicinal product contains lactose, therefore patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Ability to influence reaction speed when driving vehicles or other mechanisms
While using the drug, it is not recommended to drive vehicles or work with other mechanisms that require concentration of attention and speed of psychomotor reactions.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy or breastfeeding.
Method of administration and doses
The medicine should be taken orally after meals.
Adults and children over 12 years of age: the drug should be used in a dose of 100–200 mg 1–2 times a day. The maximum single dose is 300 mg, daily dose is 600 mg.
Children aged 5 to 12 years: use the drug at a dose of 50 mg (1/2 tablet) 1–3 times a day.
The duration of treatment is determined by the doctor depending on the nature of the disease, the achieved therapeutic effect and the tolerability of the drug.
Children
The medicine should be used in children over 5 years of age.
Overdose
Symptoms: confusion, drowsiness, impaired coordination of movements, dry mouth.
Treatment: gastric lavage until clean water is available, oral administration of activated charcoal, forced diuresis. Further treatment is symptomatic.
Adverse reactions
On the part of the organs of vision: blurred visual perception.
On the part of the gastrointestinal tract: dry mouth, dyspeptic phenomena (heartburn, nausea, pain in the epigastric region), irritation of the mucous membrane of the digestive tract.
Renal and urinary disorders: urination disorders.
From the nervous system: headache, dizziness, paresthesia, increased fatigue, drowsiness, slowing down of reaction speed, 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, angioedema.
Paradoxical reactions are sometimes observed in children: increased excitement, tremors, sleep disturbances.
Expiration date
2 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
10 tablets in a contour blister pack; 1 contour blister pack in a pack.
Vacation category
Without a prescription.
Producer
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
