Diazolin - instructions for use, doses, side effects, contraindications

Composition:active substance: mebhydroline napadisylate (mebhydroline) - 50 mg or 100 mg;
Excipients: sugar (sugar) - 187.675 mg or 224.715 mg, starch syrup - 12,005 mg or 24,700 mg, povidone - 0,095 mg or 0,270 mg, talcum - 0,125 mg or 0,175 mg, wax - 0,050 mg or 0,070 mg, sunflower oil - 0,050 mg or 0.070 mg.

Description:The dragee is white or white with a yellowish tint of color. Inside the dragee is white or white with a slightly creamy or slightly greenish tinge.

Pharmacotherapeutic group:Antiallergic agent - H1-histamine receptor blocker.

ATX: & nbsp

R.06.A.X.15 Mebrogroline

R.06.A.X Other antihistamines for systemic use

Pharmacodynamics:H1-histamine receptor blocker. Has anti-allergic effect, reduces swelling of mucous membranes.Weakens the action of histamine on the smooth muscles of the bronchi, uterus and intestines, reduces the severity of lowering blood pressure and increasing the permeability of blood vessels. Minorly penetrating the central nervous system, unlike antihistamines of the first generation, does not have a pronounced sedative and hypnotic effect. Has weakly expressed M-cholinergic and anesthetic properties.
The therapeutic effect develops 15-30 minutes after administration, the maximum effect is observed after 1-2 hours. The duration of the effect can reach 2 days.

Pharmacokinetics:Quickly absorbed from the gastrointestinal tract, penetrates into all tissues of the body. Bioavailability varies between 40-60%. The half-life of the plasma is about 4 hours. Virtually does not penetrate the blood-brain barrier. Metabolised in the liver by methylation, induces microsomal enzymes of the liver, excreted by the kidneys.

Indications:Prophylaxis and treatment of allergic rhinitis, hay fever, urticaria, Quincke edema, allergic dermatoses, accompanied by pruritus (eczema, neurodermatitis); allergic conjunctivitis, skin reaction after an insect bite.

Contraindications:Hypersensitivity to mebhydroline or other components of the drug, prostatic hyperplasia, zakratougolnaya glaucoma, peptic ulcer of the stomach and duodenum, inflammatory diseases of the gastrointestinal tract, pyloric stenosis, epilepsy, heart rhythm disturbances, pregnancy, lactation, children up to 3 years, a deficiency of sugar / isomaltase, fructose intolerance, glucose-galactose malabsorption (due to the presence of sucrose in the formulation).

Carefully:With caution apply the drug in patients with hepatic and / or renal insufficiency (you may need to adjust the dose and intervals between doses), in patients with diabetes mellitus (due to the presence of sucrose in the drug).

Pregnancy and lactation:The drug is contraindicated for use in pregnancy.
If you need to use the drug during lactation at the time of treatment should stop breastfeeding.

Dosing and Administration:Inside, not liquid, during or immediately after eating.
Adults and children from 12 years of age are prescribed 100 mg 1-3 times a day. Maximum doses for adults: single dose - 300 mg, daily - 600 mg.
The duration of the course of treatment is determined by the nature of the disease and the therapeutic effect achieved.
For children aged 3 to 5 years - 50 mg 1-2 times a day, 5 to 10 years - 50 mg 2-3 times a day, 10 to 12 years - 50 mg 2-4 times a day day.

Side effects:From the gastrointestinal tract: has an irritating effect on the mucous membrane of the gastrointestinal tract, manifested dyspepsia (heartburn, nausea, pain in the epigastric region, vomiting, constipation).
From the nervous system and sensory organs: dizziness, paresthesia, tremor, fatigue, drowsiness, anxiety (at night), slowing the speed of the psychomotor reaction, blurred vision.
From the urinary system: violation of urination.
From the hematopoiesis: granulocytopenia and agranulocytosis.
Other: dryness of the oral mucosa, allergic reactions.
Children - Paradoxical reactions: increased excitability, irritability, tremor, sleep disturbances.

Overdose:Symptoms: Confusion, drowsiness, impaired coordination of movements.In the future, as the intake of the drug is absorbed, the symptoms of central nervous system (CNS) depression may increase until the onset of coma. Overdose can lead to a stimulating effect on the central nervous system (more often observed in children). Anticholinergic actions may also develop: dryness of the oral mucosa, dilatation of the pupils, blood rushes to the upper half of the trunk, disorders of the gastrointestinal tract (nausea, epigastric pain, vomiting).
Treatment: Removing the drug, washing the stomach, taking activated charcoal, if necessary - symptomatic therapy.

Interaction:Strengthens the action of ethanol, sedatives.

Special instructions:Patients with diabetes should pay attention to the sugar content of the drug. 1 dragee contains 187.675 mg of sucrose for 50 mg tablets or 224.715 mg of sucrose for 100 mg tablets, which corresponds to 0.02 bread units (XE). Influence on the ability to drive vehicles and control mechanisms: During the period of treatment it is necessary to refrain from driving vehicles and practicing other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:Dragee 50 mg, 100 mg.
For 10 dragees in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.
For 1, 2 or 3 contour packs together with the instruction for use are placed in a cardboard pack.

Packaging:

packings
packings, cellular, planimetric (1) -tacks, cardboard (10)
packings, cellular, planimetric (3), cardboard

Storage conditions:At a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years 6 months.
Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N002412 / 01

Date of registration:19.12.2008

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp19.10.2012

Illustrated instructions

Instructions

Diazoline (Diazolin)