Eladon - instructions for use, dose, side effects, contraindications

Excipients: sucrose - 600.00 mg, glycerol (glycerin) - 225.00 mg, licorice extract dry - 2.00 mg, potassium sorbate - 1.90 mg, methyl parahydroxybenzoate (methylparaben) - 0.90 mg, flavor "Vanilla with natural extract " RX15460 - 0,50 mg, sodium saccharinate - 0,45 mg, propyl parahydroxybenzoate (propylparaben) - 0,35 mg, flavoring food "Honey 96" - 0,25 mg, natural food flavoring "Mint" - 0,08 mg, purified water - up to 1.00 ml.

Description:

The liquid is a brownish-yellow color, transparent or with slight opalescence.During storage, it is possible to form a precipitate that disappears with agitation.

Pharmacotherapeutic group:Anti-inflammatory anti-bronchoconstrictive agent

ATX: & nbsp

R.03.D.X.03 Fenspiride

Pharmacodynamics:

Anti-inflammatory and anti-bronchoconstrictive activity of fenspiride is caused by a decrease in the production of a number of biologically active substances (cytokines, especially tumor necrosis factor α (TNF-α), arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm. Inhibition of fenspiride metabolism of arachidonic acid potentiates its H₁-antigistamine action, since histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenergic receptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. In this way, fenspiride reduces the effect of a number of factors that contribute to the hypersecretion of proinflammatory factors, the development of inflammation and bronchial obstruction. Fenspiride also has an antispasmodic effect.

Pharmacokinetics:

After oral administration fenspiride well absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma after ingestion is reached after 2,3 ± 2,5 hours (from 0,5 to 8 hours). The half-life is 12 hours.

It is excreted mainly by the kidneys (90%), through the intestines - 10%.

Indications:

Symptomatic therapy of diseases of the upper and lower respiratory tract:

- rhinopharyngitis and laryngitis;

- tracheobronchitis;

- bronchitis (in the background of chronic respiratory failure or without it);

- bronchial asthma (as part of complex therapy);

- respiratory effects (cough, hoarseness, throat swelling) with measles, whooping cough and flu;

- infectious diseases of the respiratory tract, accompanied by a cough, when the standard therapy with antibiotics is shown.

Otitis and sinusitis of various etiologies, including allergic (both seasonal and permanent).

Contraindications:

- Hypersensitivity to fenspiride and / or any of the components of the drug;

- children under 2 years;

- pregnancy;

- the period of breastfeeding;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

Carefully:

Diabetes mellitus (due to the presence of sucrose in the drug), simultaneous use of sedatives.

Pregnancy and lactation:

Data on the use of fenspiride in pregnant women are absent or limited.

Taking the drug during pregnancy is not recommended.

Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred. Clinical data on the fetotoxic effect of fenspiride or its ability to cause malformations during admission during pregnancy are absent. Do not use Eladon ® during breastfeeding because of the lack of data on the penetration of fenspiride into breast milk.

Dosing and Administration:

Inside.

Shake before use.

Adults and teenagers

From 3 to 6 tablespoons of syrup (45-90 ml) per day, take before meals.

Children from 2 years old

The recommended dose is 4 mg / kg / day.

- Body weight up to 10 kg: from 2 to 4 teaspoons of syrup per day (or 10-20 ml), can be added to a bottle with food;

- body weight of more than 10 kg: 2 to 4 tablespoons of syrup per day (or 30-60 ml), taken before meals.

1 tablespoon (15 ml) of syrup contains 30 mg of fenspiride hydrochloride and 9 g of sucrose.

1 teaspoonful (5 ml) of syrup contains 10 mg of fenspiride hydrochloride and 3 g of sucrose. The duration of treatment is determined by the doctor.

Side effects:

Classification of the incidence of adverse events according to recommendations

World Health Organization (WHO):

very often ≥ 1/10;

often from ≥ 1/100 to <1/10;

infrequently from ≥ 1/1000 to <1/100;

rarely from ≥ 1/10000 to <1/1000;

very rarely <1/10000, including individual messages;

the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the side of the cardiovascular system:

rarely - moderate sinus tachycardia, the severity of which decreases with a decrease in the dose of the drug;

the frequency is unknown - a feeling of palpitations, a reduction in blood pressure, possibly associated with tachycardia.

From the digestive system:

often - gastrointestinal disorders, nausea, pain in the epigastric region; frequency unknown - diarrhea, vomiting.

From the central nervous system:

rarely - drowsiness;

frequency unknown - dizziness.

General disorders and symptoms:

frequency unknown - asthenia, increased fatigue.

From the skin and subcutaneous fat:

rarely - erythema, rash, hives, angioedema, fixed erythema pigmentosa;

frequency is unknown - skin itch, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Overdose:

When an overdose of the drug (noted cases of overdose with fenspiride intake in a dose of more than 2320 mg) should immediately seek medical help.

Symptoms

Drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment

Symptomatic therapy, gastric lavage, electrocardiogram monitoring (ECG). Maintaining vital body functions.

Interaction:

Special studies on the interaction of fenspiride with other drugs have not been conducted.

Because of the possible increase in sedation with the administration of histamine blockers H₁-receptors is not recommended the use of the drug Eladon® syrup in combination with drugs that have a sedative effect, or in conjunction with alcohol.

Special instructions:

The composition of the drug includes parabens (parahydroxybenzoates), so that the use of this drug can provoke the development of allergic reactions, including deferred.

In the event of infections of the respiratory system caused by bacteria or fungi, fenspiride it is recommended to prescribe only in combination with antibacterial and antifungal therapy.

When prescribing the drug for patients with diabetes it is necessary to take into account that the preparation Eladon® syrup contains sucrose (1 teaspoon - 3 g sucrose = 0.3 XE, 1 tablespoon - 9 g sucrose = 0.9 XE).

Effect on the ability to drive transp. cf. and fur:

Studies to study the effect of fenspiride on the ability to drive vehicles and work with mechanisms have not been conducted. Patients should be aware of the possible development of drowsiness when taking Eladon® syrup, especially at the beginning of therapy or when combined with alcohol intake, and should be careful when driving vehicles and performing work that requires a high rate of psychomotor reactions.

Form release / dosage:

Syrup 2 mg / ml.

Packaging:

150 ml or 250 ml in dark bottles made from polyethylene terephthalate with a screw cap with a first opening control of high-density polyethylene or polypropylene,or polypropylene with a ring and with a gasket of low density polyethylene.

Each vial with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004147

Date of registration:16.02.2017

Expiration Date:16.02.2022

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp

VERTEKS, AO Russia

Information update date: & nbsp25.03.2017

Illustrated instructions

Instructions

Eladon® (Eladon)