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

Excipients: sucrose - 600.00 mg; glycerin - 225.00 mg; dye sunset sunset yellow (E110) - 0.10 mg; potassium sorbate - 1.90 mg; sodium saccharinate - 0.45 mg; flavoring cherry - 1,20 mg; citric acid monohydrate¹ - q.s. sodium hydroxide¹ - q.s. water - up to 1 ml.

¹ - to bring pH to the required value (pH = 5,0).

Description:

Transparent liquid of orange-red color with a cherry smell.

Pharmacotherapeutic group:anti-inflammatory anti-bronchoconstrictive agent

ATX: & nbsp

R.03.D.X.03 Fenspiride

Pharmacodynamics:

The anti-inflammatory and anti-bronchoconstrictive activity of fenspiride is due to 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 H₁antihistamine action, t. histamine stimulates the metabolism of arachidonic acid with the formation of prostaglandins and leukotrienes. Fenspiride blocks α-adrenoceptors, 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, the maximum concentration (FROM_max) in the blood plasma is achieved after 2,3 ± 2,5 h (from 0,5 to 8 h).

It is excreted mainly by the kidneys, half-life (T_1/2) is 12 hours.

Indications:

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, pertussis, influenza;

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

- sinusitis and otitis of various etiologies.

Contraindications:

- Hypersensitivity to fenspiride and other components of the drug;

- pregnancy;

- lactation period;

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

- Children under 2 years.

Carefully:

Diabetes mellitus, simultaneous reception of sedatives.

Pregnancy and lactation:

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.

It is not known whether the fenspiride in breast milk.If it is necessary to use the drug during lactation, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Follow strictly the doctor's recommendation.

Inside, before eating. Shake before use.

Adults: from 3 to 6 tablespoons of syrup (45-90 ml) per day.

Children from 2 to 16 years old:

- body weight more than 10 kg: 2-4 tablespoons (30-60 ml) per day.

- body weight less than 10 kg: 2-4 teaspoons (10-20 ml) per day.

Can be added to the bottle with food.

The duration of therapy is determined by the doctor.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, < 1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the central nervous system

rarely: drowsiness;

frequency is unknown: dizziness.

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;

frequency is unknown: a feeling of palpitations, hypotension, possibly associated with tachycardia.

From the gastrointestinal tract

often: gastrointestinal disorders, nausea, pain in the epigastric region;

frequency is unknown: diarrhea, vomiting.

From the skin and subcutaneous tissues

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

frequency is unknown: pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Other

frequency unknown: asthenia, increased fatigue.

Overdose:

If the drug is overdosed (there have been cases of overdose when taking the drug at a dose of more than 2320 mg), you should immediately seek medical help.

Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment: symptomatic therapy, gastric lavage, monitoring of the electrocardiogram (ECG). Maintaining important body functions.

Interaction:

Because of the possible sedative effect with the administration of histamine blockers H₁-receptor is not recommended the use of the drug in combination with drugs that have a sedative effect.

It is not recommended simultaneous use of the drug with alcohol.

Special instructions:

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.

Indication for patients with diabetes mellitus: 1 tablespoon of syrup contains 0.9 XE.

Special precautions for the destruction of unused medicinal product

There is no need for special precautions when destroying an unused preparation of Erispirus®.

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

Studies to study the effect of the drug on the ability to drive vehicles and work with mechanisms have not been carried out. Patients should be aware of the possible development of drowsiness when taking the drug, especially at the beginning of therapy or in combination with the intake of alcohol. Care must be taken when working with vehicles, mechanisms.

Form release / dosage:

Syrup, 2 mg / ml.

Packaging:

To 150 ml of syrup in the bottles of yellow glass, sealed with screw caps with a protective ring.

1 bottle per pack of cardboard along with instructions for use.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002715

Date of registration:14.11.2014

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SANDOZ ILAC SANAYI VE TICARET, A.S. Turkey

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp21.09.2015

Illustrated instructions

Instructions

Erispirus ® (ERISPIRUS®)