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

Excipients: flavoring composition with hints of honey odor * 0.500 g, licorice root extract 0.200 g, vanilla tincture ** 0.400 g, glycerol 22.5 g, methyl parahydroxybenzoate 0.09 g, propyl parahydroxybenzoate 0.035 g; saccharin 0.045 g, sucrose 60.0 g, potassium sorbate 0.19 g; water purified to 100 ml.

* Ingredients: flavors, including natural, honey sunflower, water, ethanol¹

** Ingredients: natural vanilla flavor and other ingredients, including ethanol¹

¹ The total content of ethanol in 100 ml of syrup is not more than 0.29 mg.

Description:

The liquid is brownish-yellow in color or transparent opalescence. When stored 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 drug, has an antiexudative effect, interferes with the development of bronchospasm. It shows antagonism with mediators of inflammation and allergy: serotonin, histamine (blockade H₁-gistamine receptors), bradykinin. Has a myotropic antispasmodic effect. When administered in large doses reduces the production of various inflammation factors (cytokines, arachidonic acid derivatives, free radicals).

Pharmacokinetics:

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 intestine 10%.

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, whooping cough and flu;

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

Otitis and sinusitis of various etiologies.

Contraindications:

Hypersensitivity to the active substance and / or any of the components of the drug.

Children under 2 years.

Carefully:

Patients with fructose intolerance, glucose-galactose malabsorption, sugarase / isomaltase deficiency (due to the presence of sucrose in the Erespal® syrup), patients with diabetes mellitus (due to the presence of sucrose as part of Erespal® syrup).

Pregnancy and lactation:

Data on the use of Erespal® 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.

Do not use Erespal® 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: 2 to 4 teaspoons of syrup per day (or 10-20 ml), can be added to a bottle with food

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

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

1 teaspoon (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:

The most frequent adverse reactions to the drug Erespap® are observed from the side digestive system.

The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); rarely (<1/10000) and an unknown frequency (the frequency can not be calculated from the available data).

From the side of the cardiovascular system

Rarely: moderate tachycardia, the severity of which decreases with a decrease in the dose of the drug.

Unknown frequency *: palpitations, hypotension, possibly associated with tachycardia.

From the digestive system

Often: gastrointestinal disorders, nausea, pain in epigastrium.

Unidentified frequency *: diarrhea, vomiting.

From the central nervous system

Rarely: drowsiness.

Unidentified frequency *: dizziness.

General disorders and symptoms

Unknown frequency*: asthenia, increased fatigue.

From the skin and subcutaneous fat

Rarely: erythema, rash, urticaria, angioedema, fixed pigmented erythema.

Unidentified frequency *: pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.

* Data of post-registration application.

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: gastric lavage, monitoring of the electrocardiogram (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 reception of histamine H blockers₁-receptors is not recommended the use of Erespal® syrup in combination with drugs that have a sedative effect, or in combination 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 delayed.

When prescribing the drug to patients with diabetes it is necessary to take into account that Erespal® 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 Erespal® 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 Erespal® especially at the beginning of therapy or when combined with taking alcohol,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:

In the production of the Servier Industrials Laboratory, France:

For 150 ml of syrup in a plastic bottle (PVC) brown with a plastic lid with the control of the first opening. One bottle with instructions for medical use is placed in a cardboard box.

When produced at OJSC Pharmstandard-Leksredstva, Russia:

For 150 ml or 250 ml of syrup in a plastic bottle (PVC) brown with a plastic cover with the control of the first opening. One bottle with instruction for medical use is placed in a pack of cardboard.

Storage conditions:

Special storage conditions are not required.

Keep out of the reach of children.

Shelf life:3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012547 / 02

Date of registration:28.06.2010

The owner of the registration certificate:Servier LaboratoriesServier Laboratories France

Manufacturer: & nbsp

Laboratories Servier France

PHARMSTANDART-FORESTRY, OJSC Russia

Representation: & nbspServier Laboratories Servier Laboratories France

Information update date: & nbsp21.09.2015

Illustrated instructions

Instructions

Erespal® (Eurespal®)