Eladis^® (Tablets) Instructions for Use

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Contact Information

VALENTA PHARM JSC (Russia)

ATC Code

R05DB (Other antitussive drugs)

Dosage Form

Eladis®

Film-coated tablets, 40 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.

Excipients: sodium starch glycolate, microcrystalline cellulose, anhydrous lactose, talc, magnesium stearate, ready film coating (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol-3350, talc).

14 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antitussive, anti-inflammatory drug with antibronchoconstrictor action

Pharmacotherapeutic Group

Other antitussive drugs

Pharmacological Action

Mechanism of action

One of the molecular mechanisms of action of the drug Eladis^® is the inhibition of human Golgi-resident glutaminyl cyclase. Suppression of this enzyme reduces the formation of the active form of MCP family chemokines involved in chronic inflammation. This is manifested in a reduction of monocyte chemotaxis, decreased migration of eosinophils into lung tissue, and prevention of mast cell degranulation, which contributes to a reduction in the severity of inflammation symptoms. The mechanism of the antitussive activity of the drug Eladis^® is realized at the level of the peripheral links of the cough reflex, in particular, those associated with the activation of TRPA1 ion channels involved in the pathogenesis of chronic cough.

Pharmacodynamic effects

The drug Eladis^® has bronchodilatory, anti-inflammatory, antitussive, and anti-allergic effects. It reduces the manifestations of bronchospasm and inflammation in the airways, and reduces hypersecretion of mucus. It inhibits the release of inflammatory and allergic mediators and reduces airway reactivity to their action. It improves respiratory function and reduces the severity and frequency of respiratory symptoms, including coughing fits and choking.

The drug Eladis^® does not possess immunotoxic, allergenic, mutagenic, or carcinogenic properties, clastogenic or aneugenic potential, does not have a local irritant effect, and does not affect reproductive function.

Clinical efficacy and safety

In placebo-controlled clinical studies of the drug conducted in adult patients and children aged 6-17 years diagnosed with acute respiratory viral infection of the upper respiratory tract or acute bronchitis, taking the drug statistically significantly (p<0.05) led to a reduction in the frequency of “daytime” and “nocturnal” coughing fits by the 5th day of therapy compared to placebo. The average time to achieve clinical cure from cough in the drug group was 6 days for adult patients and 5 days for children aged 6-17 years.

Pharmacokinetics

Absorption

The active substance quickly enters the bloodstream from the gastrointestinal tract.

Distribution

Weakly (<50%) binds to plasma proteins. With repeated administration once daily, it does not accumulate in plasma.

Metabolism

It is not metabolized in the liver. It does not affect the human liver cytochrome system. In the body, it undergoes slight hydrolysis. The metabolite is 4-{[2-(1H-imidazol-5-yl)ethyl]carbamoyl}butanoic acid. With repeated administration once daily, the metabolite does not accumulate in plasma.

Excretion

In preclinical studies, it was found that the main excretion process occurs through the kidneys; less than 1% of the administered dose is excreted in feces.

Indications

For adults and children aged 13 years and older

• For dry non-productive cough against the background of acute respiratory viral infection and acute bronchitis.

ICD codes

Dosage Regimen

Orally. Regardless of meals.

Adults

1 tablet (40 mg) 2 times/day. Maximum daily dose is 80 mg. The recommended duration of treatment is 7 days. If symptoms persist after 7 days of therapy, treatment may be continued for another 7 days.

Special patient groups

Elderly patients

No dose adjustment is required.

Patients with renal impairment

No dose adjustment is required.

Patients with hepatic impairment

No dose adjustment is required.

Children from 13 years

The dosing regimen for children from 13 years does not differ from the dosing regimen for adults.

Adverse Reactions

The determination of the frequency of adverse reactions is carried out in accordance with the following criteria: very common (≥1/10), common (from ≥1/100 to <1/10), uncommon (from ≥1/1000 to <1/100), rare (from ≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from the available data).

From the immune system: frequency unknown – allergic reactions.

From the nervous system: very common – headache.

From the gastrointestinal tract: very common – nausea; common – diarrhea, dyspepsia, dysgeusia.

From the hepatobiliary system: very common – hyperbilirubinemia.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after registration of the medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to the active substance or any of the excipients included in the drug.

Use in Pregnancy and Lactation

Pregnancy

Due to the lack of clinical data, the use of the drug during pregnancy and in women planning pregnancy is contraindicated. If pregnancy occurs, the drug should be discontinued.

Breastfeeding period

It is unknown whether the active substance of the drug Eladis^® is excreted in breast milk. The safety of taking the drug Eladis^® during breastfeeding has not been studied. The use of the drug during breastfeeding is contraindicated. If it is necessary to take the drug during lactation, breastfeeding should be discontinued during treatment.

Fertility

No human data available.

Use in Hepatic Impairment

No dose adjustment is required.

Use in Renal Impairment

No dose adjustment is required.

Pediatric Use

The use of the drug in children under 13 years of age is contraindicated.

Geriatric Use

No dose adjustment is required.

Special Precautions

Excipients,

Lactose

The drug Eladis^® contains lactose. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take the drug Eladis^®.

Sodium

Sodium in the drug Eladis^® is contained in the excipient sodium starch glycolate. The drug contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially sodium-free.

Effect on ability to drive vehicles and machinery

It has not been studied, however, considering the mechanism of action and the profile of possible adverse reactions, it can be assumed that the drug does not affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms: no cases of overdose with the drug Eladis^® have been reported.

Treatment drug withdrawal, symptomatic therapy.

Drug Interactions

There is no information on the interaction of the drug with other medicinal products.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

Dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.