Inspiron®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INSPIRON® (INSPIRON)

Composition:

Active substance: 1 tablet contains 80 mg of fenspiride hydrochloride, calculated as 100% substance;

Excipients: calcium hydrogen phosphate dihydrate; hypromellose (hydroxypropylmethylcellulose); povidone; silicon dioxide, colloidal anhydrous; magnesium stearate; coating mixture "Opadry II WHITE" 33G28707 (hypromellose (hydroxypropylmethylcellulose); titanium dioxide (E 171); lactose monohydrate; polyethylene glycol (macrogol) 3000; triacetin).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: white, round, biconvex film-coated tablets. The core is white or almost white in color when broken.

Pharmacotherapeutic group. Agents acting on the respiratory system. Other systemic agents used in obstructive respiratory diseases.

ATX code R03DX03.

Pharmacological properties.

Pharmacodynamics.

Inspiron® has antibronchoconstrictive and anti-inflammatory properties due to the interaction of several interrelated mechanisms:

• blocks H1-histamine receptors and exerts a spasmolytic effect on bronchial smooth muscle;
• exerts anti-inflammatory action, leading to reduced production of various pro-inflammatory factors (cytokines, TNF-α, arachidonic acid derivatives, prostaglandins, leukotrienes, thromboxane, free radicals), some of which also have bronchoconstrictive effects;
• inhibits α1-adrenoreceptors that stimulate the secretion of viscous mucus.

Pharmacokinetics.

Maximum plasma concentration is reached on average 6 hours after oral administration. The elimination half-life is 12 hours. Phenospiride is excreted from the body mainly in urine.

Clinical characteristics.

Indications.

• Treatment of acute and chronic inflammatory processes of the ear, nose, throat, and respiratory tract (otitis, sinusitis, rhinitis, rhinopharyngitis, tracheitis, rhinotracheobronchitis, bronchitis), chronic obstructive pulmonary disease (COPD), as part of combination therapy for bronchial asthma.
• Seasonal and perennial allergic rhinitis and other respiratory and ENT manifestations of allergy.
• Respiratory manifestations of measles and influenza.
• Symptomatic treatment of whooping cough.

Contraindications.

Hypersensitivity (allergy) to the active substance or to any of the components of the drug.

Interaction with other medicinal products and other forms of interaction.

Appropriate studies have not been conducted.

Concomitant use of fenspiride with sedative agents or alcohol consumption is not recommended. Sedative agents and alcohol may enhance the sedative effect of drugs possessing H1-histamine receptor antagonist properties (including fenspiride).

Special precautions for use.

Treatment with the drug does not replace antibiotic therapy.

Inspiron® should be used with caution in patients with hereditary galactose intolerance, lactase deficiency, or glucose/galactose malabsorption syndrome.

Use during pregnancy or breastfeeding.

Data on the use of fenspiride during pregnancy are limited. Preclinical reproductive toxicity studies of fenspiride have shown no effect on fertility in male and female rats. Therefore, the use of the drug during pregnancy is not recommended. However, diagnosis of pregnancy during fenspiride treatment is not an indication for pregnancy termination.

It is unknown whether fenspiride is excreted in breast milk. Therefore, Inspiron® should not be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Studies on the effect of fenspiride on the ability to drive vehicles or operate machinery have not been conducted.

Since the drug may cause drowsiness, it may have a minor effect on the ability to drive vehicles or operate machinery, particularly at the beginning of treatment or when consuming alcohol.

Dosage and Administration.

Recommended for use in adults.

For oral administration.

Take before meals.

Daily dose.

The usual recommended therapeutic dose for the treatment of chronic inflammatory conditions is 2 tablets per day (1 tablet in the morning and 1 tablet in the evening).

For enhanced effect and/or in cases of acute conditions – 3 tablets per day (1 tablet in the morning, afternoon, and evening).

Duration of treatment. The treatment duration depends on the course of the disease and is determined individually by a physician.

Children.

The drug should be administered to children from 2 years of age only in the form of syrup.

Overdose.

Following ingestion of a large amount of the drug, drowsiness or excitement, nausea, vomiting, and sinus tachycardia may occur.

Treatment. Gastric lavage is required; ECG monitoring should be performed. Symptomatic therapy should be administered.

Adverse Reactions.

During the use of fenspiride, the following adverse reactions have been reported, listed below using the following classification: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000); very rare (<1/10000); frequency unknown (cannot be estimated from available data).

Neurological disorders: rare – somnolence; frequency unknown – dizziness.

Cardiac disorders: frequency unknown – moderate sinus tachycardia, which decreases after dose reduction; palpitations, likely associated with tachycardia.

Vascular disorders: frequency unknown – arterial hypotension, likely associated with tachycardia.

Gastrointestinal disorders: common – digestive disorders, nausea, stomach pain; frequency unknown – diarrhea, vomiting.

Skin and subcutaneous tissue disorders: rare – erythema, rash, urticaria, angioedema, fixed pigmented erythema; frequency unknown – pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.

General disorders: frequency unknown – asthenia (weakness), increased fatigue.

Shelf life. 2 years.

Storage conditions. Keep out of reach of children. Store in the original packaging at a temperature not exceeding 25 °C.

Packaging. 10 tablets in a blister pack, 3 blisters in a carton.

Prescription status. Prescription only.

Manufacturer. JSC "Kyivmedpreparat".

Manufacturer's address and place of business.

139 Saksahanskoho Street, Kyiv, 01032, Ukraine.