Pulmolor®

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

Composition:

Active substances: ambroxol hydrochloride, loratadine;

5 ml of ready-made suspension contain ambroxol hydrochloride 30 mg, loratadine 5 mg;

Excipients: sodium benzoate (E 211), sodium metabisulfite (E 223), disodium edetate, xanthan gum, sucralose, strawberry flavor, colloidal anhydrous silicon dioxide, menthol, sucrose.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: nearly white powder; the prepared suspension is white.

Pharmacotherapeutic group.

Medicinal products used in cough and common cold. Expectorants, excluding combined preparations containing antitussives.

ATC code R05C.

Pharmacological properties.

Pharmacodynamics.

Pulmolor® exerts a pronounced expectorant effect, soothes and relieves dry cough, facilitates breathing, normalizes bronchial mucus secretion, improves sputum clearance, reduces inflammation of the respiratory tract, exerts anti-exudative action, alleviates bronchial smooth muscle spasm and tissue edema, including mucosa of the nose, throat, paranasal sinuses and respiratory tract, reduces capillary permeability, decreases nasal congestion, runny nose, lacrimation, sneezing, itching of the palate and nose, and eye redness.

Ambroxol hydrochloride – a synthetic secretolytic and secretomotor agent. It has a pronounced expectorant effect and a slight antitussive effect. It stimulates serous cells of bronchial mucosal glands, increases the amount of serous secretion, and thus corrects the disturbed ratio between serous and mucous components. This leads to normalization of sputum rheological properties by reducing its viscosity and adhesive characteristics. Ambroxol directly stimulates ciliary activity of bronchial epithelium, prevents ciliary adhesion, and improves mucociliary clearance of sputum. Ambroxol increases surfactant content in the lungs and prevents its degradation in pneumocytes. As a mucolytic and expectorant, ambroxol improves external respiration function. The drug reduces bronchial muscle hyperreactivity in asthmatic patients. Ambroxol has anti-inflammatory effects, antioxidant properties, stimulates local immunity and restores the natural surfactant layer. With ambroxol administration, patient complaints regarding cough and sputum production decrease significantly in accordance with treatment intensity. Ambroxol hydrochloride increases antibiotic concentration in lung tissue, thus improving the course of respiratory tract diseases during bacterial lung infections.

Loratadine – a selective, long-acting peripheral H1-histamine receptor blocker without central sedative effects. It exerts antiallergic action, reduces bronchial smooth muscle spasm, decreases bronchial sensitivity to histamine, eliminates dry cough of allergic origin, reduces capillary permeability, and alleviates tissue edema, rhinorrhea, lacrimation, sneezing, itching of the palate and nose, and eye redness. It prevents the development and alleviates the course of allergic reactions. Its action occurs via competitive blockade of H1-receptors on effector cells by inhibiting calcium influx into cells, suppressing histamine release (membrane-stabilizing function), and inhibiting eosinophil chemotaxis and their accumulation in the mucosa. The antihistaminic effect of loratadine begins within 1–3 hours after administration, reaches maximum within 8–12 hours, and lasts up to 24 hours. No tolerance development is observed after 28 days of loratadine use.

Clinical characteristics.

Indications.

Symptomatic therapy in acute and chronic respiratory tract diseases with spastic and allergic components associated with impaired bronchial secretion and reduced mucus clearance. Indicated in acute and chronic bronchitis, chronic obstructive pulmonary diseases, pneumonia, and conditions accompanied by bronchial hyperreactivity.

In otorhinolaryngological practice, for the purpose of secretion thinning and edema reduction, indicated in rhinitis, including allergic rhinitis, as well as in the complex treatment of sinusitis and otitis.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other types of interactions.

Concomitant use of Pulmolor® with antibiotics is advantageous compared to administration of antibiotics alone. Pulmolor® increases antibiotic concentrations in the lungs and thus facilitates the course of respiratory tract diseases in bacterial lung infections.

The use of this drug should not be combined with alcohol consumption.

Do not take simultaneously with antitussive agents that impair expectoration.

Potential interaction is possible when using known inhibitors of CYP3A4 or CYP2D6, leading to increased loratadine levels, which in turn may increase the frequency of adverse reactions.

In controlled studies, increased plasma concentrations of loratadine have been reported after concomitant administration with ketoconazole, erythromycin, and cimetidine, although without clinically significant effects (including on ECG).

Special precautions for use

Before performing skin sensitivity tests, administration of the drug should be discontinued 48 hours prior.

There have been isolated reports of severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and acute generalized exanthematous pustulosis) occurring in temporal association with the use of ambroxol hydrochloride. In most cases, these reactions could be explained by the severity of the underlying disease and concomitant use of other medications. Additionally, in the initial stages of Stevens-Johnson syndrome or Lyell's syndrome, patients may present with nonspecific, flu-like symptoms such as chills, malaise, rhinitis, cough, and sore throat. These nonspecific, flu-like symptoms may lead to inappropriate symptomatic treatment with cough and cold remedies. Therefore, if new skin lesions or mucosal involvement occur, medical help should be sought immediately and treatment with ambroxol hydrochloride should be discontinued.

Since ambroxol may enhance mucus secretion, the drug should be used with caution in patients with impaired bronchial motility and increased mucus secretion (e.g., in rare conditions such as primary ciliary dyskinesia).

The drug should be used with caution in patients with renal impairment or severe hepatic insufficiency (i.e., the dosing interval should be prolonged or the dose reduced). In patients with severe renal insufficiency, accumulation of metabolites formed in the liver may be expected.

Excipients

The drug contains sucrose; therefore, patients with diagnosed sugar intolerance should consult their physician before taking this medicinal product.

Use during pregnancy or breastfeeding

As experience with use of the drug during pregnancy is limited, its use during pregnancy is not recommended.

Since the drug passes into breast milk, its use during breastfeeding is not recommended.

Effect on the ability to drive vehicles or operate machinery

Generally, the drug does not affect reaction speed when driving vehicles or operating machinery. However, patients should be informed about the very rare occurrence of drowsiness, which may affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

Children aged 6 to 12 years: 2.5 ml 2–3 times daily.

Adults and children aged 12 years and older: 5 ml twice daily.

Preparation of the suspension. To prepare the suspension, add boiled cooled water up to the mark on the bottle and shake well.

Shake well before each use.

Take after meals.

Duration of treatment – up to 14 days. Consult a physician if symptoms persist or worsen after 14 days.

The medication should not be used for longer than 4–5 days without consulting a physician.

Children.

Do not use in children under 6 years of age.

Overdose.

Symptoms: tachycardia, headache, drowsiness, nausea, vomiting, diarrhea, decreased blood pressure.

Treatment. In case of overdose, symptomatic and supportive treatment is recommended. Standard measures for removing unabsorbed drug from the stomach are advised: gastric lavage, ingestion of crushed activated charcoal with water.

Loratadine is not removed by hemodialysis; it is also unknown whether loratadine is removed by peritoneal dialysis.

After emergency treatment, the patient should remain under medical supervision.

Adverse reactions.

The drug is usually well tolerated.

Skin-related: alopecia.

Immune system-related: hypersensitivity reactions, including rash, urticaria, pruritus, anaphylactic reactions (including anaphylactic shock), angioneurotic edema; serious skin adverse reactions (erythema multiforme, Stevens–Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), and acute generalized exanthematous pustulosis).

Due to the presence of sodium metabisulfite in the powder for oral suspension, hypersensitivity reactions and bronchospasm may occur.

Nervous system-related: dysgeusia (taste disturbance), dizziness, convulsions, headache, nervousness, fatigue, somnolence, insomnia.

Gastrointestinal tract-related: nausea, oral cavity numbness, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth and throat, constipation, salivation, gastritis.

Respiratory system-related: rhinorrhea, dyspnea (as a symptom of hypersensitivity reaction).

Hepatobiliary system-related: liver function disorders.

Cardiovascular system-related: tachycardia, palpitations.

Urinary system-related: dysuria.

General disorders: fever, weight gain, increased appetite, mucosal reactions.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the drug. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C. After reconstitution, the suspension should be stored for 14 days at a temperature between 2 and 8 °C.

Packaging.

1 bottle of powder for the preparation of 60 mL or 100 mL of suspension, together with a measuring device on the polyethylene cap, in a cardboard package.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

MediTop Pharmaceutical Ltd.

Manufacturer's address and location of business activity.

Hungary, Edi Endre u. 1., Pilisborosjenő, 2097.

Marketing Authorization Holder.

LLC "Movi Health"

Address of the Marketing Authorization Holder.

162 A, Shevchenka Street, village Shevchenkove, Kyiv-Sviatoshynskyi district, Kyiv region, 08140, Ukraine

INSTRUCTION

for medical use of the medicinal product

PULMOLOR®

(PULMOLOR®)

Composition:

Active substances: ambroxol hydrochloride, loratadine;

5 ml of ready-to-use suspension contain 30 mg of ambroxol hydrochloride and 5 mg of loratadine;

Excipients: sodium benzoate (E 211), sodium metabisulfite (E 223), disodium edetate, xanthan gum, sucralose, strawberry flavor, colloidal anhydrous silicon dioxide, menthol, sucrose.

Pharmaceutical form. Powder for oral suspension.

Main physicochemical properties: nearly white powder; the prepared suspension is white.

Pharmacotherapeutic group.

Preparations used in cough and colds. Expectorants, excluding combined preparations containing antitussives.

ATC code R05C.

Pharmacological properties.

Pharmacodynamics.

Pulmolor® exerts a pronounced expectorant effect, soothes and relieves dry cough, facilitates breathing, normalizes bronchial mucus secretion, improves sputum clearance, reduces inflammation of the respiratory tract, exerts anti-exudative action, relieves spasm of bronchial smooth muscles and tissue edema, including mucous membranes of the nose, throat, paranasal sinuses and respiratory tract, reduces capillary permeability, alleviates nasal congestion, runny nose, lacrimation, sneezing, itching of the palate and nose, and eye redness.

Ambroxol hydrochloride is a synthetic secretolytic and secretomotor agent. It has a pronounced expectorant effect and a slight antitussive effect. It stimulates serous cells of bronchial mucosal glands, increases the amount of serous secretion, and thus corrects the disturbed ratio between serous and mucous components. This leads to normalization of sputum rheological properties, reducing its viscosity and adhesive characteristics. Ambroxol directly stimulates ciliary activity of bronchial epithelium, prevents cilia clumping, and improves mucociliary clearance of sputum. Ambroxol increases surfactant content in the lungs and prevents its destruction in pneumocytes. As a mucolytic and expectorant, ambroxol improves external respiration function. The drug reduces bronchial muscle hyperreactivity in asthmatic patients. Ambroxol has anti-inflammatory effects, antioxidant properties, stimulates local immunity and regeneration of the natural surfactant layer. With ambroxol administration, patient complaints regarding cough and sputum production significantly decrease in accordance with treatment intensity. Ambroxol hydrochloride increases antibiotic concentrations in lung tissue, thereby improving outcomes in respiratory tract infections of bacterial origin.

Loratadine is a selective, long-acting peripheral H1-histamine receptor antagonist without central sedative effects. It exerts antiallergic action, reduces spasm of bronchial smooth muscles, decreases bronchial sensitivity to histamine, eliminates dry cough of allergic origin, reduces capillary permeability, alleviates tissue edema, rhinorrhea, lacrimation, sneezing, itching of the palate and nose, and eye redness. It prevents the development and alleviates the course of allergic reactions. Its action occurs through competitive blockade of H1-receptors on effector cells by inhibiting calcium influx into cells, inhibition of histamine release (membrane-stabilizing function), and suppression of eosinophil chemotaxis and their accumulation in the mucosa. The antihistaminic effect of loratadine appears within 1–3 hours after administration, reaches maximum within 8–12 hours, and lasts up to 24 hours. No tolerance development is observed after 28 days of loratadine use.

Clinical characteristics.

Indications.

Symptomatic treatment of acute and chronic respiratory tract diseases with spastic and allergic components associated with impaired bronchial secretion and weakened mucus clearance. Indicated for acute and chronic bronchitis, chronic obstructive pulmonary diseases, pneumonia, and conditions accompanied by bronchial hyperreactivity.

In otorhinolaryngological practice, indicated for thinning secretions and reducing swelling in rhinitis, including allergic rhinitis, and as part of combination therapy for sinusitis and otitis.

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

Concomitant administration of Pulmolor® with antibiotics is advantageous compared to antibiotic use alone. Pulmolor® increases antibiotic concentrations in the lungs and thus facilitates the course of respiratory tract diseases in bacterial lung infections.

The use of this drug should not be combined with alcohol consumption.

Do not take simultaneously with antitussive agents that hinder expectoration.

Potential interaction may occur when using known inhibitors of CYP3A4 or CYP2D6, leading to increased loratadine levels, which in turn may increase the frequency of adverse reactions.

In controlled studies, increased plasma concentrations of loratadine have been reported after concomitant administration with ketoconazole, erythromycin, and cimetidine, without clinically significant changes (including on ECG).

Special precautions for use.

Before performing skin sensitivity tests, discontinue the use of the drug 48 hours prior.

There have been isolated reports of severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and acute generalized exanthematous pustulosis) occurring concurrently with the use of ambroxol hydrochloride. In most cases, these reactions could be explained by the severity of the underlying disease and concomitant use of other medications. Additionally, in the early stages of Stevens-Johnson syndrome or Lyell's syndrome, patients may present with nonspecific, flu-like symptoms such as fever, malaise, rhinitis, cough, and sore throat. Due to these nonspecific, flu-like symptoms, symptomatic treatment with cough and cold remedies may be mistakenly initiated. Therefore, if new skin lesions or mucosal involvement occur, immediate medical attention should be sought and treatment with ambroxol hydrochloride should be discontinued.

Since ambroxol may enhance mucus secretion, the drug should be used with caution in patients with impaired bronchial motility and increased mucus secretion (e.g., in rare conditions such as primary ciliary dyskinesia).

The drug should be used with caution in patients with renal impairment or severe hepatic insufficiency (i.e., the dosing interval should be prolonged or the dose reduced). In patients with severe renal insufficiency, accumulation of metabolites formed in the liver is expected.

Excipients.

The drug contains sucrose; therefore, patients with diagnosed sugar intolerance should consult their physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

As experience with the use of the drug in pregnant women is limited, its use during pregnancy is not recommended.

Since the drug passes into breast milk, its use during breastfeeding is not recommended.

Ability to influence reaction speed when driving or operating machinery.

Generally, the drug does not affect reaction speed when driving or operating machinery. However, patients should be informed about the very rare occurrence of drowsiness, which may affect the ability to drive or operate machinery.

Method of Administration and Dosage

Children aged 6 to 12 years: 2.5 ml 2–3 times daily.

Adults and children aged 12 years and older: 5 ml twice daily.

Preparation of the suspension. To prepare the suspension, add boiled and cooled water up to the mark on the bottle and shake well.

Shake well before each use.

Take after meals.

Duration of treatment – up to 14 days. Consult a doctor if symptoms persist or worsen after 14 days.

The medication should not be used for longer than 4–5 days without consulting a doctor.

Children.

Do not use in children under 6 years of age.

Overdose.

Symptoms: tachycardia, headache, drowsiness, nausea, vomiting, diarrhea, decreased arterial blood pressure.

Treatment. In case of overdose, symptomatic and supportive treatment is recommended. Standard measures for removing unabsorbed drug from the stomach are advised: gastric lavage and administration of crushed activated charcoal with water.

Loratadine is not removed by hemodialysis; it is also unknown whether loratadine is removed by peritoneal dialysis.

After emergency treatment, the patient should remain under medical supervision.

Adverse Reactions

The drug is usually well tolerated.

Skin: alopecia.

Immune system: hypersensitivity reactions, including rash, urticaria, pruritus, anaphylactic reactions (including anaphylactic shock), angioneurotic edema; serious skin adverse reactions (multiform erythema, Stevens–Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), and acute generalized exanthematous pustulosis).

Due to the presence of sodium metabisulfite in the powder for oral suspension, hypersensitivity reactions and bronchospasm may occur.

Nervous system: dysgeusia (taste disturbance), dizziness, seizures, headache, nervousness, fatigue, somnolence, insomnia.

Gastrointestinal tract: nausea, decreased oral sensitivity, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth and throat, constipation, salivation, gastritis.

Respiratory system: rhinorrhea, dyspnea (as a symptom of hypersensitivity reaction).

Hepatobiliary system: liver function abnormalities.

Cardiovascular system: tachycardia, palpitations.

Urinary system: dysuria.

General disorders: fever, weight gain, increased appetite, mucosal reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life

3 years.

Storage conditions

Store in the original packaging, out of reach of children, at a temperature not exceeding 25 °C. After reconstitution, the suspension should be stored for 14 days at a temperature between 2 and 8 °C.

Packaging

1 bottle containing powder for the preparation of 60 ml or 100 ml of suspension, together with a measuring device on the polyethylene cap, in a cardboard package.

Prescription status

Over-the-counter.

Manufacturer

Sava Helskea Ltd.

Manufacturer's address and place of business

India, GIDC Estate, 507-B-512, Vadodhan City - 363 035, Surendranagar.

Marketing Authorization Holder

TOV "Movi Hels"

Address of the Marketing Authorization Holder

08140, Ukraine, Kyiv Oblast, Kyiv-Sviatoshyn district, village Shevchenkove, Shevchenka Street, 162 A