Instructions Pulmolor tablets No. 10
Composition
active ingredients: ambroxol hydrochloride, loratadine;
1 tablet contains ambroxol hydrochloride 60 mg, loratadine 5 mg;
excipients: lactose monohydrate, corn starch, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silicon dioxide, sodium starch glycolate (type A).
Dosage form
Pills.
Main physicochemical properties: flat-cylindrical tablets of almost white color with a score on one side.
Pharmacotherapeutic group
Cough and cold remedies. Expectorants, except combined preparations containing antitussives. ATX code R05C.
Pharmacological properties
Pharmacodynamics
Pulmolor has a pronounced expectorant effect, softens and soothes dry cough, facilitates breathing, normalizes the secretion of bronchial mucus, improves sputum discharge, reduces inflammation of the respiratory tract, has an anti-exudative effect, reduces spasm of bronchial smooth muscles and swelling of tissues, including the mucous membrane of the nose, throat, maxillary sinuses and respiratory tract, reduces capillary permeability, reduces nasal congestion, runny nose, tearing, sneezing, itching of the palate and nose, and redness of the eyes.
Ambroxol hydrochloride is a synthetic secretolytic and secretomotor agent. It has a pronounced expectorant and slight antitussive effect. It stimulates serous cells of the glands of the bronchial mucosa, increases the amount of mucous secretion and, thus, changes the disturbed ratio of serous and mucous components. This leads to the normalization of the rheological parameters of sputum, reducing its viscosity and adhesive properties. It directly stimulates the motor activity of the ciliated epithelium of the bronchi, prevents its clumping and improves mucociliary evacuation of sputum. Ambroxol increases the content of surfactant in the lungs, and also prevents its destruction in pneumocytes. As a mucolytic agent and as an expectorant, ambroxol improves the function of external respiration. The drug reduces the hyperreactivity of the bronchial muscles in patients with asthma. Ambroxol has anti-inflammatory effect, antioxidant properties, stimulates local immunity and renewal of the natural surfactant layer. When taking Ambroxol, patients' complaints of cough and sputum are significantly reduced in accordance with the intensity of treatment. Ambroxol hydrochloride increases the concentration of antibiotics in the lungs and, thus, improves the course of respiratory diseases in bacterial lung infections.
Loratadine is a selective blocker of peripheral H1-histamine receptors of prolonged action without central sedative action. It has an antiallergic effect, weakens spasm of bronchial smooth muscles, reduces bronchial sensitivity to histamine, eliminates dry cough of allergic etiology, reduces capillary permeability, reduces tissue edema, runny nose, lacrimation, sneezing, itching of the palate and nose, and redness of the eyes. Prevents the development and facilitates the course of allergic reactions. Its action occurs through competitive blocking of H1-receptors on effector cells by inhibiting the flow of calcium into cells, inhibiting the release of histamine (membrane stabilizing function), inhibiting the chemotaxis of eosinophils and their accumulation in the mucous membrane. The antihistamine effect of loratadine manifests itself 1-3 hours after administration, reaches a maximum after 8-12 hours and lasts up to 24 hours. After 28 days of taking loratadine, no habituation is observed.
Indication
Symptomatic therapy for acute and chronic respiratory diseases with a spastic and allergic component, associated with impaired bronchial secretion and impaired mucus clearance. Prescribe for acute and chronic bronchitis, chronic obstructive pulmonary diseases, pneumonia, and conditions accompanied by bronchial hyperreactivity.
In ENT practice, in order to thin the secretion and reduce swelling, it is prescribed for rhinitis, including allergic rhinitis, in the complex treatment of sinusitis and otitis media.
Contraindication
Hypersensitivity to any component of the drug.
Interaction with other medicinal products and other types of interactions
Taking Pulmolor with antibiotics at the same time has an advantage over prescribing the antibiotic alone. Pulmolor increases the concentration of antibiotics in the lungs and, thus, alleviates the course of respiratory diseases in bacterial lung infections.
The use of the drug should not be combined with alcohol consumption.
Do not take simultaneously with antitussive drugs that make it difficult to expel sputum.
Potential interaction is possible with all known inhibitors of CYP3A4 or CYP2D6, leading to increased levels of loratadine, which in turn may be the cause of an increased incidence of adverse reactions.
In controlled studies, increased plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin and cimetidine, which were not accompanied by clinically significant changes (including ECG).
Application features
The drug should be discontinued 48 hours before skin tests for reactivity.
There have been isolated reports of severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and acute generalized exanthematous pustulosis) coinciding with the use of ambroxol hydrochloride. These could mostly be explained by the severity of the underlying disease in the patients and the concomitant use of another drug. Also, in the initial stage of Stevens-Johnson syndrome or Lyell's syndrome, patients may have non-specific, flu-like symptoms such as fever, aches, rhinitis, cough and sore throat. Symptomatic treatment with cough and cold medicines may be mistakenly used for such non-specific, flu-like symptoms. Therefore, if new skin or mucous membrane lesions appear, medical advice should be sought immediately and treatment with ambroxol hydrochloride should be discontinued.
Since ambroxol may increase mucus secretion, the drug should be used with caution in cases of impaired bronchial motility and increased mucus secretion (for example, in rare diseases such as primary ciliary dyskinesia).
The drug should be used with caution in patients with impaired renal function or severe hepatic insufficiency (i.e. the interval between administrations should be increased or the dose should be reduced). In patients with severe renal insufficiency, accumulation of metabolites formed in the liver is expected.
Excipients.
The drug contains lactose, therefore patients with established intolerance to some sugars should consult their doctor before taking this medicine.
Ability to influence reaction speed when driving vehicles or other mechanisms
In general, the drug does not affect the speed of reactions when driving or using other mechanisms. However, the patient should be informed about very rare cases of drowsiness, which may affect the ability to drive or use other mechanisms.
Use during pregnancy or breastfeeding
Since experience with the use of the drug in pregnant women is insufficient, it is not recommended to take it during pregnancy.
Since the drug passes into breast milk, it is not recommended to use during breastfeeding.
Method of administration and doses
Administer 1 tablet orally 2 times a day to adults and children over 12 years of age.
Take after meals and drink plenty of fluids.
Duration of treatment is up to 14 days. You should consult a doctor if symptoms persist and/or worsen after 14 days.
The drug should not be used for longer than 4–5 days without consulting a doctor.
Children
Do not use in children under 12 years of age.
Overdose
Symptoms: tachycardia, headache, drowsiness, nausea, vomiting, diarrhea, low blood pressure.
Treatment. In case of overdose, symptomatic and supportive treatment is recommended. Standard measures are recommended to remove the drug that has not been absorbed from the stomach: gastric lavage, administration of crushed activated charcoal with water.
Loratadine is not removed by hemodialysis, and it is not known whether loratadine is removed by peritoneal dialysis.
After emergency care, the patient should remain under medical supervision.
Adverse reactions
The drug is usually well tolerated.
Skin: alopecia.
Immune system disorders: hypersensitivity reactions including rash, urticaria, pruritus, anaphylactic reactions (including anaphylactic shock), angioedema; serious cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and acute generalized exanthematous pustulosis).
From the nervous system: dysgeusia (taste disorder), dizziness, convulsions, headache, nervousness, fatigue, drowsiness, insomnia.
On the part of the digestive tract: nausea, decreased sensitivity in the oral cavity, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth and throat, constipation, drooling, gastritis.
Respiratory system: rhinorrhea, dyspnea (as a symptom of a hypersensitivity reaction).
From the hepatobiliary system: liver dysfunction.
Cardiovascular system: tachycardia, palpitations.
From the urinary system: dysuria.
General disorders: fever, weight gain, increased appetite, mucous membrane reactions.
Expiration date
3 years.
Storage conditions
Store out of the reach of children in the original packaging at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Kleva S.A., Greece.
Location of the manufacturer and its business address
Greece, Parnithos Ave. 189 Acharnai Attica 13675.
