Instructions for use: Lazolvan with forest berry flavor syrup 15 mg/5 ml bottle 100 ml
Composition
active ingredient: ambroxol hydrochloride;
5 ml of syrup contains 15 mg of ambroxol hydrochloride;
excipients: sucralose, benzoic acid (E 210), hydroxyethyl cellulose, forest berry flavor (contains propylene glycol (E 1520)), vanilla flavor (contains propylene glycol (E 1520)), purified water.
Dosage form
Syrup.
Main physicochemical properties: transparent or almost transparent, colorless or almost colorless, slightly viscous syrup with a taste of wild berries.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics. ATX code R05C B06.
Pharmacological properties
Pharmacodynamics
The local anesthetic effect of ambroxol hydrochloride, which may be attributed to its sodium channel blocking properties, has been observed in a rabbit eye model. In vitro studies have shown that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration-dependent.
Ambroxol hydrochloride has demonstrated anti-inflammatory effects in vitro. Thus, ambroxol hydrochloride significantly reduces the release of cytokines from mononuclear and polymorphonuclear blood cells and tissues.
Clinical trials involving patients with pharyngitis demonstrated a significant reduction in pain and redness in the throat when using the drug.
Due to the pharmacological properties of ambroxol, pain was quickly relieved during the treatment of upper respiratory tract diseases, which was observed during studies of the clinical efficacy of inhaled forms of ambroxol.
After the use of ambroxol hydrochloride, the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin and doxycycline) in bronchopulmonary secretions and sputum increase. To date, no clinical significance has been identified for this fact.
Pharmacokinetics
Absorption: Absorption of ambroxol hydrochloride from immediate-release oral formulations is rapid and fairly complete, with a linear relationship in the therapeutic range. Peak plasma levels are reached after 1–2.5 hours for immediate-release oral formulations and on average after 6.5 hours for extended-release formulations.
The absolute bioavailability after taking a 30 mg tablet is 79%.
Distribution. When administered orally, the distribution of ambroxol hydrochloride from the blood to the tissues is rapid and pronounced, with the highest concentration of the active substance in the lungs. The volume of distribution when administered orally is 552 l. In the blood plasma in the therapeutic range, approximately 90% of the drug is bound to proteins.
Metabolism and elimination. Approximately 30% of the dose after oral administration is excreted as a result of presystemic metabolism. Ambroxol hydrochloride is metabolized mainly in the liver by glucuronidation and cleavage to dibromanthranilic acid (approximately 10% of the dose). Clinical studies in human liver microsomes have shown that CYP3A4 is responsible for the metabolism of ambroxol hydrochloride to dibromanthranilic acid.
After 3 days of oral administration, about 6% of the dose is excreted unchanged, while approximately 26% of the dose is excreted in the urine as conjugated form.
The plasma half-life is about 10 hours. Total clearance is about 660 ml/min. Renal clearance is about 8% of the total. After 5 days, about 83% of the total dose is excreted in the urine.
Pharmacokinetics in special patient groups. In patients with impaired liver function, the excretion of ambroxol hydrochloride is reduced, which results in a 1.3-2 times higher level in the blood plasma. Since the therapeutic range of ambroxol hydrochloride is quite wide, it is not necessary to change the dosage.
Age and gender have no clinically significant effect on the pharmacokinetics of ambroxol hydrochloride, therefore no dose adjustment is required.
Food intake does not affect the bioavailability of ambroxol hydrochloride.
Indication
Secretolytic therapy for acute and chronic bronchopulmonary diseases associated with disorders of bronchial secretion and impaired mucus movement.
Contraindication
Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, should not be used in patients with known hypersensitivity to ambroxol hydrochloride or other components of the drug.
Lasolvan® with forest berry flavor should be used for children under 2 years of age as prescribed by a doctor.
Interaction with other medicinal products and other types of interactions
The simultaneous use of Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, and cough suppressants may lead to excessive mucus accumulation due to suppression of the cough reflex. Therefore, such a combination is possible only after a careful assessment by the doctor of the ratio of the expected benefit and the possible risk of use.
Application features
Severe skin reactions: erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with the use of ambroxol hydrochloride. If signs of progression of the skin rash (sometimes associated with blistering or mucosal involvement) are present, ambroxol hydrochloride treatment should be discontinued immediately and medical advice should be sought.
In case of impaired bronchial motility and increased mucus secretion (for example, in a rare disease such as primary ciliary dyskinesia), the drug Lazolvan® with forest berry flavor, syrup, 15 mg/5 ml, should be used with caution due to the risk of promoting secretion accumulation.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no data on the effect on the reaction speed when driving vehicles or working with other mechanisms. Studies on the effect on the reaction speed when driving vehicles or working with other mechanisms have not been conducted.
Use during pregnancy or breastfeeding
Pregnancy: Ambroxol hydrochloride crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Clinical studies of the use of the drug after the 28th week of pregnancy have not revealed any harmful effects on the fetus.
However, the usual precautions regarding taking medications during pregnancy should be observed. In particular, it is not recommended to use Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, in the first trimester of pregnancy.
Breastfeeding. Ambroxol hydrochloride passes into breast milk. Lasolvan® with forest berry flavor is not recommended for use during breastfeeding.
Fertility: Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility.
Method of administration and doses
Unless otherwise prescribed, the recommended dose of Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml is as follows:
children under 2 years: 2.5 ml (1/2 teaspoon) 2 times a day (equivalent to 15 mg ambroxol hydrochloride per day); children 2–5 years: 2.5 ml (1/2 teaspoon) 3 times a day (equivalent to 22.5 mg ambroxol hydrochloride per day); children 6–12 years: 5 ml (1 teaspoon) 2–3 times a day (equivalent to 30–45 mg ambroxol hydrochloride per day); adults and children over 12 years: the dose is 10 ml (2 teaspoons) 3 times a day (equivalent to 90 mg ambroxol hydrochloride per day) for the first 2–3 days and then 10 ml (2 teaspoons) 2 times a day (equivalent to 60 mg ambroxol hydrochloride per day).
If necessary, the therapeutic effect for adults and children over 12 years of age can be enhanced by increasing the dose to 20 ml 2 times a day (equivalent to 120 mg ambroxol hydrochloride/day).
For adults and children over 12 years of age, the use of a syrup with a higher concentration is recommended (Lazolvan® with strawberry-cream flavor, syrup, 30 mg/5 ml).
Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, can be used regardless of food intake. The dose of Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, can be measured using the measuring cap provided.
In general, there are no restrictions on the duration of use, but long-term therapy should be carried out under medical supervision.
Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, should not be used for longer than 4–5 days without consulting a doctor.
Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, suitable for use in patients with diabetes; 5 ml contains 1.2 g of carbohydrates.
Lasolvan® with forest berry flavor, syrup, 15 mg/5 ml, alcohol-free.
Children
The drug can be used in pediatric practice. For children under 2 years of age, use as directed by a doctor.
Overdose
There are no reports of specific symptoms of overdose yet. The symptoms known from isolated reports of overdose and/or cases of medication errors correspond to known adverse reactions when using the drug Lasolvan® with forest berry flavor, syrup 15 mg/5 ml, in recommended doses and require symptomatic treatment.
Adverse reactions
The following classification was used to assess the frequency of adverse events:
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 the available data.
On the part of the immune system:
rarely - hypersensitivity reactions;
frequency unknown - anaphylactic reactions, including anaphylactic shock, angioedema and pruritus.
Skin and subcutaneous tissue disorders:
rarely - rash, urticaria;
frequency unknown - serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
From the nervous system:
often – dysgeusia (taste disorder).
From the gastrointestinal tract:
often - nausea, decreased sensitivity in the oral cavity;
infrequently - vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth;
rarely - dry throat;
From the respiratory system, chest organs and mediastinum:
often - decreased sensitivity in the throat;
frequency unknown – dyspnea (as a hypersensitivity reaction).
General disorders:
infrequently - fever, mucous membrane reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after the registration of a medicinal product is an important procedure. This allows for continued monitoring of the benefit/risk balance of this medicinal product. Healthcare professionals are asked to report all suspected adverse reactions via the national reporting system, the State Expert Center of the Ministry of Health of Ukraine.
Expiration date
3 years.
Do not use the product after the expiry date indicated on the packaging. After opening the bottle, the product is suitable for use for 6 months.
Storage conditions
Store at a temperature not exceeding 30 °C in a place inaccessible to children.
Packaging
100 ml in a glass bottle with a child-resistant plastic closure; 1 bottle complete with a plastic measuring cap in a cardboard box.
Vacation category
Without a prescription.
Producer
Boehringer Ingelheim Espana, SA, Spain.
Location of the manufacturer and its business address
Prat de la Riba, 50, 08174 SANT CUGATE DEL VALLÉS (Barcelona), Spain.
