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Lazolvan Max cough remedy with sputum capsules No. 10

A country

Germany, France
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Ambroxol

Compound

1 capsule contains: ambroxol hydrochloride 75 mg. Excipients: crospovidone - 12.55 mg, carnauba wax - 18.31 mg, stearyl alcohol - 110.94 mg, magnesium stearate - 1.2 mg. Long-acting capsules are hard gelatin, oblong, with an opaque red cap and opaque the body is orange, the lid has the printed designation “MUC 01” in white, the Boehringer Ingelheim company symbol is printed on the body. The contents of the capsule are round granules of a yellowish-white color, with a smooth, shiny surface, mixed with a small amount of powder.

pharmachologic effect

Studies have shown that ambroxol increases secretion in the respiratory tract. Enhances the production of pulmonary surfactant and stimulates ciliary activity. These effects lead to increased mucus flow and transport (mucociliary clearance). Increasing mucociliary clearance improves sputum discharge and relieves cough. In patients with COPD, long-term therapy with Lazolvan® MAX (for at least 2 months) led to a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.

Indications for use

Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum: - acute and chronic bronchitis; - pneumonia; - COPD; - bronchial asthma with difficulty in sputum discharge; - bronchiectasis.

Mode of application

The drug is administered orally, regardless of food intake. Capsules should be swallowed whole with plenty of liquid. Do not open or chew the capsules. Prescribe 1 capsule 1 time/day. If symptoms of the disease persist within 4-5 days from the start of using the drug, you should consult a doctor.

Interaction

No clinically significant adverse interactions with other drugs have been reported. Ambroxol increases the penetration of amoxicillin, cefuroxime, and erythromycin into the bronchial secretions.

Side effect

Classification of the incidence of side effects (WHO): very often (>1/10), often (from >1/100 to 1/1000 to 1/10,000 to Contraindications—I trimester of pregnancy;—lactation period;—age under 18 years ;— hypersensitivity to ambroxol or other components of the drug. Lazolvan® should be used with caution during pregnancy (II and III trimesters), with renal and/or liver failure. Use during pregnancy and lactation Ambroxol penetrates the placental barrier. Preclinical studies have not have identified direct or indirect adverse effects on pregnancy, embryonic/fetal, postnatal development and labor.Extensive clinical experience with the use of ambroxol after 28 weeks of pregnancy has not found evidence of a negative effect of the drug on the fetus. However, it is necessary to observe the usual precautions when using the drug during pregnancy.It is especially not recommended to take Lazolvan® MAX in the first trimester of pregnancy. In the second and third trimesters of pregnancy, use of the drug is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. Ambroxol can be excreted in breast milk. Despite the fact that no undesirable effects were observed in breastfed children, it is not recommended to use Lazolvan® MAX during lactation. Preclinical studies of ambroxol did not reveal any negative effects on fertility.

Overdose

Specific symptoms of overdose in humans have not been described. There have been reports of accidental overdose and/or medical error, as a result of which symptoms of known side effects of Lazolvan® MAX were observed: nausea, dyspepsia, diarrhea, vomiting, abdominal pain. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug, carry out symptomatic therapy.

special instructions

Lazolvan® MAX should not be used in combination with antitussives that impede the removal of sputum. There are isolated reports of severe skin lesions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, that coincided with the use of expectorants such as Lazolvan® MAX. In most cases, they are explained by the severity of the underlying disease and/or concomitant therapy. Patients with Stevens-Johnson syndrome or toxic epidermal necrolysis may present with fever, body aches, rhinitis, cough, and sore throat in the early phase. With symptomatic treatment, it is possible to erroneously prescribe anti-cold medications. If new lesions of the skin and mucous membranes develop, the patient should stop treatment with ambroxol and immediately seek medical help. If kidney function is impaired, the drug should be used only as prescribed by a doctor. Use in pediatrics For children and adolescents under 18 years of age, it is possible to use other dosage forms of the drug Lazolvan® ( syrup, lozenges, solution for oral administration and inhalation). Effect on the ability to drive vehicles and operate machinery. There have been no cases of the drug influencing the ability to drive vehicles or operate machinery. Studies on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions have not been conducted.

Extended-release capsules 75 mg

Application

Lazolvan® MAX is registered as a drug for the treatment of respiratory diseases with viscous sputum in adults. The dosage of the active ingredient ambroxol hydrochloride in capsules is designed for people over 18 years of age.1

It is not recommended to open Lazolvan® MAX capsules: violating the form of the drug or dividing the dose independently increases the risk of adverse reactions or incomplete effect due to errors in dosing.1, 2

If indicated, children are recommended to take other forms of Lazolvan®: syrup 15 mg/5 ml, solution for oral administration and inhalation, and for children over 6 years old - syrup 30 mg/5 ml and tablets.

During lactation

The instructions for Lazolvan® MAX prohibit its use while breastfeeding a child. The active substance is absorbed into the blood and from there passes into breast milk.

It is impossible to predict how the medicine will be distributed in the woman’s body, how much medicine will get into the milk, how much of it will enter the baby’s body during feeding.1, 2

Use during pregnancy

Lazolvan® MAX capsules are contraindicated for treatment in the first trimester of pregnancy (1). This is due to the fact that there is a close connection between the duration of pregnancy and the effect of drugs on the unborn child. Thus, in the first trimester, the formation and formation of the child’s organs and systems occurs. "Interference" of foreign substances can lead to disruption of these processes.3 Although preclinical studies have not revealed direct or indirect adverse effects of ambroxol on pregnancy, embryonic/fetal development, postnatal development and childbirth, normal precautions must be observed when using the drug during pregnancy. pregnancy time.1

The use of Lazolvan® MAX in the 2nd and 3rd trimesters is permitted with the caveat that the benefit to the mother must outweigh the likelihood of developing risks to the fetus.1

For impaired renal function

In case of kidney diseases with impaired kidney function, including renal failure, the use of Lazolvan® MAX is limited.1 A healthcare professional may prescribe it if he decides that the patient has a need for the medicine. At the same time, he will individually select the dose, frequency and frequency of administration.

When kidney function is impaired, the distribution and excretion of drugs, the rate and degree of binding to proteins changes. This affects the delivery of the active substance to the target organ, in this case the lungs, and increases the risk of adverse events.2

For liver dysfunction

In case of liver failure, it is recommended to prescribe Lazolvan® MAX with caution.1 The quality of liver function affects the absorption, distribution and excretion of drugs in the human body. If there is an indication for taking Lazolvan® MAX in a patient with liver failure, the healthcare professional may change the dose and/or frequency and duration of use to reduce the load on the liver, reduce the risk of metabolic and absorption disorders.2

Active substance

1 capsule of Lazolvan® MAX contains 75 mg of ambroxol hydrochloride. This substance belongs to the group of expectorants and mucolytics, that is, sputum thinners.1 Studies of the pharmacological activity of the substance have shown that ambroxol hydrochloride:

promotes thinning of mucus in the respiratory tract;
promotes its removal by improving the activity of the cilia, the vibrations of which help move phlegm into the larynx, from where it is expelled when coughing.

Lazolvan max

Lazolvan Max (INN abmroxol) is a drug that promotes expectoration and liquefies the pathological secretion of the tracheobronchial tree discharged during expectoration. It has been clinically established that the drug stimulates the secretory function of the respiratory tract. Lazolvan Max enhances the production of surfactants lining the pulmonary alveoli from the inside, stimulates the activity of the ciliated epithelium, incl. by the production of mucus by its goblet cells. The above effects help facilitate mucociliary transport, including the discharge and evacuation of pathological bronchial secretions, and make cough more productive. Regular use of the drug for two months or more reduces the number and duration of acute episodes in people suffering from COPD, and also reduces the duration of antibacterial therapy. The drug is quickly and completely absorbed. Peak concentrations in the blood are observed after an average of 6.5 hours, with the highest concentrations of the active substance found in the lungs. 90% of the administered dose interacts with plasma proteins. About a third of the administered dose is metabolized before entering the systemic circulation when passing through the wall of the gastrointestinal tract and the liver. The terminal half-life of the drug is 10 hours. The pharmacokinetic parameters of the drug in elderly patients do not change. Lazolvan Max is used for inflammation of the bronchi of acute or chronic origin, inflammation of the lung tissue, COPD, bronchiectasis and bronchial asthma. The presence of food contents in the gastrointestinal tract does not have a clinically significant effect on the rate and degree of absorption and bioavailability of ambroxol, so the drug can be used regardless of diet. The capsules are not intended to be chewed: they must be swallowed whole with plenty of water. Single dose – 1 capsule. The frequency of administration is 1 time per day.

If the clinical picture remains unchanged or even worsens when taking the drug for 4-5 days, you should consult your doctor. The most common side effects when taking Lazolvan Max: vomiting, dyspepsia. Allergic reactions (skin rashes, urticaria) to the drug rarely develop. Lazolvan Max is not used during pregnancy from the first day of the final menstruation to the 13th week, during breastfeeding, or in case of individual intolerance to the active or auxiliary components. In pediatric practice, the drug is not used due to the lack of data on the effectiveness and safety of the drug (clinical studies have not been conducted). From the 14th week and immediately until the birth of the child, the drug can be taken, but with extreme caution. The same is true for patients with liver and kidney diseases. Lazolvan Max is pharmacokinetically incompatible with antitussive drugs that inhibit the evacuation of pathological bronchial secretions from the respiratory tract. Lazolvan Max is an original, non-generic drug with a prolonged effect. Its safety has been demonstrated in clinical trials and confirmed in post-marketing studies. The drug facilitates the penetration of antibacterial drugs into infectious foci of the respiratory tract, which improves the prognosis and shortens recovery time. In the medical literature there are isolated descriptions of cases of severe acute bullous lesions of the mucous membranes and skin of an allergic nature that develop while taking Lazolvan Max and other drugs containing ambroxol. As a rule, these lesions are caused by the severity of the underlying pathology or the use of concomitant medications. In any case, you should immediately stop taking Lazolvan Max and consult a doctor.