Lintos Syrup 200 ml bottle 30 mg / 10 ml

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034740035
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WARNINGS
The medicine contains sorbitol. Ambroxol hydrochloride should be administered with caution to patients with peptic ulcer. Mucolytics can induce bronchial obstruction in children younger 'less than 2 years. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children under 2 years of age. In very few cases, severe skin lesions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis (TEN) have been observed simultaneously with the administration of expectorants such as ambroxol hydrochloride. Most of these cases could be explained by the severity of the patient's underlying disease and / or concomitant medications. Also, in the early stage of Stevens-Johnson Syndrome or TEN, patients may initially experience non-specific symptoms similar to those of the flu, such as fever, malaise, rhinitis, cough and sore throat. Because of these misleading symptoms it is possible that symptomatic treatment with cough and cold therapy may be undertaken. Therefore, if new skin or mucosal lesions occur, consult your doctor immediately and as a precaution stop treatment with ambroxol hydrochloride.In case of mild or moderate renal insufficiency, the drug can 'be used only after consulting your doctor. As with any drug with hepatic metabolism followed by renal excretion, accumulation of the metabolites of ambroxol in the liver is expected in the presence of severe renal impairment.
PHARMACOTHERAPEUTIC CATEGORY
Expectorants, excluding associations with antitussives.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
The drug is contraindicated in children younger than 2 years; hypersensitivity to the active ingredient or to any of the excipients; severe liver and / or kidney changes; the use of the drug is contraindicated in case of rare hereditary pathologies which may be incompatible with one of the excipients.
NAME
NEO BOROCILLIN FLUIDIFYING COUGH "30 MG / 10 ML SYRUP" - 200 ML BOTTLE
EXCIPIENTS
Hydroxyethylcellulose, 70% sorbitol, glycerol, benzoic acid, propylene glycol, tartaric acid, purified water, black cherry flavor.
SIDE EFFECTS
Adverse reactions are listed below by system organ class and frequency, according to the following categories: very common (> = 1/10); common (> = 1/100, <1/10); uncommon (> = 1 / 1,000, <1/100); rare (> = 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known. Disorders of the immune system. Not known: anaphylactic reactions, including anaphylactic shock, angioedema, pruritus and other hypersensitivity reactions. Nervous system disorders. Common: dysgeusia (eg changes in the sense of taste); rare: headache. Respiratory, thoracic and mediastinal disorders. Common: hypoesthesia of the oral cavity and pharynx; rare: rhinorrhea; not known: bronchial obstruction. Gastrointestinal disorders. Common: nausea; uncommon: vomiting, diarrhea, dyspepsia and abdominal pain, dry mouth; rare: heartburn, constipation; not known: dry throat. Skin and subcutaneous tissue disorders. Rare: rash, urticaria, contact dermatitis. Renal and urinary disorders. Rare: dysuria. General disorders and administration site conditions. Rare: fatigue. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.
PREGNANCY AND BREASTFEEDING
Ambroxol hydrochloride crosses the placental barrier. For ambroxol, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects on pregnancy, embryonal / fetal development, parturition or postnatal development. Clinical studies and extensive clinical experience have not shown any harmful effects on the fetus after the 28th week of gestation. Despite this, normal precautions should be taken when taking medications during pregnancy. Particularly during the first trimester, it is not recommended to take the medicine. The drug is secreted in breast milk. Although undesirable effects are not expected in breastfed infants, the use of the drug is not recommended during breastfeeding.
INDICATIONS
Treatment of secretion disorders in acute and chronic bronchopulmonary diseases.
INTERACTIONS
Following the administration of ambroxol the concentrations of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and saliva are increased. No clinically relevant adverse interactions were observed with other medicinal products.
DOSAGE
Adults: 10 ml (30 mg) 3 times a day. Children over 5 years: 5 ml (15 mg) 3 times a day. Children 2 to 5 years: 2.5ml (7.5mg) 3 times a day. It is recommended to take the syrup after meals. Do not exceed the recommended dose. Do not use the drug for prolonged treatments.
ACTIVE PRINCIPLES
Ambroxol hydrochloride.
034740035

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Lintos Syrup 200 ml bottle...

€11.70