Product information
Excipients with known effect: non-crystallizing liquid sorbitol. 5 ml of syrup contains 1.75 g of sorbitol.
Indications:
Acute and chronic diseases of the lungs and bronchi with mucus secretion disorders and difficulties in its transport.
Contraindications:
• Hypersensitivity to ambroxol hydrochloride or to any of the excipients.
• Hereditary, rare fructose intolerance.
Interactions:
No clinically significant adverse interactions with other medicinal products have been demonstrated. Ambroxol should not be administered concomitantly with antitussives, as a dangerous accumulation of bronchial secretions may occur due to a weakened cough reflex.
Dosage
Adults and children over 12 years of age: 20 ml of syrup twice a day.
The dose recommended in acute inflammation of the respiratory tract and in the initial period of treatment of chronic conditions, in the first 14 days of treatment.
Children aged 6 to 12 years: 10 ml of syrup 2 to 3 times a day.
Children aged 2 to 6 years: 5 ml of syrup 3 times a day.
Children aged 1 to 2 years: 5 ml of syrup 2 times a day.
The above dosage is recommended in the initial period of treatment. The dosage may be halved after 14 days of treatment.
The medicinal product should be measured using the enclosed measuring cup.
Ambroxol Hasco Junior syrup can be taken with or without food.
Method of administration
Oral use.
Precautions:
Very rare cases of severe skin conditions, such as Stevens Johnson syndrome and toxic epidermal necrolysis, have been observed in a temporal association with the use of mucolytics, e.g. ambroxol hydrochloride. Most cases could be explained by the aggravation of the underlying disease and/or concomitant medication. In addition, at the onset of Stevens-Johnson syndrome or toxic epidermal necrolysis, patients may first experience non-specific (prodromal) flu-like symptoms such as fever, generalized body ache, rhinitis, cough and sore throat. Non-specific flu-like symptoms can be mistakenly treated with cough and cold medications. Therefore, in the event of new lesions of the skin or mucous membranes,
In case of renal failure or severe liver failure, Ambroxol Hasco Junior can be used only after consulting a doctor. As with other medicinal products that are metabolised by the liver and subsequently excreted by the kidneys, accumulation of ambroxol metabolites in the body can be expected in the presence of severe renal insufficiency.
5 ml of syrup contains 1.75 g of sorbitol, which corresponds to 14 g of sorbitol in the highest recommended daily dose of the drug (40 ml). Patients with rare hereditary problems of fructose intolerance should not take this product.
The product may have a slight laxative effect. Caloric value 2.6 kcal/g of sorbitol.
Driving:
There is no evidence of an effect on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed.
Overdose:
No specific symptoms of overdose have been observed in humans so far. Based on cases of inadvertent overdose and/or reports of misuse, symptoms consistent with the known adverse effects of ambroxol at recommended doses have been observed and may require symptomatic treatment.
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.
Based on extensive clinical experience in pregnant women after 28 weeks of gestation, no harmful effects on the health of the foetus have been demonstrated. Despite this, the usual precautions should be taken when using this medicinal product in pregnant women. Particularly in the first trimester of pregnancy, the use of ambroxol hydrochloride is not recommended.
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