Deflegmin Junior, 15mg/5ml, 120ml, Bausch Health Poland

ESSAY
5 ml of syrup contains 15 mg of ambroxol hydrochloride (Ambroxoli hydrochloridum).
Excipient with known effect: sorbitol (500 mg in 1 ml of syrup).

DOSAGE
Adults and children over 1 year of age:
in adults and children over 12 years old: initially for 2-3 days, 10 ml of syrup 3 times a day, then the dose should be reduced to 10 ml of syrup 2 times a day;
children from 6 to 12 years old: 5 ml of syrup 2-3 times a day;
children aged 2 to 6 years: 2.5 ml of syrup 3 times a day;
children aged 1 to 2 years: 2.5 ml of syrup 2 times a day.

Method of application: Oral application
The patient should not use the product for more than 4-5 days without consulting a doctor.

PACKAGE
Syrup, ambroxol hydrochloride 15 mg/5 ml, 120 ml

STORAGE
Keep the medicine out of the reach of children. Store below 25°C. Store in original packaging to protect from light.

OTHER INFORMATION

Contraindications: hypersensitivity to the active substance or to any other substance
auxiliary.

Special warnings and precautions: Severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SSD), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (pustulosis) have been reported associated with the use of ambroxol hydrochloride. If signs and symptoms of a progressive skin rash (sometimes associated with the formation of blisters or lesions of the mucous membranes) appear, treatment with ambroxol hydrochloride should be stopped immediately and a doctor should be consulted. In the early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell’s syndrome), the patient may initially experience non-specific flu-like symptoms such as fever, pain, rhinitis, cough, and sore throat. Misdiagnosed as early flu symptoms, they can be treated first with cold remedies. The drug should be used with caution in patients with gastric or duodenal ulcers. Deflegmin Junior can be used in patients with impaired renal function or severe liver disease only after consulting a doctor. As with other drugs that are metabolized in the liver and then excreted by the kidneys, accumulation of hepatic metabolites of ambroxol can be expected in patients with severe renal insufficiency. Deflegmin Junior can be used in patients with impaired renal function or severe liver disease only after consulting a doctor. As with other drugs that are metabolized in the liver and then excreted by the kidneys, accumulation of hepatic metabolites of ambroxol can be expected in patients with severe renal insufficiency. Deflegmin Junior can be used in patients with impaired renal function or severe liver disease only after consulting a doctor. As with other drugs that are metabolized in the liver and then excreted by the kidneys, accumulation of hepatic metabolites of ambroxol can be expected in patients with severe renal insufficiency.

Deflegmin Junior should be used with caution in patients with a weakened cough reflex or impaired bronchial ciliary clearance due to the possibility of residual
secretions in the respiratory tract.

In patients with bronchial asthma, ambroxol may increase cough at the beginning of treatment.
The product should not be used immediately before bedtime. The product contains sorbitol.
Do not use in patients with rare hereditary fructose intolerance.
The product may have a mild laxative effect. Calorie content 2.6 kcal/g sorbitol.

Side effects: the frequency of adverse reactions is presented as follows: very often (≥1/10): often (≥1/100); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rarely (<1/10,000, including isolated cases); Not known (frequency cannot be estimated from the available data). Within each frequency group, adverse effects are presented in descending order of severity. Immune system disorders: rarely: hypersensitivity reactions. Frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema and pruritus. Nervous system disorders: Common: dysgeusia (eg change in taste). Gastrointestinal disorders: Often: nausea. Uncommon: Vomiting, diarrhea, indigestion and abdominal pain. respiratory disorders, chest and mediastinum. Often: oropharyngeal hypoesthesia. Uncommon: dry mouth. Not known: dry throat. On the part of the skin and subcutaneous tissues: rarely: rash, urticaria. Frequency unknown: Serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis).

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