“Product description
Flegamina Baby is a drug in the form of an oral suspension, intended for children over 2 years of age. The active substance of the drug is bromhexine hydrochloride, which has expectorant properties and liquefies secretions from the respiratory tract.
Indications
Acute and chronic respiratory diseases with impaired expectoration and mucus removal.
Composition
1 ml of solution contains:
active substance: bromhexine 2 mg,
excipients: propyl parahydroxybenzoate, methyl parahydroxybenzoate, ethanol 96%, hydrochloric acid 0.1N, purified water.
Action
Expectorant.
Dosage
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If in doubt, ask your doctor or pharmacist.
Children aged 2 to 6 years: 20 to 25 drops 3 times a day.
Use after a meal.
Do not administer the medicine immediately before bedtime.
If you have the impression that the effect of the medicine is too strong or too weak, talk to your doctor. The maximum recommended duration of use of the drug without medical supervision is 3 to 5 days.
Contraindications
If you are allergic to bromhexine hydrochloride or any of the other ingredients of this medicine.
In children under 2 years of age.
Storage
The medicine should be stored out of sight and reach of children, at a temperature below 25 degrees Celsius.
Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (1 in 100 people):
upper abdominal pain, nausea, vomiting, diarrhea.
Rare (1 in 1,000 people):
hypersensitivity reactions, rash, hives.
Not known (frequency cannot be estimated from the available data):
anaphylactic reactions, including anaphylactic shock, angioedema and pruritus,
serious skin side effects
headache, dizziness,
bronchospasm,
excessive sweating,
indigestion, increased liver enzymes.
Interactions
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Bromhexine should be used with caution with atropine and other anticholinergic drugs because they cause dry mucous membranes.
Bromhexine should not be used simultaneously with antitussive drugs (e.g. containing codeine and its derivatives), as they may weaken the cough reflex and cause secretions to remain in the respiratory tract.
Bromhexine may intensify the irritating effect of salicylates and other non-steroidal anti-inflammatory drugs on the gastrointestinal mucosa.
Simultaneous use of the drug with antibiotics (oxytetracycline, erythromycin, ampicillin, doxycycline, cefuroxime, amoxicillin) increases their concentration in the lung parenchyma.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
if the patient suffers from inflammation of the respiratory tract accompanied by a bacterial infection, because the drug should be administered simultaneously with antibiotics and drugs that dilate the respiratory tract recommended by the doctor,
if the patient has a fever, it is also important to properly hydrate the patient. Appropriate hydration of the body increases the thinning of bronchial secretions and facilitates expectoration,
if you currently have or have had a stomach or duodenal ulcer, as the medicine may worsen its symptoms,
if you have severe liver or kidney problems. Cases of serious skin reactions have been reported with the use of bromhexine hydrochloride.
If a rash occurs (including lesions on the mucous membranes, e.g. mouth, throat, nose, eyes, genitals), stop taking the medicine and contact your doctor immediately.”
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