“Composition
The active substance is bromhexine hydrochloride.
1 ml of syrup contains 1.6 mg of bromhexine hydrochloride.
The other ingredients of the drug are: liquid, non-crystallizing sorbitol (E 420) in the amount of 760 mg/ml, propylene glycol in the amount of 40 mg/ml, methyl parahydroxybenzoate (E 218) in the amount of 0.90 mg/ml, propyl parahydroxybenzoate (E 216) in the amount of 0.10 mg/ml, sodium saccharin (E 954), purified water, cherry flavor (propylene glycol, benzyl alcohol, triethyl citrate, lactic acid, 4-methoxyacetophenone, 3-hydroxy-2 methyl-4-pyrone (maltol ), anisaldehyde, benzoic acid).
Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.
The medicine should be taken at regular intervals, after meals.
Should not be administered immediately before bedtime.
Oral administration.
Adults, including the elderly: 5 ml (1 full measuring spoon) 3 times a day.
At the beginning of treatment, it may be necessary to increase the dose to 30 ml/day (maximum dose), (2 measuring spoons, three times a day).
Children over 12 years of age: 5 ml (1 full measuring spoon), three times a day, up to a maximum of 30 ml a day (equivalent to 48 mg of bromhexine).
Children aged 6 to 12 years: 2.5 ml (1 measuring spoon filled to 1/2 division), three times a day, up to a maximum of 10 ml per day (corresponding to 16 mg of bromhexine).
Children aged 2 to 6 years: 1.25 ml (1 measuring spoon filled to 1/4 graduation), three times a day, up to a maximum of 5 ml per day (equivalent to 8 mg of bromhexine).
Action
Flegtac Cough has an expectorant effect, liquefying secretions from the respiratory tract. This makes it easier for cilia (tiny hairs lining the respiratory tract) to transport bronchial secretions and remove them from the lungs. Bromhexine facilitates expectoration and relieves cough.
Contraindications
If you are allergic (hypersensitive) to bromhexine or any of the other ingredients of this medicine.
If you have been diagnosed with a stomach or duodenal ulcer.
In patients with congenital fructose intolerance.
Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience serious side effects such as: serious skin side effects (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis) or allergic reactions (including rash, swelling of the face, lips, tongue and (or throat, which may cause difficulty in breathing or swallowing), or other serious side effects, stop taking the medicine and contact your doctor or nearest hospital emergency department immediately.
Rare side effects (less than 1 in 1,000 patients): nausea, abdominal pain (especially upper abdominal pain), vomiting, diarrhea, rash, hives, hypersensitivity reactions.
Very rare side effects (in less than 1 in 10,000 patients): headache, dizziness, drowsiness.
Not known (frequency cannot be estimated from the available data): indigestion, excessive sweating, serious skin side effects (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis), anaphylactic reactions including anaphylactic shock, angioedema and pruritus, decreased blood pressure, increased activity of liver enzymes AST and ALT.
Warnings and precautions
This is a medicine. For safety, use it according to the leaflet included in the package. Pay attention to contraindications. If in doubt, consult your doctor or pharmacist. Keep the medicine out of the sight and reach of children. Store at temperatures below 25°C.”
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