Description Flegamina Max is an expectorant syrup, indicated for those experiencing difficulty expectorating. It works by thinning thick mucus in the respiratory tract, facilitating its removal during coughing. Composition The active substance is bromhexine hydrochloride (Bromhexini hydrochloridum ). 1 ml of syrup contains 1.6 mg of bromhexine hydrochloride ( Bromhexini hydrochloridum ). 5 ml of syrup contains 8 mg of bromhexine hydrochloride ( Bromhexini hydrochloridum ). Excipients: Liquid, non-crystallizing sorbitol (70%); Glycerol; Benzoic acid (E 210); Levomenthol; Ethanol 96%; Eucalyptus-mint flavor (contains, among others, ethanol); Citric acid monohydrate; Purified water. Dosage Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist. The recommended dose is: Children aged 7 to 12 years: 2.5 ml of syrup 3 times a day. Adults and adolescents over 12 years of age: 5 ml of syrup 3 times a day. The medication should be taken at regular intervals, after meals. It should not be taken immediately before bedtime. Flegamina Max should not be used for longer than 7 days, unless your doctor recommends otherwise. Action Flegamina Max facilitates expectoration and soothes coughing, liquefying secretions in the respiratory tract. This facilitates the transport of bronchial secretions by cilia (tiny hairs lining the respiratory tract) and their removal from the lungs. Indications Flegamina Max is used in the case of acute and chronic respiratory diseases associated with impaired expectoration and mucus removal. Contraindications The drug should not be used in case of hypersensitivity to the active substance or to any of the excipients and in patients with gastric and duodenal ulcers, as well as with hereditary fructose intolerance. Side effects Like all medicines, Flegamina Max can cause side effects, although not everybody gets them. If you experience serious side effects such as severe skin or allergic reactions 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 1000 patients): nausea, abdominal pain (especially epigastric pain), vomiting, diarrhea, rash, hives, hypersensitivity reactions. Very rare side effects (occurring in less than 1 in 10,000 patients): headache, dizziness, drowsiness. Not known (frequency cannot be estimated from the available data): dyspepsia, sweating, severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis), anaphylactic reactions including anaphylactic shock, angioedema and pruritus, decreased blood pressure, increased levels of liver enzymes AST and ALT. Warnings and precautions Before using Flegamina Max, talk to your doctor or pharmacist if: you have asthma, difficulty coughing up mucus, have been diagnosed with impaired bronchial motor function, such as a condition called ciliary dyskinesia, or have liver or kidney problems. Caution should be exercised in patients at risk of developing gastric and duodenal ulcers. Flegamina Max contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) - may cause allergic reactions (possibly delayed). Keep the medicine out of the sight and reach of children, in its original packaging to protect from light. After first opening, the medicine remains valid for 3 months. Use of other medications Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take. Flegamina Max should be used with caution with atropine and other anticholinergic drugs, as they cause dryness of the mucous membranes. It should not be administered concurrently with antitussive medications, as this may lead to a dangerous accumulation of bronchial secretions due to a weakened cough reflex. Flegamina Max may enhance the irritating effect of salicylates and other nonsteroidal anti-inflammatory drugs on the gastrointestinal mucosa, and when used in combination with certain antibiotics (drugs used to treat infections: amoxicillin, cefuroxime, erythromycin, doxycycline, oxytetracycline, ampicillin) may lead to increased antibiotic concentration in the lungs. Taking the medicine with food and drink Flegamina Max should be taken after a meal. You should drink more fluids while taking this medicine. Pregnancy and breastfeeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Flegamina Max is not recommended for use during the first trimester of pregnancy. During the remainder of pregnancy, the drug should only be used if, in the physicians opinion, the benefit to the mother outweighs the potential risk to the fetus. If you are breast-feeding, talk to your doctor before taking this medicine. Bromhexine passes into breast milk. Use of the drug in children and adolescents Do not use in children under 2 years of age. Driving and operating machinery No studies have been conducted on the effect of bromhexine on the ability to drive or operate machinery. Caution should be exercised as headaches, dizziness, or drowsiness may occur.