Description of goods Fludikaf syrup: instructions for use Instructions • Instructions Description of the dosage form Fludikaf syrup 20 mg/ml: a clear orange liquid with a banana odor. Fludicaf syrup 50 mg/ml: clear green liquid with a caramel odor. Composition 1 ml of syrup contains as an active substance (20 mg) or (50 mg) carbocysteine. Excipients: Fludicaf syrup 20 mg/ml: glycerin, methyl parahydroxybenzoate, granulated sugar, dye Sunset yellow (E110), sodium hydroxide, banana flavor AN1350, purified water. Fludicaf syrup 50 mg/ml: glycerin, methyl parahydroxybenzoate, granulated sugar, Sunset yellow dye (E110), Patent blue V A29 (E131), sodium hydroxide, Caramel flavor AN2178, purified water. Pharmacotherapeutic group Means used for coughs and colds. mucolytic agent. ATC code: R05CB03 Indications for use As a mucolytic agent for adjuvant therapy in diseases of the respiratory tract, accompanied by the formation of copious or difficult to separate secretions (sputum). Dosing and Administration The drug is taken orally 1 hour before meals or 2 hours after meals. Usual dose: 20-30 mg of carbocysteine per kg of body weight. A measuring cup with divisions according to the recommended doses is attached to the package. The drug is taken orally according to the following scheme: Fludicaf syrup 20 mg / ml: Children from 2 to 5 years old: 100-200 mg of carbocysteine (5-10 ml of syrup) 1-3 times a day. Children from 5 to 12 years old: 200-300 mg of carbocysteine (10-15 ml of syrup) 3 times a day. Children 12-15 years old: 300-500 mg of carbocysteine (15-25 ml of syrup) 3 times a day. Fludicaf syrup 50 mg/ml: Children over 15 years of age and adults, including elderly patients: 750 mg carbocysteine (15 ml syrup) 3 times a day. After improvement: 750 mg carbocysteine (15 ml syrup) 2 times a day. Duration of treatment: Acute respiratory infections: 1 to 2 weeks. Chronic diseases: 3 to 4 weeks. Violations of the liver, kidneys: Use with caution, dose adjustment is not required. The duration of treatment with Fludicaf without consulting a doctor should not exceed 8-10 days. If a dose of Fludicaf is missed, it should be taken as soon as possible after the missed dose, and the next dose of the drug should be taken at the usual time. If the time for the next dose of Fludicaf is approaching, the missed dose should not be taken. Do not make up for a missed dose by increasing the next dose. Side effect Immune system disorders: hypersensitivity reactions, including anaphylactic reactions, fixed drug rash. Gastrointestinal disorders: Vomiting, abdominal pain, nausea, diarrhea, gastrointestinal bleeding. Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, bullous dermatitis such as Stevens-Johnson syndrome and erythema multiforme. Nervous system disorders: headache. General disorders: weakness, malaise. If any of the listed side effects occur, or if any side effects are not mentioned in the package leaflet, you should consult a doctor. Contraindications Hypersensitivity to carbocysteine or other components of the drug; peptic ulcer of the stomach and duodenum in the acute phase; chronic glomerulonephritis in the acute stage, cystitis; children’s age up to 2 years; pregnancy (I-st trimester). Overdose In overdose, the following symptoms are possible: stomach pain, nausea, diarrhea. Treatment: gastric lavage and symptomatic therapy are carried out. Interaction with other drugs or food With the simultaneous use of carbocysteine with glucocorticosteroids, mutual potentiation of the therapeutic effect is noted. The effectiveness of antibiotic therapy for infectious and inflammatory diseases of the respiratory tract increases with the use of carbocysteine. The bronchodilator effect of theophylline is enhanced by simultaneous use with carbocysteine. The therapeutic activity of carbocysteine is weakened by antitussive and M-anticholinergic drugs. Precautions Fludicaf syrup 50 mg/ml should only be used in adult patients and in children over 15 years of age. If symptoms persist or worsen, therapy should be reassessed. A productive cough is a natural protective reaction of the body to remove bronchial secretions. It is strongly not recommended to suppress the cough reflex during a productive cough and / or taking mucolytics. Antitussive and / or atropine-like (suppressing bronchial secretion) drugs with mucolytics should not be administered simultaneously. Due to the physiological characteristics of the structure of the respiratory tract of infants, their ability to remove bronchial secretions is limited. Therefore, the use of mucolytic agents that thin sputum and increase the volume of bronchial mucus in children under the age of 2 years can lead to dynamic obstruction of the bronchial tract. In this regard, Fludicaf syrup should not be used in children under 2 years of age. In the event of hypersensitivity reactions, discontinue treatment and consult a doctor. In case of a cough that lasts more than 14 days, a doctor should be consulted. Fludicaf Syrup contains sucrose, which should be taken into account by persons on a low carbohydrate diet or diabetics. 15 ml syrup Fludicaf 50 mg/ml contain sucrose; 5 ml of Fludicaf syrup 20 mg/ml contain sucrose. Patients with rare hereditary diseases such as fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency should not take Fludicaf syrup. In chronic glomerulonephritis (history), peptic ulcer of the stomach and duodenum (history), Fludicaf syrup must be used with caution. The medicinal product contains the preservative methyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Fludicaf syrup 20 mg/ml contains sunset yellow dye (E110), which may cause allergic reactions (possibly delayed). Fludicaf syrup 50 mg/ml contains Sunset Yellow (EHO) and Patent Blue V A29 (E131), which may cause allergic reactions (possibly delayed). Use during pregnancy and lactation Animal studies have not shown any risk to the fetus, but controlled studies in pregnant women have not been conducted. Due to the possible risk to the unborn child, the use of carbocysteine during pregnancy is not recommended. It is not known whether carbocysteine passes from a woman’s body into breast milk. For safety reasons, carbocysteine should not be used during breastfeeding. If necessary, the use of the drug, breast-feeding should be discontinued. Influence on the ability to drive a car and work with dangerous mechanisms There is no information on the negative effect of carbocysteine on the ability to drive vehicles and other mechanisms. Packing 100 ml and 150 ml polyethylene terephthalate bottles, sealed with polymer screw caps. Each vial, together with a dosing cup and a leaflet, is placed in a cardboard box. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life 2 years. The expiration date is indicated on the packaging. Do not use after the expiry date stated on the packaging. Shelf life after opening the vial is 6 months. Conditions for dispensing from pharmacies Without a doctor’s prescription. Buy Fludicaf syrup 20mg/ml 100ml №1
INN | CARBOCYSTEIN |
---|---|
The code | 105 373 |
Barcode | 4 810 183 009 167 |
Dosage | 20mg/ml 100ml |
Active substance | Carbocysteine |
Manufacturer | Pharmtekhnologiya LLC, Belarus |
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