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Transcript
PACKAGE LEAFLET CLENBUTEROL COMPOSITION: Active substance: 1 ml syrup contains Clenbuterol hydrochloride 0.001mg The other ingredient are: Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Butyl parahydroxybenzoate, Citric acid monohydrate, Sodium citrate dihydrate, Sodium benzoate, Raspberry essence 87.7041, Sorbitol, Glycerol, Propyleneglycol, Ethanol, Water purified. PHARMACEUTICAL FORM AND PACKING Syrup 100 ml in a glass bottle in a cardboard box Syrup 100 ml in polyethileneterephtalate bottles in a cardboard box MARKETING AUTHORISATION HOLDER Balkanpharma-Troyan AD 1, Krayrechna St. 5600 Troyan ACTION Clenbuterol has a rapid and powerful bronchial-dilating action. Clenbuterol stimulates bronchial-mucosa cells, enhancing also expectoration. Clenbuterol additionally possesses a pronounced action on the metabolism in the organism, comparable to that of anabolic drugs. Its effect is expressed in a reduction of protein degradation in muscle cells, leading to an increase in muscle bulk and muscle strength. The enhanced metabolism of masts is another Clenbuterol pharmacodynamic property. In the prescribed therapeutic doses, Clenbuterol has no influence on heart rate or arterial blood pressure, and does not affect oxygen saturation of arterial blood. INDICATIONS The drug is indicated for: 1 • treatment of bronchial asthma; • complex therapy of bronchial spasm NECESSARY INFORMATION BEFORE YOU TAKE THE DRUG Contraindications • Do not take Clenbuterol if you are hypersensitive to the active substance or to any of the other ingredients. • Severe hyperthyreosis, thyreotoxicosis (thyroid gland hyper-function, increase in thyroid hormones); • Severe heart disease (hypertrophic obstructive cardiac myopathy); • Increased intraocular pressure (narrow-angle glaucoma); • Adrenal tumor (pheochromocytoma). Special precautions for use Clenbuterol should be taken with special care in the following cases: Directly after cardiac infarction; liver or renal insufficiency; tachycardiac (related to increased heart rate) heart-rhythm disorders; myocarditis (heart muscle inflammation); mitral valve prolapse; hypokalemia (decrease in blood potassium); unstable or non-compensated diabetes. The product affects the metabolism, possessing anabolic effect. Interactions with drugs and other interactions Beta-blockers inhibit Clenbuterol action; hence, a risk of bronchospasm exists at their concomitant administration. The use of the product together with anti-diabetic drugs impairs the action of the latter. Clenbuterol enhances the action and the side effects of ß-adrenergic mimetics, theophylline and anti-cholinergics. There is an increased risk of arrhythmia at simultaneous administration of chalogenated carbohydrates for narcosis (at surgical manipulations and interventions). 2 At concomitant use with MAO-inhibitors (tri-cyclic antidepressants), heart rhythm disorders could be observed. Clenbuterol might be used together with diuretics and digitalis glycosides only under a periodic monitoring of plasma electrolytes. Pregnancy and breast-feeding Due to its inhibitory action on parturition, Clenbuterol syrup should not be used in the first 3 months of pregnancy, as well as in its last trimester. Clenbuterol syrup should not be used during breast-feeding period. In the second pregnancy trimester and during breast-feeding, the use of Clenbuterol inhalation form is recommended. Effects on the ability to drive and to use machines In the first days of treatment, Clenbutertol might provoke slight tremor and anxiety, requiring an increased attention at driving and using machines. Data about of the other ingredients The product contains as ingredients methyl parahydroxybenzoate and propyl parahydroxybenzoate, the so colled parabens, which could induce urticarias and contact dermatitis (delayed allergic reactions). Rarely, immediate allergic reactions (bronchial spasm) might be provoked. As an ingredient, the product contains glycerol that at high doses could cause headache, gastric irritation and diarrhea. The drug contains 0. 005 g ethanol in 1 ml Clenbuterol; hence, it should be used with special care in patients with liver diseases, alcoholism, epilepsy, brain injuries or diseases. Due to the presence of sorbitol, the medicinal product is not suitable for use in patients with congenital intolerance to fructose. INFORMATION FOR PROPER USE Posology and method of administration The drug is for oral administration. 3 In children - the usual dosage is 0.0012 mg/kg/day, separated in 2-3 intakes: • children up to 8 months old (4-8 kg body mass) - 2.5 ml, twice daily; • children 8 months-2 years old (8-12 kg body mass) - 5 ml, twice daily; • children 2-4 years old (12-16 kg body mass) - 7.5 ml, twice daily; • children 4-6 years old (16-22 kg body mass) - 10 ml, twice daily; • children 6-12 years old (22-35 kg body mass) - 15 ml, twice daily; Adults and children over 12 years - 15 ml, 2-3 times daily. Maintaining dose: 10 ml, twice daily. OVERDOSE AND ACTIONS TO BE TAKEN At Clenbuterol overdose, the following symptoms could be observed: tremor of fingers, sweating, headache, tachycardia. In extremely severe overdose cases with the drug, collapse, seizures and coma could occur. In all cases of overdosage, Clenbuterol use is discontinued. Stomach lavage with activated charcoal, forced diuresis and symptomatic therapy should be carried out. In doses higher than the prescribed, Clenbuterol might cause aggravation of existing asthma. In such cases, an urgent doctor consultation and hospitalization (if needed) are required. POSSIBLE SIDE EFFECTS • Muscle system: fine muscle tremor; • CNS: anxiety; • Cardio-vascular system: blood pressure increase, tachycardia, anginal pains, ventricle extrasystols; • Skin and mucosa: skin rash, face edema; • Respiratory system: paradoxical bronchial spasm; • Blood-forming system: thrombopenia, hypoglycemia; • Urogenital system: micturition disturbances. The described side effects fade away without stopping the therapy, 1-2 weeks after the beginning of treatment. 4 STORING CLENBUTEROL In a dry and light-protected place, at temperature not above 25 °C. Keep out of the reach and sight of children. EXPIRY TERM Three (3) years, following the date of manufacturing. Shelf life after first opening - 1 month. Do not use the product after the expiry term stated on the pack. DATE OF LAST REVISION This leaflet was last approved in June, 2002. 5