Download Clenbuterol syrup_leaflet_engl

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:
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• 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).
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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.
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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.
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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.
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