APPLICATION INSTRUCTIONS
NEOSPAN

PHARMACOTHERAPEITIC GROUP: Spasmolytic mean.
DRUG FORM: Tablets.
COMPOSITION: Active substance: Drotaverine hydrochloride – 40 mg.
Aiding substances: Lactose, maize starch, talc, magnesium stearate, povidone.
PHARMACOLOGICAL OPERATION: Drotaverine hydrochloride belongs to spasmolytics of isochinoline derivative which contributes the relaxation of smooth muscle, inhibition of phosphodiestherase enzyme, its intracellular accumulation, increase of CAMF concentration and myosine kinasa via inactivation of light chains.
Spasmolytic action of drotaverine doesn’t depend on vegetative innervation character, it has the same spsmolytic action on gastrointestinal, billiary, urogenital and smooth musculature of vascular system.
Because of vasodilatative effect, it improves provision of tissues with blood. It is not characterized with teratogenic and embriotoxic action.
Pharmacocynetics: The preparation is absorbed rapidly and fully form gastrointestinal tract. Bioavailability is almost 100%. T1/2 is 12 hour. It distributes equally in tissues and compasses to smooth muscle cells. 95-98% of drotaverine bind to plasma proteins. Drotaverine is excreted mainly by kidneys.
INDICATIONS: IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN: 
· Smooth muscles spasm, which is associated with diseases of billiary tract; cholecystitis, cholangitis, pericholecystitis, cholecystolithiasis, cholangiolithiasis, papillitis;
· Spasm of the urination system smooth muscles: nephrolithiasis, urethrolithiasis, pyelitis, cystitis, urinary bladder tenesmus;
· Spasm of gastrointestinal smooth muscle: gastric and duodenum ulcer diseases, gastritis, enteritis, colitis,colitis due to constipation and the colitis proceeding with meteorism;
· During headaches of tension type: headache conditioned by muscle tension, psychogenic, stress, everyday headaches, transformed migraine;
· During obstetrics-gynecology:painful menstruation, during pregnancy for the decrease of uterus tonus, in case of danger of abortion.
CONTRAINDICATIONS:
· Increased sensitivity toward the components of the preparation;
· During insufficiency of liver, kidneys and heart.
SIDE EFFECTS:
Rarely may be occurred: nausea, constipation, headache, dizziness, insomnia, tachicardia, decrease of arterial pressure.
In patients with increased sensitivity to lactic sugar constipation may occurred.
APPLICATION AND DOSAGE RULE:
In adults: Daily dose is 120-240 mg, 3-6 tablets a day, which should be deal on 2-3 receipt. Single does for adults is 40-80 mg (1-2 tablets).
In children until 12 years preparation is prescribed by a doctor.
In children up to 6 years: Recommended dose is 80-200 mg, 2-5 tablets a day, which should be deal on 2-5 receipt. Single dose for children above 6 years old is 40 mg (1 tablet).
For children from 1 to 6 years: recommended daily dose is 40-120 mg, 1-3 tablets a day, which should be deal on 2-3 receipt. Single dose for children from 1 to 6 years is 20-40 mg (1/2 – 1 tablet).
INTERACTION WITH OTHER PREPARATIONS: Usage the preparation with antiparkinson medication – Levodopa decreases its’ efficiency.
PREGNANCY AND LACTATION PERIOD: Due to the lack of safety and toxicity data about the preparation, usage ,,Neospan” is permitted after estimation expected benefit for mother and potential risk for the fetus.
INFLUENCE OF VEHICLE AND MECHANISMS MANAGEMENT: In therapeutic doses the preparation doesn’t influence on concentration ability.
OVERDOSE: In case of overdose antrioventricular block, heart stop and respiratory centre paralisys occures. Specific antidote does’t exists.
In case of overdose application of the preparation should be stopped and symptomatic treatment should be carried. While antrioventricular block atropine and isoprenaline is applied in vien, in case heart stop atropine or adrenaline in vien and cardiostimulation is recommended, in case respiratory centre paralisys artificial ventilation of lung should be carried.
PACKAGE: Primary packing: 10 tablets in blister.
Secondary packing: 6 blisters in a cardboard box.
SHELF-LIFE: 5 years.
In case of visual defects and expiry of validity date, the preparation can not be used.
STORAGE CONDITIONS: Store not more than 25ºC temperature in a dark, dry place and keep away from children.
Issue: III group of a pharmaceutical product (issued without a doctor’s prescription).
MANUFACTURER: “Neopharmi” LTD

12th km alley D. Agmashenebeli. Tbilisi. Georgia.
Tel/Fax: +995 (032) 259-64-46; 259-57-90.