APPLICATION INSTRUCTION
MEDICAL MEAN
NEOSILI

PHARMACOLOGICAL GROUP: Non-steroidal anti-inflammatory agent.
DRUG FORM: Tablets.
COMPOSITION: Active substance: Nimesulide – 100 mg.
Aiding substances: starch, microcrystalline cellulose, sorbite, talc, calcium stearate, polyvinylpyrrolidone.
PHARMACOLOGICAL OPERATION: Nimesulide is an anti inflammatory nonsteroidal mean form the Sulfonanilid group. Is characterizes with anti inflammation, painkilling and temperature lowering action, that is caused by selective competitive inhibition of the enzyme cyclooxygenase – 2; it suppresses prostaglandins – intumescence, inflammation and pain mediation synthesis.
Besides that, the preparation suppresses synthesis of cartilaginous tissue’s disbanding enzyme (Colagenesis, Stromelizin, Elastaza), which delays cartilaginous tissue’s damage and subserves regulation of it’s synthesis.
PHARMACOCINETIC: After internal taking, Nimesulid is absorbed well from intestine tract. Food intake reduces absorption speed, irreplaceable to absorbing quality. Nimesulid’s maximal concentration in blood plasma is achieved after 1,5 -2,5 hours taking, but its operation continues approximately 6 hours. 99% of Nimesulid relates to plasma proteins, actively metabolizes in liver, 80% of metabolite is excreted through the urine, but 20% – together with fecal mass.
INDICATION: IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN:
· At time of joint and muscles diseases: different genesis osteoarthritis, among them rheumatic arthritis, osteoarthritis, ankylosing spondylitis, bursitis, tendenitis;
· Different etiologies of pain: at time of teeth and headache, at post operational and postraumatic period and other;
· At time of infectious – inflammatory diseases in otolaryngology;
· Dysmenorrhea (at time of painful menstruation);
· At time of fever current diseases (like involving in combined therapy).
CONTRA-INDICATION: High sensitivity towards the components of the preparation; high sensitivity towards acetylsalicylic acid or other anti-inflammatory nonsteroidal means; stomach and duodenum ulcerous diseases in an acute phase; normal or expressed disorders of the liver or kidney function; pregnancy and lactation period; for children – till 12 year.
USING RULE AND DOSAGE: Neosili is taken perorally, after eating with enough water.
Recommended dose is 100mg (1 tablet) 2 times in a day. Considering the state of the patient and the effectiveness of treatment dose can be increased to 200 mg 2 times a day.
In aged people choose and reduce of doses is determined by the doctor according to the patient’s condition.
,,Neosili” is contraindicated for children up to 12 years.
For children from 12 year Neosili is only prescribed by the doctor’s recommendation.
Taking the drug is recommended as possible in a short time, to reduce the risk of development side effects (for not more than 15 days).
SIDE EFFECTS: Neosili is characterized with good endurance, although there may be developed:
From the side of gastrointestinal tract: discomfort of epigastrium, nausea and diarrhea;
From the side of central nervous system: dizziness, headache, insomnia.
Alergic reactions: rash on the skin, erythema, nettle-rash, itch.
Rarely there may be develop reduce of urinate (oliguria) with liquid retain and local or diffuse intumescence of the tissue.
Like other anti-inflammatory nonsteroidal means Neosili may cause Steven Johnson’s, Layel’s syndrome, also anaphylactic reactions.
In case of side-effects occurance shoul get consultation from doctor and stop taking the preparation.
SAFETY MEASURES: Neosili is prescribed with caution for those patients who have blood coagulation system disorder and intestine system diseases, also patients who take anticoagulants or antiaggregant.
Patients who have kidney’s functional disorder have to reduce dosage of Nimesulide with consideration of glomerular filtration indicator.
The preparation may cause liquid retain in the tissues, so, Nimesulide should be given with caution to those patients who have heart insufficiency.
Neosili if safely given to aged patients, especially when there is expressed age weakness.
It is necessary to be carefully at time of prescribing Neosil and anticoagulants, diuresis means, antihypertensive preparations, hypoglycemic preparations, digoxin, phenytoin, lithium preparations and other nonsteroidal anti-inflammatory means, cyclosporine and methotrexate simultaneously.
OVERDOSE: In case of overdosage following symptoms may be occurred: nausea, vomiting, sleepiness.
Treatment is symptomatic, stomach ablution and taking of activated carbon is recommended.
PREGNANCY AND LACTATION PERIOD: Usage of Neosili is not recommended during the period of pregnancy and lactation.
INFLUENCE ON ABILITY OF DRIVING CARS AND MECHANISMS:
After receiving the preparation caution is required while driving car and other mechanisms, because it can cause sleepiness and dizziness what influence on the capability concentration of attention and rapid response.
INTERACTIONS WITH OTHER MEDICAL MEANS: Caution is required in case of co-administration of Neosili and anticoagulants, diuretics, antihypertensive drugs, hypoglycemic drugs, digoxin, phenytoin, lithium, other non-steroidal anti-inflammatory drugs, cyclosporine, methotrexate, as they may interact with each other.
PACKAGE: Primary packing: № 10 tablets in a blister.
Secondary packing: 2 blisters are located in a carton box.
STORAGE CONDITIONS: Store on 15-25ºC temperature in a dry, protected from light place and keep away from children.
SHELF LIFE: 3 years.
ORDER OF ISSUE: II group of a pharmaceutical product, issued with prescription form №3.
MANUFACTURER: “Neopharmi” Ltd.

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