NEOSILI (Nimesulide) №10 sachet
WITH ORANGE FLAVOUR
GENERIC NAME: NIMESULIDE.
DRUG FORM: Powder for solution in sachet – 7g.
PHARMACOLOGICAL GROUP: Non-steroidal anti-inflammatory agent from sulfonanilides group.
COMPOSITION OF ONE SACHET:
Active substance: 0,1 g nimesulide.
Aiding substances: sugar, sodium saccharin, citric acid, sodium citrate, orange emulsion, sodium lauryl sulphate, PEG 400.
PHARMACOLOGICAL OPERATION: Nimesulide is an anti-inflammatory non-steroidal mean from the Sulfonanilide group. It is characterized with anti-inflammatory, pain relieving and antipyretic action. Mechanism of the action is caused by selective competitive inhibition of the enzyme cyclooxygenase – 2, which suppresses synthesis of prostaglandins – that are mediators of intumescence, inflammation and pain.
Furthermore, the preparation suppresses synthesis of cartilaginous tissue’s disbanding enzyme (Collagenase, Stromelysin, Elastase), which delays cartilaginous tissue’s damage and subserves regulation of this system.
Pharmacokinetics: After internal taking, Nimesulide is well absorbed from intestine tract. Ingest of food reduces absorption speed, though does not influence on absorbing quality. Nimesulide’s maximal concentration in blood plasma is achieved after 1,5 -2,5 hours from taking, but effect continues approximately 6 hours. 99% of Nimesulide relates to plasma proteins, actively metabolizes in liver, 80 % of metabolite is exiled by urine, but 20% – by fecal mass.
INDICATION: IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN:
· Different etiological pains (headache, toothache, pain in the postoperative and posttraumatic period and etc);
· At time of joint and muscles diseases (different genesis osteoarthritis, among them rheumatic gout, osteoarthrosis, ankylosing spondylitis, bursitis, tendenitis);
· At time of infectious – inflammatory diseases in otolaryngology;
· Dysmenorrhea (painful menstruation);
· Diseases that occur with fever (in the combined therapy);
· Inflammatory diseases of the peripheral nervous system: neuralgia, neuritis, plexitis and etc.
· High sensitivity towards 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;
· Hemorrhagic pathology;
· Coagulatin disorder;
· Pregnancy and lactation period;
· For children – till 12 age;
· Heart insufficiency.
ADMINISTRATION AND DOSAGE RULE: The powder should be diluted in a glass of water.
Dosage rule for adults: 1 sachet (0.1g) twice a day after meal. For children from 12 to 18 year and for elderly patient dosage correction is not necessary.
In aged people choose and reduce of doses is determined by the doctor according to the patient’s condition.
For children up to 12 year the preparation is contra-indicated.
Usage of the preparation is recommended for the shortest period, to avoid appearance of side-effects.
It is not recommended to use the preparation 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, urticaria, itch;
Rarely there may be developed 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.
CAUTIONS: Neosili if carefully prescribed 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 hanking filtration indicator.
The preparation may keep liquid in the tissues, so Nimesulide should be given carefully to the patients with heart insufficiency.
The preparation is carefully prescribed to the elderly patients, especially when age weakness is expressed.
Preparation contains sucrose, which is considerable for the patients with diabetes.
OVERDOSAGE: In case of overdosage following symptoms may be occurred: nausea, vomiting, drowsiness.
Treatment is symptomatic, stomach ablution and taking of activated carbon is recommended.
PREGNANCY AND LACTATION PERIOD: Usage of the preparation is not recommended.
INFLUENCE ON ABILITY OF DRIVING CARS AND OTHER MECHANISMS: After application the preparation caution is required while driving car and other mechanisms, because the preparation may cause sleepness and dizziness. What can influence on the capability concentration of attention and ability of rapid response.
INTERACTIONS WITH OTHER DRUGS: Caution should be exercised with concomitant administration of Neosili and anticoagulants, diuretics, antihypertensive drugs, hypoglycemic drugs, digoxin, phenytoin, drugs of lithium, other non-steroidal anti-inflammatory drugs, cyclosporine, methotrexate, as there may be the case they interact.
PACKAGE: 7g powder in a sachet. 10 sachets are placed in a cardboard box.
ISSUE: Pharmaceutical product group II, issued with a form №3 prescription.
SHEIF-LIFE: 2 years.
STORAGE CONDITIONS: Store at 15-25ºC temperature, in a dry, protected from light place, keep away from children.
In case of visual defects and expiry of validity date, the preparation can not be used.
MANUFACTURER: “Neopharmi” Ltd.
12th km, David Agmashenebeli alley, Tbilisi, Georgia
Tel/Fax: +995 (032) 259-57-90; 259-64-46.