MINISTRY OF PUBLIC HEALTH OF THE REPUBLIC OF BELARUS
INSTRUCTION
(patient information leaflet)
for medical application of
NIMEFAST
Description of the drug
Trade name: Nimefast
International nonproprietary name: Nimesulide
General description
Nimefast (Nimesulide), 100 mg. Biconvex round-shaped tablets of light-yellow color.
Ingredients
Each tablet contains:
Active moiety: Nimesulide 100 mg;
Auxiliary components: microcrystalline cellulose, sodium starch glycollate (type A),
magnesium stearate, povidone, lactose.
Dosage form
Tablets
Pharmacotherapeutic class:
Other antiinflammatory and antirheumatic drugs. Nimesulide.
Indications and usage
 treatment of acute pains caused by musculoskeletal system injuries, soft tissues
injuries and wounds, inflammatory diseases of the musculoskeletal system (arthritis,
bursitis, myositis).
 symptomatic treatment of pains caused by osteoarthritis.
 primary dysmenorrheal.
The decision concerning the prescription of Nimefast should be based on the estimation of
individual risk factors of a patient.
Dosage and administration
Should be taken after meal. Before intake you should dissolve a tablet in 50-100 ml of water
or chew it until complete dissolution in the mouth cavity. The prepared solution mustn’t be
stored. A usual dose for adults amounts to 100 mg two times a day.
A daily dose for the children from 12 to 18 years old amounts to 100 mg, in case of body
weight is more than 40 kg the dose should amount to 100 mg two times a day.
The minimal therapeutic dose should be prescribed in order to decrease possible adverse
reactions to the drug. The maximum period of the nimefast intake shouldn’t exceed 15 days.
Patients suffering from renal insufficiency with creatinine clearance 30-80 ml/min, and
elderly patients don’t need the decrease of a nimefast dose.
Adverse reactions
During the administration of Nimefast the following reactions are possible:
nervous system: giddiness, encephalopathy, sleepiness, headache (Reye’s syndrome);
eyes: visual impairments;
respiratory apparatus, chest, and mediastinum: dyspnea, bronchiospasm;
gastrointestinal disturbances: nausea, vomiting, diarrhea, stool retention, meteorism, gastritis,
stomachache, dyspepsia, stomatitis, melena, gastrointestinal tract ulceration, gastrointestinal
bleeding and perforation;
liver: high activity of transaminases, prolongation of bleeding time;
hepatobiliary system: hepatitis, fulminant hepatitis (including fatal outcome), cholestatic
jaundice;
blood: anemia, eosinophilia, thrombocytopenia, leukocytopenia, agranulocytosis;
metabolism and metabolic disorder: hyperkaliemia;
psychiatric disorders: anxiety, nervousness, nightmares;
cardiovascular system: tachycardia, hypertensia, blood pressure differential, rush of blood;
kidneys and urinary tracts: dysuria, hematuria, urinary retention, oliguria, interstitial nephritis;
indisposition, asthenia;
allergic reactions: skin eruption, erythema;
rarely – anaphylactic shock, urticaria, Quincke's edema.
If any of the adverse reactions occurs stop taking the drug and consult the doctor.
Contraindications
 hypersensitivity to nimesulide and other components of the drug;
 hypersensitivity to acetylsalicylic acid and other NSAIDs (including in past medical
story), including such manifestations as bronchial asthma, urticaria or rhinitis;
 erosive-ulcero impairments of the stomach and duodenum in acute condition of the
disease;
 gastrointestinal tract bleeding in past medical story;
 serious blood-clotting disorders (pathology of the hemostasis system components, for
example coagulopathy, thrombocytopathy, angiopathy, combined hemostasiopathies);
 serious renal insufficiency (creatinine clearance is less than 30 ml/min);
 serious impaired cardial function;
 liver disorders, liver impairment;
 alcoholism, drug dependence;
 hepatotoxic reactions to nimesulide in past medical story, simultaneous prescription
with other hepatotoxic drugs;
 temperature rise and/or influenza symptoms;
 pregnancy and lactation;
 children under 12 years old.
Overdosage
If an overdose of nimefast is taken, overdosage symptoms, typical for NSAIDs can occur, like
the following: giddiness, nausea, vomiting, epigastric pains, which are reversible in case of
the supportive treatment. Gastrointestinal bleeding can occur. There are rare cases of
hypertensia and acute renal insufficiency. Anaphylactic reactions are possible.
Treatment: symptomatic and supportive, there are no specific antidotes. Hemodialysis, as well
as artificial diuresis, urine alkalization or hemoperfusion can be ineffective because of high
level (up to 97,5%) of nimesulide binding with blood proteins. It can be recommended to
force vomiting, use activated carbon (60-100 g) and osmotic laxative during the first 4 hours
after an overdosage. It’s necessary to control liver and kidneys functions.
Precautions
The drug should be prescribed with some precaution in case of arterial hypertension, impaired
cardial function, and pancreatic diabetes of type II.
Administration during pregnancy
It’s not recommended to take this drug during pregnancy. The use of nimesulide can bring
harm to women’s fertility and isn’t recommended to women planning pregnancy as well as
women who have difficulties in becoming pregnant or being under examination concerning
female sterility.
As well as other NSAIDs, which inhibit prostaglandin synthesis, nimesulide can cause
premature closure of an arterial duct, pulmonary hypertension, oliguria, oligoanion, an
increased risk of bleeding, uterine inertia and peripheral edema. Some cases have been
detected when children of the women, who took nimesulide during last months of their
pregnancy, had renal insufficiency.
Administration during lactation
It penetrates into breast milk, therefore, isn’t recommended to be taken during the lactation.
Administration by elderly people
Elderly patients are likely to experience adverse reactions of NSAIDs, including
gastrointestinal bleeding, kidneys, heart and liver disorders. So, suitable clinical monitoring is
recommended.
Special instructions
The risk of adverse reactions to nimesulide can be decreased if a short course of medical
treatment is used and the drug is withdrawn when the therapeutic action is achieved or
because of its ineffectiveness.
Patients, who are subject to liver disorders (anorexia, nausea, vomiting, stomachache,
weakness, urine darkening) while taking nimesulide or who have abnormal indicators of the
liver function, should stop taking the drug. Such patients shouldn’t be prescribed nimesulide
once again. There have been detected the cases of liver destruction even after a short intake of
the drug.
Concurrent use of different NSAIDs isn’t recommended. It’s recommended to avoid
simultaneous use of nimesulide with other analgesic drug.
Patients, who get a running temperature or influenza-like symptoms, should stop taking the
drug. During the medical treatment ulceration or gastrointestinal bleeding with or without
preceding symptoms can occur in case of the presence of GIT disorders in past medical story
or without them.
Patients with kidneys or heart disorders should be careful, as nimesulide can cause kidneys
impairment. If kidneys impairment occurs, it’s necessary to withdraw the drug.
Nimefast should be carefully used by the patients, who take drugs, which decrease blood
clotting or suppress thrombocyte aggregation. Nevertheless, nimesulide can’t be considered
an acetylsalicylic acid substitute for cardiovascular prophylaxis.
Nimefast contains lactose and therefore isn’t recommended to the patients with rare genetic
problem of galactose intolerance, Lapp lactase deficit or malabsorption syndrome of glucosegalactose. It’s recommended to avoid simultaneous use of nimesulide with alcohol.
Effects on ability to drive and use machines
The patients, who have giddiness or sleepiness while taking nimefast, should avoid driving
and working with machines, which requires high concentration of attention and accurate
coordination of movements.
Drug interactions
Pharmacodynamic interaction
Warfarin and similar anticoagulants, acetylsalicylic acid: an increased bleeding risk, therefore
simultaneous use with nimesulide isn’t recommended, and for the patients with serious blood
clotting is contraindicated. If the use of such combination is necessary, the control of
anticoagulants action is required.
Pharmacodynamic/pharmacokinetic interaction with diuretics
Furosemide: if people are healthy, nimesulide decreases Natrium and to a less extent
potassium excretion in a transient way, decreases a diuretic action of furosemide.
Simultaneous use of nimesulide and furosemide leads to AUC decrease (approximately by
20%) and the decrease of total furosemide excretion, not changing its kidneys clearance.
Simultaneous use of nimesulide and furosemide requires precautions if patients have kidneys
and heart disorders.
Pharmacokinetic interaction with other drugs
Lithium drugs: there is information that NSAIDs decrease lithium clearance, which leads to
the increase of lithium concentration in blood plasma and its toxicity. Therefore, while
simultaneous taking of nimesulide and lithium drugs it’s necessary to control regularly the
lithium concentration in blood plasma.
Interaction of nimesulide with glibenclamid, theophylline, warfarin, digoxin, cimetidine, and
antacids (the combination of aluminum and magnesium conpounds) was studied in vivo.
Clinically important interactions haven’t been detected.
Nimesulide inhibits CYP 2C9 enzyme, therefore the concentration of the drugs, metabolized
with the help of this enzyme, in blood plasma can increase while simultaneous use with
nimesulide.
Methotrexate: increase of methotrexate concentration in blood serum and, therefore, its
toxicity. It’s necessary to be careful if nimesulide is administered less than one day before or
after methotrexate intake.
Cyclosporine: increase of cyclosporine nephrotoxicity can occur while simultaneous use with
nimesulide.
Influence of other drugs on the pharmacological profile of nimesulide
Researches in vitro have showed that tolbutamide, salicylic and valproate acids force
nimesulide out of protein-binding sites. However, despite a possible increase of nimesulide
concentration in blood plasma, this interaction doesn’t have a clinical importance.
Storage conditions
It should be stored at the temperature not higher than 25°C in a dark dry place.
Keep away from children!
Shelf life is 2 years. Don’t use after the expiration date.
Conditions of sales by pharmacies
Prescription drugs.
Package Description
10 tablets in a blister, made from polyvinylchloride and aluminum film. Each pack contains
two or three blisters with an instruction for use.
Information about the manufacturer:
ООО (LLC) «Rubikon» Belarus, 210002, Vitebsk, M. Gor’kogo str, 62 B,
tel/fax: +375(212) 34-06-29