Nimulid

Nimulid – non-steroidal anti-inflammatory drug with anesthetic, antiinflammatory and febrifugal property.

Form of release and structure

Dosage forms:

• Tablets are lingvalny: pale yellow color, a round biconvex form (on 10 pieces in the blister from polyvinylchloride or aluminum foil, in a cardboard pack 1 or 2 blisters);
• Tablets: light yellow color, a round biconvex form, with the image of a logo on one party and a text of "NIMULID" – on another (on 10 pieces in the blister from polyvinylchloride or aluminum foil, in a cardboard pack on 1, 2, 3 or 10 blisters);
• Gel for external use of 1%: translucent weight with homogeneous structure of yellowish color (on 10, 20 or 30 g in aluminum or plastic tubas, in a cardboard pack 1 tuba);
• Suspension for intake (on 60 ml in glass bottles of dark color, in cardboard packaging 1 bottle complete with a measured glass).

Active ingredient of Nimulid – Nimesulide:

• 1 tablet lingvalny – 100 mg;
• 1 tablet – 100 mg;
• 1 g of gel – 10 mg;
• 1 ml of suspension – 10 mg.

Auxiliary components:

• Tablets are lingvalny: sodium of a kroskarmelloz, Mannitolum, sodium carboxymethylstarch, magnesium stearate, sodium methylparahydroxybenzoate, potassium sorbate, sodium пропилпарагидроксибензоат, silicon dioxide colloid, fragrance orange, aspartame, the water purified;
• Tablets: starch corn, croscarmellose sodium, lactose, silicon dioxide colloid, povidone, polysorbate, docusate of sodium, magnesium stearate, Acidum hydrochloricum and water purified – are removed in the course of production;
• Gel: carbomer, a hypro rod, the ethanol of 95% (purified) triacetin, phosphoric acid, dimethylacetamide, fragrance 0106-G, MSC-03 fragrance, the water purified;
• Suspension: sorbitol solution of 70% uncrystallized, gum xanthane, citric acid monohydrate, glycerin, a macrogoal глицерилгидроксистеарат (RH-40 Cremophore), sucrose, sodium disulphite, sodium methylparahydroxybenzoate, Natrium benzoicum, sodium пропилпарагидроксибензоат, silicon dioxide colloid, Acidum hydrochloricum, dye quinolinic yellow, flavoring additive (vanilla and mango), the water purified.

Indications to use

• Pseudorheumatism;
• Psoriasis arthritis;
• Osteochondrosis with a radicular syndrome;
• Osteoarthrosis;
• Ankylosing spondylarthritis;
• Bursitis, inflammation of sinews, sheaves, posttraumatic inflammation of a musculoskeletal system and soft tissues (bruises, gaps and injuries of ligaments);
• Joint syndrome at an exacerbation of gout;
• Mialgiya of rheumatic and not rheumatic genesis.

Besides, Nimulid's use in the form of two types of tablets and suspension is shown for symptomatic therapy of a pain and inflammatory syndrome at injuries, algodismenory, a headache, an arthralgia, a dentagra, a lumbar ishialgia, pain in the postoperative period, a feverish state at infectious and inflammatory diseases.

Gel is used also at a sciatica, a lumbago.

Drug does not exert impact on progressing of a disease.

Contraindications

• Erosive cankers of the digestive tract (DT) in aggravation stages, active gastrointestinal bleeding;
• Heavy hepatic or renal (clearance of creatinine (CC) less than 30 ml/min.) insufficiency;
• Instructions in the anamnesis on the phenomena of a bronkhoobstruktion, a small tortoiseshell, rhinitis against the background of reception of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NPVS) (an incomplete or full syndrome of intolerance of acetylsalicylic acid – a small tortoiseshell, rinosinusit, asthma, polyps mucous a nose);
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

Besides, the general contraindications to use of tablets and tablets lingvalny are:

• Disease Krone, nonspecific ulcer colitis and other inflammatory diseases of intestines in an aggravation phase;
• Heavy disturbances of a blood coagulation;
• The progressing disease of kidneys;
• The confirmed hyperpotassemia;
• State after performing aortocoronary shunting;
• Active disease of a liver.

With care it is necessary to appoint tablets and tablets lingvalny the patient at coronary heart disease, cerebrovascular diseases, congestive heart failure, a dislipidemiya or a lipidemia, a diabetes mellitus, diseases of peripheral arteries, smoking, KK less than 60 ml/min., existence of an infection of Helicobacter pylori, heavy somatopathies, frequent alcohol intake, long use of NPVS accompanying therapy by anticoagulants (warfarin), antiagregant (including klopidogret, acetylsalicylic acid), peroral glucocorticosteroids (GKS), selective serotonin reuptake inhibitors (fluoxetine, to tsitalopra, sertraline, пароксетин), in case of the instruction in the anamnesis to development of a canker of a GIT, to patients of advanced age.

It is impossible to apply tablets lingvalny:

• Any kinds of bleedings, including cerebrovascular;
• Exacerbation of inflammatory diseases of intestines;
• Hemophilia;
• Dekompensirovanny heart failure;
• Liver failure;
• Drug addiction, alcoholism;
• Concomitant use of potentially gepatotoksichny substances;
• Development of hepatotoxic reactions against the background of use of drugs of Nimesulide in the anamnesis.

Nimulid's tablets are contraindicated to patients with heavy heart failure.

Gel is forbidden to be applied at a dermatosis, injuries of epidermis and skin infections in a scope.

With care it is recommended to appoint gel at the liver failure expressed to heart failure, a renal failure, arterial hypertension, a diabetes mellitus 2 types, coagulation disturbances at advanced and children's age.

Nimulid in the form of suspension also do not appoint at a moderate liver failure.

Age restrictions to drug use:

• Tablets and tablets lingvalny: up to 12 years;
• Gel: up to 7 years.

Route of administration and dosage

• Tablets are lingvalny: apply by a rassasyvaniye, for this purpose after food the tablet should be placed under language and to swallow after full dissolution. Use of a minimal effective dose during minimum short period is recommended. The recommended dosing for patients is more senior than 12 years (body weight more than 40 kg): on 1 tablet 2 times a day;
• Tablets: accept inside, after food, washing down with enough liquid. Dosing for patients is more senior than 12 years (body weight more than 40 kg): on 1 tablet 2 times a day. The daily dose should not exceed 5 mg on 1 kg of weight of the patient. Patients with a chronic renal failure are recommended to appoint no more than 1 tablet a day. The period of treatment is appointed by the doctor individually on the basis of clinical indications;
• Gel: it is intended only for external use by drawing on the site with a strong pain syndrome and hypodispersion by the easy movements, without rubbing in skin. The recommended dosing: a column of gel about 3 cm long 3-4 times a day. The amount of drug and frequency rate of drawing depends on the area of the painful site and reaction of the patient. After use of gel it is necessary to wash up carefully hands with soap. It is impossible to apply gel more than 4 times a day. In case of need uses of means more than 10 days it is necessary to get advice of the doctor;
• Suspension: is accepted orally. The recommended dosing: the adult – on 100 mg 2 times a day; to children appoint from calculation for 1,5 mg to 1 kg of body weight 2-3 times a day, but no more than 5 mg on 1 kg of body weight a day divided into 2-3 receptions.

At treatment of patients of advanced age dose adjustment should not be made.

Side effects

Nimulid's use in the form of tablets lingvalny, tablets, suspension can cause side effects:

• Cardiovascular system: infrequently – arterial hypertension; seldom – inflows, tachycardia, hemorrhages;
• Alimentary system: often – nausea, vomiting, diarrhea, increase in activity of liver enzymes; infrequently – a meteorism, gastritis, a lock; very seldom – stomatitis, abdominal pains, gastrointestinal bleeding, a tar-like chair, perforation and/or stomach ulcer or a duodenum, hepatitis, fulminant hepatitis, a cholestasia, jaundice;
• System of breath: infrequently – an asthma; very seldom – a bronchospasm, an exacerbation of bronchial asthma;
• Nervous system: infrequently – dizziness; seldom – dreadful dreams, nervousness, feeling of fear; very seldom – drowsiness, a headache, a syndrome to Reja (encephalopathy);
• Kidneys and urinary system: infrequently – hypostases; seldom – an ischuria, a hamaturia, a dysuria, a hyperpotassemia; very seldom – an oliguria, a renal failure, intersticial nephrite;
• Bodies of a hemopoiesis: seldom – an eosinophilia, anemia; very seldom – a pancytopenia, thrombocytopenia, lengthening of a bleeding time, purple;
• Sense bodys: seldom – a sight illegibility;
• Allergic reactions: seldom – hypersensitivity reactions; very seldom – a small tortoiseshell, anaphylactoid reactions, puffiness of the person, a Quincke's disease, a multiformny exudative erythema (Stephens-Johnson's syndrome), a Lyell's disease;
• Dermatological reactions: infrequently – sweating strengthening, an itch, rash; seldom – dermatitis, an erythema;
• General reactions: seldom – the general weakness; very seldom – a hypothermia.

At use of gel the following side effects can develop:

• Local reactions: a skin itch, a peeling, a small tortoiseshell, passing discoloration of skin which does not demand drug withdrawal;
• System side reactions: against the background of long use or when drawing on big sites of skin – nausea, heartburn, vomiting, diarrhea, an ulceration mucous a GIT, a gastralgia, increase in activity of liver enzymes, dizziness, a headache, a hamaturia, a liquid delay, allergic reactions (including skin rash, an acute anaphylaxis), a leukopenia, thrombocytopenia, anemia, lengthening of a bleeding time, an agranulocytosis.

At deterioration in health, emergence of the specified or any other side reactions it is necessary to cancel Nimulid's use and to see a doctor.

Special instructions

Nimulid can cause a liquid delay in fabrics therefore with extra care it is necessary to appoint him the patient with disturbances of cordial activity and high arterial pressure.

It is recommended to use with care drug to patients with pathologies of upper parts of a GIT, renal failures, tendency to the bleedings which are on simultaneous therapy by anticoagulants.

It is necessary to stop immediately therapy at emergence of any vision disorder and to address for consultation the doctor-oculist.

Drug is recommended to appoint to the most minimum therapeutic the reasonable period in a minimal effective dose, it will allow to reduce a negative impact of Nimesulide by a GIT.

It is impossible to apply gel on the mucous membranes (including a conjunctiva) affected with infections or a dermatosis sites of skin, open wounds, the surfaces of skin with the broken integrity. Gel should not be rubbed in skin and to cover the sites processed by it with an occlusive bandage. The tuba should be kept with densely closed cover.

To patients with the expressed side effects in the form of drowsiness, dizziness, a sight illegibility against the background of oral administration of Nimulid it is recommended to be careful at control of vehicles and mechanisms.

Medicinal interaction

At simultaneous use Nimulid increases action of the means reducing coagulability of blood, strengthens influence of cyclosporine on kidneys, reduces therapeutic effect of furosemide, anti-hypertensive drugs, promotes increase in level of lithium in a blood plasma at therapy by lithium drugs.

At a combination to inhibitors of the return serotonin reuptake of GKS increases risk of development of bleedings from a GIT, a methotrexate – the probability of side effects increases.

Nimesulide possesses high extent of linkng with proteins of a blood plasma therefore careful medical control at simultaneous treatment of the patient is required by streptocides and hydantoin who are competitors of drug for communication with proteins of a blood plasma.

The patients accepting hypoglycemic and antihypertensives, Phenytoinum, digoxin, diuretics, lithium drugs, a methotrexate, cyclosporine, other NPVS before use of gel need to consult with the attending physician.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 25 °C:

• Tablets are lingvalny, tablets, suspension: in the protected from light, dry place;
• Gel: in the distance from direct sunshine and naked flame, storage in the refrigerator is not allowed.

Period of validity – 3 years.