Nimika - instructions for use, dose, side effects, contraindications

starch 63.36 / 73.11 mg, microcrystalcellulose - 71.64 / 124.399 mg, colloidal silicon dioxide - 5.00 / 4.00mg, gelatinized starch 9.50 / 12.00 mg, monohydrate of lemon acid - 2.00 / 3.00 mg. purified talc - 3.00 / 5.00 mg, sodium salt of glycolate starch 3.50 / 3.00 mg, aspartame 4.00 / 10.00 mg, banana flavor (for tablets 50 mg) 5.00 mg, fruit flavor (for 100 mg tablets) 10.00 mg, magnesium stearate 1.50 / 2.50 mg, purified water.

Description:

Tablets: Round, flat tablets with bevel, with risk on one side, from light yellow to yellow color, heterogeneity is permissible staining in the form of small inclusions more dark color, with a specific fruit smell.

Suspension: Yellow, pale yellow homogeneous suspension.

Pharmacotherapeutic group:nonsteroidal anti-inflammatory drug.

ATX: & nbsp

M.01.A.X Other non-steroidal anti-inflammatory drugs

M.01.A.X.17 Nimesulide

Pharmacodynamics:

Nimika is non-steroidal anti-inflammatory drug (NSAID) from the class of sulfonanilides. Has anti-inflammatory, analgesic and antipyretic effect.

Nimesulide belongs to a new generation of NSAIDs whose mechanism of action is related to the selective inhibition of cyclooxygenase II and the impact on a number of other factors: suppression of the platelet activation factor, tumor necrosis factor alpha, inhibition of proteinases and histamine.

Pharmacokinetics:

When ingested well absorbed from the gastrointestinal tract. The maximum concentration of active substance in the blood plasma is reached after 1.5 - 2.5 hours after taking the drug. The use of the drug at the same time as food reduces the absorption rate, but not influencing to its degree. The binding with plasma proteins is 99%, the volume of distribution is 0.19-0.35 l / kg. Nimesulide is actively metabolized in the liver with the formation of several metabolites, excreted mainly in urine (70%) and feces (30%).

In patients with renal insufficiency (creatinine clearance 30-80 ml / min), as well as in children and the elderly, the pharmacokinetic profile of nimesulide did not change significantly.

Indications:

Symptoms of fever associated with infections of the upper respiratory tract (viral or bacterial nature) and to alleviate pain of various origins in the postoperative period, with injuries to the musculoskeletal system, and injuries to soft tissues.

Contraindications:

Increased sensitivity to nimesulide and the components of the drug, acetylsalicylic acid or other NSAIDs,

- "aspirin" asthma,

- peptic ulcer of the stomach and duodenum in the phase of exacerbation, bleeding from the gastrointestinal tract,

- marked violations of the liver and kidneys;

- pregnancy and lactation.

- children under 12 years old.

Carefully:

Caution should be exercised when prescribing nimesulide to patients with impaired renal function, arterial hypertension, heart failure, visual impairment, type 2 diabetes.

Dosing and Administration:

Adults: Usually prescribed inside the dose of 100 mg (2 tablets of 50 mg) 2 times after meals.

Children: 1.5 mg / kg body weight 2-3 times a day.The maximum dose for children should not exceed 5 mg / kg / day, divided into 2 or 3 doses. Tablets before use should be dissolved in 5 ml (1 teaspoon) of water.

Side effects:

Usually the drug Nimika does not cause side effects. In rare cases, ulceration of the mucous membrane of the gastrointestinal tract, fluid retention, nausea, vomiting, stomach pain, diarrhea, dizziness, drowsiness, pruritus, allergic reactions (skin rash, anaphylactic shock); Thrombocytopenia, leukopenia, anemia, agranulocytosis; increased activity of "hepatic transaminases"; prolonged bleeding time; hematuria.

If any side effects occur, stop taking the medication and consult a doctor.

Overdose:Cases of drug overdose are not described. There is no specific antidote.

Interaction:

Caution should be exercised while using Nimesulide with:

- digoxin, phenytoin, and lithium preparations;

- diuretics and hypotensive drugs;

- other NTTs;

- anticoagulants;

- cyclosporin;

- methotrexate;

- oral antidiabetics.

since at the level of binding to plasma proteins Nimesulide increases the concentration of drugs competing for protein binding.

Effect on the ability to drive transp. cf. and fur:

Due to the fact that the occurrence of side effects such as dizziness and drowsiness is possible with the use of the drug, caution should be exercised when assigning it to patients engaging in potentially hazardous activities requiring increased concentration of attention and rapid mental and motor reactions.

Form release / dosage:

Tablets are dispersible 50 mg, 100 mg.

10 tablets in the blister Al / Al for 50 and 100 mg.

2 or 10 blisters in a cardboard box together with instructions for use.

Suspension for oral administration 50 mg / 5 ml.

For 30 ml of the drug in a bottle of dark glass, ukuporenny screwed aluminum lid. One bottle together with the instruction for use and a measuring cap is placed in a pack of cardboard.

Packaging:(10) - packings cellular planimetric (10) - packs cardboard
(10) - packings, cellular, outline (2) - packs, cardboard

Storage conditions:

Store in a dry, protected from light place at a temperature below 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date shelf life.

Terms of leave from pharmacies:On prescription

Registration number:П N014507 / 01

Date of registration:15.12.2008

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India

Information update date: & nbsp15.08.2015

Illustrated instructions

Instructions

Nimika (Nimica)