NEULAB [Nimesulide] 100 mg Tablets

Instruction for Medical Use

NEULAB

Brand name: Neulab.

Active ingredient (international non-proprietary name): Nimesulide.

Administration form: Tablets.

Composition

Each tablet contains:

active ingredient: nimesulide, ВР     100 mg

excipients: binders                           q.s.

Pharmacotherapeutic group: non-steroidal anti-inflammatory drugs (NSAIDs).

ATC code: М01АХ17.

Pharmacological properties

Pharmacodynamics

Nimesulide has anti-inflammatory, analgesic, and antipyretic action. It selectively inhibits cyclo-oxygenase-2, suppresses synthesis of prostaglandins in the inflammation site. It inhibits lipid peroxidation, does not influence blood stasis and phagocytosis.

Pharmacokinetic properties

After intake, the drug is well absorbed from the gastrointestinal tract. Cmax is reached after 1,5-2,5 hours. It circulates in blood in the protein-binding form (up to 99%). Plasma elimination half-life (Т ½) is 2-3 hours. It is bio-transformed in the liver. The main metabolite is pharmacoactive hydroxynimesulide (25%). It is excreted through kidneys (98% within 24 hours). It is not cumulated during prolonged administration.

Therapeutic indications

Arthritides, including rheumatoid arthritis, arthrosis, osteoarthrosis, arthralgias, myosalgias, bursitis, fever, pain of various genesis (in case of trauma, during post-surgical period, in gynecological and inflammatory diseases).

Nimesulide (particularly in granulated form) shows its analgesic effect very fast - within 20 minutes. That is why it may be used in case of acute paroxymal pain.

Contraindications

Gastroduodenal ulcer in the exacerbation phase, acute bleeding from the gastrointestinal tract, moderate and significant hepatic failure, kidney failure (glomerular filtrate rate is less than 30 ml/min), hypersensitivity to nimesulide and other NSAIDs (including acetylsalicylic acid).

Before using NEULAB, patients with hypersensitivity to aspirin, as well as patients with asthma, should consult with their doctor. If symptoms persist for more than 2 days, then it is necessary to stop taking the medication or consult a doctor.

Dosage and administration

Administration:  intake, after meal washing down with water.

Dosage: Adults and children over 12 years – one tablet two times a day (every 12 hours).

Children under 12 years – the drug is not recommended.

Overdosing must be avoided.

Side effects

Rare:

- headache, dizziness, sleepiness;

- nausea, acid indigestion, stomach ache, tarry stool (melena);

- petechiae, purpura;

- oliguria.

Very rare: thrombocytopenia.

Allergic reactions: exanthema, redness, urticaria fever.

Special instructions

To be carefully administered by the patients with intestinal issues, elevated blood pressure, edemas, hypersensitivity to acetylsalicylic acid, asthma, diabetes mellitus; by seniors.

If the symptoms last for more than 2 days, a person should stop administer the drug and consult a prescribing physician.

This drug is contradicted during pregnancy. Breast-feeding should be stopped for the treatment period.

To be carefully administered by the persons working with machines and by the persons whose occupation requires increased concentration fixation.

Interaction with other drugs

Possible development of drug interaction at simultaneous administration of nimesulide and digoxin, lithium medicines, diuretics, antihypertensive drugs, other NSAIDs, anticoagulants, ciclosporins, methotrexate, oral hypoglycemic drugs.

Recommendations on storage

Store in a dry, protected from light place, at temperature of not above 25°С.

Store the drug out of reach of children.

Expiration date

36 months.

Pharmaceutical form

12 tablets/blister pack/instruction for medical use/package.

Prescription status

Medical prescription