Nurofen Express Lady, 400 mg 12 pcs

Pharmacotherapeutic group:

Non-steroidal anti-inflammatory drug (NSAID).

ATC code: M01AE01

Pharmacological properties

Pharmacodynamics:

The mechanism of action of ibuprofen, a derivative of propionic acid from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to the inhibition of the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermia.

Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thus inhibiting the synthesis of prostaglandins. It has a fast directed action against pain (analgesic), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation.

Pharmacokinetics:

Absorption – high, quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach the maximum concentration (Cmax) of ibuprofen in blood plasma is reached after 30-35 minutes.

Taking the drug with food may increase the time to reach the maximum concentration (TCmax). The binding to the blood plasma proteins is more than 90%.

Slowly penetrates into joint cavity, stays in synovial fluid creating higher concentrations in it than in blood plasma. After absorption about 60% of pharmacologically inactive R-form is slowly transformed into active S-form. It is metabolized in the liver. The half-life (T1/2) is 2 hours. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, with the bile.

In elderly people there were no significant differences in the pharmacokinetic profile of the drug compared to younger people.

In limited studies ibuprofen was found in very low concentrations in breast milk.

Indications

Active ingredient

Composition

One film-coated tablet contains:

the active ingredient – ibuprofen sodium dihydrate 512 mg (equivalent to ibuprofen 400 mg);

excipients:

croscarmellose sodium 60 mg,

xylitol 60 mg,

microcrystalline cellulose 60 mg,

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magnesium stearate 16 mg,

colloidal silicon dioxide 4 mg;

coating composition:

sodium carmellose 1 mg, talc 48 mg, acacia gum 1.6 mg, sucrose 186.2 mg, titanium dioxide (E171) 3.3 mg, macrogol-6000 0.5 mg, red ink [Opacode S-1-15094] (shellac 41,49%, iron oxide red dye (E172) 31.00%, butanol* 14.00%, isopropanol* 7.00%, propylene glycol 5.50%, ammonia aqueous 1.00%, simethicone 0.01%).

*Solvents evaporated after the printing process.

How to take, the dosage

Interaction

Special Instructions

Contraindications

Side effects

The risk of side effects can be minimized by taking the drug in a short course, at the lowest effective dose necessary to relieve symptoms.

The side effects are mostly dose-dependent.

The following adverse reactions have been reported with short-term administration of ibuprofen in doses not exceeding 1200 mg/day (6 capsules). When treating chronic conditions and with long-term use, other adverse reactions may occur.

The incidence of adverse reactions has been evaluated on the basis of the following criteria: Very frequent (≥ 1/10), Frequent (≥ 1/100 to < 1/10), Infrequent (≥ 1/1000 to < 1/100), Rare (≥ 1/10 000 to < 1/1000), Very rare (< 1/10 000), Frequency unknown (data to estimate frequency are not sufficient).

Blood and lymphatic system disorders

Very rare: hematopoiesis disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of these disorders are fever, sore throat, superficial mouth ulcers, flu-like symptoms, marked weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

Immune system disorders

Infrequent: hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, respiratory reactions (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.

Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and throat, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke’s edema or severe anaphylactic shock).

Gastrointestinal disorders

Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, bloating).

Rare: diarrhea, flatulence, constipation, vomiting.

Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases fatal, especially in elderly patients, ulcerative stomatitis, gastritis.

Prevalence unknown: exacerbation of colitis and Crohn’s disease.

Hepatic and biliary tract disorders

Very rare: hepatic dysfunction (especially with long-term use), hepatitis and jaundice.

Renal and urinary tract disorders

Very rare: Acute renal failure (compensated and decompensated) especially with prolonged use, combined with an increase in plasma urea concentration and appearance, edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

Infrequent: headache.

Very rare: aseptic meningitis.

Cardiovascular system disorders

Frequent unknown: heart failure, peripheral edema, with prolonged use, increased risk of thrombotic complications (such as myocardial infarction), increased blood pressure.

Respiratory and mediastinal disorders

Area unknown: bronchial asthma, bronchospasm, dyspnea.

Others

Very rare: edema, including peripheral edema.

Laboratory measures

Hematocrit or hemoglobin (may decrease)

bleeding time (may increase)

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plasma glucose concentration (may decrease)

creatinine clearance (may decrease)

/p>

Plasma creatinine concentration (may increase)

Hepatic transaminase activity (may increase)

If side effects occur, stop taking the drug and see a physician.

Overdose

In children, overdose symptoms may occur after a dose greater than 400 mg/kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of the drug in overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, epigastric pain or, less frequently, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: somnolence, rarely – agitation, seizures, disorientation, coma.

In cases of severe poisoning metabolic acidosis and increased prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is possible.

The treatment: symptomatic, with mandatory provision of airway patency, ECG monitoring and basic vital signs until the patient’s condition normalizes.

The oral administration of activated charcoal or gastric lavage within 1 hour after taking a potentially toxic dose of ibuprofen is recommended.

If ibuprofen is already absorbed, alkaline drinking may be prescribed in order to eliminate the acidic derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be controlled with intravenous diazepam or lorazepam. In worsening bronchial asthma the use of bronchodilators is recommended.

Pregnancy use

Nurofen Express Lady is not prescribed during pregnancy, lactation and children under 12 years of age.

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