Nurofen Express - instructions for use, dose, side effects, contraindications

Composition:One tablet, film-coated, contains active substance - ibuprofen lysinate 342 mg (corresponding to 200 mg ibuprofen) and Excipients: povidone 14 mg, sodium carboxymethyl starch 36 mg, magnesium stearate 3 mg. Shell composition: hypromellose 7.8 mg, talc 1.6 mg, dye dangerous white M-1-7 W B 2.6 mg [hypromellose, titanium dioxide (E171)]. Inks Opacode S-1-27794 black [shellac, iron oxide black oxide (E172), propylene glycol].

Description:

White or almost white tablets capsular shaped, homogeneous structure with a polished surface, film-coated, with a black overprint "N" " on one side of the tablet.

Type of tablet on a cross-section: white or almost white mass.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:The drug belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Nurofen® Express has analgesic, antipyretic and anti-inflammatory effects. Non-selectively blocks COX1 and COX2. The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia.

Pharmacokinetics:Absorption is high. T1 / 2 (half-life) -2 h, the connection with plasma proteins - 90%.The maximum concentration C (max) ibuprofen in the plasma is achieved 35 minutes after taking the drug, which is twice as fast as the standard Nurofen® tablets. Lysine does not have pharmacological activity. Ibuprofen lysinate dissociates into ibuprofen and lysine. Slowly penetrates into the joint cavity, is retained in the synovial fluid, creating in it greater concentrations than in the plasma. After absorption about 60% of pharmacologically inactive Rform is slowly transformed into an active S-form. Exposed to metabolism. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

Indications:Headache and toothache, migraine, painful menstruation, neuralgia, back pain, muscle and rheumatic pains; feverish conditions with influenza and colds.

Contraindications:

- Hypersensitivity to any of the ingredients that make up the drug. Hypersensitivity to acetylsalicylic acid or other NSAIDs in history, incl. anamnestic data on an attack of bronchial obstruction, rhinitis, hives after taking acetylsalicylic acid or other NSAIDs; a complete or incomplete syndrome of intolerance to acetylsalicylic acid (rhinosinusitis, urticaria, polyps of the nasal mucosa,bronchial asthma).

- Erosive and ulcerative diseases of the gastrointestinal tract in the stage of exacerbation (including peptic ulcer of the stomach and duodenum, Crohn's disease, ulcerative colitis).

- Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

- The period after aortocoronary bypass surgery.

- Gastrointestinal bleeding and intracranial hemorrhage.

- Severe hepatic impairment or active liver disease.

- Renal failure (creatinine clearance <30 mL / min), confirmed hyperkalemia.

- Pregnancy III trimester.

- Children under 6 years.

- Decompensated heart failure.

Carefully:advanced age, heart failure, arterial hypertension, ischemic heart disease, cerebrovascular disease, dyslipidemia, diabetes, peripheral arterial disease, smoking, frequent alcohol use, liver cirrhosis with portal hypertension, liver and / or renal failure, nephrotic syndrome, hyperbilirubinemia, peptic gastric ulcer and duodenal ulcer (in history)gastritis, enteritis, colitis, blood diseases of unclear etiology (leukopenia and anemia), lactation period, long-term use of NSAIDs, severe somatic diseases, simultaneous intake of oral GCS (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (incl. acetylsalicylic acid, clopidogrel), pregnancy I-II trimester, selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline)

Dosing and Administration:

Adults and children over 12 years of age, after eating in tablets of 200 mg 3-4 times a day. Tablets should be washed down with water.

To achieve a rapid therapeutic effect in adults, the dose can be increased to 400 mg (2 tablets) 3 times a day.

Children from 6 to 12 years: 1 tablet no more than 4 times a day; the drug can be used only in the case of a child's body weight of more than 20 kg. The interval between taking the tablets is at least 6 hours. Do not take more than 6 tablets in 24 hours. The maximum daily dose is 1200 mg. The maximum daily dose for children from 12-17 years is 1000 mg. If symptoms persist for 2-3 days after taking the drug, stop treatment and consult a doctor.

Side effects:

When the drug is administered, the following side effects may occur:

- Gastrointestinal tract (GIT)

NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation, rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis.

- Hepatobiliary system

Hepatitis.

- Respiratory system

Shortness of breath, bronchospasm.

- Sense organs

Hearing impairment: hearing loss, ringing or tinnitus; visual impairment: toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).

- Central and peripheral nervous system

Headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

- The cardiovascular system

Heart failure, tachycardia, increased blood pressure.

- Urinary system

Acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.

- Allergic reactions

Skin rash (usually erythematous or urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

- Hematopoietic organs

Anemia (including hemolytic, aplastic), thrombocytopenia and thromboditopenic purpura, agranulocytosis, and leukopenia.

- Other

Increased sweating

- Laboratory indicators:

- bleeding time (may increase)

- serum glucose concentration (may decrease)

- clearance of creatinine (may decrease)

- hematocrit or hemoglobin (may decrease)

- serum creatinine concentration (may increase)

- activity of "liver" transaminases (may increase)

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

Overdose:

Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy.

Interaction:

It is not recommended simultaneous reception of Nurofen® Express with acetylsalicylic acid and other NSAIDs. With simultaneous appointment ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (possibly increasing the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after the onset of ibuprofen administration). When administered with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time. Simultaneous reception with serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline) increases the risk of developing serious gastrointestinal bleeding. Cefamandol, cefapperazone, cefotetan, valproic acid, plikamycin, increase the frequency of hypoprothrombinemia. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandin in the kidneys, which is manifested by an increase nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and

the likelihood of developing its hepatotoxic effects. Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic effects. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochloride azide. Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics.Increases the side effects of mineralocorticoids, glucocorticoids, estrogens, ethanol. Enhances the effect of oral

hypoglycemic drugs and insulin, sulfonylurea derivatives. Antacids and colestramine reduce absorption. Increases the concentration in the blood of digoxin, lithium preparations, methotrexate.

Myelotoxic drugs increase manifestations of drug hematotoxicity Caffeine strengthens the analgesic effect.

Special instructions:

During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is performed, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction. During treatment should refrain from drinking alcohol.

Form release / dosage:

Tablets, film-coated 200 mg.

Packaging:

For 6 or 12 tablets in a blister (PVC / PVDC / aluminum).

One blister (6 or 12 tablets) or two blisters (6 or 12 tablets each) are placed in a cardboard box together with instructions for use.

Storage conditions:In a dry place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N016032 / 01

Date of registration:13.10.2009

The owner of the registration certificate:Rekitt Benckiser Helsar International Ltd.Rekitt Benckiser Helsar International Ltd. United Kingdom

Manufacturer: & nbsp

RECKITT BENCKISER HEALTHCARE INTERNATIONAL, Ltd. United Kingdom

Representation: & nbspREKITT BENKIZER HELSKER LTD. REKITT BENKIZER HELSKER LTD. United Kingdom

Information update date: & nbsp09.04.2012

Illustrated instructions

Instructions

Nurofen® Express (Nurofen® Express)