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

One tablet, coated, contains the active substance: 200 mg of ibuprofen; auxiliary substances: croscarmellose sodium 30 mg, sodium lauryl sulfate 0.5 mg, sodium citrate dihydrate 43.5 mg, stearic acid 2.0 mg, silicon dioxide colloid 1.0 mg.The composition of the shell: carmellose sodium 0.7 mg, talc 33.0 mg, acacia gum 0.6 mg, sucrose 116.1 mg, titanium dioxide 1.4 mg, macrogol 6000 0.2 mg, black ink [Opacode S-1 -277001] (shellac 28.225%, iron dye black oxide (E172) 24.65%, propylene glycol 1.3%, isopropanol * 0.55%, butanol * 9.75%, ethanol * 32.275%, purified water * 3, 25%).

Solvents evaporated after the printing process.

Description:Round, biconvex tablets covered with a white or almost white coating with an overprint of black Nurofen on one side of the tablet. On the cross-section of the tablet, the core is white or almost white, the shell is white or almost white.

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® has analgesic, antipyretic and anti-inflammatory act.

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, the connection with plasma proteins is 90%.Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating in it greater concentrations than in the plasma. In the cerebrospinal fluid, lower concentrations of ibuprofen are found in comparison with plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into an active S-form in the gastrointestinal tract and liver. It is metabolized in the liver. Time to reach the maximum concentration in plasma Tmax - 1-2 hours.

The half-life is 2h. It is excreted by the kidneys (70-90% of the administered dose in the form of ibuprofen and its metabolites, unchanged not more than 1%) and, to a lesser extent, bile (less than 2%).

Indications:Nurofen is used for headache and toothache, migraine, painful menstruation, neuralgia, back pain, muscle and rheumatic pain; and also at a feverish condition at a flu and catarrhal diseases.

Contraindications:

- erosive and ulcerative lesions of the gastrointestinal tract in the phase of exacerbation, including peptic ulcer and duodenal ulcer in the acute stage, ulcerative colitis, peptic ulcer, Crohn's disease;

- heart failure;

- severe course of arterial hypertension;

- hypersensitivity to ibuprofen or to the components of the drug;

- complete or incomplete syndrome of intolerance to acetylsalicylic acid (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

- Diseases of the optic nerve; violation of color vision, amblyopia, scotoma;

- deficiency of glucose-b-phosphate dehydrogenase, hemophilia and other disorders of blood coagulability, hemorrhagic diathesis, hypocoagulation conditions

- pregnancy III trimester, lactation period;

- pronounced violations of the liver function;

- marked renal failure (creatinine clearance less than 30 ml / min);

- Hearing loss, pathology of the vestibular apparatus;

- period after aortocoronary shunting;

- gastrointestinal bleeding and intracranial hemorrhage;

- hemophilia and other disorders of blood coagulability, hemorrhagic diathesis;

- children under 6 years.

Carefully:elderly age, ischemic heart disease, cerebrovascular disease, dyslipidemia, diabetes mellitus, peripheral arterial diseases, smoking, frequent alcohol use, prolonged use of NSAIDs,severe somatic diseases, simultaneous administration of oral GCS (incl. prednisolone), anticoagulants (incl. warfarin, clopidogrel, acetylsalicylic acid), the reception of selective serotonin reuptake inhibitors, diseases when taking the drug in patients with peptic ulcer and duodenal ulcer in history, with gastritis, enteritis, colitis, with anamnestic information about bleeding from the gastrointestinal tract; in the presence of concomitant diseases of the liver and / or kidneys; with cirrhosis of the liver with portal hypertension, nephrotic syndrome, chronic heart failure; arterial hypertension; with blood diseases of unclear etiology (leukopenia and anemia); at a bronchial asthma, at a hyperbilirubinemia; pregnancy (I, II trimesters); age younger than 12 years.

Pregnancy and lactation:The use of the drug during pregnancy is possible only under the supervision of a doctor. Application during I, II trimesters is undesirable, but perhaps with caution. Application during the III trimester is contraindicated. The use of the drug during lactation is possible with caution.

Dosing and Administration:

Nurofen® is prescribed for adults and children over 12 years inside, after eating 200 mg tablets 3-4 times a day in tablets. 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. If symptoms persist for 2-3 days after taking the drug, stop treatment and consult a doctor.

Side effects:

With the use of Nurofen® in the course of 2-3 days, side effects are practically not observed. In the case of prolonged use, the following side effects may occur:

- From the gastrointestinal tract: nausea, vomiting, heartburn, anorexia, pain and discomfort in the epigastric pain, diarrhea, flatulence, you may experience erosive and ulcerative lesions of the gastrointestinal tract (in some cases complicated by perforation and bleeding), abdominal pain, irritation,dryness of the oral mucosa or pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis, constipation, hepatitis.

- From the nervous system: headache, dizziness, insomnia, agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

- From the cardiovascular system: heart failure, increased blood pressure (BP), tachycardia.

- From the urinary system: nephrotic syndrome (edema), acute renal failure, allergic nephritis, polyuria, cystitis.

- From the hematopoiesis: anemia (including haemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

- From the sense organs: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis), scotoma.

- Allergic reactions: skin rash, itching, urticaria, Quincke's edema, anaphylactoid reactions, anaphylactic shock, fever, multiform exudative erythema (incl.Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

- From the respiratory system: bronchospasm, shortness of breath.

- Other: increased sweating.

With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (violation of color vision, scotoma, amblyopia).

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 and hepatic insufficiency, gastrointestinal bleeding, lowering blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, stopping breathing, increasing prothrombin time, spasms are rarely possible.

Treatment: gastric lavage (only for an hour after taking), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy.In the case of frequent or prolonged seizures, it is necessary to use anticonvulsants (diazepam or lorazepam intravenously).

Interaction:It is not recommended to take Nurophen tablets with acetylsalicylic acid (ASA) and other NSAIDs simultaneously. With simultaneous appointment ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (ASA) (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid (ASA) 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. Cefamandol, cefapperazone, cefotetan, valproic acid, plikamycin, increase the purity of hypoprothrombinemia. Cyclosporin and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of 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 developing severe hepatotoxic reactions. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic effects. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics. Increases the side effects of mineral corticosteroids, glucocorticosteroids, estrogens, ethanol. Strengthens the effect of oral hypoglycemic drugs, derivatives of sulfonylureas and insulin ,. Antacids and colestramine reduce absorption. Increases the concentration in the blood of digoxin, lithium preparations, methotrexate. 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

esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), 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 related to the management of vehicles and work with moving mechanisms, as well as other types of potentially dangerous activities related to concentration of attention and increased speed of psychomotor reactions.

During treatment should refrain from drinking alcohol.

Effect on the ability to drive transp. cf. and fur:Patients should refrain from all activities related to the management of vehicles and work with moving mechanisms, as well as other types of potentially dangerous activities related to concentration of attention and increased speed of psychomotor reactions.

Form release / dosage:

The tablets are coated. 200 mg.

Packaging:By 6, 8, 10 or 12 tablets in a blister (PVC / PVDC / aluminum). One blister (6, 8, 10 or 12 tablets) or two blisters (6, 8, 10 or 12 tablets) or 3 blisters (10 or 12 tablets) or 4 blisters (12 tablets) or 8 blisters 12 tablets) together with the instructions for use are placed in a cardboard box or plastic container.

Storage conditions:

Store in a dry place at a temperature not exceeding + 25 ° C.

Keep the drug out of the reach of children!

Shelf life:

3 years.

Do not use the drug with expired shelf life.

Terms of leave from pharmacies:Without recipe

Registration number:П N013012 / 01

Date of registration:10.05.2011

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: & nbsp10.01.2013

Illustrated instructions

Instructions

Nurofen® (Nurofen® )