Nurofen 200 mg 8 pcs. film-coated tablets for children from 6 years of age
pharmachologic effect
Non-steroidal anti-inflammatory drug (NSAID).
Composition and release form Nurofen 200 mg 8 pcs. film-coated tablets for children from 6 years of age
Tablets - 1 tablet:
- active substance: 200 mg ibuprofen;
- excipients: croscarmellose sodium 30 mg, sodium lauryl sulfate 0.5 mg, sodium citrate dihydrate 43.5 mg, stearic acid 2.0 mg, colloidal silicon dioxide 1.0 mg;
- shell composition: 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 that have evaporated after the printing process.
Film-coated tablets. 200 mg.
6, 8, 10 or 12 tablets per blister (PVC / PVDC / aluminum). One blister (6, 8, 10 or 12 tablets each) or two blisters (6, 8, 10 or 12 tablets each) or 3 blisters (10 or 12 tablets each) or 4 blisters (12 tablets each) or 8 blisters (each 12 tablets) together with instructions for use are placed in a cardboard box or plastic container.
Description of the dosage form
Round, biconvex, white or off-white film-coated tablets with black Nurofen imprint on one side of the tablet. On a cross-section of the tablet, the core is white or almost white, the shell is white or almost white.
Directions for use and doses
NUROFEN® is prescribed to adults and children over 12 years of age orally, after meals, in tablets of 200 mg 3-4 times a day. The tablets should be taken 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 old: 1 tablet no more than 4 times a day; the drug can only be used if the child weighs more than 20 kg. The interval between taking 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 after taking the drug for 2-3 days, you should stop treatment and consult a doctor.
Pharmacodynamics
The drug belongs to non-steroidal anti-inflammatory drugs (NSAIDs). Nurofen® has analgesic, antipyretic and anti-inflammatory effects.
Indiscriminately blocks COX1 and COX2. The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction.
Pharmacokinetics
Absorption is high, binding to plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating higher concentrations in it than in plasma. Lower concentrations of ibuprofen are found in cerebrospinal fluid compared to plasma. After absorption, about 60% of the pharmacologically inactive R form is slowly transformed into the active S form in the gastrointestinal tract and liver. Metabolized in the liver. The time to reach maximum plasma concentration Tmax is 1-2 hours.
The half-life is 2 hours. It is excreted by the kidneys (70-90% of the administered dose in the form of ibuprofen and its metabolites; unchanged, no more than 1%) and, to a lesser extent, with bile (less than 2%).
Indications for use Nurofen 200 mg 8 pcs. film-coated tablets for children from 6 years of age
Nurofen is used for headaches and toothaches, migraines, painful menstruation, neuralgia, back pain, muscle and rheumatic pain; as well as in case of fever due to influenza and colds.
Contraindications
- Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, including gastric and duodenal ulcers in the acute phase, ulcerative colitis, peptic ulcer, Crohn's disease;
- heart failure;
- severe arterial hypertension;
- hypersensitivity to ibuprofen or to the components of the drug;
- complete or incomplete acetylsalicylic acid intolerance syndrome (rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
- optic nerve diseases; impaired color vision, amblyopia, scotoma;
- deficiency of glucose-b-phosphate dehydrogenase, hemophilia and other bleeding disorders, hemorrhagic diathesis, hypocoagulation conditions;
- pregnancy III trimester, lactation period;
- severe liver dysfunction;
- severe renal failure (creatinine clearance less than 30 ml/min);
- hearing loss, pathology of the vestibular apparatus;
- period after coronary artery bypass surgery;
- gastrointestinal bleeding and intracranial hemorrhage;
- hemophilia and other bleeding disorders, hemorrhagic diathesis;
- children under 6 years old.
With caution: elderly age, coronary heart disease, cerebrovascular diseases, dyslipidemia, diabetes mellitus, diseases of peripheral arteries, smoking, frequent alcohol consumption, long-term use of NSAIDs, severe somatic diseases, concomitant use of oral corticosteroids (including prednisolone), anticoagulants (including warfarin, clopidogrel, acetylsalicylic acid), taking selective serotonin reuptake inhibitors, diseases when taking the drug in patients with a history of gastric and duodenal ulcers, gastritis, enteritis, colitis, with anamnestic information about bleeding from the gastrointestinal tract; in the presence of concomitant liver and/or kidney diseases; for liver cirrhosis with portal hypertension, nephrotic syndrome, chronic heart failure; arterial hypertension; for blood diseases of unknown etiology (leukopenia and anemia); for bronchial asthma, for hyperbilirubinemia; pregnancy (I, II trimesters); age under 12 years.
Application of Nurofen 200 mg 8 pcs. film-coated tablets for children over 6 years of age during pregnancy and breastfeeding
The use of the drug during pregnancy is possible only under the supervision of a physician. Use during the 1st and 2nd trimesters is undesirable, but possible with caution. Use during the third trimester is contraindicated. The use of the drug during lactation is possible with caution.
special instructions
During long-term treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a complete blood count (hemoglobin determination), and a stool test for occult blood. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Patients should refrain from all activities related to driving vehicles and working with moving mechanisms, as well as other types of potentially hazardous activities associated with concentration and increased speed of psychomotor reactions.
During the treatment period you should refrain from drinking alcoholic beverages.
Impact on the ability to drive vehicles and operate machinery
Patients should refrain from all activities related to driving vehicles and working with moving mechanisms, as well as other types of potentially hazardous activities associated with concentration and increased speed of psychomotor reactions.
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal and liver failure, gastrointestinal bleeding, decreased blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, respiratory arrest, increased prothrombin time, rarely convulsions.
Treatment: gastric lavage (only within an hour after administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy. In case of frequent or prolonged seizures, it is necessary to use anticonvulsants (diazepam or lorazepam intravenously).
Side effects Nurofen 200 mg 8 pcs. film-coated tablets for children from 6 years of age
When using the drug NUROFEN® for 2-3 days, practically no side effects are observed. In case of long-term use, the following side effects may occur:
- From the gastrointestinal tract: nausea, vomiting, heartburn, anorexia, pain and discomfort in the epigastrium, diarrhea, flatulence, possible 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 gum mucosa, 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 hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.
- From the senses: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma.
- Allergic reactions: skin rash, itching, urticaria, Quincke's edema, anaphylactoid reactions, anaphylactic shock, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
- From the respiratory system: bronchospasm, shortness of breath.
- Other: increased sweating.
With long-term use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, amblyopia).
If side effects occur, you should stop taking the drug and consult a doctor.
Drug interactions
It is not recommended to take NUROFEN tablets simultaneously with acetylsalicylic acid (ASA) and other NSAIDs. When administered simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (ASA) (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid (ASA) as an antiplatelet agent is possible after starting ibuprofen). When prescribed with anticoagulant and thrombolytic drugs (alteplase, streptokinase, urokinase), the risk of bleeding simultaneously increases. Cefamandole, cefaperazone, cefotetan, valproic acid, plicamycin, increase the incidence of hypoprothrombinemia. Cyclosporine and gold preparations enhance 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 developing its hepatotoxic effects. Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen. Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe hepatotoxic reactions. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxicity. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics. Increases the side effects of mineralocorticosteroids, glucocorticosteroids, estrogens, ethanol. Enhances the effect of oral hypoglycemic drugs, sulfonylurea derivatives and insulin. Antacids and cholestyramine reduce absorption. Increases the blood concentration of digoxin, lithium preparations, methotrexate. Caffeine enhances the analgesic effect.
Nurofen film-coated tablets from 12 years 200 mg 12 pcs
With simultaneous use, ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemide, hydrochlorothiazide).
When used simultaneously with anticoagulants, their effect may be enhanced.
When used simultaneously with GCS, the risk of side effects from the gastrointestinal tract increases.
When used simultaneously, ibuprofen can displace indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), and oral hypoglycemic drugs, sulfonylurea derivatives, from compounds with blood plasma proteins.
When used simultaneously with amlodipine, a slight decrease in the antihypertensive effect of amlodipine with acetylsalicylic acid is possible - the concentration of ibuprofen in the blood plasma with baclofen decreases - a case of increased toxic effect of baclofen is described.
When used simultaneously with warfarin, an increase in bleeding time is possible; microhematuria and hematomas with captopril were also observed - a possible decrease in the antihypertensive effect of captopril with cholestyramine - a moderately pronounced decrease in the absorption of ibuprofen.
When used simultaneously with lithium carbonate, the concentration of lithium in the blood plasma increases.
When used simultaneously with magnesium hydroxide, the initial absorption of ibuprofen with methotrexate increases - the toxicity of methotrexate increases.
The simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.
There is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs. With simultaneous use of NSAIDs and cyclosporine, the risk of nephrotoxicity increases.
NSAIDs may reduce the effectiveness of mifepristone, so taking NSAIDs should be started no earlier than 8-12 days after stopping mifepristone.
Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received concomitant treatment with zidovudine and ibuprofen.
In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may increase.
In patients receiving concomitant NSAIDs and myelotoxic drugs, hematotoxicity increases.
With the simultaneous use of ibuprofen and cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin, the incidence of hypoprothrombinemia increases.
With the simultaneous use of ibuprofen and drugs that block tubular secretion, there is a decrease in excretion and an increase in plasma concentration of ibuprofen.
With the simultaneous use of ibuprofen and inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), there is an increase in the production of hydroxylated active metabolites and an increased risk of developing severe intoxications.
