Nurofen for children suspension (orange) 100mg / 5ml, 200 ml

For children from 3 months to 12 years old:

as a symptomatic treatment as an antipyretic agent for acute respiratory infections (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature;

as a symptomatic pain reliever for pain syndrome of mild or moderate intensity, incl. toothache, headache, migraine, neuralgia, ear pain, sore throat, sprain pain, muscle pain, rheumatic pain, joint pain and other types of pain.

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Inside. NurofenЃ for children is a suspension specially designed for children.

Patients with hypersensitivity of the stomach are advised to take the drug with meals.

For short term use only.

Read the instructions carefully before taking the drug.

Shake the bottle thoroughly before use. A convenient measuring syringe is included for accurate metering of the drug dose. 5 ml of the drug contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.

Using a measuring syringe

Insert the measuring syringe tightly into the neck of the bottle. Turn the bottle upside down and gently pull the plunger down, drawing the suspension into the syringe to the desired mark. Return the bottle to its original position and remove the syringe by gently turning it. Place the syringe in the oral cavity and slowly push the plunger, smoothly releasing the suspension.

After use, rinse the syringe in warm water and dry it out of the reach of the child.

Fever (fever) and pain

The dosage for children depends on the age and body weight of the child. The maximum daily dose should not exceed 30 mg / kg with intervals between doses of the drug 6-8 hours. Children aged 3-6 months (child weight from 5 to 7.6 kg) - 2.5 ml (50 mg) up to 3 once within 24 hours, no more than 7.5 ml (150 mg) per day.

Children aged 6-12 months (child weight 7.7-9 kg): 2.5 ml (50 mg) up to 3-4 times within 24 hours, no more than 10 ml (200 mg) per day. Children aged 1-3 years (child weight 10-16 kg): 5 ml (100 mg) up to 3 times within 24 hours, no more than 15 ml (300 mg) per day.

Children aged 4Ц6 years (child weight 17Ц20 kg): 7.5 ml (150 mg) up to 3 times within 24 hours, no more than 22.5 ml (450 mg) per day.

Children aged 7Ц9 years (child weight 21Ц30 kg): 10 ml (200 mg) up to 3 times within 24 hours, no more than 30 ml (600 mg) per day.

Children aged 10-12 years (child weight 31-40 kg): 15 ml (300 mg) up to 3 times within 24 hours, no more than 45 ml (900 mg) per day.

The duration of treatment is no more than 3 days. Do not exceed the indicated dose.

If symptoms persist or worsen when taking the drug for 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older), you must stop treatment and consult a doctor.

Post-immunization fever

Children under the age of 6 months: 2.5 ml (50 mg) of the drug. If necessary, another 2.5 ml (50 mg) after 6 hours. Do not use more than 5 ml (100 mg) within 24 hours.

5 ml of NurofenЃ suspension for children contains the active ingredient - ibuprofen 100 mg and

excipients: polysorbate 80 0.5 mg, glycerol 0.5 ml, maltitol syrup 1.625 ml, sodium saccharinate 10 mg, citric acid 20 mg, sodium citrate 25.45 mg, xanthan gum 37.5 mg, sodium chloride 5.5 mg, domiphene bromide 0.5 mg, orange flavor 2M16014 12.5 mg, purified water up to 5 ml.

Х Hypersensitivity to ibuprofen or any of the components that make up the drug.

Х Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs.

Х Bleeding or perforation of gastrointestinal ulcers in history, provoked by the use of NSAIDs.

Х Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis) or ulcerative bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding).

Х Severe liver failure or active liver disease.

Х Renal failure of severe severity (creatinine clearance <30 ml / min), confirmed hyperkalemia.

Х Decompensated heart failure, the period after coronary artery bypass grafting.

Х Cerebrovascular or other bleeding.

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

Х Pregnancy (III trimester).

Х Fructose intolerance.

Х Child's body weight up to 5 kg.

Carefully:

If you have the conditions listed in this section, you should consult your doctor before using the drug. Concomitant use of other NSAIDs, a history of a single episode of gastric ulcer or gastrointestinal ulcer bleeding, gastritis, enteritis, colitis, Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the stage of exacerbation or in history - the development of bronchospasm is possible; severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharp's syndrome) - the risk of aseptic meningitis is increased; chickenpox; renal failure, including dehydration (creatinine clearance 30-60 ml / min), fluid retention and edema, liver failure, arterial hypertension and / or heart failure, cerebrovascular diseases,dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, blood diseases of unknown etiology (leukopenia, anemia); concomitant use of other drugs that can increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), breastfeeding period, old age.which can increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), or antiplatelet agents (in including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), breastfeeding period, old age.which can increase the risk of ulcers or bleeding, in particular, oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), or antiplatelet agents (in including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), breastfeeding period, old age.elderly age.elderly age.

Application during pregnancy and breastfeeding:

The use of the drug in the third trimester of pregnancy is contraindicated. Before using the drug in the I-II trimesters of pregnancy or during breastfeeding, consult your doctor. There is evidence that small amounts of ibuprofen can pass into breast milk without any adverse effects on the health of the infant.

Pharmacology.

The mechanism of action of ibuprofen, a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), as a result of which it inhibits the synthesis of prostaglandins. In addition, ibuprofen reversibly inhibits platelet aggregation. It has analgesic, antipyretic and anti-inflammatory effects. The analgesic effect is most pronounced for inflammatory pain. The action of the drug lasts up to 8 hours.

Pharmacokinetics:

Absorption - high, quickly and almost completely absorbed from the gastrointestinal tract (GIT) (connection with blood plasma proteins - 90%). After taking the drug on an empty stomach in adults, ibuprofen is found in the blood plasma after 15 minutes, the maximum concentration (Cmax) of ibuprofen in the blood plasma is reached after 60 minutes. Taking the drug with food can increase the time to reach the maximum concentration (TCmax) up to 1-2 hours. The half-life (T1 / 2) is 2 hours. It slowly penetrates into the joint cavity, retains in the synovial fluid, creating higher concentrations in it than in the blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. It is excreted by the kidneys (unchanged, no more than 1%) and, to a lesser extent, with bile.In limited studies, ibuprofen has been found in breast milk at very low concentrations.

Special instructions:

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms. During long-term treatment, it is necessary to monitor the peripheral blood picture and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, general blood count (hemoglobin determination), and fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment, it is not recommended to take ethanol. The drug is contraindicated in patients with fructose intolerance, as it contains maltitol. NurofenЃ for children can be used in children with diabetes mellitus, as the drug does not contain sugar Does not contain dyes.Patients with renal insufficiency should consult a doctor before using the drug, as there is a risk of deterioration in the functional state of the kidneys. Patients with hypertension, including a history of and / or chronic heart failure, should consult a doctor before using the drug, as the drug can cause fluid retention, increased blood pressure and edema. The use of NSAIDs in patients with chickenpox may be associated with an increased risk of developing severe purulent complications of infectious and inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid the use of the drug for chickenpox. Patients who experience dizziness, drowsiness, lethargy, or visual impairment while taking ibuprofen,driving or operating machinery should be avoided.

Side effect:

The risk of side effects can be minimized by taking the drug in a short course, in the minimum effective dose necessary to eliminate symptoms. Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term administration of ibuprofen in doses not exceeding 1200 mg / day. In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur. The assessment of the frequency of occurrence of adverse reactions was made on the basis of the following criteria: very frequent (? 1/10), frequent (from? 1/100 to <1/10), infrequent (from? 1/1000 to <1/100), rare ( from? 1/10 000 to <1/1000), very rare (<1/10 000), the frequency is unknown (data on the estimated frequency are not available). Blood and lymphatic system disorders Х Very rare:hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology. Immune system disorders Х Infrequent: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its aggravation, bronchospasm, shortness of breath, dyspnoea), skin reactions (itching, urticaria, purpura, edema Quincke, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Lyell's syndrome, Stevens-Johnson syndrome, erythema multiforme),allergic rhinitis, eosinophilia. Х Very rare: severe hypersensitivity reactions, including swelling of the face, tongue and larynx, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke's edema or severe anaphylactic shock). Gastrointestinal tract disorders Х Uncommon: abdominal pain, nausea, dyspepsia. Х Rare: diarrhea, flatulence, constipation, vomiting. Х Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis. Х Frequency unknown: exacerbation of ulcerative colitis and Crohn's disease. Liver and biliary tract disorders Х Very rare: liver dysfunction. Renal and urinary tract disorders Х Very rare: acute renal failure (compensated and decompensated), especially with prolonged use,in combination with an increase in the concentration of urea in the blood plasma and the appearance of edema, papillary necrosis. Nervous system disorders Х Uncommon: headache. Х Very rare: aseptic meningitis (in patients with autoimmune diseases). Violations of the cardiovascular system Х Frequency unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (eg, myocardial infarction, stroke), increased blood pressure. Respiratory and mediastinal disorders Х Frequency unknown: bronchial asthma, bronchospasm, shortness of breath. Other Х Very rare: edema, including peripheral.Laboratory indicators Х hematocrit or hemoglobin (may decrease) Х bleeding time (may increase) Х plasma glucose concentration (may decrease) Х creatinine clearance (may decrease) Х plasma creatinine concentration (may increase) Х activity of 'hepatic' transaminases (may increase) If side effects appear, stop taking the drug and consult a doctor.

Overdose:

In children, overdose symptoms may occur after taking a dose exceeding 400 mg / kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of the drug in case of overdose is 1.5-3 hours. Symptoms include nausea, vomiting, epigastric pain or, less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, manifestations from the central nervous system are observed: drowsiness, rarely - agitation, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and an increase in prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, an exacerbation of this disease is possible. Treatment: symptomatic,with the obligatory provision of airway patency, monitoring of the ECG and vital signs until the patient's condition is normalized. Oral administration of activated charcoal or gastric lavage is recommended within 1 hour after taking a potentially toxic dose of ibuprofen. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to eliminate the acidic ibuprofen derivative by the kidneys, and forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.Oral administration of activated charcoal or gastric lavage is recommended within 1 hour after taking a potentially toxic dose of ibuprofen. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to eliminate the acidic ibuprofen derivative by the kidneys, and forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.Oral administration of activated charcoal or gastric lavage is recommended within 1 hour after taking a potentially toxic dose of ibuprofen. If ibuprofen has already been absorbed, an alkaline drink may be prescribed to eliminate the acidic ibuprofen derivative by the kidneys, and forced diuresis. Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam. When bronchial asthma worsens, the use of bronchodilators is recommended.When bronchial asthma worsens, the use of bronchodilators is recommended.When bronchial asthma worsens, the use of bronchodilators is recommended.

Interaction with other medicinal products:

Simultaneous use of ibuprofen with the following drugs should be avoided: Х Acetylsalicylic acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a doctor, since combined use may increase the risk of side effects. With the simultaneous use of ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen). Х Other NSAIDs, including selective COX-2 inhibitors: the simultaneous use of two or more drugs from the NSAID group should be avoided due to the possible increase in the risk of side effects.Use with caution together with the following drugs: Х Anticoagulants and thrombolytic drugs: NSAIDs can enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs. Х Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs can reduce the effectiveness of drugs in these groups. Diuretics and ACE inhibitors can increase the nephrotoxicity of NSAIDs. Х Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding. Х Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding. Х Cardiac glycosides: concomitant administration of NSAIDs and cardiac glycosides may worsen heart failure,a decrease in the rate of glomerular filtration and an increase in the concentration of cardiac glycosides in blood plasma. Х Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma with the use of NSAIDs. Х Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in blood plasma with the use of NSAIDs. Х Cyclosporine: increased risk of nephrotoxicity with concomitant administration of NSAIDs and cyclosporine. Х Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs can reduce the effectiveness of mifepristone. Х Tacrolimus: concomitant administration of NSAIDs and tacrolimus may increase the risk of nephrotoxicity. Х Zidovudine: Concomitant use of NSAIDs and zidovudine may increase hematotoxicity.There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who received co-treatment with zidovudine and ibuprofen. Х Quinolone antibiotics: in patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, there may be an increased risk of seizures.