Nurofen for children oral suspension orange 100 mg/5 ml 200 ml bottle 1 pc. in Moscow

Nurofen® for children is a suspension specially designed for children. For oral administration. Patients with hypersensitivity of the stomach are recommended 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. To accurately measure the dose of the drug, a convenient measuring syringe is included. 5 ml of the drug contain 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.

Using a measuring syringe:

Insert the measuring syringe firmly 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 level. Return the bottle to its original position and remove the syringe, gently turning it. Place the syringe in the mouth and slowly press 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 (heat) 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 of the child’s body weight with intervals between doses of the drug of 6-8 hours.

Children aged 3-6 months (child weight from 5 to 7.6 kg): 2.5 ml (50 mg) up to 3 times 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): 5.0 ml (100 mg) up to 3 times within 24 hours, no more than 15 ml (300 mg) per day.

Children aged 4-6 years (child weight 17 - 20 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 7-9 years (child weight 21 - 30 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 after taking the drug within 24 hours (in children aged 3-5 months) or within 3 days (in children aged 6 months and older), you should stop treatment and consult a doctor.

Post-immunization fever: Children under 6 months of age: 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) in 24 hours.

Nurofen suspension for internal use for children 100 mg/5 ml 200 ml orange

Compound

Active substance: ibuprofen 100 mg. Excipients: polysorbate 80 - 0.5 mg, glycerol - 0.5 mg, maltitol syrup - 1.625 mg, sodium saccharinate - 10 mg, citric acid - 20 mg, sodium citrate - 25.45 mg, xanthan gum - 37.5 mg, sodium chloride - 5.5 mg, domiphen bromide - 0.5 mg, orange flavor 2M16014 - 12.5 mg, purified water - up to 5 ml.

Pharmacokinetics

When taken orally, ibuprofen is almost completely absorbed from the gastrointestinal tract. Concomitant food intake slows down the rate of absorption. Metabolized in the liver (90%). T1/2 is 2-3 hours. 80% of the dose is excreted in the urine mainly in the form of metabolites (70%), 10% - unchanged; 20% is excreted through the intestines in the form of metabolites.

Indications for use

Nurofen® suspension for children is used in children from 3 months to 12 years of age for symptomatic treatment as an antipyretic for acute respiratory diseases (including influenza), childhood infections, other infectious and inflammatory diseases and post-vaccination reactions accompanied by an increase in body temperature .

The drug is used as a symptomatic analgesic for pain of mild or moderate intensity, including: toothache, headache, migraine, neuralgia, ear pain, sore throat, sprain pain, muscle pain, rheumatic pain, joint pain .

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

Contraindications

Hypersensitivity to ibuprofen or any of the components included in the drug.
Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs.
A history of bleeding or perforation of a gastrointestinal ulcer caused by the use of NSAIDs.
Erosive and ulcerative diseases of the gastrointestinal tract (including gastric and duodenal ulcers, 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).
Severe liver failure or active liver disease.
Severe renal failure (creatinine clearance <30 ml/min), confirmed hyperkalemia.
Decompensated heart failure, the period after coronary artery bypass grafting.
Cerebrovascular or other bleeding.
Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
Pregnancy (III trimester).
Fructose intolerance.
The child's body weight is up to 5 kg.

With caution:
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 ulcerative bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, the presence of Helicobacter pylori infection, ulcerative colitis; bronchial asthma or allergic diseases in the acute stage or in history - bronchospasm may develop; severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (Sharpe's syndrome) - increased risk of aseptic meningitis; chicken pox; 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, diseases blood of unknown etiology (leukopenia, anemia); simultaneous use of other drugs that may 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 (including acetylsalicylic acid, clopidogrel); pregnancy (I-II trimester), breastfeeding period, old age.

Directions for use and doses

Nurofen® for children is a suspension specially developed for children. For oral administration. Patients with hypersensitivity of the stomach are recommended to take the drug with meals.

For short term use only. Read the instructions carefully before taking the drug.

Using a measuring syringe:

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

Fever (heat) and pain:

Children aged 3-6 months (child weight from 5 to 7.6 kg): 2.5 ml (50 mg) up to 3 times 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): 5.0 ml (100 mg) up to 3 times within 24 hours, no more than 15 ml (300 mg) per day.

Children aged 4-6 years (child weight 17-20 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 7-9 years (child weight 21-30 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.

Post-immunization fever:

Children under 6 months of age: 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) in 24 hours.

Storage conditions

At a temperature not higher than 25 °C. Keep out of the reach of children.

Best before date

3 years. Use within 6 months after opening the bottle. Do not use a drug that has expired.

special instructions

It is recommended to take the drug for the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.

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. During the treatment period, ethanol intake is not recommended. The drug is contraindicated in patients with fructose intolerance, as it contains maltitol.

Nurofen® for children can be used by children with diabetes mellitus, since the drug does not contain sugar. Does not contain dyes.

Patients with renal failure 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 hypertension and/or chronic heart failure, should consult a physician before using the drug, as the drug may 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 inflammatory diseases of the skin and subcutaneous fat (for example, necrotizing fasciitis). In this regard, it is recommended to avoid using the drug for chickenpox.

Description

Non-steroidal anti-inflammatory drug (NSAID).

Use in children

Allowed from 3 months.

Pharmacodynamics

NSAIDs, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic and antipyretic effects.

The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to both peripheral (indirectly, through suppression of prostaglandin synthesis) and central mechanisms (inhibition of prostaglandin synthesis in the central and peripheral nervous system). Suppresses platelet aggregation.

Side effects

The risk of side effects can be minimized if the drug is taken in a short course, at the minimum effective dose required to eliminate symptoms.

Side effects are predominantly dose-dependent. The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg/day. When treating chronic conditions and with long-term use, other adverse reactions may occur.

The frequency of adverse reactions was assessed based on the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare ( from ≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), frequency unknown (no frequency estimates available).

Blood and lymphatic system disorders

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

Uncommon: hypersensitivity reactions - nonspecific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (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 larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylactic shock).

Gastrointestinal disorders

Uncommon: abdominal pain, nausea, dyspepsia.
Rare: diarrhea, flatulence, constipation, vomiting.
Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, hematemesis, ulcerative stomatitis, gastritis.
Frequency unknown: exacerbation of ulcerative colitis and Crohn's disease.

Disorders of the liver and biliary tract

Very rare: liver dysfunction.

Nocturnal and urinary tract disorders

Very rare: acute renal failure (compensated and decompensated), especially with long-term 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

Uncommon: headache.
Very rare: aseptic meningitis (in patients with autoimmune diseases).

Cardiovascular disorders

Frequency unknown: heart failure, peripheral edema, with long-term use there is an increased risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood pressure.

Disorders of the respiratory system and mediastinal organs

Frequency unknown: bronchial asthma, bronchospasm, shortness of breath.

Others

Very rare: edema, including peripheral edema.

Laboratory indicators

hematocrit or hemoglobin (may decrease)
bleeding time (may increase)
plasma glucose concentration (may decrease)
creatinine clearance (may decrease)
plasma creatinine concentration (may increase)
activity of “liver” transaminases (may increase)

If side effects occur, you should stop taking the drug and consult a doctor.

Use during pregnancy and breastfeeding

The use of the drug is contraindicated in the third trimester of pregnancy.
Before using the drug in the first and second trimesters of pregnancy or during breastfeeding, you should consult your doctor. There is evidence that ibuprofen can pass into breast milk in small quantities without any adverse effects on the health of the nursing infant.

Interaction

The simultaneous use of ibuprofen with the following drugs should be avoided:

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 simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (an increase in the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent is possible after starting ibuprofen).

Other NSAIDs, including selective COX-2 inhibitors: The simultaneous use of two or more NSAIDs should be avoided due to a possible increased risk of side effects.

Use with caution simultaneously with the following medications:

Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants, in particular warfarin and thrombolytic drugs.

Antihypertensives (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.

Glucocorticosteroids: increased risk of gastrointestinal ulceration and gastrointestinal bleeding.

Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Cardiac glycosides: simultaneous administration 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.

Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs.

Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.

Cyclosporine: increased risk of nephrotoxicity when NSAIDs are administered concomitantly with cyclosporine.

Mifepristone: NSAIDs should be started no earlier than 8 to 12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.

Tacrolimus: When NSAIDs and tacrolimus are coadministered, the risk of nephrotoxicity may increase.

Zidovudine: Concomitant use of NSAIDs and zidovudine may result in 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.

Quinolone antibiotics: In patients receiving concomitant treatment with NSAIDs and quinolone antibiotics, the risk of seizures may be increased.

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: 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 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.

Treatment: symptomatic, with mandatory maintenance of airway patency, monitoring of ECG and vital signs until the patient’s condition is normalized. Oral use 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 in order to eliminate the acidic derivative of ibuprofen by the kidneys, forced diuresis.

Frequent or prolonged seizures should be treated with intravenous diazepam or lorazepam.

If bronchial asthma worsens, the use of bronchodilators is recommended.

Impact on the ability to drive vehicles and operate machinery

Patients who experience dizziness, drowsiness, lethargy, or blurred vision while taking ibuprofen should avoid driving or operating machinery.