Nurofen 100mg/5ml d/children's 100ml suspension /strawberry/

Manufacturer: Реккит Бенкизер
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Brief information

Производитель

Реккит Бенкизер

Действующее вещество

Ибупрофен

The appearance of the product may differ from the photos on the site.

General description
Источник:  РЛС

Composition

Oral suspension 100 mg (orange, strawberry)5 ml
active substance: 
ibuprofen100 mg
auxiliary substances: Polysorbate 80 — 0.5 mg; glycerol — 0.5 ml; syrup maltitol — 1,625 ml; sodium saccharine 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 2М16014 or strawberry flavoring 500244Е — 12.5 mg; purified water to 5 ml 

Description of the dosage form

A white or almost white suspension of syrupy consistency with an orange or strawberry smell.

Pharmacokinetics

Absorption-high, quickly and almost completely absorbed from the gastrointestinal tract (the connection with plasma proteins-90%). After taking the drug on an empty stomach in adults ibuprofen is detected in plasma after 15 min, Cmax of ibuprofen in the blood plasma is reached after 60 min. taking the drug together with food may increase Tmax of 1-2 h, T1/2 — 2 hours penetrates Slowly into the cavity, delayed in the synovial fluid, creating in it big concentration, than in plasma. After absorption, about 50% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Undergoes metabolism in the liver. Excreted by the kidneys unchanged no more than 1% and, to a lesser extent, with bile.

In clinical studies, ibuprofen was found in breast milk in very low concentrations.

Pharmacodynamics

The mechanism of action of ibuprofen, a propionic acid derivative from the NSAID group, is due to inhibition of the synthesis of PG-mediators of pain, inflammation and hyperthermic reaction. Indiscriminately blocks COX-1 and COX-2, thereby inhibiting the synthesis of PG. In addition, ibuprofen reversibly inhibits platelet aggregation. It has an analgesic, antipyretic and anti-inflammatory effect. Analgesic effect is most pronounced in inflammatory pain. The effect of the drug lasts up to 8 hours.

Indications of the drug

For children from 3 months to 12 years:

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 analgesic for mild or moderate pain syndrome, including toothache, headache, migraine, neuralgia, ear pain, sore throat, sprained ligaments, 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, and does not affect the progression of the disease.

Contraindications

hypersensitivity to ibuprofen or any of the components that make up the drug;

complete or incomplete combination of bronchial asthma, recurrent nasal and sinus polyposis, and intolerance to acetylsalicylic acid or other NSAIDs;

bleeding or perforation of a gastrointestinal ulcer in the anamnesis, provoked by the use of NSAIDs;

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

severe liver failure or liver disease in the active phase;

severe renal failure (CL creatinine <30 ml / min), confirmed hyperkalemia;

decompensated heart failure, period after coronary artery bypass grafting;

cerebrovascular or other bleeding;

hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

pregnancy (W trimester);

fructose intolerance;

the child's body weight is up to 5 kg.

Caution: in case of conditions specified in this section before using the drug should consult a doctor — concomitant use of other NSAIDs, a history of a single episode of peptic ulcer or bleeding of the gastrointestinal tract, gastritis, enteritis, colitis, infection with Helicobacter pylori, ulcerative colitis, bronchial asthma or allergic diseases in the acute stage or in history — may develop bronchospasm; severe somatic diseases, systemic lupus erythematosus or mixed connective tissue disease (sharp's syndrome) — increased risk of aseptic meningitis; renal failure, including dehydration (Cl creatinine 30-60 ml/min), fluid retention and edema, hepatic failure, arterial hypertension and/or heart failure, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, blood disorders unclear etiology (leukopenia, anemia); the simultaneous use of other drugs that may increase the risk of ulcers or bleeding, particularly oral corticosteroids (including prednisone), anticoagulants (including warfarin), SSRIs (including citalopram, fluoxetine, paroxetine, of sertraline) or antiplatelet agents (including aspirin, clopidogrel); pregnancy (I–II trimester), breastfeeding, old age.

Use during pregnancy and lactation

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, you should consult your doctor. There is evidence that ibuprofen in small amounts can enter breast milk without any negative consequences for the health of the infant.

Dosage and administration

Inside. Nurofen for children is a suspension specially developed for children.

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

Only for short-term use.

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 attached. 5 ml of the drug contains 100 mg of ibuprofen or 20 mg of ibuprofen in 1 ml.

The use of 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, collecting the suspension in the syringe to the desired level. Return the vial to its original position and remove the syringe by gently turning it. Place the syringe in the mouth and slowly press the plunger, gently 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 child's age and body weight. 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 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 for 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 for 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 for 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 for 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 for 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 specified dose.

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

Postimmunization 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) for 24 hours.

Side effect

The risk of side effects can be minimized if you take 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 ibuprofen administration at doses not exceeding 1200 mg/day. In the treatment of chronic conditions and long-term use, other adverse reactions may occur.

The frequency of adverse reactions was estimated based on the following criteria: very often (≥1/10); often (from ≥1/100 to <1/10); infrequently (from ≥1/1000 to <1/100); rarely (from ≥1/10000 to <1/1000); very rare (<1/10000); frequency unknown (no data on frequency estimation).

From the blood and lymphatic system: very rare — hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

The immune system: infrequently — hypersensitivity reactions — non-specific allergic reactions and anaphylactic reactions, reactions of the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, shortness of breath, dyspnea), skin reactions (pruritus, urticaria, purpura, angioedema, exfoliative and bullous dermatitis, including toxic epidermal necrolysis, Lyell's syndrome, Stevens-Johnson, erythema multiforme), allergic rhinitis, eosinophilia; very rare — severe hypersensitivity reactions, including swelling of the face, tongue and throat, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe anaphylaxis).

From the gastrointestinal tract: infrequently-abdominal pain, nausea, dyspepsia; rarely-diarrhea, flatulence, constipation, vomiting; very rarely-peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, ulcerative stomatitis, gastritis; frequency unknown-exacerbation of ulcerative colitis and Crohn's disease.

From the liver and biliary tract: very rarely — violations of liver function.

The kidneys and urinary tract: very rarely — acute renal failure (compensated and decompensated), especially with prolonged use, in combination with increasing concentrations of urea in plasma and edema, papillary necrosis.

From the nervous system: infrequently-headache; very rarely-aseptic meningitis (in patients with autoimmune diseases).

On the part of CCC: the frequency is unknown — heart failure, peripheral edema, with long-term use, the risk of thrombotic complications (for example, myocardial infarction, stroke), increased blood PRESSURE is increased.

From the respiratory system and mediastinal organs: the frequency is unknown — bronchial asthma, bronchospasm, shortness of breath.

Other: very rarely — edema, including peripheral.

Laboratory parameters: hematocrit or Hb (may decrease); bleeding time (may increase); plasma glucose concentration (may decrease); creatinine clearance (may decrease); plasma creatinine concentration (may increase); liver transaminase activity (may increase). If side effects occur, stop taking the drug and consult a doctor.

Interaction

Simultaneous use of ibuprofen with the following drugs should be avoided

Acetylsalicylic acid: except for low doses of acetylsalicylic acid (no more than 75 mg/day) prescribed by a doctor, as co-administration may increase the risk of side effects. When used simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (it may increase the frequency of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting ibuprofen).

Other NSAIDs, including selective COX-2 inhibitors: avoid simultaneous use of two or more drugs from the NSAID group because of the possible increase in the risk of side effects.

Use with caution at the same time as the following drugs

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

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

GCS: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

Antiplatelet agents and SSRIs: increased risk of gastrointestinal bleeding.

Cardiac glycosides: simultaneous administration of NSAIDs and cardiac glycosides can lead to worsening of heart failure, decreased glomerular filtration rate, and increased concentration of cardiac glycosides in blood plasma.

Lithium preparations: there is data on the probability of increasing the concentration of lithium in blood plasma against the background of NSAIDs.

Methotrexate: there is data on the probability of increasing the concentration of methotrexate in blood plasma against the background of NSAIDs.

Cyclosporine: increased risk of nephrotoxicity with simultaneous administration of NSAIDs and cyclosporine.

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

Tacrolimus: with simultaneous administration of NSAIDs and tacrolimus, the risk of nephrotoxicity may increase.

Zidovudine: 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 co-treatment with zidovudine and ibuprofen.

Quinolone-type antibiotics: patients receiving co - treatment with NSAIDs and quinolone-type antibiotics may have an increased risk of seizures.

Overdose

In children, overdose symptoms may occur after taking a dose exceeding 400 mg / kg. in adults, the dose-dependent effect of overdose is less pronounced. T 1/2 of the drug in an overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, pain in the epigastric region or, less frequently, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations of the Central nervous system: drowsiness, rarely-excitement, convulsions, disorientation, coma. In cases of severe poisoning, metabolic acidosis and increased PV may develop, kidney failure, liver tissue damage, decreased blood PRESSURE, respiratory depression, and cyanosis. Patients with bronchial asthma may have an exacerbation of this disease.

Treatment: symptomatic, with mandatory airway patency, ECG monitoring and basic vital signs until the patient's condition is normalized.

Oral administration of activated charcoal or gastric lavage for 1 hour after taking a potentially toxic dose of ibuprofen is recommended. If ibuprofen has already been absorbed, an alkaline drink may be prescribed for the purpose of removing the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged convulsions should be stopped on / in the introduction of diazepam or lorazepam. If bronchial asthma worsens, use of bronchodilators is recommended.

Special instruction

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 picture of peripheral blood and the functional state of the liver and kidneys. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a General blood test (HB determination), and a fecal analysis for hidden blood.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Ethanol is not recommended during treatment. The drug is contraindicated in patients with fructose intolerance, because it contains maltitol.

Nurofen for children can be used for children with diabetes, because 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 of the functional state of the kidneys.

Patients with hypertension, including a history of hypertension and/or CHF, should consult a doctor before using the drug, since the drug can cause fluid retention, increased blood PRESSURE, and edema.

Impact on the ability to manage transport and other potentially dangerous mechanisms. Patients who experience dizziness, drowsiness, lethargy, or visual impairment when taking ibuprofen should avoid driving vehicles or operating machinery.

Form release

Oral suspension (orange, strawberry), 100 mg/5 ml. PET bottle with a lid made of LDPE or polypropylene with a gasket containing 100 ml, 150 ml or 200 ml of suspension.

Each bottle is complete with a syringe dispenser, Packed in a cardboard box.

Conditions of supply of pharmacies

Without a prescription.

Manufacturer

Reckitt Benckiser helscare limited, Dansom lane, hull, East Yorkshire, HYW8 7DS, United Kingdom.

Reckitt Benckiser helscar India limited, Khasra 701/534, p. Sandholi, buddy-Nalagar road, buddy, Solan district (Himachal Pradesh), India (for oral suspension (orange).

Legal entity in whose name the certificate of registration: Reckitt Benckiser helsker international Ltd., Tain road, Nottingham, NG90 2DB, United Kingdom.

Representative in Russia/organization accepting customer complaints: LLC Reckitt Benckiser helsker. 14 Kozhevnicheskaya street, Moscow, 115114, Russia.

Phone: 8-800-505-1-500 (toll-free in Russia).

contact_ru@rb.com

The appearance of the product may differ from the photos on the site.

Information about prescription drugs is for professionals only. The information provided should not be used by patients to make an independent decision on the use of the presented drugs and cannot serve as a substitute for a full-time consultation with a doctor.

A description of the active substances of the drug is provided. The scientific information provided is generalized and cannot be used to decide on the possibility of using a specific drug.

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