Active substanceIbuprofenIbuprofen
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, 200 mg, contains:

    composition of the core of the tablet:

    active substance: ibuprofen 200.00 mg;

    auxiliary substances: cellulose microcrystalline 15.60 mg, silicon dioxide colloid 12.78 mg, croscarmellose sodium 6.92 mg, magnesium stearate 1.37 mg;

    composition of the tablet shell: hypromellose 1.43 mg, macrogol-400 0.15 mg, titanium dioxide 0.70 mg, talc 0.65 mg.

    1 tablet, film-coated, 400 mg, contains:

    composition of the core of the tablet:

    active substance: ibuprofen 400.00 mg;

    auxiliary substances: microcrystalline cellulose 31,20 mg, silicon colloidal dioxide 25.55 mg, croscarmellose sodium 13.84 mg, magnesium stearate 2.75 mg;

    composition of the tablet shell: hypromellose 3.56 mg, macrogol-400 0.38 mg, titanium dioxide 1.75 mg, talc 1.63 mg.

    Description:

    Tablets 200 mg

    White round biconvex tablets, covered with a film membrane.

    Cross-sectional view: white.

    Tablets 400 mg

    White oblong biconvex tablets, covered with a film sheath, with a risk on both sides.

    Cross-sectional view: white.

    Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)
    ATX: & nbsp

    M.01.A.E.01   Ibuprofen

    Pharmacodynamics:Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), has an anesthetic,antipyretic and anti-inflammatory effect due to indiscriminate blockade of cyclooxygenase 1 and cyclooxygenase 2. The mechanism of action of ibuprofen is caused by inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermic reaction. Has an inhibitory effect on the aggregation of platelets.
    Pharmacokinetics:Absorption is high. 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. Time to reach the maximum concentration in the blood plasma (Tmax) - 1-2 hours. The connection with plasma proteins is about 99%. It is metabolized in the liver. After absorption, about 60% of the pharmacologically inactive R-form of ibuprofen is slowly transformed into an active S-form in the gastrointestinal tract and liver. The half-life period is 2 hours. It is mainly excreted by the kidneys (about 90%) in the form of metabolites, in unchanged form - no more than 1%, to a lesser extent - with bile.
    Indications:

    Symptomatic treatment:

    - pain syndrome of mild and moderate severity, for example, headache and toothache, menstrual pain, neuralgia, back pain, muscle and rheumatic pains;

    - febrile conditions for influenza and colds.

    Contraindications:

    - Hypersensitivity to ibuprofen and / or other components of the drug;

    - intolerance of acetylsalicylic acid or other NSAIDs in history, incl. bronchospasm, bronchial asthma, rhinitis, urticaria, gastrointestinal bleeding, or perforation after taking acetylsalicylic acid or other NSAIDs in the anamnesis;

    - violation of hematopoiesis of unknown etiology;

    - erosive and ulcerative diseases of the organs of the gastrointestinal tract or gastrointestinal bleeding in the stage of exacerbation or in anamnesis;

    - cerebrovascular or other bleeding;

    - Inflammatory bowel disease;

    - pronounced violations of the liver function;

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

    progressive kidney disease;

    - severe heart failure;

    - period after aortocoronary shunting;

    - III trimester of pregnancy;

    - Children under 6 years of age (body weight less than 20 kg) for a dosage of 200 mg; - Children under 12 years of age for a dosage of 400 mg.

    Carefully:Elderly age, cirrhosis with portal hypertension,hyperbilirubinemia, gastric ulcer and duodenum 12 (history), gastritis, enteritis, colitis, ulcerative colitis, Crohn's disease, liver and / or renal failure with a creatinine clearance of 30-60 ml / min, nephrotic syndrome, chronic heart failure, hypertension, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, presence of H. Ru1ory infection, long-term use of NSAIDs, frequent alcohol consumption, cord lye somatic diseases, simultaneous reception of other NSAIDs, oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel, aspirin), selective serotonin reuptake inhibitors (in incl, citalopram, fluoxetine, paroxetine, sertraline), blood diseases of unknown etiology (leucopenia and anemia), pregnancy (1-2 trimester), lactation, porphyrins inborn error of metabolism (e.g., acute intermittent porphyria), disorders convolution Niya blood, systemic lupus erythematosus (SLE)mixed collagenosis (mixed connective tissue disease), in patients after open surgery, as well as in patients with hay fever, with nasal polyps or chronic obstructive pulmonary diseases.
    Pregnancy and lactation:

    The use of ibuprofen in the third trimester of pregnancy is contraindicated.

    In the first and second trimesters of pregnancy, the prescription of the drug is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

    Ibuprofen and its metabolites penetrate into breast milk in small amounts. Since adverse effects on the child have not been observed so far, it is usual for short-term admission to stop breastfeeding. If you need a long-term use of the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:

    Doses of the drug are indicated in the tables below.

    In children and adolescents, the dosage depends on body weight or age and is usually 7-10 mg / kg body weight in a single dose; the maximum daily dose is 30 mg / kg of body weight.

    The intervals between doses of the drug depend on the severity of the symptoms and the total maximum daily dosage. The interval between doses should be at least 6 hours.

    If you keep complaints for more than 4 days, you need to consult a doctor.

    Tablets, film-coated, 200 mg

    Body weight (age)

    Dose for a single dose

    Maximum daily dosage

    20-29 kg (children aged 6 to 9 years)

    1 tablet, film-coated (corresponding to 200 mg of ibuprofen)

    3 tablets, film-coated (corresponding to 600 mg of ibuprofen)

    30-39 kg (children aged 10 to 12 years)

    1 tablet, film-coated (corresponding to 200 mg of ibuprofen)

    4 tablets, film-coated (corresponding to 800 mg of ibuprofen)

    > 40 kg (children and adolescents from 12 years, and also

    1-2 tablets, film-coated

    6 tablets, film-coated


    Film-coated tablets, 400 mg

    Body weight (age)

    Dose for a single dose

    Maximum daily dosage

    > 40 kg (children and adolescents from 12 years old, as well as adults)

    1/2 tablet - 1 tablet, film-coated (corresponding to 200-400 mg of ibuprofen)

    3 tablets, film-coated (corresponding to 1200 mg of ibuprofen)

    The tablets covered with a film cover, accept not chewing, squeezed by a sufficient quantity of a liquid during or after reception of nutrition.

    For patients with stomach diseases it is recommended to take Ibuprofen Sandoz® with food.

    Unwanted reactions can be reduced by taking the lowest effective dose for as short a period of time as necessary to control the symptoms.

    Older patients: in the selection of dosage is not necessary. Careful observation is necessary in view of possible side effects.

    Impaired renal and hepatic function: in patients with mild and moderate renal failure, a dose reduction is not required.

    Side effects:

    According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, < 1/10000, rarely (> 1/10000, <1/1000), very rarely (<1/10000), the frequency is unknown (the frequency can not be determined based on the available data).

    From the cardiovascular system:

    rarely: tachycardia, heart failure, myocardial infarction, arterial hypertension.

    From the side of the blood and lymphatic system:

    rarely: violation of hematopoiesis (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).

    From the nervous system:

    infrequently: headache, dizziness, insomnia, agitation, irritability or fatigue.

    From the side of the organ of vision: infrequently: impaired vision.

    From the organ of hearing: rarely: noise in ears.

    From the gastrointestinal tract:

    often: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, minor gastrointestinal bleeding, which in exceptional cases can lead to the development of anemia;

    infrequently: peptic ulcer with possible complications (bleeding, perforation), ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis;

    rarely: esophagitis, pancreatitis, the development of intestinal membrane strictures.

    From the liver and bile ducts:

    rarely: impaired liver function, hepatotoxicity, especially with long-term treatment, liver failure, acute hepatitis.

    From the side of the kidneys and urinary tract:

    rarely: the development of edema, especially in patients with hypertension or renal insufficiency, nephrotic syndrome,interstitial nephritis, which can be accompanied by acute renal failure, damage to the renal tissue (papillary necrosis), and an increase in the level of uric acid in the blood.

    From the skin and subcutaneous tissues:

    rarely: Bullous eruptions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), alopecia.

    Infectious and parasitic diseases:

    rarely: aggravation of inflammation due to infection (for example, the development of necrotizing fasciitis); symptomatic of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or confusion, especially in patients with autoimmune diseases (SLE, mixed connective tissue diseases).

    From the immune system:

    infrequently: hypersensitivity reactions accompanied by urticaria and itching, as well as asthmatic attacks (possibly with a drop in blood pressure);

    rarely: severe general hypersensitivity reactions, manifested in the form of facial swelling, swelling of the tongue, internal swelling of the larynx, accompanied by difficulty breathing, dyspnea,tachycardia, a drop in blood pressure until the development of a shock that poses a threat to life.

    Disorders of the psyche:

    rarely: psychotic reactions, depression.

    If side effects occur, stop taking the medication and consult a doctor.

    Overdose:

    Symptoms: headache, dizziness, drowsiness, loss of consciousness (children also have myoclonic cramps), abdominal pain, nausea and vomiting. Possible development of bleeding from the gastrointestinal tract, as well as hepatic and renal failure. Also hypotension, respiratory depression and cyanosis can be observed.

    Treatment: gastric lavage (only for an hour after ingestion), 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). There is no specific antidote.

    Interaction:

    Other NSAIDs, including salicylates

    It is not recommended joint use of ibuprofen and other NSAIDs, incl. acetylsalicylic acid because of increased risk of ulceration of the gastrointestinal tract and bleeding.Co-administration with ibuprofen can reduce the inhibitory effect on aggregation of low-dose acetylsalicylic acid platelets.

    Digoxin, phenytoin, lithium preparations

    Joint use of ibuprofen with digoxin, phenytoin or lithium preparations may lead to an increase in the concentration of these drugs in the blood plasma. In most cases, when using therapeutic doses of ibuprofen, there is no need to monitor the concentration of lithium, digoxin and phenytoin in the blood plasma (no more than 4 days).

    Diuretics, ACE inhibitors and angiotensin II receptor antagonists

    Nonsteroidal anti-inflammatory drugs can weaken the effect of diuretics and antihypertensive drugs. In patients with impaired renal function (eg, dehydrated or elderly patients), joint administration of ACE inhibitors or angiotensin II receptor antagonists with cyclooxygenase inhibiting drugs may lead to further impairment of renal function, including the possible development of acute renal failure, which in most cases is reversible. Such combinations of drugs should be used with caution, especially in elderly patients.After the beginning of combination therapy, the patient should regularly monitor the amount of fluid consumed and the function of the kidneys.

    The concomitant use of ibuprofen and potassium-sparing diuretics can lead to hyperkalemia.

    Glucocorticoids

    With the joint use of ibuprofen and glucocorticoids, the risk of ulcers of the gastrointestinal tract and gastrointestinal bleeding is increased.

    Selective serotonin reuptake inhibitors (SSRIs)

    The risk of developing gastrointestinal bleeding is increased with the joint use of ibuprofen and SSRIs.

    Methotrexate

    The use of ibuprofen for 24 hours before and after taking methotrexate may lead to an increase in the concentration of methotrexate in the blood plasma and increased toxic effects.

    Cyclosporin

    The risk of nephrotoxic effects associated with the administration of cyclosporine increases with the simultaneous use of some non-steroidal anti-inflammatory drugs. This effect can not be excluded also for the combination of cyclosporine with ibuprofen.

    Anticoagulants

    Non-steroidal anti-inflammatory drugs can enhance the effect of anticoagulants, such as warfarin.

    Derivatives of sulfonylureas

    At the moment, the interaction between ibuprofen and sulfonylureas is not described, but as a precautionary measure, it is recommended to assess the blood glucose level when these preparations are taken together.

    Special instructions:

    During 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 including esophagogastroduodenoscopy, a blood test with the determination of Hb, a hematocrit, a fecal occult blood test are shown.

    To prevent the development of NSAIDs, gastropathy is recommended to be combined with preparations of prostaglandin E (misoprostol).

    If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

    During treatment should refrain from drinking alcohol. During the treatment in very rare cases, it is possible to damage the hematopoiesis. The first signs of hemopoiesis disorders can be fever, sore throat, superficial ulceration of the oral cavity, influenza-like symptoms, severe weakness, epistaxis, hemorrhagic skin rashes.If these symptoms occur, stop taking the medication and consult a doctor.

    If severe pain occurs in the epigastric region, melena or vomiting with an admixture of blood should stop taking the medication and immediately consult a doctor.

    Effect on the ability to drive transp. cf. and fur:Since taking ibuprofen can lead to unwanted reactions from the CNS (less than 1% of cases), care should be taken when driving vehicles or working with mechanisms that require increased attention.
    Form release / dosage:Tablets, film-coated, 200 mg, 400 mg.
    Packaging:

    2 or 6 tablets are placed in a PVC / A1-blister or polypropylene / A1-blister.

    For 1, 2, 3 or 4 blisters are placed in a cardboard box together with instructions for medical use.

    For 5 or 10 tablets are placed in PVC / A1-blister or polypropylene / A1-blister.

    For 1, 2, 3, 4, 5 or 10 blisters are placed in a cardboard box together with instructions for medical use.

    Storage conditions:

    At a temperature not exceeding 25FROM.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002043
    Date of registration:10.04.2013 / 27.04.2017
    Expiration Date:10.04.2018
    Date of cancellation:2017-05-31
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp20.10.2017
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