Active substanceIbuprofen + Codeine phosphate hemihydrateIbuprofen + Codeine phosphate hemihydrate
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  • Nurofen® Plus
    pills inwards 
  • Dosage form: & nbspFilm-coated tablets
    Composition:

    One tablet, film-coated, contains active substances: 200 mg of ibuprofen and 12.8 mg of codeine phosphate hemihydrate (equivalent to 10 mg of codeine) and excipients: microcrystalline cellulose 355.44 mg, sodium carboxymethyl starch 45 mg, hypromellose 8.16 mg, pregelatinized starch 25.6 mg; composition-shells: dangerous substances M-1-7111B 4.31 mg (hypromellose 3%, titanium dioxide 30%, water purified 57%, alcohol denatured * 10%), talc 2.61 mg, hypromellose 13.08 mg.
    [* - purified water and denatured alcohol are removed during production]

    Description:

    Tablets capsular, biconvex, film-coated, white with engraving "N+" on one side.

    Pharmacotherapeutic group:Analgesic agent (NSAIDs + analgesic opoid).
    ATX: & nbsp

    N.02.A.A.59   Codeine in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    The drug is a combination of drugs. Has analgesic, antipyretic, anti-inflammatory and antitussive effect.The mechanism of action of ibuprofen is due to inhibition of the synthesis of prostaglandins - mediators of pain, inflammation and hyperthermia.

    Codeine - an analgesic, acts on the opioid receptors of the central nervous system (CNS) and has an antitussive effect.

    Pharmacokinetics:

    Absorption of ibuprofen is high, binding to plasma proteins is 90%. Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating in it greater concentrations than in the plasma. After absorption about 60% of pharmacologically inactive Rform is slowly transformed into an active S-form. The half-life (T 1/2) -2 h. It is metabolized. It is excreted by the kidneys (in an unchanged form not more than 1%) and, to a lesser extent, with bile.

    Codeine after intake is rapidly absorbed from the gastrointestinal tract. Connection with blood plasma proteins - 30%. Time to reach the maximum concentration (TCmax) - 2-4 hours Metabolized in the liver to active metabolites. It is excreted by the kidneys (5-15% unchanged and 10% in the form of morphine and its metabolites), and also with bile. The half-life (T 1/2) - 3 hours

    Indications:

    Pain syndrome of mild to moderate severity (dental and headache, migraine, painful menstruation, neuralgia, back pain,muscular and rheumatic pains); febrile syndrome of various genesis (including influenza, ARVI).

    Contraindications:

    - erosive and ulcerative lesions of the gastrointestinal tract in the phase of exacerbation, including ulcerative colitis, peptic ulcer, Crohn's disease;

    - heart failure;

    - respiratory insufficiency; ,

    - severe course of arterial hypertension;

    - increased intracranial pressure;

    - craniocerebral trauma (in the anamnesis);

    - hypersensitivity to ibuprofen, codeine or other components of the drug;

    - bronchial asthma, urticaria, rhinitis, triggered by the use of acetylsalicylic acid (salicylates) or other non-steroidal anti-inflammatory drugs (NSAIDs);

    - diseases of the optic nerve; violation of color vision, amblyopia, scotoma;

    - deficiency of glucose-6-phosphate dehydrogenase, hemophilia and other disorders of blood coagulability, hemorrhagic diathesis, hypocoagulation states;

    - pregnancy III trimester;

    - severe violations of the liver and / or kidney function;

    - chronic constipation;

    - period after aortocoronary shunting;

    - simultaneous administration of monoamine oxidase inhibitors (MAO);

    - hearing loss, pathology of the vestibular apparatus;

    - children's age (up to 12 years).

    Carefully:Elderly age, coronary heart disease, cerebrovascular diseases, dyslipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol use, prolonged use of NSAIDs, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (incl. prednisolone), anticoagulants (incl. warfarin, clopidogrel, acetylsalicylic acid), the reception of selective serotonin reuptake inhibitors, diseases when taking the drug in patients with peptic ulcer and duodenal ulcer in history, with gastritis, enteritis, colitis, with anamnestic information about bleeding from the gastrointestinal tract; in the presence of concomitant diseases of the liver and / or kidneys; with cirrhosis of the liver with portal hypertension, nephrotic syndrome, chronic heart failure; arterial hypertension; with blood diseases of unclear etiology (leukopenia and anemia); at a bronchial asthma, at a hyperbilirubinemia; pregnancy (I, II trimesters), the period of breastfeeding.
    Pregnancy and lactation:The use of the drug in the I and II trimester is possible only under the supervision of a doctor.
    Dosing and Administration:

    Inside. Nurofen® Plus is prescribed for adults and children over 12 years of age, 1 tablet 3-4 times a day, with water.

    To achieve a rapid therapeutic effect, the dose can be increased to 2 tablets 3 times a day.

    Do not take more than 6 tablets in 24 hours. The maximum daily dose of ibuprofen is 1200 mg, equivalent to 6 tablets of the drug.

    If symptoms persist for 2-3 days after taking the drug, stop treatment and consult a doctor.

    Side effects:

    When Nurofen® Plus is used, almost no side effects are observed within 2-3 days. In the case of prolonged use, the following side effects may occur:

    From the gastrointestinal tract:

    Nausea, vomiting, heartburn, anorexia, pain and discomfort in the epigastrium, diarrhea, flatulence, there may be 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 mucous membrane of the gums, aphthous stomatitis, pancreatitis, constipation, hepatitis.

    From the side, the nervous system:

    Headache, dizziness, insomnia, agitation, drowsiness, depression, confusion, hallucinations, 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 hematopoiesis:

    Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.

    From the sense organs:

    Hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dry and irritated eyes, conjunctival edema and eyelids (allergic genesis), scotoma.

    Allergic reactions:

    Skin rash, itching, urticaria, Quincke's edema, anaphylactoid reactions, anaphylactic shock, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

    From the respiratory system:

    Bronchospasm, shortness of breath, respiratory failure, suppression of the cough center.

    Other: increased sweating.

    With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (violation of color vision, scotoma, amblyopia).

    Regular use of codeine leads to the development of dependence, as well as to an excited state and irritability when the drug is withdrawn.

    If side effects occur, discontinue use and consult a doctor.

    Overdose:Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, pupil narrowing, metabolic acidosis, coma, acute renal failure, lowering of blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

    Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy.

    When respiratory depression is used a specific opioid antagonist - naloxone (narcan).

    Interaction:It is not recommended simultaneous administration of Nurofen® Plus tablets with acetylsalicylic acid and other NSAIDs. Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic effects. Reduces the hypotensive activity of vasodilators, natriuretic in furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs, increases the effect of indirect anticoagulants, antiaggregants, fibrinolytics. Increases the side effects of mineralocorticoids, glucocorticoids, estrogens, ethanol. Enhances the hypoglycemic effect of sulfonylurea derivatives. Antacids and colestramine reduce absorption. Increases the concentration in the blood of digoxin, lithium preparations, methotrexate. Caffeine strengthens the analgesic effect.
    Special instructions:During long-term treatment, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and analysis of feces for latent blood are shown. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test. During the period of treatment, alcohol intake is not recommended.
    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    The tablets covered with a cover.

    Packaging:For 2, 4, 6 or 12 tablets coated with a film sheath in a blister (PVC / PVDC / aluminum). One blister (2, 4, 6, or 12 tablets coated with a film shell) or two blisters (2, 4, 6 or 12 tablets coated with a film coating), or four blisters (12 tablets coated with a film coating) are put in a cardboard box together with instructions for the use of the drug.
    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C.

    Keep the drug out of the reach of children!

    Shelf life:

    Shelf life 3 years.

    Do not use the drug with expired shelf life.


    Terms of leave from pharmacies:Without recipe
    Registration number:П N012229 / 01
    Date of registration:16.08.2011
    The owner of the registration certificate:Rekitt Benckiser Helsar International Ltd.Rekitt Benckiser Helsar International Ltd. United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspREKITT BENKIZER HELSKER LTD. REKITT BENKIZER HELSKER LTD. United Kingdom
    Information update date: & nbsp18.03.2014
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