Новиган®

General characteristics. Structure:

Active agents: ibuprofen of 400 mg, pitofenona hydrochloride of 5 mg, fenpiveriniya bromide of 0,1 mg.
Excipients: cellulose of microcrystallic 55 mg, starch of corn 76 mg, глицерол 2,9 mg, silicon dioxide of colloid 5 mg, talc of 12 mg, magnesium stearate of 4 mg; cover: gipromelloza of 6 cps of 5,686 mg, macrogoal of 6000 1,124 mg, talc of 1,957 mg, titanium dioxide of 1,059 mg, mg polysorbate 80 0,058, sorbic acid of 0,058 mg, диметикон 0,058 mg.

Description
Round biconvex tablets, film coated white color, with NOVIGAN stamping on one party. A look on cross section: from white till almost white color.

Pharmacological properties:

Pharmacodynamics. The combined drug, has analgeziruyushchy, antiinflammatory and spasmolytic effect. Suppresses synthesis of prostaglandins (Pg). Anti-inflammatory drug an ibuprofen, a myotropic antispasmodic of a pitofenon a hydrochloride and m-holinoblokiruyushchee means of the central and peripheral action a fenpiveriniya bromide is a part of drug nonsteroid.
The ibuprofen is derivative fenilpropionovy acid. Possesses soothing, antiinflammatory and febrifugal action. The main mechanism of action – oppression of biosynthesis of prostaglandins – modulators of painful sensitivity, thermal control and an inflammation in the central nervous system and peripheral fabrics. At women with primary dysmenorrhea reduces the increased level of prostaglandins in myometriums at the expense of what reduces the intrauterine pressure and frequency of uterine reductions.
Pitofenona a hydrochloride, like a papaverine, has direct myotropic effect on smooth muscles of internals and causes its relaxation.
Fenpiveriniya bromide at the expense of m-holinoblokiruyushchego of action makes the additional weakening impact on smooth muscles.

The combination of three components of drug leads to mutual strengthening of their pharmacological action.

Pharmacokinetics. Components of the drug Novigan® are well soaked up in digestive tract. The peak of concentration in a blood plasma is reached, approximately, in 1-2 hours after administration of drug. The main component of drug an ibuprofen for 99% contacts proteins of a blood plasma, can collect in synovial fluid, is metabolized in a liver and brought to 90% with urine in the form of metabolites and conjugates. A small part of drug is excreted with bile. Plasma elimination half-life of blood makes 2 hours.

Indications to use:

Poorly or moderately expressed pain syndrome at spasms of smooth muscles of internals: renal and bilious colic, dyskinesia of biliary tract, intestinal colic.

Gynecologic diseases: dysmenorrhea.
Headache, including, migrenozny character.
Short-term symptomatic treatment at joint pains, neuralgia, an ischialgia, a mialgiya.

Route of administration and doses:

Inside, for 1 h to or in 3 h after food. In order to avoid irritant action on a stomach it is possible to accept drug right after food or to wash down with milk. In the absence of special doctor's instructions it is recommended to accept Novigan® at spastic pains on 1 tablet to 3 times a day. The maximum daily dose – 3 tablets. Do not exceed the specified dose!

The course of treatment the drug Novigan®, without consultation of the doctor, should not exceed 5 days. More prolonged use is possible under observation of the doctor with control of indicators of peripheral blood and a functional condition of a liver.

Features of use:

At prolonged use control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary. For decrease in risk of development of the undesirable phenomena from digestive tract it is necessary to use minimum effective dose. At emergence of symptoms of a gastropathy the careful control including carrying out an ezofagogastroduodenoskopiya, blood test with definition of hemoglobin and a hematocrit, the analysis a calla on the occult blood is shown. In need of definition of 17 ketosteroids, drug should be cancelled in 48 hours prior to a research. During treatment it is necessary to refrain from alcohol intake.

Influence on ability to manage vehicles, mechanisms

During treatment the patient has to abstain from the occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

In the recommended doses the drug Novigan® does not cause side effects. From digestive tract: NPVP-gastropathy (abdominal bokl, nausea, vomiting, heartburn, loss of appetite, diarrhea, meteorism, lock; ulcerations of a mucous membrane of digestive tract which, in some cases, are complicated by perforation and bleedings; irritation or dryness of a mucous cover of an oral cavity, mouth pain, ulceration of a mucous membrane of gums, aphthous stomatitis, pancreatitis.
From gepatobiliarny system: hepatitis.
From respiratory system: asthma, bronchospasm.
From sense bodys: hearing disorder: decrease in hearing, ring or sonitus; sight nakrusheniye: toxic damage of an optic nerve, illegibility of zriktelny perception, scotoma, dryness and irritation of eyes, hypostasis of a konjyunktikva and century (allergic genesis), accommodation paresis.
From the central and peripheral nervous system: a headache, a golovokrukzheniye, sleeplessness, uneasiness, nervousness and irritability, psychomotor arousing, drowsiness, a depression, confusion of consciousness, a galklyutsination, aseptic meningitis (is more often at patients with autoimmune zakbolevaniye).
From cardiovascular system: heart failure, tachycardia, pokvysheniye of arterial pressure. From an urinary system: an acute renal failure, allergicheksky nephrite, a nephrotic syndrome (hypostases), an oliguria, an anury, a polyuria, a proteinuria, cystitis, coloring of urine in red color.
Allergic reactions: skin rash (usually erythematic or krapivnikets), skin itch, Quincke's edema, anaphylactoid reactions, acute anaphylaxis, bronchospasm or диспноэ, fever, mnogoformny exudative erythema (including, Stephens-Johnson's syndrome), toxic epidermal necrolysis (Lyell's disease), eosinophilia, allergic rhinitis.
From bodies of a hemopoiesis: anemia (including, hemolitic, aplastic), thrombocytopenia and Werlhof's disease, agranulocytosis, leukopenia.
Others: strengthening or decrease in sweating.
From laboratory indicators: a bleeding time (can increase), concentration of glucose in serum (can decrease), clearance of creatinine (can decrease), a hematocrit or hemoglobin (can decrease), serumal concentration of creatinine (can increase), activity of "hepatic" transaminases (can raise).
If administration of drug caused change of your usual state, stop accepting it and immediately see a doctor.

Interaction with other medicines:

In therapeutic doses drug Novigan does not enter significant interactions with widely used drugs. Inductors of enzymes of a microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, флумецинол, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites, increasing risk of development of heavy intoxications. Inhibitors of a microsomal oxidation reduce risk of development of a hepatotoxic action. Reduces hypotensive activity of vazodilatator and natriuretic effect of furosemide and a hydrochlorothiazide. Reduces efficiency of uricosuric drugs. Strengthens effect of indirect anticoagulants, antiagregant, fibrinolitik (that increases risk of development of bleedings). Strengthens side effects of mineralokortikosteroid, glucocorticosteroids (danger of gastrointestinal bleeding increases), estrogen, ethanol; strengthens hypoglycemic effect of derivatives of sulphonylurea. Antacids and Colestyraminum reduce absorption of an ibuprofen. Increases concentration in blood of digoxin, drugs of lithium and a methotrexate. Strengthens action M-holinoblokatorov, H1-gistaminoblokatorov, phenyl propyl ketones, fenotiazin, an amantadin and quinidine. Co-administration of other NPVP increases the frequency of side effects. Caffeine strengthens the analgeziruyushchy (anesthetizing) effect. At co-administration reduces antiinflammatory and antiagregantny effect of acetylsalicylic acid (increase in frequency of development of acute coronary insufficiency in the patients receiving small doses of acetylsalicylic acid as antiagregantny means after the beginning of administration of drug Novigan is possible). Tsefamandol, цефоперазон, цефотетан, valproic acid, пликамицин increase the frequency of development of a prothrombinopenia at co-administration. Myelotoxic medicines strengthen manifestations of a gematotoksichnost of drug. Cyclosporine and drugs of gold strengthen influence of an ibuprofen on synthesis of prostaglandins in kidneys that is shown by increase in nephrotoxicity. The ibuprofen increases plasma concentration of cyclosporine and probability of development of its hepatotoxic effects. The medicines blocking canalicular secretion reduce removal and increase plasma concentration of an ibuprofen.

Contraindications:

Hypersensitivity to any of the ingredients which are a part of drug; erosive and ulcer changes of a mucous membrane of a stomach or duodenum, active gastrointestinal bleeding; inflammatory diseases of intestines in an aggravation phase, including, ulcer colitis; anamnestic data on an attack of a bronkhoobstruktion, rhinitis, small tortoiseshell, after reception of acetylsalicylic acid or other non-steroidal anti-inflammatory drug – NPVP (the full or incomplete syndrome of intolerance of acetylsalicylic acid – rinosinusit, a small tortoiseshell, polyps of a mucous membrane of a nose, bronchial asthma); liver failure or active disease of a liver; a renal failure (clearance of creatinine less than 30 ml/min.), the progressing disease of kidneys; the confirmed hyperpotassemia; hemophilia and other disturbances of coagulability of blood (including, hypocoagulation), hemorrhagic diathesis; the period after performing aortocoronary shunting; the acute "alternating" porphyria; granulocytopenia; hemopoiesis disturbances; deficit glyukozo-6-fosfatdegidrogenazy; tachyarrhythmia; closed-angle glaucoma; diseases of an optic nerve; prostate hyperplasia; intestinal impassability; pregnancy and the period of breastfeeding, age up to 16 years.

Precautionary measures at use
Advanced age, congestive heart failure, cerebrovascular diseases, arterial hypertension, coronary heart disease, dislipidemiya / lipidemia, diabetes mellitus, diseases of peripheral arteries, nephrotic syndrome, clearance of creatinine less than 30-60 ml/min., a hyperbilirubinemia, a peptic ulcer of a stomach and duodenum (in the anamnesis), existence of an infection of Helicobacter pylori, gastritis, enteritis, colitis, long use of NPVP, a disease of blood of not clear etiology (a leukopenia, anemia), smoking, frequent alcohol intake (alcoholism), heavy somatopathies, the accompanying therapy of the following drugs: anticoagulants (for example, warfarin), antiagregant (for example, acetylsalicylic acid, klopidogret), peroral glucocorticosteroids (for example, Prednisolonum), selective serotonin reuptake inhibitors (for example, to tsitalopra, fluoxetine, пароксетин, sertraline).

Overdose:

Do not exceed the specified dose. If you exceeded a dose, immediately see a doctor or in the nearest medical institution. Take with yourself drug packaging. Symptoms: abdominal pain, nausea, vomiting, block, drowsiness, depression, headache, sonitus, metabolic acidosis, coma, acute renal failure, lowering of arterial pressure, bradycardia, tachycardia, fibrillation of auricles, apnoea.
Treatment: a gastric lavage (only within an hour after reception), absorbent carbon, alkaline drink, an artificial diuresis, symptomatic therapy (correction of an acid-base state, arterial pressure). There is no specific antidote.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity of 5 years. Not to use after the expiry date specified on packaging.

Issue conditions:

Without recipe

Packaging:

Tablets, film coated. On 10 tablets in PVC / the aluminum blister. On 1 or 2 blisters with the application instruction in a pack cardboard.