Novigan, pills 20 pcs.

Composition

Each film-coated tablet contains:Active ingredients: ibuprofen 400 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg. Auxiliary substances:microcrystalline cellulose 55 mg, corn starch 76 mg, glycerol 2.9 mg, colloidal silicon dioxide 5 mg, talc 12 mg, magnesium stearate 4 mg; shell: Hypromellose 6 cps 5.686 mg, macrogol 6000 1.124 mg, talc 1.957 mg, titanium dioxide 1.059 mg, polysorbate-80 0.058 mg, sorbic acid 0.058 mg, dimethicone 0.058 mg

. Pharmacological action

Pharmacodynamicacombinated drug, has analgesic, anti-inflammatory and antispasmodic effects. Inhibits the synthesis of prostaglandins (Pg). The composition of the drug includes a non-steroidal anti-inflammatory agent-ibuprofen, a myotropic antispasmodic agent-pitofenone hydrochloride and an m-cholinoblocking agent of central and peripheral action-fenpiverinium bromide. Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of prostaglandin biosynthesis-modulators of pain sensitivity, thermoregulation, and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, it reduces the increased level of prostaglandins in the myometrium, thereby reducing intrauterine pressure and the frequency of uterine contractions. Pitofenone hydrochloride, like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation. Fenpiverinium bromide has an additional relaxing effect on smooth muscles due to its m-holinoblocking effect. The combination of the three components of the drug leads to a mutual strengthening of their pharmacological action. Pharmacokinetic components of Novigan® are well absorbed in the gastrointestinal tract. The peak concentration in blood plasma is reached approximately 1-2 hours after taking the drug. The main component of the drug – ibuprofen is 99% bound to plasma proteins, can accumulate in synovial fluid, is metabolized in the liver and is excreted by 90% in the urine in the form of metabolites and conjugates. A small part of the drug is excreted in the bile. The plasma elimination half-life is 2 hours.

Indications

Mild or moderate pain syndrome with spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic. Gynecological diseases: dysmenorrhea. Headache, including migraines. Short-term symptomatic treatment for joint pain, neuralgia, sciatica, and myalgia.

Contraindications

Hypersensitivity to any of the ingredients that make up the drug; erosive and ulcerative changes in the gastric or duodenal mucosa, active gastrointestinal bleeding; inflammatory bowel diseases in the acute phase, including ulcerative colitis; anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or another nonsteroidal anti-inflammatory drug-NSAIDs (complete or incomplete intolerance syndrome acetylsalicylic acid – rhinosinusitis, urticaria, nasal polyps, bronchial asthma); liver failure or active liver disease; renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease; confirmed hyperkalemia; hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis; the period after aorto – coronary bypass surgery; acute “”intermittent porphyria; granulocytopenia; hematopoietic disorders; glucose-6-phosphate dehydrogenase deficiency; tachyarrhythmia; angle-closure glaucoma; diseases of the optic nerve; prostatic hyperplasia; intestinal obstruction; pregnancy and lactation, age up to 16 years. With caution:Elderly, congestive heart failure, cerebrovascular diseases, arterial hypertension, coronary heart disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial diseases, nephrotic syndrome, creatinine clearance less than 30-60 ml/min, hyperbilirubinemia, gastric and duodenal ulcer (in the anamnesis), presence of Helicobacter pylori infection, gastritis, enteritis colitis, long-term use of NSAIDs, blood diseases of unknown etiology (leukopenia, anemia), smoking, frequent alcohol consumption (alcoholism), severe somatic diseases, concomitant therapy with the following drugs: anticoagulants (e. g., warfarin), antiplatelet agents (e. g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e. g., prednisone), selective serotonin reuptake inhibitors (e. g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

In the recommended doses, Novigan® does not cause side effects. From the gastrointestinal tract: NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; ulceration of the gastrointestinal mucosa, which in some cases are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis. From the side of the hepatobiliary system: hepatitis. From the respiratory system: shortness of breath, bronchospasm. Sensory disorders: hearing disorders: hearing loss, ringing or tinnitus; visual impairment: toxic damage to the optic nerve, blurred vision, scotoma, dry and irritated eyes, conjunctival and eyelid edema (allergic origin), accommodation paresis. From the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases). From the cardiovascular system: heart failure, tachycardia, increased blood pressure. From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining in red. Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), eosinophilia, allergic rhinitis. From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. Other: increased or decreased sweating. From the side of laboratory parameters:  bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), “hepatic” transaminase activity (may increase). If taking the drug has caused a change in your usual condition, stop taking it and contact your doctor immediately.

Interaction

In therapeutic doses, Novigan® does not enter into significant interactions with widely used drugs.

Inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication.

Microsomal oxidation inhibitors reduce the risk of developing hepatotoxic effects.

Reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

Increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

Increases the side effects of mineralocorticosteroids, corticosteroids (increases the risk of gastrointestinal bleeding), estrogens, ethanol; increases the hypoglycemic effect of sulfonylurea derivatives.

Antacids and colestyramine reduce the absorption of ibuprofen.

Increases the concentration of digoxin, lithium and methotrexate in the blood.

Increases the effect of m-holinoblokatorov, blockers of H1-histamine receptors, butyrophenones, phenothiazines, amantadine and quinidine.

Concomitant administration of other NSAIDs increases the frequency of side effects.

Caffeine enhances the analgesic (analgesic) effect.

When administered concomitantly, it reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (it is possible to increase the frequency of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting Novigan®).

Cefamandol, cefoperazone, cefotetan, valproic acid, and plicamycin increase the incidence of hypoprothrombinemia when administered concomitantly.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of PG in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce the excretion and increase the plasma concentration of ibuprofen.

How to take it, course of administration and dosage

Inside,1 hour before or 3 hours after a meal. To avoid irritating effects on the stomach, you can take the drug immediately after a meal or drink milk. In the absence of special medical instructions, it is recommended to take Novigan® for spastic pain 1 tablet up to 3 times a day. The maximum daily dose is 3 tablets. Do not exceed the indicated dose!The course of treatment with Novigan® without consulting a doctor should not exceed 5 days. Longer-term use is possible under the supervision of a doctor with monitoring of peripheral blood parameters and liver function.

Overdose

Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only within an hour after ingestion), administration of activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). There is no specific antidote to the drug.

Do not exceed the recommended dosage. If the recommended doses are exceeded, you should immediately consult a doctor or the nearest medical facility (have the drug’s packaging with you).

Description

Round biconvex tablets, white film-coated tablets with NOVIGAN embossed on one side. Cross-sectional view: white to almost white in color.

Special instructions

With prolonged use, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, you should refrain from taking alcohol. During treatment, the patient should refrain from engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 25 C. Keep out of reach of children!

Shelf life

5 years

Active ingredients

: Ibuprofen, Pitofenone, Fenpiverinium bromide

Dosage form

Tablets

Purpose

Children over 16 years of age, For adults as prescribed by a doctor

Indications

Migraine, Colitis, Biliary Dyskinesia, Arthritis, Cold, Flu, Gastrointestinal Spasm, Osteoarthritis, Bursitis, Sciatica, Tendon Inflammation

Weight

Weight: 22 gr.