Novigan tablets, No. 10

• Weak or moderate pain syndrome with spasms of smooth muscles of internal organs - renal and biliary colic, biliary dyskinesia, intestinal colic;

• gynecological diseases - dysmenorrhea;

• headache, incl. migraine in nature;

• short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia.

Inside, 1 hour before or 3 hours after meals. To avoid irritating effect on the stomach, you can take the drug immediately after a meal or drink it with milk.

In the absence of special prescriptions from a doctor, it is recommended to take NoviganЃ for spastic pain, 1 table. up to 3 times a day. The maximum daily dose is 3 tablets.

The course of treatment with NoviganЃ without consulting a doctor should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood parameters and the functional state of the liver.

Film-coated tablets

1 tab.

active substances: ibuprofen 400 mg

pitofenone hydrochloride 5 mg

fenpiverinium bromide 0.1 mg

excipients: MCC - 55 mg; corn starch - 76 mg; glycerol - 2.9 mg; colloidal silicon dioxide - 5 mg; talc - 12 mg; magnesium stearate - 4 mg film 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

• Hypersensitivity to any of the ingredients that make up the drug;

• erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;

• inflammatory bowel diseases in the acute phase, incl. ulcerative colitis;

• anamnestic data about an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete syndrome of acetylsalicylic acid intolerance - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

• liver failure or active liver disease;

• renal failure (Cl creatinine less than 30 ml / min), progressive kidney disease;

• confirmed hyperkalemia;

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

• period after coronary artery bypass grafting;

• acute intermittent porphyria;

• granulocytopenia;

• hematopoietic disorders;

• deficiency of glucose-6-phosphate dehydrogenase;

• tachyarrhythmia;

• angle-closure glaucoma;

• diseases of the optic nerve;

• hyperplasia of the prostate;

• intestinal obstruction;

• pregnancy and the period of breastfeeding;

• age up to 16 years.

Precautions: advanced age; congestive heart failure; cerebrovascular diseases; arterial hypertension; coronary heart disease; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; nephrotic syndrome; Cl creatinine 30-60 ml / min; hyperbilirubinemia; peptic ulcer of the stomach and duodenum (history); 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 (eg warfarin), antiplatelet agents (eg acetylsalicylic acid, clopidogrel), oral corticosteroids (eg prednisolone), SSRIs (eg citalopram, fluoxetine, paroxetine,sertraline).

pharmachologic effect

The combined preparation has an analgesic, anti-inflammatory and antispasmodic effect. Suppresses the synthesis of prostaglandins. The drug contains the NSAID ibuprofen, the myotropic antispasmodic agent pitofenone hydrochloride and the m-anticholinergic agent of central and peripheral action fenpiverinium bromide.

Ibuprofen is a phenylpropionic acid derivative. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of the synthesis of prostaglandins - 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 and thereby reduces intrauterine pressure and the frequency of uterine contractions.

Pitofenone hydrochloride has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.

Fenpiverinium bromide, due to its anticholinergic action, has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Pharmacokinetics

Absorption and distribution

When taken orally, the components of NoviganЃ are well absorbed in the gastrointestinal tract. Cmax in blood plasma is achieved in about 1-2 hours. The main component of the drug ibuprofen is 99% bound to plasma proteins, accumulates in the synovial fluid.

Metabolism and excretion

Ibuprofen is metabolized in the liver and excreted 90% in the urine as metabolites and conjugates. A small portion of ibuprofen is excreted in the bile. T1 / 2 from blood plasma is 2 hours.

Side effect

In recommended doses, NoviganЃ does not cause side effects.

From the digestive system: NSAIDs-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 mucous membrane of the gums, aphthous stomatitis), pancreatitis, hepatitis.

Respiratory system: shortness of breath, bronchospasm.

From the side of the central nervous system 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 side of the organ of hearing: hearing impairment, hearing loss, ringing in the ears.

From the side of the organ of vision: visual impairment (toxic damage to the optic nerve, blurred vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis), accommodation paresis).

From the side of 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, red urine staining.

Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal syndrome (epidermal toxicity) Lyell), eosinophilia, allergic rhinitis.

From the side of hematopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Others: increased or decreased sweating.

On the part 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) ).

Application during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Contraindicated for use in liver failure or active liver disease

Application for impaired renal function

It is contraindicated for use in renal failure (CC less than 30 ml / min), progressive kidney disease. With caution - with nephrotic syndrome, CC less than 30-60 ml / min.

Application in children

Contraindicated in children under 16 years of age

Use in elderly patients

The drug should be used with caution in elderly patients.

special instructions

With prolonged use, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, blood tests with determination of hemoglobin and hematocrit, and fecal occult blood test.

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

During the period of treatment, you should refrain from drinking alcohol.

Influence on the ability to drive vehicles and mechanisms

During the period of treatment, the patient should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

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), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). There is no specific antidote.

Drug interactions

In therapeutic doses, NoviganЃ 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.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic effects.

The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

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

It enhances the side effects of mineralocorticoids, glucocorticoids (the risk of gastrointestinal bleeding increases), estrogens, ethanol.

Enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of ibuprofen.

The drug increases the concentration of digoxin, lithium preparations, methotrexate in the blood.

Enhances the action of m-anticholinergics, blockers of histamine H1 receptors, butyrophenones, phenothiazines, amantadine and quinidine.

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

Caffeine enhances the analgesic effect.

With simultaneous administration, it reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting NoviganЃ).

Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the incidence of hypoprothrombinemia when administered simultaneously.

Myelotoxic drugs increase the manifestations of the drug's hematotoxicity.

Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

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