Combination drug, has analgesic, anti-inflammatory and antispasmodic effects. Inhibits the synthesis of prostaglandins (Pg). The drug contains a non-steroidal anti-inflammatory agent – ibuprofen, myotropic antispasmodic agent – pitofenone hydrochloride and m-cholin-blocking agent of central and peripheral action – phenpiveryinia bromide.
Bursitis, Headache, Gallic Colic, Arthritis, Renal Colic, Colitis, Colic, Toothache, Fever, GI Spasms, Flu, Myalgia (muscle pain), Biliary Dyskinesia, Neuralgia, Migraine, Inflamed tendons, Arthrosis, Radiculitis, Colds Mild or moderate pain syndrome in spasms of smooth muscles of internal organs: Renal and biliary colic, biliary dyskinesia, intestinal colic.
Gynecological disorders: dysmenorrhea.
Headache, including migraine.
Short-term symptomatic treatment for joint pain, neuralgia, ischialgia, myalgia.
Ibuprofen, Pitofenone, Phenpiveryinia bromide
How to take, the dosage
Orally, 1 hour before or 3 hours after a meal. To avoid irritating the stomach, the drug may be taken immediately after a meal or with milk.
In the absence of special doctor’s prescriptions, 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 stated dose!
The course of treatment with Novigan® without physician’s consultation should not exceed 5 days. Longer use is possible under the supervision of a physician with control of peripheral blood parameters and functional status of the liver.
In therapeutic doses Novigan® has no significant interactions with commonly used drugs.
The 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 hepatotoxic effects.
Decreases the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.
Decreases the effectiveness of uricosuric drugs.
Accelerates the effect of indirect anticoagulants, antiaggregants, fibrinolytics (which increases the risk of bleeding).
Accelerates the side effects of mineralocorticosteroids, GCS (increased risk of gastrointestinal bleeding), estrogen, ethanol; increases the hypoglycemic effect of sulfonylurea derivatives.
Antacids and colestiramine decrease absorption of ibuprofen.
Enhances blood concentrations of digoxin, lithium drugs and methotrexate.
It increases the effect of m-cholinoblockers, H1-histamine receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine.
The concomitant administration of other NSAIDs increases the frequency of side effects.
Caffeine increases the analgesic (analgesic) effect.
When taken concomitantly it reduces anti-inflammatory and antiaggregant effect of acetylsalicylic acid (increased incidence of acute coronary failure is possible in patients receiving low doses of acetylsalicylic acid as an antiaggregant after initiation of Novigan® administration).
Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the incidence of hypoprothrombinemia when administered simultaneously.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Cyclosporine and gold drugs increase the effect of ibuprofen on PG synthesis in kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.
Like drugs that block tubular secretion decrease excretion and increase the plasma concentration of ibuprofen.
In case of long-term use it is necessary to monitor peripheral blood picture and functional state of the liver and kidneys.
To reduce the risk of gastrointestinal tract adverse events, the lowest effective dose should be used. In case of gastropathy symptoms it is required thorough control including esophagogastroduodenoscopy, blood test with hemoglobin and hematocrit determination, fecal occult blood test.
If 17-ketosteroids determination is required the preparation should be discontinued 48 hours prior to the test.
During the treatment period the patient should refrain from taking alcohol.
During the treatment the patient should refrain from potentially dangerous activities that require high concentration and rapid psychomotor reactions.
Hypersensitivity to any of the ingredients included in the drug; erosive-ulcerative changes of the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; inflammatory bowel disease in the acute phase, including ulcerative colitis; anamnestic evidence of an attack of bronchoobstruction, rhinitis, urticaria, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drug – NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome – rhinosinusitis, urticaria, polyps of nasal mucosa, bronchial asthma); hepatic insufficiency or active liver disease; renal insufficiency (creatinine clearance less than 30 ml/min).), advanced renal disease; confirmed hyperkalemia; hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis; period after coronary artery bypass grafting; acute “intermittent” porphyria; Granulocytopenia; hematopoiesis disorders; glucose-6-phosphate dehydrogenase deficiency; tachyarrhythmia; closed-angle glaucoma; optic nerve disease; prostatic hyperplasia; intestinal obstruction; pregnancy and breast-feeding, age under 16.
Older age, congestive heart failure, cerebrovascular disease, arterial hypertension, coronary heart disease, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, nephrotic syndrome, creatinine clearance less than 30-60 ml/min, hyperbilirubinemia, gastric and duodenal ulcer (history), Helicobacter pylori infection, gastritis, enteritis, colitis, long-term use of NSAIDs, blood diseases of unclear etiology (leukopenia, anemia), smoking, frequent alcohol consumption (alcoholism), severe somatic diseases, concomitant therapy with the following drugs anticoagulants (e.g., warfarin), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).
Novigan® does not cause side effects in the recommended doses.
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased BP, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.
The treatment: gastric lavage (only within one hour after ingestion), prescription of activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, BP). There is no specific antidote to the drug.
Do not exceed the recommended doses. If the recommended doses are exceeded, seek immediate medical attention or contact the nearest medical facility (bring the drug package with you).
|Conditions of storage|
At a temperature not exceeding 25 C. Keep out of reach of children!
Dr. Reddy's, India
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