Instruction for use: Novigan

Active substance Ibuprofen + Pitofenone + Fenpiverinium bromide

Indications

Weak and moderately severe pain syndrome with spasms of smooth muscles of internal organs - renal and biliary colic, dyskinesia of bile ducts, intestinal colic; gynecological diseases (dysmenorrhea); headache, incl. migraine nature; short-term symptomatic treatment for pain in the joints, neuralgia, ischialgia, myalgia.

Contraindications

Hypersensitivity; erosive and ulcerative changes in the mucous membrane of the stomach or duodenum; active gastrointestinal bleeding; Inflammatory bowel disease in the phase of exacerbation, incl. ulcerative colitis; anamnestic data on the occurrence of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma); hepatic insufficiency or active liver disease; renal failure (Cl creatinine <30 mL / min); progressive kidney disease; confirmed hyperkalemia; Hemophilia and other disorders of blood clotting, incl. hypocoagulation; hemorrhagic diathesis; period after aorto-coronary bypass surgery; acute intermittent porphyria; granulocytopenia; disorders of hematopoiesis; 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 to 16 years.

pregnancy and lactation

The use of a combination of ibuprofen + pitofenone + fenpireinia bromide is contraindicated during pregnancy. When appointing during the period of breastfeeding, the question of its cessation should be resolved.

Side effects

The incidence of adverse events is classified according to WHO recommendations as very often (≥10%); often (≤1%, <10%); infrequently (≥0.1%, <1%); rarely (≥0.01%, <0.1%); very rarely, including individual messages (<0.01%).

On the part of the digestive system: often - NPVC-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation); infrequent - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding, irritation and dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis; very rarely - pancreatitis, hepatitis, a violation of liver function, hepatotoxicity.

From the respiratory system: rarely - shortness of breath, bronchospasm.

From the senses: rarely - hearing loss, ringing or noise in the ears; infrequent - blurred vision, scotoma, dry and irritated eyes, edema of the conjunctiva and eyelids (allergic genesis), amblyopia; very rarely - paresis of accommodation, toxic damage to the optic nerve.

From the central nervous system (central nervous system) and the peripheral nervous system: infrequently - headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression; very rarely - confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).

From the CCC side: infrequent - tachycardia, increased blood pressure; rarely - heart failure.

From the urinary system: infrequently - nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining in red; rarely acute renal failure, allergic nephritis.

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

On the part of the organs of hematopoiesis: infrequently - thrombocytopenia and thrombocytopenic purpura; Very rarely - anemia (including hemolytic, aplastic), agranulocytosis, leukopenia, eosinophilia.

Other: very rarely - increased or decreased sweating.

On the part of laboratory indicators: increased bleeding time, reduced serum glucose concentration, decreased creatinine clearance, hematocrit or Hb level, increased serum creatinine concentration, increased hepatic transaminase activity.

Precautionary measures

With long-term use, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.

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 including esophagogastroduodenoscopy, a blood test with the determination of Hb and hematocrit, and analysis of feces for latent blood are shown.

If it is necessary to determine 17-ketosteroids, the combination of ibuprofen + pitofenone + fenpiperinium bromide should be discontinued 48 hours before the study.

During treatment should refrain from drinking alcohol.

Influence on the ability to drive vehicles, mechanisms. During the treatment period, the patient should refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.