NOVIGAN PILLS

Indications

- mild or moderate pain syndrome in spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic;

- dysmenorrhea;

- headache, incl. migraine nature;

- short-term symptomatic treatment of pain in the joints, neuralgia, sciatica, myalgia.

Dosage and administration

Inside, 1 hour before or 3 hours after meals. In order to avoid irritating the stomach, you can take the drug immediately after a meal or drink milk.

In the absence of special doctor's instructions Novigan ® It is recommended to take when spastic pains 1 tab. up to 3 times / day The maximum daily dose - 3 tab. Do not exceed the specified dose!

The course of treatment drug Novigan®, without consulting a doctor, should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood and functional status of the liver.

Adverse effects

In recommended doses, the drug Novigan® does not cause side effects.

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

On the part of the 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 organ of hearing: hearing loss, hearing loss, ringing in the ears.

Special senses: visual impairment (toxic damage to the optic nerve, blurred vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), accommodation paresis).

Since the cardiovascular system: heart failure, tachycardia, increased blood pressure.

Urogenital: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining in red.

Allergic reactions: skin rash (typically erythematous or urticaria), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchoconstriction or dyspnea, fever, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

From the side of blood-forming organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

Other: increased or decreased sweating.

From the laboratory indicators: 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).

Contraindications

- erosive and 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 data on the attack of bronchial obstruction, rhinitis, urticaria, after taking Acetylsalicylic acid or other NSAIDs (complete or incomplete intolerance syndrome of acetylsalicylic acid - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);

— liver failure or active liver disease;

- renal failure (CC less than 30 ml / min), progressive kidney disease;

- confirmed hyperkalemia;

- hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis;

- the period after coronary artery bypass surgery;

- acute intermittent porphyria;

- granulocytopenia;

- violations of blood formation;

- deficiency of glucose-6-phosphate dehydrogenase;

- tachyarrhythmias;

- angle-closure glaucoma;

- diseases of the optic nerve;

- prostatic hyperplasia;

- intestinal obstruction;

- pregnancy;

- lactation period (breastfeeding);

- age up to 16 years;

- hypersensitivity to any component of the drug.

WITH caution:

- elderly age;

- congestive heart failure;

- cerebrovascular diseases;

- arterial hypertension;

- CHD;

- dyslipidemia / hyperlipidemia;

- diabetes;

- diseases of peripheral arteries;

- nephrotic syndrome;

- QC less than 30-60 ml / min;

- hyperbilirubinemia;

- peptic ulcer and duodenal ulcer (in history);

- the presence of Helicobacter pylori infection;

— gastritis, enteritis, colitis;

- long-term use of NSAIDs;

- blood diseases of unknown etiology (leukopenia, anemia);

- smoking;

- frequent use of alcohol (alcoholism);

- severe somatic diseases;

- concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral GCS (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, Fluoxetine, paroxetine, sertraline).

Use during pregnancy and lactation

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

Application for violations of the liver

Contraindicated use in liver failure or active liver disease

Application for violations of kidney function

Contraindicated 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.

Use in children

Contraindicated in children under 16 years

Use in elderly patients

The drug should be used with caution in elderly patients.

Special notes

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

To reduce the risk of adverse events from the gastrointestinal tract should use the minimum effective dose. When symptoms of gastropathy appear, close monitoring is shown, including esophagogastroduodenoscopy, a blood test with hemoglobin and hematocrit, and fecal occult blood analysis.

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

During the period of treatment should refrain from taking alcohol.

Influence on ability to drive motor transport and control mechanisms

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

Overdosage

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

Treatment: gastric lavage (only one hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). There is no specific antidote.

Drug interaction

In therapeutic doses, the drug Novigan® does not enter into significant interactions with widely 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.

Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action.

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

Reduces the effectiveness of uricosuric drugs.

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

Strengthens the side effects of mineralocorticoids, glucocorticoids (the risk of gastrointestinal bleeding increases), estrogen, ethanol.

Enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and colestyramine reduce the absorption of Ibuprofen .

The drug increases the concentration of Digoxin, lithium preparations, Methotrexate in the blood.

Enhances the effect of m-anticholinergic blockers, histamine N blockers1-receptors, butyrophenones, phenothiazines, amantadine and quinidine.

The simultaneous appointment of other NSAIDs increases the frequency of side effects.

Caffeine enhances the analgesic effect.

With simultaneous appointment reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients who receive small doses of acetylsalicylic acid as an antiplatelet agent, after starting the drug Novigan®).

Cefamandol, cefoperazone, cefotetan, valproic acid, plykamycin increase the incidence of hypoprothrombinemia with simultaneous appointment.

Myelotoxic drugs increase the hematotoxicity of the drug.

Cyclosporine and gold preparations enhance 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 its hepatotoxic effects.

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

Pharmacy sales terms

The drug is approved for use as a means of OTC.

Terms and conditions of storage

The drug should be stored in a dry, protected from light, out of reach of children at a temperature not exceeding 25 ° C.