Instructions Novigan film-coated tablets blister No. 10
Composition
active ingredients: ibuprofen, p-piperidinoethoxy-o-carbomethoxybenzophenone hydrochloride, alpha-piperidinoethyldiphenylacetamide methobromide;
1 film-coated tablet contains ibuprofen 400 mg, p-piperidinoethoxy-o-carbomethoxybenzophenone hydrochloride 5 mg, alpha-piperidinoethyldiphenylacetamide methobromide 0.1 mg;
Excipients: microcrystalline cellulose, corn starch, glycerin, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E 171), polysorbate-80, sorbic acid, dimethicone.
Dosage form
Film-coated tablets.
Main physicochemical properties: white, round, biconvex, film-coated tablets, with smooth one side and embossed “NOVIGAN” on the other side.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory and antirheumatic drugs. Ibuprofen, combinations. ATX code M01A E51.
Pharmacological properties
Pharmacodynamics.
Novigan® is a combined drug belonging to the group of analgesics and antispasmodics. The drug contains: ibuprofen – a nonsteroidal anti-inflammatory drug (NSAID), p-piperidinoethoxy-o-carbomethoxybenzophenone hydrochloride – a myotropic antispasmodic, and alpha-piperidinoethyldiphenylacetamide methobromide – an anticholinergic agent of central and peripheral action.
The main mechanism of pharmacological action of ibuprofen is the inhibition of prostaglandin synthesis. Non-selective non-steroidal anti-inflammatory drugs, to which ibuprofen belongs, act as systemic inhibitors (peripheral and central) of the synthesis of prostaglandin G/H enzymes, also known as cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). These enzymes are responsible for the conversion of arachidonic acid to various tissue-specific prostaglandins and thromboxanes. COX-1 is constitutively expressed in all tissues and is responsible for the production of prostaglandins that support organ function, protect the integrity of the gastric mucosa and generate thromboxane, which is responsible for platelet aggregation and vasoconstriction. During inflammation, COX-2 is induced, which produces prostaglandins that mediate pain and inflammatory processes.
P-piperidinoethoxy-o-carbomethoxybenzophenone hydrochloride has a direct myotropic effect on the smooth muscles of internal organs. It inhibits phosphodiesterase, causes the accumulation of cAMP and a decrease in calcium content in the cell, and weakens the smooth muscles of blood vessels and internal organs.
Alpha-piperidinoethyldiphenylacetamide methobromide, due to its ganglioblocking and parasympathetic action, reduces the tone and motility of the smooth muscles of the stomach, intestines, biliary and urinary tracts.
Pharmacokinetics.
Ibuprofen is well absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are reached 1-2 hours after administration. Approximately 99% of ibuprofen is bound to plasma proteins. It is excreted mainly in the urine as unchanged drug or as oxidized inactive metabolites. It is completely eliminated from the body within 24 hours.
The combination of the three components of the drug causes a mutual enhancement of their pharmacological action, which leads to pain relief, relaxation of smooth muscles, and a decrease in elevated body temperature.
Indication
Mild or moderately expressed pain syndrome with spasms of smooth muscles of internal organs - renal or hepatic colic, biliary dyskinesia, intestinal spasms, spastic dysmenorrhea and other spastic conditions of smooth muscles of internal organs. Headache, including migraine. Short-term symptomatic treatment of pain in the joints, neuralgia, sciatica, myalgia. To reduce elevated body temperature in colds and infectious and inflammatory diseases.
Contraindication
Increased individual sensitivity to the components of the drug and to other nonsteroidal anti-inflammatory drugs.
Hypersensitivity reactions (e.g. bronchial asthma, rhinitis, angioedema or urticaria) previously observed after taking ibuprofen, acetylsalicylic acid (aspirin) or other NSAIDs.
Novigan® is contraindicated in patients with a history of erosive-ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding or perforation after the use of NSAIDs.
Severe liver and kidney dysfunction, heart failure.
The use of ibuprofen, especially in high doses, with other nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the possibility of additive effects and the development of adverse reactions from the heart, stroke.
The drug is also contraindicated in hepatic porphyria, hereditary glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmia, optic nerve damage, hematopoietic or blood clotting disorders, blood disease, angle-closure glaucoma, heart failure, prostatic hypertrophy, mechanical obstruction of the gastrointestinal tract, or megacolon.
Cerebrovascular or other bleeding.
Severe dehydration.
Children under 16 years of age.
Interaction with other medicinal products and other types of interactions
Concomitant use of Novigan® with other nonsteroidal anti-inflammatory drugs (NSAIDs) or non-narcotic analgesics may lead to a double increase in toxic effects.
The simultaneous use of Novigan® in combination with the following drugs should be avoided:
Acetylsalicylic acid: The concomitant use of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects. There is evidence to suggest that ibuprofen may competitively inhibit the effect of low-dose acetylsalicylic acid on platelet aggregation when used concomitantly. Therefore, the cardioprotective effect of low-dose acetylsalicylic acid may be reduced with prolonged use of ibuprofen.
Novigan® should be used with caution in combination with the following drugs:
Anticoagulants: NSAIDs may enhance the effects of anticoagulants such as warfarin.
Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the therapeutic effect of these drugs. In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the concomitant use of an ACE inhibitor or angiotensin II antagonist and drugs that inhibit cyclooxygenase may lead to further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, such combinations should be prescribed with caution, especially in elderly patients. If long-term treatment is necessary, the patient should be adequately hydrated and consideration should be given to monitoring renal function at the beginning of the combination treatment and periodically thereafter.
Diuretics may increase the risk of nephrotoxic effects of NSAIDs.
Corticosteroids: increased risk of gastrointestinal ulcers and bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
Cardiac glycosides - when used simultaneously with NSAIDs, exacerbation of heart failure, a decrease in glomerular filtration rate, and an increase in the concentration of cardiac glycosides in the blood plasma are possible.
Lithium preparations – simultaneous use reduces the elimination of lithium preparations and increases their toxicity and concentration in blood plasma.
Methotrexate – simultaneous use reduces the elimination of methotrexate and increases its toxicity and concentration in blood plasma.
Cyclosporine – when used simultaneously with NSAIDs, nephrotoxicity increases.
Mifepristone – the use of NSAIDs is allowed only 8-12 days after discontinuation of mifepristone, as NSAIDs reduce the effect of mifepristone.
Quinolone antibiotics – NSAIDs may increase the risk of convulsions associated with taking quinolones.
Zidovudine – there is evidence of an increased risk of hemarthrosis and hematoma in HIV-infected patients receiving concomitant treatment with zidovudine and ibuprofen.
Tacrolimus – the risk of nephrotoxicity increases with the simultaneous use of NSAIDs with tacrolimus.
The herbal preparation ginkgo biloba may potentiate the risk of bleeding when used with nonsteroidal anti-inflammatory drugs.
Application features
The drug should be used with caution and under the supervision of a physician to treat patients with moderate hepatic or renal impairment, with a tendency to arterial hypertension, bronchospasm, with systemic lupus erythematosus and other systemic connective tissue diseases - increased risk of aseptic meningitis; with a history of heart failure, which was accompanied by fluid retention and edema during the use of nonsteroidal anti-inflammatory drugs.
Effects on the cardiovascular and cerebrovascular systems.
Clinical trial and epidemiological data suggest that ibuprofen use, particularly at high doses (2400 mg/day), and long-term use may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke). Overall, epidemiological data do not suggest that low-dose ibuprofen use (e.g. ≤ 1200 mg/day) is associated with an increased risk of myocardial infarction. In patients with uncontrolled hypertension, congestive heart failure, established coronary artery disease, peripheral arterial disease and/or cerebrovascular disease, long-term treatment should only be considered by the physician after careful consideration. Patients with significant risk factors for cardiovascular complications (such as hypertension, hyperlipidemia, diabetes mellitus, smoking) should exercise caution and consult a doctor before starting the drug, as fluid retention, hypertension, and edema have been reported with NSAIDs.
Effects on the respiratory system.
Other NSAIDs.
The concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided as this increases the risk of adverse reactions.
Effect on the kidneys.
Risk of renal failure due to deterioration of renal function: long-term use of NSAIDs can lead to a dose-dependent decrease in prostaglandin synthesis and provoke the development of renal failure. The risk of this reaction is high in patients with impaired renal function, cardiac disorders, impaired liver function, in patients taking diuretics and in elderly patients. In such patients, renal function should be monitored. Dehydrated patients are at increased risk of impaired renal function.
Impact on fertility in women.
There is limited evidence that medicinal products that inhibit cyclooxygenase/prostaglandin synthesis may affect ovulation. This is reversible after discontinuation of treatment. Long-term use (at doses of 2400 mg/day and for treatment durations exceeding 10 days) of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation for infertility, the drug should be discontinued.
Effect on the gastrointestinal tract.
NSAIDs should be used with caution in patients with chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated. Gastrointestinal bleeding, perforation, and ulceration, which may be fatal, have been reported at any time during NSAID treatment, regardless of the presence of warning symptoms or a history of severe gastrointestinal disorders.
Increasing the dose of NSAIDs, older age, and a history of peptic ulcer disease are risk factors for gastrointestinal adverse reactions. During treatment in such cases, it is recommended to use the minimum effective dose of the drug.
The drug should be used with caution in patients receiving therapy with drugs that may increase the risk of gastric and duodenal ulcers or bleeding, in particular oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. Patients who have experienced gastrointestinal disorders, especially the elderly, should discontinue treatment and consult a doctor if any undesirable symptoms (especially bleeding from the digestive tract) occur.
On the skin and subcutaneous tissue.
Very rarely, severe skin reactions, some of which may be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur with NSAIDs. The risk of these reactions is highest early in treatment, with most onset occurring within the first month of treatment. Acute generalized exanthematous pustulosis (AGEP) has been reported with ibuprofen-containing products.
Novigan® should be discontinued and a doctor should be consulted immediately at the first signs of skin rash, blistering of the skin, pathological changes in the mucous membranes, or any other signs of hypersensitivity, as these manifestations may be the first signs of a serious skin reaction.
The drug should be avoided in chickenpox, as concomitant use of NSAIDs may worsen the course of the disease. NSAIDs may contribute to the development of complications such as serious skin and soft tissue infections.
With prolonged (more than a week) use of the drug, it is necessary to monitor peripheral blood parameters and liver function.
The drug may affect the psychophysiological state of patients when taken simultaneously with alcohol and CNS depressants.
Prolonged and uncontrolled use of painkillers, especially combinations of different painkilling active ingredients, can lead to chronic kidney damage with the risk of kidney failure (analgesic nephropathy).
The drug should not be used in the presence of hereditary intolerance to galactose and dairy products, lactase deficiency.
Masking the symptoms of underlying infections
As with other NSAIDs, ibuprofen-containing products may mask the symptoms of an infectious disease, which may delay appropriate treatment and thus complicate the course of the disease. This has been observed with bacterial community-acquired pneumonia and bacterial complications of varicella.
When Novigan® is used for fever or to relieve pain in infections, monitoring for infectious disease is recommended. In outpatient settings, the patient should consult a doctor if symptoms persist or worsen.
Use during pregnancy or breastfeeding
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/fetal development. Epidemiological data indicate an increased risk of miscarriage and birth defects after exposure to prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with increasing dose and duration of therapy.
From the 20th week of pregnancy, the use of the drug may cause oligohydramnios due to fetal renal dysfunction. This disorder may occur shortly after the start of treatment and is usually reversible after discontinuation of treatment. In addition, there are reports of narrowing of the ductus arteriosus in the fetus after treatment in the second trimester of pregnancy, which in most cases disappeared after discontinuation of treatment. Therefore, Novigan® should not be prescribed during the first and second trimester of pregnancy unless clearly necessary. If the drug is used by a woman attempting to conceive or during the first and second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
Antenatal monitoring for oligohydramnios and ductus arteriosus may be appropriate if exposure has occurred for several days starting from the 20th week of gestation. The drug should be discontinued if oligohydramnios or ductus arteriosus is detected.
During the third trimester of pregnancy, the use of any prostaglandin synthesis inhibitors carries the following risks:
for the fetus:
cardiopulmonary toxicity (premature narrowing/closure of the fetal ductus arteriosus with pulmonary hypertension);
renal dysfunction, which may progress to renal failure with oligohydramnios (see above);
for the mother at the end of pregnancy and for the newborn:
prolongation of bleeding time, antiaggregatory effect, which may occur even at very low doses;
suppression of uterine contractions, leading to delayed or prolonged labor.
Therefore, ibuprofen is contraindicated during the third trimester of pregnancy (see section "Contraindications").
Breastfeeding should be discontinued during treatment with the drug.
The ability to influence the reaction speed when driving or working with other mechanisms
Caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
The lowest effective dose necessary to control symptoms should be used for the shortest possible time. If symptoms persist for more than 5 days after starting treatment or worsen, a doctor should be consulted.
Novigan® should be taken either 1 hour before or 3 hours after a meal. The tablets should be swallowed with water, not chewed. To prevent stomach irritation, take immediately after a meal or with milk.
The drug is recommended to be taken 1 tablet up to 3 times a day. The maximum recommended daily dose is 3 tablets.
Repeat the dose if necessary after 4-6 hours. Do not exceed 1200 mg of ibuprofen per day.
Elderly people do not require special dosage.
Children
Do not prescribe the drug to children under 16 years of age.
Overdose
Symptoms: Manifested as gastrointestinal disorders (diarrhea, nausea, vomiting, anorexia, epigastric pain), manifestations of hepatotoxicity, impaired consciousness.
Tinnitus, headache and gastrointestinal bleeding may also occur. In severe poisoning, toxic damage to the central nervous system is observed, manifested by drowsiness, sometimes by an excited state and disorientation or coma. Sometimes patients develop convulsions. In more severe poisoning, metabolic acidosis and an increase in prothrombin time/INR may occur (presumably due to interaction with blood clotting factors circulating in the bloodstream). Acute renal failure and liver damage may occur. In patients with bronchial asthma, exacerbation of asthma may occur.
Treatment. Symptomatic and supportive therapy is indicated, including ensuring airway patency and monitoring of cardiac function and vital signs until the patient's condition normalizes. Gastric lavage and activated charcoal are indicated within one hour after taking a large dose. Adequate diuresis should be ensured and renal and hepatic function should be monitored. After taking potentially toxic doses, patients should be observed for at least 4 hours. In case of convulsions, diazepam or lorazepam intravenously can be used. In case of bronchial asthma, bronchodilators should be used.
Side effects
The occurrence of adverse reactions can be minimized by short-term use of the lowest effective doses of the drug.
Adverse reactions associated with the use of ibuprofen are classified by system organ class and frequency. The frequency is defined as follows: very common: ≥1/10; common: ≥1/100 and <1/10; uncommon: ≥1/1000 and <1/100; rare: ≥1/10000 and <1/1000; very rare: <1/10000, frequency unknown (frequency cannot be estimated from the available data).
From the gastrointestinal tract.
Possible - abdominal pain, dyspepsia, nausea.
Rarely – diarrhea, flatulence, constipation, vomiting.
Very rare: peptic ulcers, perforation or gastrointestinal bleeding, heartburn, melena, hematemesis (sometimes fatal), ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, gastritis, esophagitis.
From the blood and lymphatic system.
Very rare: haematopoietic disorders1.
1 Includes anemia, leukopenia, thrombocytopenia, pancytopenia, and agranulocytosis. The first signs of these disorders are fever, sore throat, superficial oral ulcers, flu-like symptoms, severe wasting, bleeding, and hematomas of unknown etiology.
Cardiovascular system: Rare: tachycardia, shortness of breath, cerebrovascular complications, arterial hypotension, palpitations.
Very rare: edema, hypertension, heart failure.
With long-term use and in high doses (2400 mg/day), there may be an increased risk of arterial thrombotic complications (e.g. stroke or myocardial infarction) and a decrease in the effectiveness of antihypertensive drugs.
General disorders: Very rare: non-specific allergic reactions and anaphylactic shock, asthma or worsening of asthma, bronchospasm, rash, pruritus, urticaria, purpura, angioedema.
Nervous system disorders: Uncommon: headache.
Very rare: optic neuritis, paraesthesia, nervousness, dizziness, drowsiness, irritability, tinnitus, depression, insomnia, anxiety, psychomotor agitation, emotional instability, convulsions. Frequency unknown: hallucinations, confusion.
From the immune system.
Uncommon: hypersensitivity reactions accompanied by urticaria and pruritus2. Very rare: severe hypersensitivity reactions, symptoms of which may include swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock).
2 Hypersensitivity reactions may include: (a) non-specific allergic reactions and anaphylaxis, (b) airway reactivity including asthma, asthma exacerbation, bronchospasm and dyspnoea or (c) various forms of skin reactions including pruritus, urticaria, purpura, angioedema and, less commonly, exfoliative and bullous dermatoses including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.
In patients with systemic lupus erythematosus and mixed connective tissue diseases, taking ibuprofen may, in rare cases, lead to symptoms of aseptic meningitis, namely - stiffness of the occipital muscles, headache, vomiting, high fever or disorientation.
From the side of the blood and lymphatic system. Very rare: disorders of the blood system (hemolytic anemia, aplastic anemia, thrombocytopenia, neutropenia, eosinophilia, decrease in hematocrit and hemoglobin level, pancytopenia, agranulocytosis). The first signs are high fever, sore throat, mouth ulcers, flu symptoms, severe exhaustion, unexplained bleeding and bruising. Reversible platelet aggregation, alveolitis, pulmonary eosinophilia.
On the part of the organs of vision. Very rare: blurred vision, change in color perception, toxic amblyopia. Frequency unknown: visual impairment.
Hepatobiliary system: Very rare: liver dysfunction, hepatitis, jaundice, duodenitis, pancreatitis, hepatorenal syndrome, hepatic failure, hepatonecrosis.
Skin and subcutaneous tissue disorders: Rare: skin peeling, alopecia, photosensitivity, various skin rashes. Very rare: bullous lesions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis. Frequency unknown: drug reaction with eosinophilia and systemic symptoms (DRESS), skin and soft tissue infections (in exceptional cases, complications such as severe skin and soft tissue infections may occur with varicella), acute generalized exanthematous pustulosis (AGEP). If a red, scaly, widespread rash with induration under the skin and blisters, localized mainly in skin folds, on the trunk and upper extremities, accompanied by fever at the beginning of treatment, appears, the use of the drug should be discontinued and a doctor should be consulted immediately, as these signs may be manifestations of acute generalized exanthematous pustulosis (see section "Special instructions").
Renal and urinary disorders: Very rare: papillonecrosis, cystitis, haematuria, nephrotic syndrome, oliguria, polyuria, tubular necrosis, glomerulonephritis, renal impairment, toxic nephropathy in various forms including interstitial nephritis, nephrotic syndrome and renal failure, acute renal failure.3
Other effects: Rare: dryness of the mucous membranes of the eyes and mouth, stomatitis, high fever, malaise, weakness, increased fatigue, hearing impairment, ulcerative stomatitis.
Very rare: changes in the endocrine system and metabolism, decreased appetite.
Laboratory studies.
Very rare: decreased hemoglobin level.
Reporting of suspected adverse reactions.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua
Expiration date
5 years.
Storage conditions
Store in a dry, dark place out of the reach of children at a temperature not exceeding 25 °C.
Packaging
10 tablets in a blister, 1 blister in a cardboard box.
Vacation category
Without a prescription.
Producer
Dr. Reddy's Laboratories Limited.
Location of the manufacturer and address of its place of business.
Production site – VI Village Khol, Nalagar Road, Baddi, Solan District, Himachal Pradesh, 173205, India.
You can report an adverse reaction or lack of effectiveness when using a medicine by calling (24/7):
+380 44 207 51 97 or +380 50 414 39 39; and also by email: DrugSafetyUa@drreddys.com
