Nobedolak tab n / 400mg film about 28 pc


Nobedolak tab n / 400mg film about 28 pc



Active substance:
Etodolac DC (98%) (equivalent to 400 mg of etodolac) 408.0 mg
146.50 mg of lactose anhydrous, microcrystalline cellulose PH 200 245.00 mg Sodium croscarmellose 34.50 mg Anhydrous colloidal silica (Aerosil 200) 2.00 mg Magnesium stearate 13.00 mg 16.00 mg Povidone K30;
film coating (Opadry II pink (85F240035)) 40,00 mg polyvinyl alcohol (E 1203) 40,000%, titanium dioxide (E 171) 24.930% macrogol 20,200%, 14,800% talc, iron oxide red (E 172) 0.070 %.
Oblong biconcave tablets, film-coated light pink color, with the mark on one side and with an engraving deposited «NOBEL» embossing method to another. The core in cross section – a white or nearly white.
Product form:
Tablets, film-coated 400 mg.
28 tablets, film-coated: 14 tablets / pills 14 x 2 blisters together with instructions for medical application is placed in a pile of cardboard.
• hypersensitivity to etodolac or other components of the formulation;
• intolerance to acetylsalicylic acid and medicaments pyrazolone series;
• contraindicated in the post-coronary artery bypass surgery;
• decompensated heart failure;
• the full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including history).;
• erosive and ulcerative changes in gastric mucosa and 12 duodenal ulcer, active gastrointestinal bleeding;
• bleeding or ulcer perforation of the gastrointestinal tract in history, triggered by the use of NSAIDs;
• inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• rare hereditary disease (intolerance to lactose, lactase deficiency, glucose-galactose malabsorption (due to the presence of lactose)).
• cerebrovascular bleeding or other bleeding;
• severe hepatic impairment or active liver disease;
• severe renal failure in patients not undergoing dialysis (creatinine clearance less than 30 mL / min), progressive renal disease including confirmed by hyperkalemia;
• pregnancy, breast-feeding;
• Children up to age 15 years.
Ischemic heart disease, cerebrovascular disease, chronic heart failure, dyslipidaemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, liver failure, chronic renal failure (creatinine clearance of 30-60 ml / min).
Simultaneous administration of other NSAIDs, gastritis, enteritis, colitis, asthma or allergic diseases in the acute stage or history – possibly bronchoconstriction, systemic lupus erythematosus and mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic meningitis, cirrhosis with portal hypertension , hyperbilirubinemia, nephrotic syndrome, hypertension, edema. A history of the development of ulcerative lesions of the gastrointestinal tract, the presence of infection Helicobacter pylori, old age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases, concomitant use of drugs that can increase the risk of ulceration or bleeding:
• anticoagulants (e.g., warfarin);
• antiplatelet agents (e.g., aspirin, clopidogrel);
• oral corticosteroids (e.g., prednisone);
• selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline);
• Children up to age 18 years.
To reduce the risk of adverse effects on the gastrointestinal tract should use the lowest effective dose of the lowest possible short course.
400 mg
• inflammatory and degenerative diseases of the musculoskeletal system: psoriatic rheumatoid, gouty arthritis, ankylosing spondylitis (Bechterew’s disease) osteoarthritis;
• pain: myalgia, ossalgia, arthralgia, headache, dental pain, post-traumatic pain, accompanied by inflammation, tuberculosis;
• intended for symptomatic therapy, reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
antihypertensive drugs
Nobedolak® reduces the effect of antihypertensive agents, ACE inhibitors.
With simultaneous use of antacids is no effect on the overall absorption of etodolac. Antacids can reduce Cmax etodolac from 15 to 20%, however, determines no effect on Cmax.
quinolone antibiotics
These studies on animals indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of seizures.
It enhances the action of hypoglycemic agents for oral administration, phenytoin.
Other NSAIDs, including selective COX-2 inhibitors
It should avoid the simultaneous use of two or more NSAIDs (including acetylsalicylic acid) because of a possible increase in the incidence of adverse effects.
Cyclosporine, digoxin, methotrexate, tacrolimus
Etodolac, like other NSAIDs, may affect the excretion of prostaglandins, lead to an increase in cyclosporine levels, digoxin, methotrexate and increase their toxicity. May increase the nephrotoxicity of tacrolimus and tsiklosorina.
Together with the admission cardiac glycosides NSAIDs can aggravate heart failure, reduce glomerular filtration rate and cardiac glycosides increase the concentration in plasma.
While the use of methotrexate amplified side effects of the latter on the hematopoietic system (risk of anemia and leukopenia shown periodic blood count control).
To prevent specific toxicity of these drugs must be carefully monitor the condition of patients who are taking etodolac or other NSAIDs, especially in patients with impaired renal function.
Data regarding the interaction reactions while the use of furosemide and hydrochlorothiazide no. However, there are reports that etodolac in some patients reduces the natriuretic effect of furosemide and thiazides. This is due to inhibition of prostaglandin synthesis. Need to avoid concomitant administration of etodolac and diuretics due to a decrease diuretic effect on the one hand and increase the risk of kidney damage – on the other. It is necessary to monitor renal function.
There are no data concerning pharmacokinetic interaction etodolac and glibenclamide.
NSAIDs may increase the level of lithium in blood plasma and reduce the renal clearance of lithium. The mean Cmax of lithium is increased by 15% in blood, renal clearance is reduced by 20%, respectively. This is due to suppression of prostaglandin synthesis by the kidneys. Therefore, while the use of lithium and lithium etodolac increased toxicity.
We recommend monitoring the concentration of lithium in the blood.
Not recommended simultaneous application phenylbutazone and etodolac as phenylbutazone increases (up to 80%) of the free fraction of etodolac, the study in vivo were not conducted.
There are no apparent pharmacokinetic interaction between phenytoin and etodolac.
While the use of anticoagulants (heparin, ticlopidine) and with thrombolytic drugs (streptokinase, fibrinolizin) increases the risk of bleeding (requires periodic monitoring of blood coagulation parameters).
While the use of antiplatelet agents and selective serotonin reuptake inhibitors increases the risk of gastrointestinal bleeding.
In the application of NSAIDs and warfarin increases the risk of ulcers and gastrointestinal bleeding. Short pharmacokinetics study shows that while the use of warfarin and etodolac warfarin reduced binding to plasma proteins, but does not change the clearance of warfarin. When such a combination is necessary to avoid bleeding monitor the prothrombin time.
Since etodolac appreciably bind to plasma proteins, can require an adjustment of the dose of other drugs that bind to plasma proteins.
Due to the presence of phenolic metabolites in urine etodolac possible false-positive tests for bilirubin (Ehrlich’s reagent).
At the same time taking NSAIDs and zidovudine increases the risk of hematologic toxicity. There is evidence of an increased risk of hemarthrosis and hematoma in HIV-positive patients with hemophilia who received both zidovudine and ibuprofen.
NSAIDs should not be used for 8-12 days after administration of mifepristone, as NSAIDs can reduce its therapeutic effect.
When concomitantly with corticosteroids increase the risk of ulcers and bleeding from the gastrointestinal tract.
Symptoms include nausea, vomiting, epigastric pain, gastrointestinal-bleeding, hypernatremia, hyperkalemia, edema, high blood pressure, allergic interstitial nephritis, jaundice, hepatitis, bronchospasm.
Treatment: No specific antidote; with an overdose of the drug should be to gastric lavage, administration of activated charcoal (during the next hour), symptomatic therapy.
pharmachologic effect
Pharmacological group:
nonsteroidal anti-inflammatory drug.
Etodolac – a non-steroidal anti-inflammatory drug (NSAID), indoleacetic acid derivative, which differs from other NSAIDs presence tetragidropiranoindola nucleus. Etodolac has antiinflammatory, analgesic and antipyretic properties. The drug reduces the synthesis of prostaglandins from arachidonic acid by inhibiting the enzyme cyclooxygenase (COX), thereby reducing the sensitivity of receptors to the mediators of pain (histamine, bradykinin), reduced exudation, migration of leukocytes, and also the sensitivity of hypothalamic centers thermoregulation to endogenous pyrogen (interleukin-1, and et al.). Etodolac has moderate selectivity for COX-2 therefore acts mainly in inflammation.
The oral route of etodolac is rapidly absorbed from the gastrointestinal tract. Cmax in plasma attained at 60 min and at 18 ug / ml. The bioavailability of etodolac is not less than 80%, food intake and antacids do not affect the bioavailability.
Binding to plasma proteins – 95%, free fraction is 1,2-4,7%. The volume of distribution – 0.4 l / kg body weight. Plasma clearance – 41 ml / h / kg.
Etodolac is metabolized in the liver and is excreted mainly by the kidneys (up to 60% as a metabolite).
The half-life of plasma – about 7 hours.
Pregnancy and breast-feeding
Etodolac is contraindicated for use in pregnant women and women during the breastfeeding period.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often – at least 10%; often – at least 1% but less than 10%; infrequently – at least 0.1% but less than 1%; rarely – at least 0.01% but less than 0.1%; very rarely – less than 0.01%; unknown frequency – can not be estimated from available data.
From the blood and lymphatic system:
rarely – leucopenia;
very rarely – thrombocytopenia, hemolytic anemia, neutropenia, pancytopenia, lymphadenopathy, aplastic anemia and agranulocytosis.
Allergic reactions:
rarely – hypersensitivity reaction;
unknown frequency – anaphylactic reaction (including anaphylactic shock), angioedema.
From the nervous system:
often – headache;
infrequently – dizziness, taste disturbance, fatigue / weakness, paresthesias, somnolence, insomnia, nervousness, depression;
rare – disturbance of consciousness, agitation, sleep disorders, convulsions, coma, hallucinations, meningitis, tremor, fatigue;
unknown frequency – reports of aseptic meningitis (especially in patients with autoimmune disorders such as systemic lupus erythematosus, mixed connective tissue disease).
From a sight organ:
rarely – blurred vision, photophobia, visual disturbances passing, conjunctivitis.
On the part of the organ of hearing:
unknown frequency – hearing impairment, including deafness and / or tinnitus.
Cardio-vascular system:
rarely – palpitations, “tides” of blood to the face;
unknown frequency – arterial hypertension, chronic heart failure, syncope, vasculitis (including necrotizing and allergic), arrhythmia “pirouette” type, ventricular tachycardia, arterial thrombotic complications (myocardial infarction or stroke).
The respiratory system:
rarely – shortness of breath, pulmonary infiltration with eosinophilia system, bronchitis, asthma, pharyngitis, rhinitis, sinusitis, respiratory depression, pneumonia, epistaxis.
On the part of the gastrointestinal tract:
Uncommon: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, bleeding / perforation, heartburn, nausea, vomiting, vomiting blood, glossitis, ulcers (gastric / duodenal ulcers) with or without bleeding and / or perforation, gastritis, melena, thirst, dry mouth, ulcerative stomatitis, anorexia, belching;
very rare: intestinal ulceration, pancreatitis, esophagitis with or without strictures or cardiospasm colitis.
On the part of the kidney and urinary tract:
infrequently: disruption of water-electrolyte metabolism, hypernatremia, dysuria, frequent urination, increased BUN, renal insufficiency, renal papillary necrosis, oliguria, polyuria, proteinuria, cystitis, hematuria, Leucorrhœa;
unknown frequency: kidney stones, interstitial nephritis, irregular uterine bleeding, nephrotoxicity, hyperkalemia.
Of the liver and biliary tract:
infrequently increased activity of “liver” transaminases;
unknown frequency cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic insufficiency, hepatic necrosis.
Skin and subcutaneous tissue disorders:
infrequently: itching, skin rash, angioedema, sweating, urticaria, bullous vesicle-change, cutaneous vasculitis with purpura;
rarely – photosensitivity reactions;
unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, pigmentation, alopecia, maculopapular rash, skin peeling.
Metabolic disorders:
infrequently: edema, increased creatinine levels, hyperglycemia in patients with controlled blood glucose levels, changes in body weight in patients with diabetes mellitus;
infrequently – chills and fever, infections, sepsis, a sense of fatigue.
special instructions
To reduce the risk of adverse events, use the lowest effective dose of the lowest possible short course.
cardiac disorders
In carrying out studies of some selective COX-2 inhibitors and nonselective NSAIDs note cardiovascular thrombotic complications, myocardial infarction, and seizures that can lead to death. All NSAIDs, both selective and nonselective, may cause such a risk. To reduce the severity of adverse reactions from the cardio-vascular system as far as possible use the lowest effective dose of NSAIDs for the shortest possible period. Cardiac disorders can occur even without any previous symptoms. There is no evidence to mitigate symptoms of the cardiovascular system, while the use of acetylsalicylic acid.
The use of NSAIDs for the relief of pain in the first 10-14 days during coronary artery bypass surgery increases the risk of myocardial infarction (see. Section “Contraindications”).
It should avoid the simultaneous use of etodolac and other NSAIDs, including selective COX-2 inhibitors.
Arterial hypertension
NSAIDs, including etodolac, may lead to increased blood pressure, or deterioration with existing hypertension, which may lead to side reactions with the cardiovascular system. Patients who concurrently with etodolac taking thiazide and loop diuretics, may experience a decrease in the action of the latter. While receiving an NSAID is necessary to control blood pressure.
Chronic heart failure and edema
Patients taking NSAIDs, there is fluid retention and swelling. Etodolac with caution in patients with fluid retention or heart failure.
Impact on the gastrointestinal tract
NSAIDs, including Etodolac may cause serious adverse reactions from the gastrointestinal tract, including inflammation, bleeding, ulcers and perforation of the stomach, intestines, which can lead to death.
NSAIDs with caution in patients with a history of gastric ulcer and duodenal ulcer or gastrointestinal bleeding. Other risk factors that increase the risk of gastrointestinal bleeding include simultaneous oral corticosteroids, anticoagulants, prolonged intake of NSAIDs, smoking, alcohol use, advanced age, severe general condition. Most spontaneous reports recorded in the elderly and debilitated patients. To reduce the potential risk of adverse reactions from the gastrointestinal tract use the lowest effective dose for the shortest possible period. It must be remembered about the symptoms of gastrointestinal bleeding and ulcers during treatment with NSAIDs in cases of suspected adverse reactions is necessary to evaluate the condition of the patient to stop taking the drug and take appropriate action. In these patients, consideration should be given combination therapy with gastroprotectives (eg misoprostol or proton pump inhibitors.
Effects on kidneys
Prolonged use of NSAIDs can cause papillary necrosis and other damage to the kidneys. Renal prostaglandins play a compensatory role in the support of renal perfusion. Patients in the application of NSAIDs can be observed a dose-dependent reduction in the formation of prostaglandins, which leads to the development of renal decompensation. К пациентам с высоким риском развития этих реакций относятся лица с нарушением функции почек, сердечной недостаточностью, нарушением функции печени, те, кто принимает диуретики и ингибиторы АПФ, больные пожилого возраста. Прекращение приема НПВП приводит к восстановлению предыдущего состояния.
Ухудшение состояния при заболеваниях почек
Отсутствует информация о применении этодолака у пациентов с прогрессирующей почечной недостаточностью, поэтому у них не рекомендуется применять этодолак. Перед началом лечения этодолаком необходимо провести контроль функции почек.
Анафилактические реакции.
Как и при приеме других НПВП, у пациентов, которые принимают НПВП, могут отмечаться анафилактические реакции с/без наличия в анамнезе реакций гиперчувствительности. Не следует применять препарат у пациентов с аспириновой астмой. Эти симптомы возникают у больных БА с ринитом с/без назальных полипов или с развитием тяжелых потенциально смертельных случаев бронхоспазма после приема ацетилсалициловой кислоты или других НПВП.
НПВП, включая этодолак, могут вызвать тяжелые кожные реакции, такие как эксфолиативный дерматит, синдром Стивенса — Джонсона и токсический эпидермальный некролиз, иногда приводящий к смерти. Пациентов необходимо информировать о симптомах тяжелых кожных проявлений. Пациенты подвергаются повышенному риску подобных реакций в начале терапии: в большинстве случае реакции развивались в течение первого месяца лечения. При появлении кожных высыпаний или других реакций гиперчувствительности применение препарата необходимо прекратить.
У пациентов с системной красной волчанкой и смешанными заболеваниями соединительной ткани может быть повышен риск асептического менингита.
Are common
Этодолак не заменяет кортикостероидов при кортикостероидной недостаточности. Внезапное прекращение приема этодолака может приводить к обострению заболевания. Пациентам, продолжительно применяющим кортикостероиды, отменять их необходимо постепенно.
Влияние на печень
При применении этодолака отмечается повышение уровня ферментов печени. Лабораторные изменения могут прогрессировать, оставаться неизменными или проходить после прекращения терапии. Значительное повышение АлАТ и АсАТ (в 3 и больше раз) отмечалось у 1% пациентов во время проведения клинических исследований НПВП. Сообщалось о единичных случаях тяжелых реакций со стороны печени, включая желтуху и летальный фульминантный гепатит, некроз печени, печеночную недостаточность, иногда с летальным исходом. При развитии клинических симптомов нарушения функции почек возможны системные проявления (эозинофилия, кожная сыпь), в таком случае применение этодолака необходимо прекратить.
Влияние на кровь
Иногда при применении НПВП, включая этодолак, отмечается анемия вследствие задержки жидкости в организме, при желудочно-кишечном кровотечении, нарушении эритропоэза. При продолжительном применении НПВП, включая этодолак, необходимо контролировать уровень гемоглобина и гематокрита в крови. НПВП подавляют агрегацию тромбоцитов и у некоторых пациентов удлиняют время кровотечения. По сравнению с ацетилсалициловой кислотой влияние этодолака на тромбоциты значительно меньше, уменьшается время лечения, отмечается обратное влияние. У пациентов, которые принимают этодолак и антикоагулянты, необходимо контролировать уровень тромбоцитов в крови, поскольку возможно изменение коагуляции.
Бронхиальная астма
У пациентов с БА возможна медикаментозная астма. Применение ацетилсалициловой кислоты при медикаментозной астме вызывает тяжелый бронхоспазм. Не следует принимать препарат у пациентов, в анамнезе которых при лечении другими НПВП были указания на возникновение астмы, ринита, крапивницы.
Препарат содержит лактозу, поэтому его не следует применять при наследственной непереносимости галактозы, дефиците лактазы Лаппа или нарушении мальабсорбции глюкозы-галактозы.
Применение этодолака может негативно повлиять на женскую фертильность, поэтому его не рекомендуется применять женщинам, пытающимся забеременеть. У женщин, которые испытывают трудности с зачатием или подвергаются исследованиям на бесплодие, следует рассмотреть возможность отмены этодолака.
Не применяют у детей.
Effect on the ability to drive mechanisms and
Применение препарата может вызывать возникновение нежелательных эффектов в виде головной боли и головокружений. Следует отказаться от управления транспортными средствами и выполнения действий, требующих повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
At a temperature of not higher than 25 degrees.
Keep out of the reach of children.
Dosing and Administration
Взрослые и дети старше 18 лет: рекомендованная суточная доза препарата Нобедолак® составляет 400 – 1200 мг. The maximum daily dose – 1200 mg. Препарат назначается дважды в день: по 1 таблетке утром и вечером после еды. В случае необходимости доза может быть увеличена до 3 таблеток в сутки.
У пациентов с массой тела меньше 60 кг максимальная суточная доза препарата не должна превышать 20 мг/кг.
При ревматических заболеваниях курс лечения зависит от эффективности терапии и характера заболевания. При условии продолжительного курса терапии дозу необходимо корригировать через каждые 2-3 недели применения препарата.
При лечении болевых состояний вследствие острых воспалительных процессов (таких как зубная боль, миозиты, тендиниты), а также послеоперационных болевых синдромов курс лечения составляет 5 суток. При головной и менструальной боли Нобедолак® назначается по 1-2 таблетке в сутки по необходимости, на протяжении не более 3 суток.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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