Alental tab n / 100mg film about 20 pc


Alental tab n / 100mg film about 20 pc


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Active substance:
1 tablet contains: aceclofenac – 100.0 mg ;.
Microcrystalline Cellulose – 82.6 mg; Croscarmellose Sodium – 8.0 mg; Povidone K-30 – 6.4 mg; Sodium stearyl fumarate – 3.0 mg; film coating: [hypromellose – 3.6 mg Talc – 1.2 mg Titanium dioxide – 0.66 mg macrogol 4000 (polyethylene glycol 4000) – 0.54 mg] or [dry film coating mixture comprising hypromellose (60 %), talc (20%), titanium dioxide (11%), macrogol 4000 (polyethylene glycol 4000) (9%)] – 6.0 mg.
Round biconvex tablets, film-coated white or almost white. The cross-sectional core of a white or nearly white.
Product form:
Tablets, film-coated, 100 mg. 10, 15 or 20 tablets in blisters of PVC or polyvinyl chloride film / polyvinylidene chloride and aluminum foil. 20, 30 or 60 tablets in a bank of high-density polyethylene. 2, 3 or 6 contour cell packs of 10 tablets, 2 or 4 blisters 15 tablets 1 or 3 blisters with 20 tablets or one bank together with instructions for use in a stack of cardboard.
Erosive-ulcerous lesions of the gastrointestinal tract (GIT) in the acute phase (including ulcerative colitis, Crohn’s disease); gastrointestinal bleeding or suspicion of it; complete or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history); hypersensitivity to the drug component or aceclofenac; liver dysfunction, severe or active liver disease; violations of blood and coagulation; violation severe renal impairment (creatinine clearance
Diseases of the liver, kidneys and gastrointestinal history; the presence of infection Helicobacter pylori; bronchial asthma; arterial hypertension; reduction in circulating blood volume (including immediately after major surgery); coronary artery disease; chronic renal, hepatic and cardiac insufficiency; creatinine clearance less than 60 mL / min; ulcerative lesions of the gastrointestinal tract in history; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral artery disease; smoking; elderly age; alcoholism; severe somatic diseases; in patients with defects in hemostasis, with the risk of cardiovascular thrombosis (myocardial infarction, acute stroke (ischemic, hemorrhagic stroke)); systemic lupus erythematosus; long-term use of NSAIDs; simultaneous reception of glucocorticoids, anticoagulants, antiplatelet agents, serotonin reuptake inhibitors.
100 mg
Relief of inflammation and pain in lumbago, toothache, frozen shoulder, rheumatic soft tissue. Symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis.
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
With the exception of warfarin, drug interaction studies have been conducted.
Aceclofenac is metabolized by means CYP2C9 isozyme; in vitro data indicate that aceclofenac could be an inhibitor of the enzyme. Thus, the risk of possible pharmacokinetic interaction while receiving aceclofenac with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole.
As with other NSAIDs, the risk pharmacokinetic interactions with other drugs, which are excreted by renal active secretion, such as methotrexate and lithium preparations.
Aceclofenac is highly bound to plasma albumin of blood and therefore can displacement type interactions with other drugs that bind to proteins.
Below is a class-specific information for NSAIDs.
Methotrexate: NSAIDs inhibit the tubular secretion of methotrexate; Moreover, there may be a small metabolic interaction that leads to a decrease in clearance of methotrexate. Therefore, when high-dose methotrexate NSAIDs should be avoided.
drugs lithium and digoxin: some NSAIDs inhibit the renal clearance of lithium and digoxin, which leads to an increase in plasma concentrations of both substances. Avoid joint use unless frequent control is carried out and the lithium concentration of digoxin in plasma.
Anticoagulants: NSAIDs inhibit platelet aggregation and damage the mucous membrane of the gastrointestinal tract, which can lead to increased action of anticoagulants and increase the risk of gastrointestinal bleeding in patients receiving anticoagulants. combined use should be avoided aceclofenac and oral anticoagulants coumarin group, and ticlopidine thrombolytics, if not carried out careful monitoring of the patient.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) or combined with NSAIDs may increase the risk of gastrointestinal bleeding.
Cyclosporin, tacrolimus: while taking NSAIDs with cyclosporine or tacrolimus should consider the risk of increased renal toxicity due to lower education renal prostacyclin. Therefore, while taking should carefully monitor renal function.
Other NSAIDs: the simultaneous administration of aspirin or other NSAIDs may increase the incidence of side effects, so caution.
Steroids: increases the risk of ulceration of the digestive tract or gastrointestinal bleeding.
Diuretics: aceclofenac, like other NSAIDs, may inhibit the activity of diuretics, may reduce the diuretic effect of furosemide and bumetanide and antihypertensive effect of thiazide. Co-administration with potassium-sparing diuretics may lead to an increase in the potassium content in the blood plasma. Aceclofenac did not affect blood pressure control when combined with bendrofluazidom, although we can not exclude cooperation with other diuretics.
Antihypertensive drugs: NSAIDs may also reduce the effect of antihypertensive drugs. Co-administration of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists and NSAIDs can cause renal dysfunction. The risk of acute renal failure, which usually is reversible, may be increased in some patients with impaired renal function, such as elderly patients, or dehydration. Therefore, when used together with antihypertensive drugs NSAIDs caution. Patients should consume the necessary amount of fluid and under appropriate supervision (monitoring of renal function at the beginning of a joint application and periodically during treatment).
Hypoglycemic agents: clinical studies show that diclofenac may be used in conjunction with oral hypoglycemic agents without influencing their clinical effect. However, there are isolated reports of hypoglycaemic and hyperglycaemic effects of diclofenac. Thus, upon receipt of aceclofenac should conduct correction doses of drugs that can cause hypoglycemia.
Zidovudine: while receiving NSAIDs and zidovudine increases the risk of hematologic toxicity. There is evidence of an increase in the risk of hemarthrosis and hematoma in HIV-positive (HIV – human immunodeficiency virus) patients with hemophilia receiving zidovudine and ibuprofen.
Mifepristone: aceclofenac could be used 8-12 days after mifepristone, as NSAIDs reduce the effect of the drugs in this group.
Cholestyramine: other drugs, including NSAIDs, should be applied at least for 1 hour before or 4-6 hours after ingestion of cholestyramine to reduce its effect on the absorption of drugs.
There are no data on overdose of aceclofenac in humans.
Possible symptoms:
Nausea, vomiting, stomach pain, dizziness, headache, hyperventilation phenomenon with increased convulsive readiness.
Gastric lavage, administration of adsorbent (activated carbon), symptomatic therapy. Forced diuresis, hemodialysis not sufficiently effective.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Aceclofenac has antiinflammatory, analgesic and antipyretic action. It inhibits the synthesis of prostaglandins, and thus affects the pathogenesis of inflammation, pain and fever of occurrence. In rheumatic diseases inflammatory and analgesic effect of aceclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of the joints, which improves the functional status of the patient.
After oral administration, aceclofenac is rapidly absorbed and its bioavailability is close to 100%. The maximum concentration (Cmax) in blood plasma obtained 1,25-3 hours after ingestion. Food intake delays absorption, but does not affect its extent.
Aceclofenac is highly bound to plasma proteins (> 99.7%). Aceclofenac penetrates into the synovial fluid, where its concentration reaches 60% of its concentration in plasma. The volume of distribution of 30 l.
It is believed that aceclofenac metabolized by CYP2C9 isoenzyme to form a metabolite 4-OH-aceclofenac whose contribution to the clinical effect of the drug is likely to be minimal. Diclofenac and 4-OH-aceclofenac among the numerous metabolites aceclofenac.
The average half-life (T1 / 2) is 4-4.3 hours. Clearance is 5 l / h. Approximately 2/3 of the dose is excreted by the kidneys, mainly – in the form of conjugated gidroksimetabolitov. Only 1% of the dose after oral administration is output unchanged.
Pregnancy and breast-feeding
Alental® The drug is contraindicated in pregnancy. Information on the use of aceclofenac during pregnancy is not available. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and / or the development of the embryo / fetus.
During the third trimester all prostaglandin synthesis inhibitors, having a cardio-pulmonary toxicity, can cause premature closure of the arterial duct with the development of pulmonary hypertension and violation fetal kidney function, which can progress to renal failure in combination with hydramnios.
Women in late pregnancy and newborn: aceclofenac may affect the duration of bleeding due to antiplatelet effect, which may occur even after the use of very low doses; aceclofenac can suppress the uterine contraction, leading to delay in delivery or prolonged delivery.
Alental® The drug should not be taken during breastfeeding. Data on the allocation of aceclofenac to breast milk are absent; when assigning radioactive 14C aceclofenac lactating rats appreciable transfer of radioactivity in milk were observed.
NSAIDs can affect fertility and are not recommended for women planning pregnancy.
Conditions of supply of pharmacies
side effects
Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO): very common> 1/10; often by> 1/100 to 1/1000 to 1/10000 to
Blood disorders and lymphatic system: rarely – anemia; very rarely – inhibition of bone marrow activity, granulocytopenia, thrombocytopenia, neutropenia, haemolytic anemia.
Disorders of immune system: rarely – anaphylactic reactions, including shock; hypersensitivity.
Violations by the psyche: very rarely – depression, “unusual” (atypical) dreams, insomnia.
Disorders of the nervous system: often – dizziness; very rarely – paresthesia, tremor, somnolence, headache, dysgeusia (taste perversion).
Violations by the organ of vision: rarely – visual impairment.
Violations by the organ of hearing and labyrinth disorders: very rare – vertigo, tinnitus.
Violations of the cardiovascular system: rarely – heart failure, high blood pressure; very rarely – tachycardia, flushing of the skin, “tides” (transient sensation of heat accompanied by sweating), vasculitis.
Violations of the respiratory system, thorax and mediastinum: rarely – shortness of breath; very rarely – bronchospasm.
Disorders of the gastrointestinal tract: often – dyspepsia, abdominal pain, nausea, diarrhea; infrequently – flatulence, gastritis, constipation, vomiting, ulceration of the oral mucosa; rarely – melena, ulceration of the gastrointestinal mucosa, hemorrhagic diarrhea, hemorrhages gastrointestinal mucosa; very rarely – stomatitis, vomiting blood, bowel perforation, flow deterioration of Crohn’s disease and ulcerative colitis, pancreatitis.
Violations of the liver and biliary tract: often – increased activity of “liver” enzymes; very rarely – liver damage (including hepatitis), elevated alkaline phosphatase;
Violations of the skin and subcutaneous tissue disorders: rarely – itching, rash, dermatitis, urticaria; rarely – angioedema; very rarely – purpura, eczema, severe reactions of the skin and mucous membranes (including Stevens-Johnson syndrome and toxic epidermal necrolysis); in some cases there were serious skin infections and soft tissue infections while taking NSAIDs at the time of the disease chickenpox.
Violations of the kidneys and urinary tract: infrequently – increasing concentrations of urea and creatinine in blood plasma; very rarely – nephrotic syndrome, renal failure, interstitial nephritis.
General disorders: very rarely – fatigue, muscle spasms of the lower limbs.
Violations by the Metabolism and nutrition: very rarely – hyperkalemia, increased body mass index.
special instructions
Avoid the simultaneous ingestion Alental® and other NSAIDs, including selective cyclooxygenase-2 (COX-2).
Adverse effects can be minimized by applying the minimum effective dose and reducing the duration of treatment required to control the symptoms.
Effect on GI
Bleeding ulcer or perforation GI deaths were observed when receiving any NSAIDs at any time during the treatment, both with the appropriate symptoms, and the presence of serious gastrointestinal diseases in history (gastric ulcer and duodenal ulcer, Crohn’s disease, ulcerative colitis, etc.), So without them.
The risk of bleeding, ulceration and perforation of the gastrointestinal tract increased with increasing doses of NSAIDs in patients with peptic ulcer history, especially if it is accompanied by bleeding or perforation, as well as in elderly patients. Such patients should be administered a minimum effective dose of aceclofenac. Also in the treatment of these groups of patients and patients who require simultaneous use of acetylsalicylic acid in small doses or other drugs that may increase the risk of gastrointestinal complications, it is necessary to consider the need for a combination therapy with drug-protectors (e.g., misoprostol or proton pump inhibitors ).
Patients with diseases of the gastrointestinal tract, including the elderly, should report any unusual symptoms related to the gastrointestinal tract (especially bleeding), including the initial admission Alental® drug. Particular caution should be observed in patients receiving both drugs that may increase the risk of bleeding or ulcers, such as systemic steroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors or antiplatelet agents (such as acetylsalicylic acid).
In the event of gastrointestinal bleeding or ulcer, treatment with Alental® should be abolished.
Influence on the cardiovascular and central nervous system
Patients with arterial hypertension and / or congestive heart failure, mild or moderate need appropriate observation because NSAIDs (particularly at high doses for prolonged use) could be slightly increased risk of arterial thrombosis (for example myocardial infarction or stroke). There are no reliable data on the absence of such a risk when taking aceclofenac.
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular Caution should be exercised when taking Alental® drug. Also prior to the first drug intake Alental® caution in patients with risk factors for cardiovascular (e.g., hypertension, hyperlipidemia, diabetes, smoking).
Effect on the liver and kidneys
NSAIDs can cause dose-dependent reduction in the formation of prostaglandins and acute renal failure. The importance of prostaglandins for maintenance of renal blood flow should be taken into account when taking Alental® the drug in patients with impaired function of the heart, kidney or liver disease, in patients treated with diuretics in patients after surgery, as well as in elderly patients.
Caution must be exercised when administering the drug Alental® patients with impaired liver function and kidney mild or moderate, as well as patients with other conditions predisposing to fluid retention. In such patients, NSAIDs can cause renal dysfunction and fluid retention. Patients on diuretics, and those with an increased risk of hypovolemia should also be careful when receiving Alental® drug. It is necessary to assign the minimum effective dose and regular medical monitoring of renal function. Нежелательные явления со стороны почек обычно разрешаются после прекращения приема ацеклофенака.
Прием ацеклофенака следует прекратить, если изменения показателей функции печени сохраняются или ухудшаются, развиваются клинические признаки или симптомы заболеваний печени, либо возникают другие проявления (эозинофилия, сыпь). Гепатит может развиться без продромальных симптомов.
Применение НПВП у пациентов с печеночной порфирией может спровоцировать приступ.
Гиперчувствительность и кожные реакции
Как и другие НПВП, ацеклофенак может вызвать аллергические реакции, включая анафилактические/анафилактоидные реакции, даже если принимается впервые. Тяжелые кожные реакции (некоторые из них могут привести к летальному исходу), включая эксфолиативный дерматит, синдром Стивенса-Джонсона и токсический эпидермальный некролиз, после приема НПВП наблюдались очень редко. Самый высокий риск возникновения этих реакций наблюдается в течение первого месяца приема ацеклофенака. При возникновении кожной сыпи, повреждений слизистой оболочки полости рта или других признаков гиперчувствительности следует прекратить прием препарата Аленталь®.
В отдельных случаях при ветряной оспе могут возникнуть инфекции кожи и мягких тканей. В настоящее время нельзя исключить роль НПВП в ухудшении течения этих инфекций. Поэтому следует избегать приема препарата Аленталь® при ветряной оспе.
Гематологические нарушения
Ацеклофенак может вызвать обратимое угнетение агрегации тромбоцитов.
Violations of the respiratory system
Следует соблюдать осторожность при приеме препарата Аленталь® пациентам с бронхиальной астмой в анамнезе или с текущей бронхиальной астмой, так как прием НПВП может спровоцировать развитие внезапного бронхоспазма у таких пациентов.
elderly patients
Следует соблюдать осторожность при приеме препарата Аленталь® у пожилых пациентов, так как у них чаще возникают побочные явления (особенно кровотечение и прободение ЖКТ) при приеме НПВП. Осложнения могут привести к летальному исходу. Также пожилые пациенты чаще страдают заболеваниями почек, печени или сердечно-сосудистой системы.
Длительное применение
Все пациенты, получающие длительное лечение НПВП, должны находиться под тщательным наблюдением (например, общий анализ крови, функциональные печеночные и почечные тесты).
Effects on ability to drive vehicles and mechanisms
Следует воздержаться от управления транспортными средствами и занятий другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций, так как препарат может вызывать головокружение и другие побочные эффекты, которые могут влиять на указанные способности.
Storage conditions
Store in a dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside. Таблетку следует проглатывать целиком, запивая достаточным количеством воды.
Препарат следует принимать в течение как можно более короткого периода времени. Курс лечения назначается врачом индивидуально.
Обычно взрослым назначают по одной таблетке по 100 мг 2 раза в сутки (утром и вечером).
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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