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Description
СОСТАВдействующее вещество: адеметионин;
1 таблетка содержит 949 мг адеметионина 1,4-бутандисульфоната, что соответствует 500 мг катиона адеметионина;
вспомогательные вещества: кремния диоксид коллоидный, целлюлоза микрокристаллическая, крахмал натрия (тип А), стеарат магния, сополимер метакрилата (тип А), полиэтиленгликоль 6000, полисорбаты, эмульсия симетикона, гидроксид натрия, тальк.
ФАРМАКОЛОГИЧЕСКАЯ ГРУППА
Агенты, влияющие на пищеварительную систему и обменные процессы.
Аминокислоты и их производные.
ПОКАЗАНИЯ
Внутрипеченочный холестаз у взрослых, в том числе у больных хроническим гепатитом различной этиологии и циррозом печени,
внутрипеченочный холестаз у беременных.
ПРОТИВОПОКАЗАНИЯ
Повышенная чувствительность к действующему веществу или любому вспомогательному веществу препарата.
Генетические дефекты, влияющие на метиониновый цикл и / или вызывающие гомоцистинурию и / или гипергомоцистеинемию (например, дефицит цистатионин-бета-синтазы, нарушение метаболизма витамина 12).
ВЗАИМОДЕЙСТВИЕ С ДРУГИМИ НАРКОТИКАМИ И ДРУГИМИ ВИДАМИ ВЗАИМОДЕЙСТВИЯ
Сообщалось о развитии серотонинового синдрома у пациента, который принимал адеметионин во время приема кломипрамина.
Из-за этого, хотя возможность взаимодействия теоретически предполагается, следует проявлять осторожность при одновременном применении адеметионина с селективными ингибиторами обратного захвата серотонина (СИОЗС), трициклическими антидепрессантами (такими как кломипрамин), лекарствами и лечебными травами, содержащими триптофан.
ПРИМЕНЕНИЕ ВО ВРЕМЯ БЕРЕМЕННОСТИ ИЛИ ГРУДНОГО ВСКАРМЛЕНИЯ
In the course of clinical studies in women who were treated with ademetionine in the third trimester of pregnancy, no adverse reactions were observed. Ademetionine should be used only if absolutely necessary in the first two trimesters of pregnancy. During breastfeeding, ademetionine is used only when the potential benefit from its use outweighs the potential risk to the infant.
ABILITY TO INFLUENCE THE RATE OF RESPONSE WHEN DRIVING MOTOR VEHICLES OR OTHER MECHANISMS
Some patients may experience dizziness when using ademetionine. Patients should refrain from driving vehicles or working with other mechanisms until it is completely certain that ademetionine therapy does not affect their ability to perform these activities.
OVERDOSE
Cases of ademetionine overdose have been observed rarely. In case of overdose, doctors should contact local poison control centers. In general, observation of the patient and the use of supportive care are recommended
ADVERSE REACTIONS
More than 2,100 patients have used ademetionine in clinical trials. Headache, diarrhea, and nausea were reported most frequently with ademetionine treatment. The following adverse reactions were reported with the specified frequency during clinical trials of ademetionine (n = 2115), as well as in spontaneous reports. Adverse reactions are classified by organ systems (according to MedDRA) and by frequency of occurrence: very common (≥1 / 10), often (≥1 / 100, <1/10), infrequent (≥1 / 1000, <1/100), liquid (≥1 / 10000, <1/1000), very rarely (<1/10000). Gastrointestinal disorders: often - abdominal pain, diarrhea, nausea infrequently - dry mouth, dyspepsia, flatulence, gastrointestinal pain, gastrointestinal bleeding, gastrointestinal disorders, liquid vomiting - bloating, esophagitis. General disorders and reactions at the injection site: infrequently - asthenia, edema, hyperthermia, chills *, reactions at the injection site * 1, necrosis at the injection site * 1; rarely - malaise. From the immune system: infrequently - hypersensitivity, anaphylactoid reactions or anaphylactic reactions (for example, hyperemia, shortness of breath, bronchospasm, back pain, chest discomfort, changes in blood pressure (hypotension, hypertension) or pulse rate (tachycardia, bradycardia)) *. Infections and invasions: infrequently - urinary tract infections. From the musculoskeletal system and connective tissue: infrequently - arthralgia, muscle cramps. From the nervous system: often - headache; infrequently - dizziness, paresthesia, dysgeusia *.Mental disorders: often - anxiety, insomnia infrequently - agitation, confusion. From the respiratory system, chest and mediastinal organs: infrequently - laryngeal edema *. Skin and subcutaneous tissue disorders: often - itching infrequently - hyperhidrosis, angioedema *, allergic skin reactions (for example, rash, pruritus, urticaria, erythema) *. Vascular disorders: infrequently - hot flashes, hypotension, phlebitis. * Adverse reactions from spontaneous messages that were not observed in clinical trials, classified according to the frequency of occurrence of "rare" due to the fact that the upper limit of the 95% confidence interval for the expected frequency does not exceed 3 / X, where X = 2115 (total number of volunteers in clinical trials).