Cardiomagnet tablets p / o 150mg + 30.39mg, No. 100

• Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age).

• Prevention of recurrent myocardial infarction and blood vessel thrombosis.

• Prevention of thromboembolism after vascular surgery (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty).

• Unstable angina.

The tablets are swallowed whole with water.

If desired, the tablet can be broken in half, chewed or pre-ground.

Primary prevention of cardiovascular diseases such as thrombosis and congestive heart failure in the presence of risk factors (eg, diabetes mellitus, hyperlipidemia, hypertension, obesity, smoking, old age)

1 tablet of Cardiomagnyl containing ASA at a dose of 150 mg on the first day, then 1 tablet of Cardiomagnyl containing ASA at a dose of 75 mg 1 time per day.

Prevention of recurrent myocardial infarction and blood vessel thrombosis

1 tablet of Cardiomagnyl containing ASA at a dose of 75 - 150 mg once a day.

Prevention of thromboembolism after vascular surgery (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)

1 tablet of Cardiomagnyl containing ASA at a dose of 75 - 150 mg once a day.

Unstable angina

1 tablet of Cardiomagnyl containing ASA at a dose of 75 -150 mg 1 time per day.

Active ingredients:

Acetylsalicylic acid - 150 mg

Magnesium hydroxide - 30.39 mg

Excipients:

Corn starch - 19.0 mg

Microcrystalline cellulose - 25.0 mg

Magnesium Stearate - 305 mcg

Potato starch - 4.0 mg

Shell

Hypromellose (methylhydroxypropylcellulose 15) - 1.2 mg

Propylene glycol - 240 mcg

Talc - 720 mcg

• Hypersensitivity to ASA, excipients of the drug and other NSAIDs, cerebral hemorrhage;

• bleeding tendency (vitamin K deficiency, thrombocytopenia, hemorrhagic diathesis);

• bronchial asthma induced by the intake of salicylates and NSAIDs;

• erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);

• gastrointestinal bleeding;

• severe renal failure (creatinine clearance less than 10 ml / min.);

• pregnancy (I and III trimesters);

• lactation period;

• deficiency of glucose-6-phosphate dehydrogenase;

• simultaneous reception with methotrexate (more than 15 mg per week);

• children under 18 years of age.

Carefully

With gout, hyperuricemia, a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal and / or liver failure, bronchial asthma, hay fever, nasal polyposis, allergic conditions, in the II trimester of pregnancy.

Trade name of the drug: Cardiomagnyl

International non-proprietary name or group name:

Acetylsalicylic acid + Magnesium hydroxide

Dosage form : film-coated tablets

Composition.

One tablet contains:

Active ingredients:

Acetylsalicylic acid - 150 mg

Magnesium hydroxide - 30.39 mg

Excipients:

Corn starch - 19.0 mg

Microcrystalline cellulose - 25.0 mg

Magnesium Stearate - 305 mcg

Potato starch - 4.0 mg

Shell

Hypromellose (methylhydroxypropylcellulose 15) - 1.2 mg

Propylene glycol - 240 mcg

Talc - 720 mcg

Description

Film-coated tablets containing 75 mg / 15.2 mg of acetylsalicylic acid and magnesium hydroxide, respectively: film-coated tablets, white in the shape of a stylized 'heart'

Film-coated tablets containing 150 mg / 30.39 mg of acetylsalicylic acid and magnesium hydroxide, respectively: film-coated tablets, white, oval in shape with a line on one side.

Pharmacotherapeutic group:

Antiplatelet agent

ATX CODE: B01AC3

Pharmacological properties Pharmacodynamics

The mechanism of action of acetylsalicylic acid (ASA) is based on irreversible inhibition of cyclooxygenase (COX-1), as a result of which the synthesis of thromboxane A2 is blocked and platelet aggregation is suppressed. It is believed that ASA has other mechanisms for suppressing platelet aggregation, which expands the scope of its application in various vascular diseases. ASA also has anti-inflammatory, analgesic, antipyretic effects. Magnesium hydroxide, which is part of Cardiomagnyl, protects the mucous membrane of the gastrointestinal tract from the effects of acetylsalicylic acid.

Pharmacokinetics

ASA is absorbed from the gastrointestinal tract almost completely. The half-life of ASA is about 15 minutes. with the participation of enzymes, ASA is rapidly hydrolyzed to salicylic acid (SA) in the intestine, liver and blood plasma. The half-life of SC is about 3 hours, but it can be significantly increased with the simultaneous administration of large doses of ASA (more than 3.0 g) as a result of saturation of the enzyme systems.

The bioavailability of ASA is about 70%, but this value fluctuates to a large extent, since ASA undergoes presystemic hydrolysis (gastrointestinal mucosa, liver) in the SC under the action of enzymes. The bioavailability of SC is 80-100%.

The doses of magnesium hydroxide used do not affect the bioavailability of acetylsalicylic acid.

Indications for use

• Primary prevention of cardiovascular diseases such as thrombosis and acute heart failure in the presence of risk factors (for example, diabetes mellitus, hyperlipidemia, arterial hypertension, obesity, smoking, old age).

• Prevention of recurrent myocardial infarction and blood vessel thrombosis.

• Prevention of thromboembolism after vascular surgery (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty).

• Unstable angina.

Contraindications

• Hypersensitivity to ASA, excipients of the drug and other NSAIDs, cerebral hemorrhage;

• bleeding tendency (vitamin K deficiency, thrombocytopenia, hemorrhagic diathesis);

• bronchial asthma induced by the intake of salicylates and NSAIDs;

• erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);

• gastrointestinal bleeding;

• severe renal failure (creatinine clearance less than 10 ml / min.);

• pregnancy (I and III trimesters);

• lactation period;

• deficiency of glucose-6-phosphate dehydrogenase;

• simultaneous reception with methotrexate (more than 15 mg per week);

• children under 18 years of age.

Carefully

With gout, hyperuricemia, a history of ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding, renal and / or liver failure, bronchial asthma, hay fever, nasal polyposis, allergic conditions, in the II trimester of pregnancy.

Application during pregnancy and during breastfeeding

The use of large doses of salicylates in the first 3 months of pregnancy is associated with an increased incidence of fetal defects. In the second trimester of pregnancy, salicylates can be prescribed only with a rigorous assessment of the risks and benefits.

In the last trimester of pregnancy, salicylates in a high dose (more than 300 mg / day) cause inhibition of labor, premature closure of the ductus arteriosus in the fetus, increased bleeding in the mother and fetus, and administration just before childbirth can cause intracranial hemorrhage, especially in premature babies. The appointment of salicylates in the last trimester of pregnancy is contraindicated.

The available clinical data are insufficient to establish the possibility or impossibility of using the drug during breastfeeding. Before prescribing acetylsalicylic acid during lactation, the potential benefit of drug therapy should be assessed relative to the potential risk to infants.

Method of administration and dosage

The tablets are swallowed whole with water.

If desired, the tablet can be broken in half, chewed or pre-ground.

Primary prevention of cardiovascular diseases such as thrombosis and congestive heart failure in the presence of risk factors (eg, diabetes mellitus, hyperlipidemia, hypertension, obesity, smoking, old age)

1 tablet of Cardiomagnyl containing ASA at a dose of 150 mg on the first day, then 1 tablet of Cardiomagnyl containing ASA at a dose of 75 mg 1 time per day.

Prevention of recurrent myocardial infarction and blood vessel thrombosis

1 tablet of Cardiomagnyl containing ASA at a dose of 75 - 150 mg once a day.

Prevention of thromboembolism after vascular surgery (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)

1 tablet of Cardiomagnyl containing ASA at a dose of 75 - 150 mg once a day.

Unstable angina

1 tablet of Cardiomagnyl containing ASA at a dose of 75 -150 mg 1 time per day.

Side effect

The frequency of the adverse reactions listed below was determined according to the following:

-Often ? 1/10;

-often> 1/100,? 1/10;

- sometimes> 1/1000,? 1/100;

- rarely> 1/10 000,? 1/1000;

-rarely ? 1/10 000, including selected messages.

Allergic reactions: urticaria (often), Quincke's edema (often).

Immune system: anaphylactic reactions (sometimes).

Gastrointestinal tract: nausea (common), heartburn (very common), vomiting (common), pain in the abdomen, ulcers of the stomach and duodenal mucosa (sometimes), including perforation (rare), gastrointestinal bleeding (sometimes), increased activity of 'liver' enzymes (rare), stomatitis (very rare), esophagitis (very rare), erosive lesions of the upper gastrointestinal tract (very rare), strictures (very rare), colitis (very rare) , exacerbation of intestinal irritation (very rare).

Respiratory system: bronchospasm (common)

Hematopoietic system: increased bleeding (very common), anemia (rarely), hypoprothrombinemia (very rare), thrombocytopenia (very rare), neutropenia, aplastic anemia (very rare), eosinophilia (very rare), agranulocytosis (very rare).

Central nervous system: dizziness (sometimes), headache (often), insomnia (often), drowsiness (sometimes), tinnitus, intracerebral hemorrhage (rare).

Overdose

Overdose symptoms of moderate severity

nausea, vomiting, tinnitus, hearing impairment, dizziness, confusion.

Treatment: rinse the stomach, take activated charcoal. Treatment is symptomatic.

Severe overdose symptoms

fever, hyperventilation, ketoacidosis, respiratory alkalosis, coma, cardiovascular and respiratory failure, severe hypoglycemia.

Treatment: immediate hospitalization in specialized departments for emergency therapy - gastric lavage, determination of acid-base balance, alkaline and forced alkaline diuresis, hemodialysis, administration of solutions, activated carbon, symptomatic therapy. When carrying out alkaline diuresis, it is necessary to achieve pH values ??between 7.5 and 8. Forced alkaline diuresis should be carried out when the concentration of salicylates in plasma is more than 500 mg / l (3.6 mmol / l) in adults and 300 mg / l (2, 2 mmol / l) in children.

Interaction with other medicinal products (see also the section 'Special instructions')

With the simultaneous use of ASA enhances the effect of the following drugs:

Methotrexate by reducing renal clearance and displacing it from the connection with proteins

Heparin and indirect anticoagulants due to dysfunction of platelets and displacement of indirect anticoagulants from the connection with proteins

Thrombolytic and antiplatelet and anticoagulant drugs (ticlopidine)

Digoxin due to a decrease in its renal excretion

Hypoglycemic agents for oral administration (sulfonylurea derivatives) and insulin due to the hypoglycemic properties of ASA itself in high doses and displacement of sulfonylurea derivatives from the connection with blood plasma proteins

Valproic acid due to its displacement from the connection with proteins

The simultaneous use of ASA with ibuprofen leads to a decrease in the cardioprotective effects of ASA.

јддитивный эффект наблюдаетс¤ при одновременном приеме ј—  с этанолом (алкоголем).

ј—  ослабл¤ет действие урикозурических средств (бензбромарона) вследствие конкурентной тубул¤рной элиминации мочевой кислоты.

”силива¤ элиминацию салицилатов, системные глюкокортикостероиды (v —) ослабл¤ют их действие.

јнтациды и колестирамин снижают всавывание препарата.

ќсобые указани¤

ѕрепарат следует примен¤ть после назначени¤ врача.

ј—  может провоцировать бронхоспазм, а также вызывать приступы бронхиальной астмы и другие реакции повышенной чувствительности. ‘акторами риска ¤вл¤ютс¤ наличие бронхиальной астмы в анамнезе, сенной лихорадки, полипоза носа, хронических заболеваний дыхательной системы, а также аллергических реакций на другие препараты (например, кожные реакции, зуд, крапивница).

ј—  может вызвать кровотечени¤ различной степени выраженности во врем¤ и после хирургических вмешательств. «а несколько дней до планируемого хирургического вмешательства должен быть оценен риск развити¤ кровотечени¤ по сравнению с риском развити¤ ишемических осложнений у пациентов, принимающих низкие дозы ј— . ?сли риск развити¤ кровотечени¤ значительный, прием ј—  должен быть временно прекращен.

—очетание ј—  с антикоагул¤нтами, тромболитиками и антитромбоцитарными препаратами сопровождаетс¤ повышенным риском развити¤ кровотечений.

ј—  в низких дозах может спровоцировать развитие подагры у предрасположенных пациентов (имеющих сниженную экскрецию мочевой кислоты).

—очетание ј—  с метотрексатом сопровождаетс¤ повышенной частотой развити¤ побочных эффектов со стороны органов кроветворени¤.

¬ысокие дозы ј—  оказывают гипогликемический эффект, что необходимо иметь в виду при назначении ее пациентам с сахарным диабетом, получающим гипогликемические средства дл¤ приема внутрь и инсулина.

ѕри сочетанном применении системных глюкокортикостероидов (v —) и салицилатов следует помнить, что во врем¤ лечени¤ концентраци¤ салицилатов в крови снижена, а после отмены системных глюкокортикостероидов (v —) возможна передозировка салицилатов.

Ќе рекомендуетс¤ сочетание ј—  с ибупрофеном у пациентов с повышенным риском сердечно- сосудистых заболеваний: при одновременном применении с ибупрофеном отмечаетс¤ уменьшение антиагрегатного действи¤ ј—  в дозах до 300 мг, что приводит к снижению кардиопротекторных эффектов ј— .

ѕревышение дозы ј—  свыше рекомендуемых терапевтических доз сопр¤жено с риском желудочно-кишечного кровотечени¤.

ѕри длительном приеме низких доз ј—  в качестве агрегантной терапии необходимо соблюдать осторожность у пожилых пациентов в св¤зи с риском развити¤ желудочно- кишечного кровотечени¤.

ѕри одновременном приеме ј—  с алкоголем повышен риск повреждени¤ слизистой оболочки желудочно-кишечного тракта и удлинени¤ времени кровотечени¤.

¬ли¤ние на способность управл¤ть транспортными средствами и движущимис¤ механизмами

¬ период лечени¤ препаратами ј—  необходимо соблюдать осторожность при управлении транспортными средствами и зан¤ти¤ми потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска

“аблетки покрытые пленочной оболочкой 75 мг +15,2 мг и 150 мг + 30.39 мг

ѕо 30 или 100 таблеток в стекл¤нные флаконы коричневого цвета, укупоренные навинчивающейс¤ крышкой белого цвета (из полиэтилена), с вмонтированной съемной капсулой с силикагелем и кольцом, обеспечивающим контроль первого вскрыти¤. Ќа каждый флакон наклеивают этикетку. ќдин флакон с инструкцией по применению помещают в картонную пачку.

”слови¤ хранени¤

¬ защищенном от света месте, при температуре не выше 25 ?—. ’ранить в недоступном дл¤ детей месте.

—рок годности

3 года.

Ќе использовать после окончани¤ срока годности.

”слови¤ отпуска из аптек

Ѕез рецепта.

ёридическое лицо, на им¤ которого выдано регистрационное удостоверение

ќќќ Ђ“акеда ‘армасьютикалсї, –осси¤, 119048, г. ћосква, ул. ”сачева, д.2, стр. 1

ѕроизводитель

“акеда vмб’, vермани¤

Takeda GmbH, Germany

Lehnitzstrasse 70-98, 16515 Oranienburg, Germany или

LLC 'Takeda Pharmaceuticals' Russia, 150030, Yaroslavl, st. Technoparkovaya, 9

Tel .: (495) 933-55-11

Fax: (495) 502-16-25

Or

Takeda Pharma A / S, Denmark

Takeda Pharma A / S, Denmark Apotekerstein 9, 9500 Hobro, Denmark

Packer / Packer / Issuing quality control

Takeda GmbH, Germany Takeda GmbH, Germany

Lehnitzstrasse 70-98, 16515 Oranienburg, Germany or

LLC 'Takeda Pharmaceuticals' Russia, 150030, Yaroslavl, st. Technoparkovaya, 9

Tel .: (495) 933-55-11

Fax: (495) 502-16-25

Consumer claims should be sent to:

LLC 'Takeda Pharmaceuticals', Russia, 119048, Moscow, st. Usacheva, 2, building 1 Phone: (495) 933-55-11

Fax: (495) 502-16-25

Email: [email protected]

Internet address: www.takeda.com.ru