Metapril 500 mg / 10 mg capsule number 30

Author Ольга Кияница

2017-05-11

Amount in a package -
Product form Capsules
Manufacturer Grindeks (Latvia)
Registration certificate UA/10815/01/01
The main medicament Metapril
morion code 221959

Metapril (METAPRIL) instructions for use

Composition

active substances : meldonium, lisinopril;

1 capsule contains 500 mg meldonium and 5 mg or 10 mg or 20 mg of lisinopril

auxiliary substances : corn starch corn, potato starch, silicon dioxide, povidone, calcium stearate

capsule (body and lid) of titanium dioxide (E 171), gelatin.

Dosage form

Capsules are solid.

Pharmacological group

Other cardiac preparations. ATS C01E C code

Clinical characteristics.

Indications

  • Arterial hypertension (AH), including symptomatic;
  • chronic heart failure (CHF) of I-III functional class according to NYHA (as part of complex therapy).

Contraindications.

  • Hypersensitivity to meldonia, lisinopril or to any of the components of the drug
  • increased sensitivity to other ACE inhibitors
  • increased intracranial pressure (with violation of venous outflow, intracranial tumors), organic lesions of the central nervous system (CNS)
  • angioedema in anamnesis during previous treatment with ACE inhibitors
  • hereditary or idiopathic angioedema
  • pregnant women or women who are planning to become pregnant.

Method of administration and dose.

The drug is taken orally, regardless of food intake.

In connection with the possible stimulating meldonium, it is not recommended to use Metapril shortly before sleep.

Before beginning treatment, it is necessary to compensate for the loss of fluid and salts. During therapy, it is necessary to monitor kidney function and potassium concentration in the blood serum.

The dosage of mulodonium / lisinopril therapy is individual for each particular patient, depending on the indices of arterial pressure. Individual selection of maintenance dose is performed by the doctor by titration of doses according to the recommended scheme:

  • 1 capsule 500 / 2.5 * mg per day
  • 2 capsules 500 / 2.5 * mg per day
  • 1 capsule 500/5 mg and 1 capsule 500 / 2.5 * mg per day
  • 2 capsules 500/5 mg per day
  • 1 capsule 500/10 mg and 1 capsule 500 / 2.5 * mg per day
  • 1 capsule 500/10 mg and 1 capsule 500/5 mg per day
  • 1 capsule 500/20 mg or 2 capsules 500/10 mg per day.

Total hypotensive effect Metapril usually develops in 2-4 weeks from the beginning of treatment, which should be taken into account when increasing the dose.

The maximum daily dose of Metapril should not exceed 1000/20 mg per day.

Monotherapy of arterial hypertension meldonium / lisinopril is prescribed once a day, in the morning, with an initial dose of 500 / 2.5 * mg. If the expected effect is not observed, individual dose adjustment is carried out.

If the patient received prior treatment with diuretics, diuretics should be discontinued 2-3 days before Metapril is started.If this is not possible, the initial dose of Metapril should not exceed 1000/5 mg per day. The first dose should be administered under the supervision of a doctor (the maximum effect occurs approximately in 6-7 hours) in connection with a possible decrease in blood pressure.

With insufficient clinical effect, it is possible to combine the drug with other antihypertensive drugs.

With reninvascular hypertension or other conditions with increased activity of renin-angiotensin it is advisable to start therapy with low doses of lisinopril at 2.5 * 5 mg per day under the supervision of a physician (blood pressure control, kidney function, potassium concentration in blood serum). The maintenance dose is determined in depending on the dynamics of blood pressure and taken under the supervision of a doctor.

In the treatment of chronic heart failure as part of a comprehensive therapy, mestonium / lisinopril is used in combination with diuretics and, if there are indications from digitalis or beta-blockers. Treatment can begin with an initial dose of 500 / 2.5 * mg once a day under control to determine the initial effect of the drug on blood pressure.

The dose of the drug should be increased with an interval of at least 2 weeks, taking into account the clinical response of a particular patient.

With diabetic nephropathy, the daily dose of lisinopril for insulin-independent patients with diabetes mellitus and hypertension is 10 mg (1 capsule of Metapril 500/10 mg or 2 capsules 500/5 mg) once a day. If necessary, the dose can be increased: 1 capsule Metapril 500/20 mg or 2 capsules 500/10 mg once a day to achieve a steady BP <90 mm Hg.Art.

If the kidney function is impaired, you need to monitor the level of creatinine. Depending on the reaction, it is necessary to determine the maintenance dose in conditions of frequent monitoring of kidney function, potassium level, sodium in the blood serum.

CK (ml / min) The initial dose of lisinopril in Metapril (mg / day)
31-80 5-10
10-30 2.5 * -5
less than 10 (Including patients on hemodialysis) 2.5 *

If you need a dose of lisinopril 2.5 mg, you should use lisinopril in the appropriate dosage or dosage form.

If liver function is impaired, it is necessary to monitor the level of hepatic transaminases.

In elderly people , a more pronounced prolonged hypotensive effect is often observed, which is associated with a decrease in the rate of excretion of lisinopril. Therefore, during treatment, correction of the Metapril dosage regimen is necessary.

In a clinical trial, the duration of treatment with Metapril was 8 weeks.

Adverse Reactions

During the treatment, the following adverse reactions were reported, which are classified according to the frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1 / 100), rarely (≥ 1/10 000 and <1/1000), very rarely (<1/10 000), the frequency is unknown (can not be estimated from the available data).

From the hematopoietic and lymphatic system:

  • rarely: a decrease in the level of hemoglobin and hematocrit and eosinophils;
  • very rarely: bone marrow suppression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune diseases.

From the side of metabolism and nutrition:

  • very rarely hypoglycemia.

From the nervous system and psyche:

  • often dizziness, headache
  • infrequent sudden changes in mood, paresthesia, vertigo, dyspnoea, sleep disturbance;
  • rarely confusion, disturbed balance, disorientation, tinnitus and decreased visual acuity, fainting;
  • frequency is unknown: symptoms of depression, fainting.

From the cardiovascular system:

  • often: orthostatic effects (including hypotension)
  • infrequently: myocardial infarction and stroke, probably as complications of arterial hypotension in high-risk patients, palpitation, arrhythmia (atrial tachycardia, bradycardia), Raynaud's syndrome.

When Metapril is used in patients with acute myocardial infarction, severe blocking of the II-III degree, severe arterial hypotension and / or renal dysfunction are possible, especially in the first 24 hours, in some cases ̶ cardiogenic shock.

From the respiratory system:

  • often: cough, bronchitis;
  • infrequently rhinitis
  • very rarely bronchospasm, sinusitis, allergic alveolitis / eosinophilic pneumonia, glossitis.

From the digestive tract:

  • often: diarrhea, vomiting
  • infrequently: nausea, abdominal pain and digestive disorders;
  • rarely: dry mouth
  • very rarely pancreatitis, intestinal angioedema, hepatocellular or cholestatic hepatitis, jaundice or liver failure.

From the skin and its derivatives:

  • infrequently: rash, itching, hypersensitivity / angioedema swelling of the face, extremities, lips, tongue, glottis and / or throat;
  • rarely: urticaria, alopecia, psoriasis;
  • very rarely: excessive sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pseudolymphoma of the skin.

A complex of symptoms has been reported that may include: fever, vasculitis, myalgia, arthralgia / arthritis, positive antinuclear antibodies (PAA), increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, rash, photosensitivity or other dermatological manifestations.

Allergic reactions:

  • rarely skin allergic reactions (rash, eczema, urticaria)
  • very rarely: fever, angioedema, including the lips, face, larynx, pharynx and / or tongue, extremities, increased titer of antinuclear antibodies.

From the urinary system:

  • often: impaired renal function
  • rarely uremia, acute renal failure
  • very rarely oliguria / anuria.

On the part of the reproductive system and mammary glands:

  • infrequent impotence
  • rarely gynecomastia.

Common violations:

  • infrequently: fatigue, asthenia, hypoglycemia.

Others: weight gain, development of infections, including herpes zoster, diabetes mellitus, dehydration.

Overdose

There is a limited amount of data on cases of overdose rights.

Symptoms : sudden changes in blood pressure, arterial hypotension, vascular collapse, electrolyte imbalance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough, headache and general weakness are possible.

Treatment . In case of an overdose of the drug, customized treatment is infusion of physiological solution. In case of arterial hypotension, the patient should be placed in a horizontal position with a low headboard. If necessary, treat infusion of angiotensin II and / or prescribe catecholamines intravenously. If the drug has been taken recently, general detoxification measures are taken (for example, gastric lavage, vomiting, absorption of absorbents or sodium sulfate). In the presence of treatment-resistant bradycardia, the use of a pacemaker can be shown. It is necessary to constantly monitor the indicators of vital functions, the level of electrolytes in the blood serum and the concentration of creatinine.

Use during pregnancy or lactation.

The drug should not be used by pregnant women or women who plan to become pregnant. If during pregnancy this drug is confirmed pregnancy, its use should be immediately stopped and replaced with another drug approved for use in pregnant women.

Metapril penetrates the placental barrier and into breast milk. If it is necessary to use during breastfeeding, breastfeeding should be discontinued.

Children

Safety and efficacy in children have not been proven. Therefore, Metapril is not used in pediatric practice.

Application features

Symptomatic hypotension. Clinical manifestations of arterial hypotension are rare in patients with uncomplicated arterial hypertension. In patients with hypertension taking Metapril, the likelihood of hypotension is higher if there is dehydration, for example, with diuretic therapy, diarrhea, due to emesis, the use of a salt-free diet, dialysis, or in those who have a severe form of renin-dependent hypertension. Patients with heart failure with or without renal failure may experience symptomatic hypotension. The likelihood of its occurrence is higher in patients with more severe forms of heart failure, observed with high doses of loop diuretics, hyponatremia or functional renal failure. Initiation of therapy and dose adjustment for patients with an increased risk of symptomatic hypotension should be carefully monitored. Similar precautions should be taken in relation to patients with coronary heart disease or cerebrovascular disease, in which excessive lowering of blood pressure can lead to myocardial infarction or stroke.

If there is an arterial hypotension, the patient should be placed on his back and, if necessary, infused with physiological saline. Temporary decrease in blood pressure is not a contraindication for the further administration of the drug. As soon as the arterial pressure rises after the recovery of the volume of fluid, the drug can be used without reservations.

In some patients with heart failure, have normal or low blood pressure, with the use of Metapril, there may be an additional reduction in systemic blood pressure. This effect is expected and usually does not cause the cessation of treatment. If the manifestations of arterial hypotension acquire a clinical nature, it may be necessary to reduce the dose or discontinue the use of the drug.

Arterial hypotension in acute myocardial infarction. Treatment of Metapril should not be started by patients with acute myocardial infarction, in which there is a risk of further hemodynamic complications after treatment with vasodilators.This group includes patients who have a systolic blood pressure of 100 mm Hg. Art. or lower, or those who developed cardiogenic shock. If during the first 3 days after a heart attack the systolic blood pressure is 120 mm Hg. Art. or lower, the dose should be reduced. If the systolic blood pressure is 100 mm Hg. Art. or lower, it is necessary to reduce the maintenance dose to 500/5 mg or temporarily to 500 / 2.5 * mg. Metapril therapy should be discontinued if arterial hypotension persists (systolic blood pressure is below 90 mmHg for more than 1:00).

Stenosis of aortic and mitral valves / hypertrophic cardiomyopathy. Metapril should be used with caution in patients with stenosis of the mitral valve and obstruction of outflow from the left atrium, for example, with aortic stenosis or hypertrophic cardiomyopathy.

Impaired renal function. In case of renal insufficiency (creatinine clearance <80 ml / min), the initial dose of Metapril should be prescribed according to the patient's QC (see Table), and further ̶ according to the patient's response to treatment. In such patients, regular monitoring of potassium and creatinine levels is part of routine medical practice. In patients with heart failure, arterial hypotension, occurs at the beginning of treatment, can lead to further impairment of kidney function. In such cases, acute renal failure was reported, which is usually reversible. In some patients with bilateral stenosis of the renal artery or stenosis of the artery of a single kidney, there was an increase in the level of urea and creatinine in the blood serum, usually of little reversible nature after discontinuation of therapy. This is especially true for patients with renal insufficiency. If Renovascular hypertension also develops, the risk of severe arterial hypotension and renal failure increases. Treatment of such patients should be started under close medical supervision with the appointment of low doses of the drug and careful titration of the dose. Although diuretic treatment may be a factor contributing to the above-mentioned phenomena, before taking Metapril, their reception should be canceled and the kidney function monitored within the first weeks treatment with Metapril.

In some patients with arterial hypertension without obvious manifestations of renal vascular disorders, an increase in the level of urea and serum creatinine was observed, which is usually insignificant and reversible, especially in combination with metapril with diuretics. The occurrence of such phenomena is higher in patients with existing renal insufficiency. In such cases, a reduction in dose and / or discontinuation of diuretics and / or Methapril is required.

In acute myocardial infarction, Metapril treatment of patients with signs of impaired renal function (serum creatinine concentration above 177 μmol / L and / or proteinuria above 500 mg / g), do not start. If renal failure occurs during treatment with Metapril (serum creatinine concentration above 265 μmol / L or twice the level that was observed before treatment), the doctor must decide to discontinue therapy with Metapril.

Hypersensitivity / angioedema. Sometimes it was reported on the development of angioedema, facial, extremities, lips, tongue, glottis and / or larynx in patients taking Metapril. These phenomena can occur at any time during treatment. In such cases, you must immediately stop taking Metapril, prescribe appropriate treatment and carry out continuous monitoring until the symptoms disappear completely in the patient.

In cases where edema is localized in the area of the tongue without causing breathing problems, the patient may require prolonged follow-up if treatment with histamine and corticosteroids is insufficient.

Very rarely reported on the lethal effects of angioedema, associated with edema of the larynx or tongue. In patients with edema in the area of the tongue, glottis or larynx, airway obstruction is possible, especially in those with operative airway interventions. In such cases, emergency measures must be taken immediately.

They may include the administration of adrenaline and / or maintenance of airway patency

patient. The patient should be under close medical supervision until complete and sustained resolution of symptoms.

Patients with a history of angioedema, even if its development is not associated with ACE inhibitors are at increased risk of angioedema during therapy Metaprilom.

Anaphylactic reactions during apheresis low density lipoprotein (LDL). Rarely patients during LDL apheresis with dextrin sulphate were observed anaphylactic reactions, life-threatening. The occurrence of such reactions can be avoided by temporarily discontinue therapy Metaprilom prior to apheresis.

Desensitization.Patients taking Metapril during treatment (eg hymenoptera venom) may have anaphylactic reactions. They disappear when suspending the use Metaprilu, but they can reappear by careless re-appointment of the drug.

Liver failure.Very rarely Metaprilu application associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is unknown. If patients taking Metapril, developed jaundice or a marked increase in liver enzyme levels, you should stop using the product and to provide appropriate medical pomosch.Neytropeniya / agranulocytosis. Reported cases of neutropenia / agranulocytosis, thrombocytopenia and anemia in patients who took Metapril. In patients with normal renal function who have no other complications, neutropenia occurs rarely. Neutropenia and agranulocytosis disappear after cessation of therapy. It should be very carefully applied Metapril patients who have a vascular kolagenoz,receiving immunosuppressive therapy, are treated with allopurinol or procainamide or have several of these complicating factors, especially in the case of existing renal dysfunction. In some of these patients develop serious infections in which intensive antibiotic therapy does not give the desired rezultata.Esli Metapril administered to such patients, the periodic monitoring of the number of leukocytes is recommended and should inform the patient of the need to inform the doctor about any signs of infection.If Metapril administered to such patients, it is recommended to carry out periodic monitoring of the number of leukocytes, and must inform the patient of the need to inform the doctor about any signs of infection.If Metapril administered to such patients, it is recommended to carry out periodic monitoring of the number of leukocytes, and must inform the patient of the need to inform the doctor about any signs of infection.

Race.ACE inhibitors cause higher occurrence frequency angioedema in blacks compared to other races. Metapril may be less effective when needed to reduce blood pressure in blacks compared with the other species, possibly due to more common among patients blacks hypertensive condition characterized by low renin status.

Cough. It reported cases of cough, which was caused by the use of Metaprilu. In typical cases, it was a dry and persistent cough, but one that quickly disappears after discontinuation of treatment. During the differential diagnosis of cough must be considered that the occurrence of cough can be caused by treatment Metaprilu.

Surgery / anesthesia. In patients undergoing major surgical intervention or anesthesia agents that cause hypotension, Metapril can block the formation of angiotensin II after compensatory renin secretion. If as a result of this mechanism, hypotension occurred, it is necessary to restore the level of liquid.

Hyperkalemia. The increase in the level of potassium in the blood serum is observed in some patients taking Metapril. Increased risk of hyperkalemia exists in patients with renal insufficiency, diabetes or those which are used simultaneously or potassium-sparing diuretics solezamenitelya containing potassium; or patients taking other drugs, the use of which is associated with an increase in potassium level in serum (e.g., heparin). When the simultaneous application of the aforementioned substances necessary, it is recommended to regularly monitor the level of potassium in serum.

Diabetics. During the first month of Metaprilu diabetics who take oral antidiabetic medication or insulin, necessary to carefully carry out the glycemic control.

Application of patients with kidney transplant. Experience destination Metaprilu patients who have a kidney transplant was recently performed, no. Therefore, treatment is not recommended Metaprilom.

Lithium. usually not recommended simultaneous lithium Metaprilu.

Use of the drug should be under a doctor's supervision.

During therapy with regular monitoring of blood pressure, renal function, hemogram parameters, body weight, and protein and the level of potassium in the blood plasma, urea and creatinine, the diet.

It is not recommended to use the drug in patients on hemodialysis using dialysis membranes with high permeability, due to the risk of anaphylactoid reactions.

During treatment should refrain from drinking alcoholic beverages because of the risk of increased antihypertensive effect.

Caution should be exercised during exercise, especially in hot weather, because of the risk of development of dehydration and increase the antihypertensive effect.

If necessary, use a dose of 2.5 mg lisinopril lisinopril should be used in appropriate dosage or dosage form.

The ability to influence the reaction rate when driving vehicles or other mechanisms

Due to the possibility of dizziness and fatigue of the drug can affect the ability to drive or work with complex mechanisms.

Interaction with other drugs and other interactions

Anticoagulants, cyclosporine, while the use Metaprilom increase the risk of hyperkalemia.

Diuretics. The antihypertensive effect is usually more pronounced if, in addition to therapy for patients administered Metaprilom diuretics. In patients receiving diuretics, especially those who started this treatment recently after adding Metaprilu sometimes can be observed a significant drop in blood pressure. The likelihood of symptomatic hypotension caused Metaprilom, can be reduced to halt the use of diuretics before starting treatment Metaprilom.

Dietary supplements containing potassium sparing diuretics abo solezamenitelya containing potassium. Although the level of potassium in the blood serum usually remains at a normal level, some patients observed hyperkalemia. Risk factors contributing to the development of hyperkalemia is renal failure, diabetes, or the simultaneous use of potassium-sparing diuretics (e.g. spironolactone, triamterene or amiloride), food additives, containing potassium or solezamenitelya containing potassium.

While admission Metaprilu and potassium-sparing diuretics may develop hyperkalemia caused by diuretics.

Lithium. When simultaneous administration of lithium and ACE inhibitors reported reversible increase in the concentration of lithium in blood serum and growth toxicity. Simultaneous with the appointment of thiazide diuretics with ACE inhibitors increases the risk of lithium poisoning and increases the already increased risk of lithium toxicity. Simultaneous treatment with lithium and Metaprilu not recommended, but if their combined use is necessary, there should be careful monitoring of lithium levels in blood serum.

Nonsteroidal anti-inflammatory drugs (NPZSH., Including acetylsalicylic acid at a dose of ≥ 3 g / d y). Long term use of NSAIDs can reduce the antihypertensive effect of the ACE inhibitors. NSAIDs and ACE inhibitors cause an additional effect of potassium level in serum growth and may lead to a deterioration of renal function. These effects are usually reversible. Rarely observed acute renal failure, especially in patients with compromised renal function such as elderly patients or patients with dehydration.

Other antihypertensive drugs. The simultaneous use of such drugs can increase Metaprilu hypotensive effect. The simultaneous use of nitroglycerine and other nitrate or other vasodilator may result in further reduction of blood pressure.

Tricyclic antidepressants / antipsychotics / anesthetics. Simultaneous use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to a further decrease in blood pressure.

Sympathomimetics. Sympathomimetics may reduce the antihypertensive effect of the ACE inhibitors.

Antidiabetic drugs. Epidemiological studies show that co-administration of ACE inhibitors and antidiabetic drugs (insulin, oral antidiabetics) may cause an accelerated decline in blood glucose levels with risk of hypoglycemia. This effect is more likely to occur during the first weeks of combined treatment and in patients with impaired renal function.

Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates. Metapril may be used together with acetylsalicylic acid (at cardiological doses), thrombolytics, beta-blockers and / or nitrates.

Alcohol. Potentiates the hypotensive effect of Metaprilu.

Allopurinol, cytostatic agents, immunosuppressants, corticosteroids, procainamide. In an application with Metaprilom may cause leukopenia.

Medicines that suppress bone marrow function. In an application with Metaprilom increase the risk of neutropenia and / or agranulocytosis.

Estrogens. When concomitant administration may reduce the hypotensive effect Metaprilu due to fluid retention in the body.

Antacids and cholestyramine may decrease absorption Metaprilu.

Metapril may exacerbate the effects of nitroglycerin, nifedipine, beta-blockers, antihypertensives and peripheral vasodilators.

Metapril not be used concomitantly with other drugs meldoniy- and lizinoprilvmisniimy.

Pharmacological properties

Pharmacological .

Meldonium - structural analogue of γ-butyrobetaine - substances that are found in every cell of the human body. In high load conditions meldonium restores the balance between cell delivery and oxygen demand, eliminates the accumulation of toxic products of metabolism in the cells, protecting them from damage; also it has a tonic effect. As a result of its use increases the body's resistance to stress and ability to quickly restore energy reserves. By lowering the concentration of carnitine intensively synthesized γ-butyrobetaine, which has vasodilatory properties. In the case of acute myocardial ischemic injury meldonium inhibits the formation of necrotic zone, reduces the duration of the rehabilitation period. In chronic heart failure improves myocardial contractile function,increases exercise tolerance, reduces the frequency of angina attacks. In acute and chronic ischemic disorders of cerebral blood circulation improves blood circulation in the ischemic focus, promotes redistribution of blood to the ischemic area. The drug eliminates functional disorders of the nervous system in patients with chronic alcoholism during abstinence syndrome.

Lisinopril - an ACE inhibitor. It blocks the formation of angiotensin II and reduces its vasoconstrictor effect. Against the background of the drug happens reduction of systolic and diastolic blood pressure, renal vascular resistance is reduced and improves circulation.

In most patients, the antihypertensive effect of lisinopril manifests within 1-2 hours after ingestion, maximum - after approximately 6-9 hours. Stabilization of the therapeutic effect observed after 3-4 weeks of starting treatment. Withdrawal are not logged in.

Pharmacokinetics .

meldonium

After oral administration, rapidly absorbed meldonium. Bioavailability - 78%. Maximum plasma concentration is achieved 1-2 hours after ingestion. It is metabolized in the body into two major metabolites are excreted by the kidneys. The half-life when administered depends on the dose and is 3-6 hours.

lisinopril

After taking lisinopril, the absorption in the gastrointestinal tract is slow and partial. On average, 30% of the received lisinopril is absorbed, but, depending on the individual characteristics of the patient, this value can vary from 6 to 60%.Bioavailability is 25%. Almost does not bind to blood plasma proteins. The maximum concentration in blood plasma (90 ng / ml) is reached at 7:00. Permeability through the blood-brain and placental barrier is low.

Lizinopril is not biotransformed in the body. It is excreted by the kidneys unchanged. The elimination half-life is 12:00.

In patients with CHF, absorption and clearance of lisinopril are reduced.

In patients with renal insufficiency, the concentration of lisinopril is several times higher than the concentration in the blood plasma, there is an increase in the time to reach the maximum concentration in the blood plasma and an elongation of the half-life.

In elderly patients, the concentration in the blood plasma and the area under the curve is 2 times greater than in patients of a young age.

Basic physical and chemical properties

to the apsules 500/5 mg : hard gelatin capsules of white color with an inscription of black color M + 5. The content is a white crystalline powder with a weak odor. The powder is hygroscopic;

capsules 500/10 mg : hard gelatin capsules of white color with an inscription of black color M + 10. Content - a white crystalline powder with a weak odor. The powder is hygroscopic;

capsules 500/20 mg hard gelatin capsules of white color with an inscription of black M + 20. The content is a white crystalline powder with a weak odor. The powder is hygroscopic.

Shelf life

3 years.
Do not use after the expiration date stated on the package.

Storage conditions

Store in a dry place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Packaging

10 capsules in a blister pack. For 2, 3 or 6 blisters in a cardboard box.

Category of leave

On prescription.


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