Inhibice - instructions for use, dose, side effects, contraindications

Active substanceCilazaprilCilazapril

Similar drugsTo uncover

Incibice®

pills inwards

Hoffmann-La Roche Ltd. Switzerland

Dosage form: & nbspfilm-coated tablets

Composition:

One tablet, film-coated, contains:

active substance: Cilazapril (anhydrous) - 1 mg / 2.5 mg / 5 mg;

Excipients: lactose monohydrate - 81.506 mg / 124.39 mg / 121.78 mg, corn starch - 39.00 mg / 60.00 mg / 60.00 mg, hypromellose 3 cps - 5.20 mg / 8.00 mg / 8.00 mg, talc 1.95 mg / 3.00 mg / 3.00 mg, sodium stearyl fumarate - 1.30 mg / 2.00 mg / 2.00 mg;

tablet shell: hypromellose 6 cps - 1.50 mg / 2.50 mg / 2.50 mg, talc - 0.75 mg / 1.25 mg / 1.25 mg, titanium dioxide (E 171) - 0.60 mg / 1.00 mg / 0.25 mg, iron coloration yellow oxide (E 172) - 0.15 mg / 0.10 mg / 0 mg, iron dye red oxide (E 172) - 0 mg / 0.15 mg, 1.00 mg.

Description:

Tablets 1 mg: oval, biconvex tablets, covered with a film coat of pale yellow color; on one side of the tablet the engraving "CIL 1", on the other - the risk. Tablet dimensions: length 9.6-10.6 mm; width 5.0-5.6 mm; height 2.7-3.7 mm.

Tablets 2.5 mg: oval, biconvex tablets, covered with a film coat of pale red color; on one side of the tablet the engraving "CIL 2.5", on the other side - the risk. Tablet sizes: length 11.2-12.2 mm; width 5.9-6.5 mm; height 3.1-4.3 mm.

Tablets 5 mg: oval, biconvex tablets, covered with a film coat from reddish-brown to brown; on one side of the tablet the engraving "CIL 5", on the other side - the risk. Tablet sizes: length 11.2-12.2 mm; width 5.9-6.5 mm; height 3.1-4.3 mm.

Pharmacotherapeutic group:Angiotensin-converting enzyme (ACE) inhibitor

ATX: & nbsp

C.09.A.A.08 Cilazapril

Pharmacodynamics:

Cilazapril is a specific long-acting inhibitor of the angiotensin-converting enzyme (ACE). Blocking ACE, reduces the formation of angiotensin II from angiotensin I and thereby inhibits the function of the renin-angiotensin-aldosterone system, which leads to a decrease in the secretion of aldosterone, a reduction in total peripheral vascular resistance (OPSS), blood pressure (BP) and preload. In recommended doses, the effect of cilazapril in patients with arterial hypertension (AH) and in patients with chronic heart failure persists for up to 24 hours.

In patients with normal renal function during treatment with cilazapril, the concentration of potassium ions in serum usually remains within normal limits. In patients taking concomitantly potassium-sparing diuretics, potassium levels may increase.

Cilazapril reduces systolic and diastolic blood pressure both in a standing and lying position, usually without orthostatic reactions. The drug is effective for any degree of hypertension, as well as for renovascular hypertension.The antihypertensive effect of cilazapril is usually manifested within the first hour after ingestion and reaches a maximum after 3-7 hours. Reflex tachycardia does not occur, although there may be slight changes in heart rate that are not clinically significant. In some patients, the decrease in blood pressure may decrease by the time of the next administration of the drug. With prolonged treatment, the antihypertensive effect of cilazapril is preserved. There is no withdrawal syndrome.

In patients with hypertension and with moderate or severe renal insufficiency, the rate of glomerular filtration and renal blood flow in the treatment of cilazapril usually do not change, despite a clinically significant decrease in blood pressure.

As with other ACE inhibitors, the antihypertensive effect of cilazapril in patients of the Negroid race may be less pronounced than in patients of other races. If cilazapril is used in combination with hydrochlorothiazide, there is no difference in the effect of the drug in patients of different racial attachments.

In patients with chronic heart failure, the activity of the renin-angiotensin-aldosterone system,as well as the sympathetic nervous system is usually increased, which leads to an increase in systemic vasoconstriction and an increase in the delay of sodium and fluid in the body. In patients receiving diuretics and / or cardiac glycosides, cilazapril, suppressing the function of the renin-angiotensin-aldosterone system, reduces the burden on the heart, reducing OPSS (afterload) and pressure in the pulmonary capillaries (preload). In addition, these patients significantly improve the tolerance of physical exertion, which increases the quality of their life. Hemodynamic and clinical effects are achieved quickly and persist for a long time.

Pharmacokinetics:

Cilazapril is well absorbed from the gastrointestinal tract. The intake of food immediately before taking the drug somewhat delays and reduces absorption, which, however, has no therapeutic significance. Metabolized with the formation of an active metabolite - cilazaprilata. After taking cilazapril, the bioavailability of cilazaprilate is about 60%. Maximum concentrations of cilazapril and its active metabolite of cilazaprilate in blood plasma are achieved within 2 hours after administration and are directly proportional to the dose.

Cilazaprilat is excreted unchanged through the kidneys; the period of its half-elimination with ingestion once a day is 9 hours. In patients with renal insufficiency, the concentration of cilazaprilate in the blood plasma is higher than in patients with normal renal function. In patients with terminal stage of renal failure, there is no elimination, but by means of hemodialysis, concentrations of both cilazapril and cilazaprilate can be reduced.

In elderly patients, the concentration of cilazaprilate in the blood plasma can be 40% higher, and the clearance is 20% lower than in young patients.

In patients with cirrhosis, an increase in plasma concentrations and a decrease in plasma and renal clearance is observed, which is more pronounced with respect to cilazapril than to its active metabolite cilazaprilat.

In patients with chronic heart failure, the clearance of cilazaprilat correlates with creatinine clearance (CC). Thus, correction of the dosing regimen in patients with chronic heart failure is performed depending on the CK (see section "Dosing and Administration").

Indications:

Arterial hypertension.

Chronic heart failure.

Contraindications:

Hypersensitivity to cilazapril or other ACE inhibitors, hereditary lactose intolerance, lactase deficiency Lapp, glucose-galactose malabsorption, angioedema in the anamnesis (including hereditary, idiopathic, as well as angioedema, caused by the use of other ACE inhibitors), porphyria, pregnancy, the period of breastfeeding, hemodialysis through high-permeability membranes from polyacrylnitrite-metal-sulfate (for example, AN69), hemofiltration or apheresis of low-density lipoproteins (LDL-apheresis ).

Carefully:

Chronic renal failure (proteinuria more than 1 g per day), severe circulatory insufficiency, connective tissue diseases (including systemic lupus erythematosus, scleroderma), arterial hypotension, mitral stenosis, aortic stenosis, hypertrophic obstructive cardiomyopathy, ischemic heart disease, oppression bone marrow hematopoiesis, bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, condition after kidney transplantation, in patients on hemodialysis,diabetes, gout, hyperuricemia, diet with restriction of table salt, cirrhosis of the liver, conditions accompanied by a decrease in the volume of circulating blood (bcc) (including diarrhea, vomiting), chronic obstructive pulmonary disease.

In children under 18 years of age, the efficacy and safety of Inhibise® has not been established.

Pregnancy and lactation:

Taking cilazapril during pregnancy is contraindicated (see section "Contraindications"). Pregnant women should be informed of the potential risk to the fetus and should not use the Incibis® medication (see "Contraindications"). Patients planning a pregnancy should be given alternative antihypertensive therapy with an established safety profile. In the case of diagnosing or confirming pregnancy during treatment, taking ACE inhibitors should be stopped and alternative treatment initiated, if necessary. An increase in the risk of developing cardiovascular defects in the fetus (atrial and / or interventricular septal defect, pulmonary artery stenosis, Botalov ductal proliferation), central nervous system (microcephaly, spina bifida) and kidney developmental disorders associated with the administration of ACE inhibitors in the first trimester of pregnancy.The fetotoxic effect of ACE inhibitors during their second and third trimester of pregnancy in humans (renal dysfunction, low blood pressure, slowing ossification of the skull bones) and toxicity in newborns (renal failure, arterial hypotension, hyperkalemia) has been established.

In the case of the use of ACE inhibitors during pregnancy, it is recommended to perform an ultrasound examination of the kidneys and fetal skull at the beginning of the second trimester of pregnancy. It is necessary to carefully monitor the development of arterial hypotension in newborns whose mothers have been taking ACE inhibitors.

During the treatment with the drug, it is necessary to abolish breastfeeding (the penetration of cilazaprilate into the milk of lactating rats is established, there is no data in humans). Alternative treatment with an established safety profile should be prescribed for use during breastfeeding.

Dosing and Administration:

Inhibais® should be taken orally, once a day at the same time of the day, regardless of food intake.

Arterial hypertension: the recommended initial dose is 1 mg once daily.The dose should be selected individually depending on the dynamics of blood pressure. Supportive doses of the drug Inhibeys® - from 2.5 to a maximum dose of 5 mg, once a day.

In patients with increased activity of the renin-angiotensin-aldosterone system (in particular, with loss of salts and / or fluid, cardiac decompensation and severe arterial hypertension), a sharp drop in blood pressure after the first administration of the drug is possible. The recommended initial dose in these patients is 0.5 mg (1/2 tablet, 1 mg) once a day. Treatment should be started under the supervision of a doctor.

Patients with arterial hypertension receiving diuretics: the recommended initial dose for these patients is 0.5 mg (1/2 tablet, 1 mg) once a day. If possible, to reduce the likelihood of symptomatic arterial hypotension, the diuretic should be discontinued 2-3 days before the start of treatment with the Incibis®. If necessary, you can resume it later.

Patients of advanced age with arterial hypertension: the initial dose of the drug Inhibais® is from 0.5 (1/2 tablets of 1 mg) to 1 mg per day.The maintenance dose is adjusted individually depending on the tolerability of the drug, the patient's response to treatment and his clinical condition.

Chronic heart failure: Inhibeys drug treatment should begin with a dose of 0.5 mg (1.2 to 1 mg tablets) once daily under close medical supervision. Depending on tolerability and clinical condition of the lowest dose was increased to a maintenance dose of 1 mg per day. Further selection of the dose within the usual maintenance dose of 1-2.5 mg per day is made on the basis of the therapeutic response of the patient to treatment, its clinical status and tolerability of the drug. The maximum daily dose is 5 mg.

Patients with advanced age with chronic heart failure, taking large doses of diuretics, you should strictly follow the recommended initial dose of 0.5 mg.

Renal insufficiency: patients with renal insufficiency may need a dose reduction depending on the CK.

The following dosing regimen is recommended:

Creatinine clearance	Initial dose	The highest dose
more than 40 ml / min	1 mg once daily	5 mg once daily
10-40 ml / min	0.5 mg once daily	2.5 mg once daily
less than 10 ml / min	Not recommended

Cirrhosis of the liver: If patients with cirrhosis of the liver (without ascites) require treatment of hypertension, the Inhibice ® drug should be administered with caution in a dose not exceeding 0.5 mg (1/2 tablet, 1 mg) once a day, providing thorough control of the arterial pressure, because the expressed arterial hypotension can develop.

Children under 18 years: effectiveness and safety of the use of the drug Inhibeys not established.

Side effects:

Clinical researches

The most common adverse reactions with the use of the drug Inhibase ® for the treatment of hypertension were headache and dizziness.

The most frequent adverse reactions with the use of the drug Incibice® for the treatment of chronic heart failure were cough and dizziness.

Postmarketing surveillance

Adverse reactions are presented according to the categories of frequency of occurrence, namely: very often> 1/10, often> 1/100 and <1/10, infrequently> 1/1000 and <1/100, rarely <1/1000.

The following adverse reactions were observed with the use of cilazapril or other ACE inhibitors.

Violations of the blood and lymphatic system: rarely - neutropenia, agranulocytosis, thrombocytopenia, anemia.

Immune system disorders: infrequently - angioedema (can spread to the face, lips, tongue, vocal apparatus and / or larynx, gastrointestinal tract); rarely anaphylactic shock, lupus syndrome (may include the following symptoms: vasculitis, myalgia, arthralgia / arthritis, an increase in the titer of antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis).

Impaired nervous system: often - headache; infrequently - dysgeusia (change in taste perception); rarely - transient ischemic attack, stroke.

Heart Disease: infrequently - angina pectoris, tachycardia, palpitation; rarely - myocardial infarction.

Vascular disorders: often - dizziness; infrequent - marked decrease in blood pressure.

Disturbances from the respiratory system, chest and mediastinal organs: often - a cough.

Disorders from the digestive system: often - nausea; rarely - pancreatitis.

Disorders from the liver and bile ducts: rarely - there were isolated cases of cholestatic hepatitis with necrosis or without necrosis,as well as impaired liver function (increased activity of "liver" transaminases, alkaline phosphatase, gamma-glutamyltransferase, bilirubin concentration).

Disturbances from the skin and subcutaneous tissues: infrequent skin rash; rarely - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, bullous pemphigoid, dermatitis exfoliative, psoriasis dermatitis, psoriasis, flatulence, urticaria, vasculitis / purpura photosensitivity reaction, alopecia, onycholysis.

Disorders from the kidneys and urinary tract: rarely - renal dysfunction, acute renal failure, increased urea concentration, creatinine in the blood, hyperkalemia, hyponatremia.

General disorders and disorders at the site of administration: often - increased fatigue.

At the beginning of treatment or with an increase in the dose of the drug, it is possible to develop arterial hypotension, especially in patients with relevant risk factors (see section "Special instructions"). Symptomatic manifestations of arterial hypotension may include fainting, weakness, dizziness and blurred vision.

Renal impairment and acute renal failure are most likely in patients with severe heart failure, stenosis of the renal arteries, an existing renal dysfunction, or hypovolemia (see section "Special instructions"),

Hyperkalemia is most likely in patients with impaired renal function, as well as in patients taking potassium-sparing diuretics or potassium preparations. Rare cases of transient ischemic attack and stroke, which were reported when taking ACE inhibitors, may be associated with arterial hypotension in the presence of concomitant cerebrovascular disease. Likewise, myocardial ischemia can be associated with arterial hypotension on the background of concomitant ischemic heart disease.

Overdose:

Data on drug overdose in patients are very few.

Symptoms: marked decrease in blood pressure, vascular collapse, electrolyte balance disturbance, impaired renal function, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough.

Treatment: Activated carbon (in the first 2 hours after an overdose), gastric lavage.In the case of a marked decrease in blood pressure, give the patient a horizontal position with raised legs. To increase the volume of circulating blood (BCC) - intravenous injection of 0.9% solution of sodium chloride or other plasmasubstitutional solution, control of blood pressure, and also consider the possibility of intravenous catecholamines.

With bradycardia, which is not amenable to treatment, electrocardiostimulation is shown. It is necessary to monitor vital signs, the concentration of creatinine and electrolytes in the blood serum.

If necessary, partial removal of cilazaprilate (active metabolite of cilazapril) by hemodialysis is possible (see section "Special instructions").

Interaction:

Lithium

With simultaneous use of ACE inhibitors and lithium preparations, a reversible increase in serum concentrations of the latter was observed. Simultaneous administration of thiazide diuretics can increase the risk of lithium toxicity and exacerbate the already existing risk of toxicity when used concomitantly with ACE inhibitors. The use of ACE inhibitors in combination with lithium preparations is not recommended.However, if taking this combination is considered necessary, you should carefully monitor the concentration of lithium in the blood serum.

Other antihypertensives

If Inhibice® is used in combination with other antihypertensive drugs, additive effects can occur and the risk of developing arterial hypotension increases.

Use with drugs that cause oppression of bone marrow hematopoies, increases the risk of developing neutropenia and / or agranulocytosis. Application simultaneously with digoxin did not lead to an increase in the concentration of digoxin in the blood plasma. There were no clinically significant interactions of the drug Incibice® with nitrates, coumarinic anticoagulants and H2-histamine receptor blockers. With simultaneous administration with furosemide, thiazide diuretics pharmacokinetic interactions were not noted.

Potassium-sparing diuretics, potassium preparations or potassium-containing salt substitutes

Against the backdrop of the use of the drug Incibice®, the serum potassium content is usually within the normal range, but some patients may develop hyperkalemia.The use of potassium-sparing diuretics (including spironolactone, triamterene or amiloride), food additives and salt substitutes containing potassium, can lead to a significant increase in potassium in the blood serum. Thus, the combined use of these drugs and the Inhibise® preparation is not recommended (see section "Special instructions"). In the presence of confirmed hypokalemia, a combined use of these drugs may be prescribed, however, in this case, care should be taken and the potassium content in serum is monitored.

Diuretics (thiazide and loop)

With previous treatment with diuretics in high doses, a decrease in BCC and an increased risk of developing arterial hypotension at the start of treatment with the Inhibise® preparation is possible. The antihypertensive effect can be reduced by eliminating the diuretic, increasing fluid volume or salt intake, or by using a low initial dose of the Inhibise® drug.

Tricyclic antidepressants / antipsychotics / anesthetics / drugs

Simultaneous use of anesthetics, used for general anesthesia,or tricyclic antidepressants or antipsychotic drugs with ACE inhibitors may cause further lowering of blood pressure (see section "Special instructions").

Non-steroidal anti-inflammatory drugs, including acetylsalicylic acid ≥3 mg per day

Simultaneous administration of ACE inhibitors and non-steroidal anti-inflammatory drugs (including acetylsalicylic acid in the regime for anti-inflammatory action, selective inhibitors of cyclooxygenase (COX) 2 and nonselective NSAIDs) can attenuate the antihypertensive effect. Simultaneous administration of ACE inhibitors and NSAIDs may lead to an increased risk of impaired renal function, including acute renal failure, and an increase in potassium in the blood serum, especially in patients with previous renal impairment. Care should be taken when taking this combination, especially in elderly patients.

Patients should not have signs of dehydration. At the beginning of the combined use of ACE inhibitors and NSAIDs, and also periodically during the treatment should monitor the kidney function.

Sympathomimetic drugs

Sympathomimetic drugs can reduce the antihypertensive effect of ACE inhibitors.

Hypoglycemic agents

According to the results of epidemiological studies, ACE inhibitors can increase the decrease in blood glucose concentration by insulin and hypoglycemic agents for ingestion and thus cause a risk of hypoglycemia. This interaction was observed mainly in patients with renal insufficiency, as well as in the first weeks of treatment.

Preparations of gold

The development of nitrate-like reactions ("blood flushes" to the face, nausea, vomiting, arterial hypotension) was reported in patients who simultaneously took gold injections (sodium aurotomyalate) and ACE inhibitors.

Special instructions:

Arterial stenosis / hypertrophic obstructive cardiomyopathy

Caution should be exercised when taking ACE inhibitors in patients with obstructive heart disease (mitral stenosis, aortic stenosis, hypertrophic obstructive cardiomyopathy). In this case, there is a risk of severe arterial hypotension, due to the fact that the ability to increase the volume of cardiac output to compensate for systemic vasodilation is lost.

Arterial hypotension

Against the background of taking ACE inhibitors, severe arterial hypotension may develop, especially at the beginning of treatment. Arterial hypotension after the first administration of the drug most often occurs in patients with an activated renin-angiotensin-aldosterone system, for example, in renal vascular hypertension or other conditions causing kidney hypoperfusion, with a decrease in sodium or hypovolemia, or with previous treatment with other vasodilators. These conditions can be observed simultaneously with severe heart failure.

In case of arterial hypotension, the patient should be laid with raised legs and injected with a drug that increases the BCC. After completing the BCC treatment with the drug Incibex® can be continued. However, if the symptoms of arterial hypotension do not disappear, you should reduce the dose or cancel the drug.

Patients with a risk of hypotension should begin treatment with the drug Incibex ® under the supervision of a doctor, starting with a low dose and with careful titration. If possible, diuretic therapy should be temporarily discontinued.

Similar recommendations should be adhered to patients with angina pectoris or cerebrovascular diseases, as in such patients arterial hypotension can cause ischemia of the myocardium or brain.

Hypersensitivity reactions / angioedema

About cases of angioedema along with therapy with ACE inhibitors was reported at a frequency of approximately 0.1-0.5%. Angioedema, caused by ACE inhibitors, can occur as a resurgent episode of edema that stops when the drug is withdrawn, or in the form of acute swelling of the oropharynx and potentially life-threatening airway obstruction, which requires emergency medical attention. Also within 24-48 hours after the first admission, it is possible to develop angioedema of the intestine. Patients with angioneuroticeski edema, unrelated to ACE inhibitors, in the anamnesis belong to the group at increased risk.

Anaphylactic reactions

Anaphylactic reactions against the background of the administration of ACE inhibitors have been observed in patients on hemodialysis through high-permeability membranes of polyacrylnitrite-metal-sulfate (for example, AN 69).Such patients should consider the question of changing the type of membrane for hemodialysis or about the appointment of an antihypertensive drug of another class.

In patients who underwent LDL-apheresis with dextran sulfate on the background of the use of ACE inhibitors, sometimes life-threatening anaphylactic shock developed. The development of this reaction can be avoided by suspending the administration of ACE inhibitors for the duration of each apheresis session.

Anaphylactic reactions can occur in patients undergoing hyposensitization using aspen or bee venom and receiving simultaneously an ACE inhibitor. For this reason, ingibies® should be discontinued before desensitization begins. In addition, in this situation, Inhibase® can not be replaced with beta-blockers.

Dysfunction of the liver

When using the drug Inhibise®, cases of cholestatic hepatitis and an increase in liver function (activity of "hepatic" transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase, bilirubin content) have been reported. With the development of jaundice or a significant increase in the activity of "liver" enzymes, the drug should be discontinued and the appropriatemedical assistance. It is not recommended to take Inhibeys ® in patients with ascites in liver cirrhosis.

Neutropenia

With the administration of ACE inhibitors, rare cases of neutropenia and agranulocytosis are associated, especially in patients with renal insufficiency or vascular disorders in connective tissue diseases, as well as in those receiving immunosuppressive therapy. Such patients should periodically monitor the number of leukocytes.

The content of potassium in the blood serum

ACE inhibitors can cause an increase in potassium in the blood serum, because they have a suppressive effect on the production of aldosterone. In patients with normal renal function, this effect is not significantly expressed. However, in patients with impaired renal function and / or taking additional sources of potassium (in particular, salt substitutes), potassium-sparing diuretics and, especially, aldosterone antagonists, development of hyperkalemia is possible. When concomitantly taking ACE inhibitors with potassium-sparing diuretics, care should be taken and the kidneys and serum potassium content should be carefully monitored.

Diabetes

The use of ACE inhibitors in patients with diabetes mellitus may increase the decrease in glucose concentration when treated with hypoglycemic agents for oral administration, especially in patients with impaired renal function. At the beginning of the use of ACE inhibitors in these patients, the concentration of glucose in the blood should be carefully monitored.

Surgery / anesthesia

Arterial hypotension can cause the use of ACE inhibitors during surgical procedures in combination with means for general anesthesia, which also have an antihypertensive effect. In such cases, the patient may be shown an increase in BCC. Before surgery (including dental surgery), it is necessary to alert the surgeon / anesthesiologist about the use of ACE inhibitors.

Race

The antihypertensive effect of ACE inhibitors is less pronounced in representatives of the Negroid race of African descent. Also, in persons of the Negroid race, the risk of angioedema development is increased.

Lactose intolerance

Inhibise® contains lactose monohydrate. It is not recommended to take Inhibise® in patients with hereditary lactose intolerance, with lactase deficiency Lapp or glucose-galactose malabsorption.

Patients with renal insufficiency may need a dose reduction depending on the QC (see the section "Dosing and Administration"). Against the background of treatment with ACE inhibitors, an increase in the concentration of urea nitrogen and / or serum creatinine is possible. Although these changes are usually reversible after the discontinuation of the Inhibise® drug and diuretic therapy, serious cases of kidney failure and, rarely, acute renal failure have been reported.

In patients with renal artery stenosis, the risk of renal dysfunction, in particular, the development of acute renal failure, has been increased with Inhibice® treatment. The use of the drug in such patients should be done with caution. In these groups of patients should monitor the kidney function in the first weeks of therapy. If kidney failure occurs, discontinue treatment.

Instructions for the destruction of an unused product or expired

The presence of the drug in the environment should be minimized. The disposal of an unused preparation or an expired product should be carried out in accordance with local requirements.

Effect on the ability to drive transp. cf. and fur:Care should be taken when driving vehicles and engaging in other potentially hazardous activities due to the possible occurrence of dizziness and increased fatigue, especially at the beginning of treatment.

Form release / dosage:

Tablets, film-coated, 1 mg, 2.5 mg, 5 mg.

Packaging:

Tablets, film-coated, 1 mg, 2.5 mg, 5 mg.

7 tablets per blister of OPA / A1 / PVC film and aluminum foil.

For 4 blisters together with instructions for use are placed in a cardboard box.

Tablets, film-coated, 2.5 mg (packaging at JSC "MAKIZ-PHARMA")

For 15, 30, 50 or 100 tablets in bottles of brown glass with a screwed polyethylene cover with the control of the first opening. Free space in the vial is filled with cotton absorbent cotton. Each vial with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ° C, out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:On prescription

Registration number:П N015295 / 01

Date of registration:08.09.2009

Expiration Date:Unlimited

The owner of the registration certificate:Hoffmann-La Roche Ltd.Hoffmann-La Roche Ltd. Switzerland

Manufacturer: & nbsp

MAKIZ-PHARMA, LLC Russia

Representation: & nbspF.Hoffmann-La Roche Ltd. F.Hoffmann-La Roche Ltd. Switzerland

Information update date: & nbsp27.11.2017

Illustrated instructions

Instructions

Incibice® (Inhibace®)