indapamide, Perindopril | Noxspray spray 0.05%, 20 ml p1srewrel 1047 tablets 2.5 mg 30 pcs.

Release form

Tablets.



packaging 30 pcs

Pharmacological action

NOLIPREL A BI-FORTE - a combined preparation containing perindopril arginine and indapamide. Pharmacological properties of the drug Noliprel® A Bi-Forte combine the individual properties of each of the components. The combination of perindopril arginine and indapamide enhances the action of each of them.

Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (an ACE inhibitor). ACE, or kininase II, is an exopeptidase that carries out both the conversion of angiotensin I into a vasoconstrictor substance angiotensin II, and the destruction of bradykinin, which has a vasodilating effect, to an inactive heptapeptide. As a result, perindopril reduces the secretion of aldosterone, by the principle of negative feedback increases the activity of renin in blood plasma, with prolonged use reduces OPSS, which is mainly due to the effect on the vessels in the muscles and kidneys. These effects are not accompanied by a delay in salt and water or the development of reflex tachycardia.

Perindopril normalizes the myocardium, reducing preload and afterload. When studying hemodynamic parameters in patients with chronic heart failure, it was revealed: a decrease in filling pressure in the left and right ventricles of the heart, a decrease in heart rate, an increase in cardiac output, and an increase in cardiac index, an increase in muscle peripheral blood flow.

Indapamide belongs to the group of sulfonamides, in pharmacological properties it is close to thiazide diuretics. Indapamide inhibits the reabsorption of sodium ions in the cortical segment of the loop of Henle, which leads to an increase in the excretion of sodium ions by the kidneys, chlorine and to a lesser extent potassium and magnesium ions, thereby enhancing diuresis, and lowering blood pressure.

Indications

Essential hypertension (patients who require therapy with perindopril at a dose of 10 mg and indapamide at a dose of 2.5 mg).

Contraindications

- history of angioedema (Quincke's edema) associated with the administration of an ACE inhibitor

- hereditary / idiopathic angioedema

- bilateral renal artery stenosis or minor stenosis - less than 40 ml of arterial stenosis

- severe liver failure (including with encephalopathy)

- hypokalemia

- the presence of lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome, lactose intolerance

- simultaneous administration with potassium-sparing diuretics, potassium and lithium preparations, and in patients with a high content of potassium ions in blood plasma

- simultaneous use with drugs, capable of causing arrhythmias such as pirouette

- simultaneous administration of drugs that extend the QT interval

- pregnancy

- breastfeeding period

- age up to 18 years (effectiveness and safety have not been established)

- increased sensitivity to perindopril and other ACE inhibitors

- indapamide and other sulfonamides

- hypersensitivity to excipients that make up the drug.

Use during pregnancy and lactation

NoliprelВ® A Bi-Fort is contraindicated in pregnancy.

When planning a pregnancy or when it occurs while taking the drug, you should immediately stop taking the drug and prescribe another antihypertensive therapy. Appropriate controlled studies of ACE inhibitors in pregnant women have not been conducted. Limited data on the effects of the drug in the first trimester of pregnancy indicate that the drug did not lead to malformations associated with fetotoxicity.

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Long-term use of thiazide diuretics in the third trimester of pregnancy can cause maternal hypovolemia and a decrease in uteroplacental blood flow, which leads to fetoplacental ischemia and fetal growth retardation. In rare cases, while taking diuretics shortly before birth, newborns develop hypoglycemia and thrombocytopenia.

If the patient received NoliprelВ® A Bi-Forte in the II or III trimesters of pregnancy, it is recommended to perform an ultrasound examination of the fetus to assess the condition of the skull bones and kidney function.

NoliprelВ® A Bi-Forte is contraindicated during breastfeeding. It is not known whether perindopril is excreted in breast milk.

Indapamide is excreted in breast milk. Taking thiazide diuretics causes a decrease in the amount of breast milk or suppression of lactation. In this case, a newborn may develop hypersensitivity to sulfonamide derivatives, hypokalemia and nuclear jaundice.

Since the use of perindopril and indapamide during lactation can cause severe complications in an infant, it is necessary to assess the significance of therapy for the mother and decide whether to stop breastfeeding or to stop taking the drug.

Ingredients

Active ingredients: paracetamol 500 mg caffeine 30 mg phenylephrine hydrochloride 10 mg chlorpheniramine maleate 2 mg

Excipients: MCC magnesium starch stearate talc sodium starch glycolate gelatin polyvinyl pyrrolidone methyl paraben propyl paraffenfenfenfenfenfenfenferfenfenferfenferfenfenfenferfenferfenfaprfenfpfenfpredfenfpredfenfpredfenfprenfenfenpfenfpredfenfpindflpfenfpindflpfenpfenfpindflapfenfenpfenfpindflapfenfenpfenfpindflapfenfenpfenfpindflapfenfenpfenpfenfpindflpfenfenfenfenfenpfenpfenfind 5 2.5 mg

Excipients: lactose monohydrate - 142.66 mg Magnesium stearate - 0.9 mg Maltodextrin - 18 mg colloidal silicon dioxide, anhydrous - 0.54 mg sodium carboxymethyl starch (type A) - 5, 4 mg

Film coating: macrogol 6000 - 0.27828 mg magnesium stearate - 0.2622 mg titanium dioxide (E171) - 0.83902 mg glycerol - 0.2622 mg hypromellose - 4.3583 mg).

Dosage and administration of

The drug is prescribed orally, 1 tab. 1 time / day, preferably in the morning, before meals.

In elderly patients, creatinine clearance is calculated taking into account age, body weight and gender. Elderly patients with normal renal function are prescribed Noliprel® A Bi-Fort, 1 tab. 1 time / day, while the degree of reduction in blood pressure should be monitored.

The drug is contraindicated in patients with moderate to severe renal failure (CC less than 60 ml / min).

Patients with QC? 60 ml / min during therapy requires regular monitoring of the concentration of creatinine and potassium in the blood plasma.

The drug is contraindicated in patients with severe hepatic impairment. With moderate hepatic insufficiency, dose adjustment is not required.

Noliprel® A Bi-Fort should not be prescribed to children and adolescents under 18 years of age due to a lack of data on the efficacy and safety of the drug in patients of this age group.

Side effects of

Perindopril has an inhibitory effect on the renin-angiotensin-aldosterone (RAAS) system and reduces the excretion of potassium ions by the kidneys while taking indapamide. In 6% of patients with the use of Noliprel® A Bi-Forte, the development of hypokalemia was noted.

Frequency of adverse reactions, which may occur during therapy is given in the form of the following gradation: very often (> 1/10) often (> 1/100, <1/10) infrequently (> 1/1000, <1/100) rarely (> 1 / 10000, <1/1000) very rarely (<1/10000) of an unspecified frequency (the frequency cannot be calculated from the available data).

From the circulatory and lymphatic systems

Very rarely: thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia.

In certain clinical situations (patients after kidney transplantation, patients undergoing hemodialysis), ACE inhibitors can cause anemia (see section "Special Instructions").

From the central nervous system

Often: paresthesia, headache, dizziness, asthenia.

Infrequently: sleep disturbance, mood lability.

Very rare: confusion.

From the organ of vision

Often: visual impairment.

On the part of the hearing organ

Often: tinnitus.

From the cardiovascular system

Infrequently: marked decrease in blood pressure, including orthostatic hypotension.

Very rare: cardiac arrhythmias, including bradycardia, ventricular tachycardia, atrial fibrillation, as well as angina pectoris and myocardial infarction, possibly due to an excessive decrease in blood pressure in patients at high risk (see section "Special Instructions").

On the part of the respiratory system, chest organs and mediastinum

Often: with the use of ACE inhibitors, a dry cough may occur, which persists for a long time while taking this group of drugs and disappears after they are canceled. Dyspnea.

Infrequently: bronchospasm.

Very rare: eosinophilic pneumonia, rhinitis.

From the digestive system

Often: dry oral mucosa, nausea, vomiting, abdominal pain, epigastric pain, impaired taste, loss of appetite, dyspepsia, constipation, diarrhea.

Rarely: angioedema of the intestines, cholestatic jaundice.

Very rare: pancreatitis

Unspecified frequency: hepatic encephalopathy in patients with hepatic insufficiency (see "Contraindications" and "Special Instructions").

From the skin and subcutaneous fat

Often: skin rash, itching, maculopapular rash.

Infrequently: angioedema of the face, lips, limbs, mucous membrane of the tongue, glottis and / or larynx urticaria (see section "Special Instructions") hypersensitivity reactions in patients, predisposed to bronchial obstructive and allergic reactions hemorrhagic vasculitis.

Patients with acute systemic lupus erythematosus may worsen the course of the disease.

Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

There have been cases of photosensitivity reaction (see section "Special instructions").

From the musculoskeletal system and connective tissue

Often: muscle cramps.

Urinary system

Infrequently: renal failure.

Very rare: acute renal failure.

From the reproductive system

Infrequently: impotence.

General disorders and symptoms of

Infrequently: increased sweating.

Laboratory findings

- Hypokalemia, especially significant for patients belonging to the risk group (see section "Special instructions").

- Hyponatremia and hypovolemia, leading to dehydration and orthostatic hypotension.

- An increase in the concentration of uric acid and glucose in the blood while taking the drug.

- A slight increase in the concentration of creatinine in the urine and in the blood plasma that occurs after discontinuation of therapy, more often in patients with renal artery stenosis, in the treatment of hypertension with diuretics and in case of renal failure.

- Hyperkalemia, often transient.

Rarely: hypercalcemia.

overdose

Symptoms: the most likely symptom of overdose is a marked decrease in blood pressure, sometimes in combination with nausea, vomiting, convulsions, dizziness, drowsiness, confusion and oliguria, which can turn into a result. Electrolyte disorders (hyponatremia, hypokalemia) can also occur.

Treatment: Emergency measures are reduced to the elimination of the drug from the body: gastric lavage and / or intake of activated carbon followed by restoration of the water-electrolyte balance. With a significant decrease in blood pressure, the patient should be placed in a supine position with his / her feet elevated, and, if necessary, correction of hypovolemia (eg, infusion of 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, can be removed from the body by dialysis.

Expiration

3 years.

active substance

Indapamide, Perindopril

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Servye, France