|The name of the preparation
||Character; dose; package
||Price after refund
||In which pharmacy?
4 mg (1 table contains 4 mg perindopril with tert-butylamine, corresponding to 3.338 mg perindopril);
8 mg (1 table contains 8 mg perindopril with tert-butylamine, corresponding to 6.676 mg perindopril);
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:perindopril
The drug is available on prescription
What is Apo-Perindox?
A drug from the group of angiotensin-converting enzyme inhibitors, which, like all preparations in this group, inhibits the formation of angiotensin II, a substance that causes vasoconstriction and stimulates the release of aldosterone.
What does Apo-Perindox contain and how does it work?
The active substance is Perindopril
belonging to a group of medicines called angiotensin converting enzyme inhibitors. The common mechanism of action of drugs in this group consists in inhibiting the activity of the enzyme responsible for the formation of angiotensin II (this enzyme is an angiotensin convertase, often abbreviated as ACE, which is derived from the English nameAngiotensin Converting Enzyme
). Inhibition of this enzyme results in limiting the conversion (conversion) of inactive angiotensin I to active angiotensin II. Angiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The effect of drugs from the angiotensin-converting enzyme group leads to a decrease in the angiotensin II concentration, and thus to a decrease in blood pressure. In addition, ACE inhibitors exacerbate the effects of bradykinin (a substance that relaxes on blood vessels), exert a protective effect on vessels and have antiatherosclerotic activity. They are used as blood pressure lowering drugs and in the treatment and prophylaxis of cardiovascular diseases as well as in the treatment of kidney diseases (diabetic nephropathy and non-diabetic nephropathy). In clinical trials, many of them have been proven effective in reducing cardiovascular mortality. In patients with heart failure
, ACE inhibitors reduce vascular resistance, which improves hemodynamic conditions and increases exercise capacity, positively affecting the quality of life.
Perindopril is rapidly absorbed and in the liver is converted to the active form - perindoprilat. In addition to perindoprilat, other inactive metabolites are also formed. The maximum concentration of perindopril is obtained within 1 hour and perindoprilat within 3-4 days. hours after taking the drug. The antihypertensive effect is strongest between 4-6. hour. The full development of antihypertensive effect is achieved after approximately 4 weeks of application.
When should I use Apo-Perindox?
The preparation is indicated for the treatment of:
· Symptomatic heart failure
· Stable ischemic heart disease - to reduce the risk of cardiac events in patients with a history of myocardial infarction and / or coronary revascularization.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients of the preparation or to another ACE inhibitor. You can not use the preparation if:
· You have ever had angioneurotic edema
or there is congenital (hereditary) angioneurotic edema.
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. It is not recommended during the first trimester of pregnancy.
Take special care with Apo-Perindox?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
If an episode of unstable angina occurs in patients with stable coronary artery disease during the first month of use, a physician should be consulted who, after considering the risk / benefit ratio, will decide whether to continue treatment or to discontinue use.
Special care should be taken because the preparation may cause a sudden and significant reduction in blood pressure. The increased risk of hypotension after taking the preparation concerns especially people:
· With a reduced volume of circulating, dehydrated or electrolyte-depleted (eg taking diuretics, low-salt diets, sodium deficient, dialysed, diarrhea or vomiting)
· With increased activation of the renin-angiotensin-aldosterone system (RAA), which may be suspected in the case of severe hypertension, congestive heart failure, hemodynamically significant impairment of the inflow or outflow of blood from the left ventricle (eg aortic stenosis or mitral [bipolar]) , unilateral renal artery stenosis with a second active kidney), people with liver cirrhosis and / or ascites, people undergoing surgery or anaesthetized
· With severe congestive heart failure (also possible with oliguria, progressive azotemia and acute renal failure
· With an increased risk of myocardial ischemia or the brain in severe hypotension (eg people with ischemic heart disease or cerebrovascular narrowing, in whom hypotension could cause a heart attack, stroke).
In the above cases, treatment can only be started under close medical supervision. Due to the increased risk of hypotension, special medical supervision and careful observation are required, especially in the initial phase of treatment and each time during dose escalation.
In the case of symptomatic hypotension, the patient should be placed on the back and called for medical help. The occurrence of hypotension after the first dose of the preparation is not a contraindication for further use of the preparation, however, it is necessary to achieve stabilization of blood pressure and fluid volume.
Caution should be exercised in patients with impaired left-ventricular blood flow (eg aortic stenosis or mitral stenosis, hypertrophic cardiomyopathy) due to the risk of severe hypotension.
Before and during the treatment, your doctor will recommend checking your kidney function. If you are dehydrating your body, reducing the volume of circulating blood or electrolyte disturbances, your doctor will advise you on appropriate measures before starting treatment. In patients with impaired renal function (creatinine clearance less than 60 ml / min), a reduction of the initial dose and a further dose adjustment depending on the creatinine concentration are necessary; in these cases, the individual doctor adjusts the dose individually. Regular monitoring of potassium and creatinine in the blood is necessary. The risk of renal dysfunction, including acute renal failure, especially occurs in patients with heart failure.
After administration of the preparation in patients with bilateral renal artery stenosis or arterial stenosis of the sole active kidney, an increase in urea and creatinine in the blood may occur, especially if the preparation is used in parallel with the diuretic. If necessary, your doctor will prescribe a dose reduction or discontinuation of the diuretic. The risk of these disorders is increased in people with renal insufficiency, and renal arterial hypertension additionally promotes the occurrence of severe hypotension. In these patients, treatment can only be carried out under strict medical supervision.
After administration of the preparation in patients with hypertension without renal impairment, urea and creatinine may increase in the blood, especially if the preparation is used in parallel with a diuretic. If necessary, your doctor will recommend a dose reduction or discontinuation of the diuretic and / or perindopril. The risk of these disorders is further increased in patients with impaired renal function.
There are no clinical data on the use of the preparation in patients after recent kidney transplantation.
Procedures for extracorporeal circulation (hemodialysis, hemofiltration, apheresis of low-density lipoproteins), during which blood is exposed to electrically negatively charged surfaces, may lead to severe anaphylactoid reactions, manifested by facial edema, hypotension, dyspnea, sudden feeling hot. To prevent these reactions, your doctor will advise you to do the right thing.
The preparation may cause angioneurotic edema (swelling of the face, lips, tongue, throat, larynx that may impede breathing and may be life-threatening). In the event of the first symptoms of edema, stop using the preparation and seek medical help immediately. It is necessary to stay in hospital, to monitor the patient until the symptoms have completely and permanently resolved, and sometimes to receive appropriate treatment. After the occurrence of angioneurotic edema, the preparation or other ACE inhibitors may not be used again. The risk of angioneurotic edema is increased in people who have had angioedema in the past and in black people.
In black people, the preparation may be less effective in lowering blood pressure.
The use of the preparation is associated with an increased risk of anaphylactic reaction to insect venom and other allergens, also during desensitization (if desensitization is planned, a doctor should be consulted who, if possible, will recommend temporary discontinuation of the preparation).
Very rarely, the use of the preparation may be associated with the onset of cholestatic jaundice, which may lead to fulminant hepatic necrosis, sometimes fatal. If you have cholestatic jaundice or increase in liver transaminases, you should immediately consult a doctor because it may be necessary to discontinue use and initiate appropriate treatment.
The preparation may cause haematological disorders, including neutropenia (decrease in the number of neutrophils). Your doctor will advise you to regularly check your blood counts, especially at the beginning of your treatment, and if you have kidney problems, people with connective tissue disease (such as lupus erythematosus or scleroderma) and those who are using other medicines that can cause changes in blood counts (allopurinol, immunosuppressants, corticosteroid
s, procainamide, cytostatics). In the event of any symptoms of infection (eg fever, enlargement of the lymph nodes, sore throat) it is necessary to consult a doctor and make sure that the body's immunity has not been reduced.
ACE inhibitors can also cause persistent cough (due to the severity of bradykinin), without coughing, which disappears after discontinuation of the preparation.
Inform the doctor about the use of the preparation if you are planning an operation or other procedure requiring anesthesia. Using the product in parallel with anesthetics may lead to significant hypotension and even shock.
The preparation may cause hyperkalaemia (increase in potassium in the blood). Hyperkalaemia may cause serious arrhythmias. Your doctor will monitor the level of potassium in your blood, especially if you are at increased risk for hyperkalaemia (people with kidney failure, people with diabetes, people taking blood-raising medicines, including potassium salts, potassium or Heparin
-retaining diuresis, dehydrated people) , people with heart failure or metabolic acidosis).
In diabetic patients taking oral antidiabetic agents or insulin
, your doctor will prescribe blood Glucose
monitoring, especially during the initial period of use. There is a risk of hypoglycaemia, an excessive reduction in blood glucose.
Parallel use of lithium is not recommended.
Parallel use of potassium-sparing diuretics, potassium preparations or potassium chloride substitutes is not recommended.
Additional information about the other ingredients of the preparation:
· The product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of glucose-galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
It should be taken into account that the preparation may cause dizziness, weariness or other symptoms that may impair the ability to drive vehicles and operate machinery and equipment.
Dosage of Apo-Perindox
The preparation is in the form of tablets. It is intended for oral use. The product should be taken every day at the same time of the day, in the morning, before meals. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Hypertension (monotherapy or combination treatment): initially 4 mg once daily, in the morning. In patients at particular risk of hypotension with strong activation of the renin-angiotensin-aldosterone system (especially with renovascular hypertension, water-electrolyte disorders, decompensated heart failure or severe hypertension) the recommended starting dose is 2 mg per day, and treatment it can only be started under the strict supervision of a physician. After approximately 4 weeks of treatment, your doctor may ask you to increase the dose to 8 mg once a day.
In people taking diuretics in parallel there is an increased risk of complications resulting from a sudden and significant reduction in blood pressure. In addition, in this group of patients dehydration and electrolyte disturbances may occur and therefore an individual dose adjustment by a physician is necessary. If possible, your doctor will advise you to stop using diuretic therapy 2-3 days before starting the treatment. If the diuretic can not be discontinued, the preparation should be started under close medical supervision. The initial dose for these patients is usually 2 mg per day. It is necessary to control renal function and potassium levels in the blood. The doctor will adjust the further dosage depending on the blood pressure value.
In elderly patients, the starting dose is 2 mg per day; then your doctor may recommend increasing the dose to 4 mg, and if necessary to 8 mg daily. The doctor will adjust the further dosage depending on kidney function.
Symptomatic heart failure: it is recommended that initiation of the preparation in combination with diuretic not saving potassium and / or with digitalis glycosides and / or beta-blockers takes place under specialist medical care with an initial dose of 2 mg 1 once a day in the morning. The doctor will adjust the dose based on the patient's individual response to treatment. After 2 weeks of treatment, he may increase the dose to 4 mg a day.
In the case of severe heart failure, as well as in patients with renal failure, water-electrolyte disorders, using diuretics or vasodilators, treatment should be started under strict medical supervision.
In patients particularly at risk of hypotension who are dehydrated, reduced circulating blood volume or electrolyte disturbances (including, but not limited to, hyponatremia), the physician will recommend leveling out the existing disorders before starting treatment. Blood pressure, potassium levels and renal function should be carefully monitored.
Stable coronary heart disease: initially 4 mg once daily for 2 weeks, followed by 8 mg once daily, provided that the 4 mg dose per day was well tolerated. In elderly patients, initially 2 mg 1 once a day for a week, then 4 mg once daily for the next week, followed by 8 mg once daily. The doctor will increase the dose only if the lower dose is well tolerated by the patient. It is necessary to adjust the dosage depending on kidney function.
In patients with impaired renal function (creatinine clearance less than 60 ml / min), individual dosage adjustment is necessary; an appropriately adjusted dose is determined by the doctor. In these people, treatment can only be carried out under strict medical supervision.If the creatinine clearance is less than 15 ml / min and the patient undergoes dialysis, the dose (2 mg) is administered on dialysis day after dialysis.
No dose adjustment is required in patients with hepatic impairment.
There are insufficient data on the safety and efficacy of the preparation in children. For this reason, the preparation should not be used in this age group.
Can I use Apo-Perindox during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The preparation should not be used during the first trimester of pregnancy. The use of the preparation in the second and third trimester of pregnancy is contraindicated. If a woman is planning a pregnancy, it is recommended to change the way of antihypertensive treatment. If you suspect or confirm pregnancy during the period of taking the preparation, you should consult a doctor as soon as possible because immediate discontinuation of the preparation is required. Your doctor may prescribe other antihypertensive agents.
The use of the preparation is contraindicated during breast-feeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Diuretics increase the hypotensive effect of perindopril.
Early use of diuretics may increase the risk of hypotension after starting treatment with perindopril. Whenever possible, your doctor will advise you to stop using diuretics and adequate hydration and increased supply of electrolytes before you start taking the product.
Parallel use of drugs that affect the level of potassium in the blood (potassium salts, some diuretics and antihypertensive agents, eg spironolactone, triamterene, amiloride, potassium supplements, trimethoprim, tacrolimus, cyclosporine, heparin) and potassium-containing salt substitutes can lead to increased potassium levels in blood (hyperkalemia). Parallel use of perindopril with the preparations mentioned above is not recommended. If it is necessary to use them, the doctor will recommend regular monitoring of potassium in the blood.
The preparation may increase the toxic effects of lithium salts. Parallel administration of lithium is not recommended, and if necessary, combination of lithium should be monitored. Parallel use of diuretics increases the risk of lithium toxicity.
Non-steroidal anti-inflammatory drugs (eg Acetylsalicylic acid
, COX-2 inhibitors) may reduce the antihypertensive effects of the preparation and may cause renal dysfunction and increase in potassium in the blood. The occurrence of these disorders is particularly likely in people with impaired renal function, dehydrated and elderly.
If the preparation is used in conjunction with antihypertensive drugs or other medicines that can lower blood pressure (eg Nitroglycerin
e and other nitrates, tricyclic antidepressants, anesthetics, antipsychotics, barbiturates, opioid medicines), there may be an increase in antihypertensive effect and hypotension.
Taking the product in parallel with antidiabetic medicines (oral preparations, insulin) may increase blood glucose levels and increase the risk of hypoglycaemia. Blood glucose should be carefully monitored, especially during the first weeks of treatment and in patients with impaired renal function.
Drugs that increase blood pressure (eg sympathomimetics, isoproterenol, dobutamine, Dopamine
, epinephrine) may reduce the antihypertensive effect of the preparation. Blood pressure should be monitored regularly.
Drugs that can affect blood counts (allopurinol, immunosuppressive drugs, corticosteroids, procainamide, cytostatics) increase the risk of hematological disorders.
The preparation can be used in combination with acetylsalicylic acid (in cardiac doses), thrombolytics, beta-blockers (beta-blockers) and nitrates.
What side effects can occur?
Like all medicines, including Apo-Perindox, it can cause side effects, although they will not occur in all patients who use this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Common side effects include: headache and dizziness, symptomatic hypotension (including dizziness, syncope, impaired balance), blurred vision, tinnitus, paresthesia (tingling and numbness), dry persistent cough, shortness of breath, diarrhea, nausea , vomiting, indigestion, constipation, rash, pruritus, muscle cramps, fatigue and weakness. Uncommonly possible: sleep disturbances, mood disorders, bronchospasm, dry mouth, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in occasional cases that may cause narrowing of the airways, impede breathing and threaten life), renal failure , excessive sweating, sexual dysfunction (impotence). Rarely possible: increase in liver enzymes and increase in bilirubin in the blood, increase in blood creatinine and urea, increase in potassium in the blood (hyperkalemia). Very rare: haematological abnormalities (decreased white blood cell counts [leukopenia], decreased neutrophil counts [neutropenia], agranulocytosis, thrombocytopenia, haemolytic anemia, confusional states, myocardial ischemia, including angina pectoris or myocardial infarction, arrhythmia, palpitations) , increased heart rate (tachycardia), ischemic stroke
(secondary to excessive hypotension), eosinophilic pneumonia, rhinitis, pancreatitis, cytolytic or cholestatic hepatitis, erythema multiforme, acute renal failure.
Other preparations on the Polish market containing perindopril
Perindopril Teva (Perindoprilum 123ratio) (coated tablets)
Prestarium 5 mg (coated tablets)
Prestarium 10 mg (coated tablets)