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► Amlessa (amlodipine + perindopril) - Medycyna Praktyczna

Amlessa (amlodipine + perindopril) - tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Amlessa tablets; 4 mg perindopril + 5 mg amlodipine (1 tablet contains: 4 mg perindopril with tert-butylamine, corresponding to 3.34 mg perindopril, 5 mg amlodipine as amlodipine besilate); 90 tabl. Krka 41.29 0.00
33.52
Check
Amlessa tablets; 4 mg perindopril + 10 mg amlodipine (1 tablet contains: 4 mg perindopril with tert-butylamine, corresponding to 3.34 mg perindopril, 10 mg amlodipine as amlodipine besylate); 30 tabl. Krka 17.53 0.00
14.94
Check
Amlessa tablets; 4 mg perindopril + 10 mg amlodipine (1 tablet contains: 4 mg perindopril with tert-butylamine, corresponding to 3.34 mg perindopril, 10 mg amlodipine as amlodipine besylate); 90 tabl. Krka 41.29 0.00
33.52
Check
Amlessa tablets; 4 mg perindopril + 5 mg amlodipine (1 tablet contains: 4 mg perindopril with tert-butylamine, corresponding to 3.34 mg perindopril, 5 mg amlodipine as amlodipine besilate); 20 tables Krka b / d Check
Amlessa tablets; 4 mg perindopril + 5 mg amlodipine (1 tablet contains: 4 mg perindopril with tert-butylamine, corresponding to 3.34 mg perindopril, 5 mg amlodipine as amlodipine besilate); 30 tabl. Krka 17.53 0.00
14.94
Check
Amlessa tablets; 8 mg perindopril + 10 mg amlodipine (1 tablet contains: 8 mg perindopril with tert-butylamine, corresponding to 6.68 mg perindopril, 10 mg amlodipine as amlodipine besilate); 30 tabl. Krka 28.50 0.00
23.32
Check
Amlessa tablets; 8 mg perindopril + 10 mg amlodipine (1 tablet contains: 8 mg perindopril with tert-butylamine, corresponding to 6.68 mg perindopril, 10 mg amlodipine as amlodipine besilate); 90 tabl. Krka 80.73 0.00
65.19
Check
Amlessa tablets; 8 mg perindopril + 5 mg amlodipine (1 tablet contains: 8 mg perindopril with tert-butylamine, corresponding to 6.68 mg perindopril, 5 mg amlodipine as amlodipine besilate); 30 tabl. Krka 28.50 0.00
23.32
Check
Amlessa tablets; 8 mg perindopril + 5 mg amlodipine (1 tablet contains: 8 mg perindopril with tert-butylamine, corresponding to 6.68 mg perindopril, 5 mg amlodipine as amlodipine besilate); 90 tabl. Krka 80.73 0.00
65.19
Check

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:amlodipine + perindopril

The drug is available on prescription

What is Amlessa?

Combined preparation containing an angiotensin converting enzyme inhibitor (perindopril) and a Calcium antagonist from the group of dihydropyridine derivatives (amlodipine).

What does Amlessa contain and how does it work?

It is a combined preparation containing 2 active substances, Perindopril and Amlodipine . Perindopril is an angiotensin-converting enzyme inhibitor. 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).
The second active substance is amlodipine, a dihydropyridine derivative belonging to a group of medicines called calcium channel blockers (or calcium channel blockers). Calcium antagonists act by blocking calcium channels, structures that allow the passage of calcium ions across the cell membrane. Amlodipine blocks the inflow of calcium ions from the extracellular space into the smooth muscle cells of the walls of the blood vessels and to a lesser extent into the cells of the heart muscle. Increasing the intracellular calcium concentration is necessary for the contraction of muscle cells. Amlodipine works mainly on peripheral blood vessels. Blockage of calcium channels reduces the tension of the vessel walls and vasodilation. The immediate effect of this action of amlodipine is lowering blood pressure. Enlargement of peripheral arterioles reduces peripheral vascular resistance, which relieves the heart (it reduces energy consumption by the myocardium and its oxygen demand). Coronary arteries are also likely to expand, which increases oxygen transport to the myocardium.As a result, in patients with angina pectoris, exercise tolerance increases (the time to angina pain increases during exercise) and the incidence and severity of angina pains decreases. The clinical condition of patients with angina pectoris improves and Nitroglycerin consumption decreases. In hypertensive patients, taking once daily with amlodipine provides a clinically significant reduction in blood pressure over 24 hours.

When should I use Amless?

It is indicated for the treatment of primary hypertension and / or stable coronary artery disease in those who achieve adequate symptom control using perindopril and amlodipine simultaneously, in the form of two separate preparations, in the same doses as in the combined preparation.

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 or to other ACE inhibitors or calcium dihydropyridine antagonists.
You can not use the preparation if you are present:
· Congenital (hereditary) angioneurotic edema or whenever there has been angioneurotic edema
· Severe hypotension
· Shock, including cardiogenic shock
· Narrowing of the outflow path from the left ventricle (eg severe stenosis of the aortic valve)
Hemodynamically unstable heart failure after myocardial infarction.
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. The preparation should not be used during the first trimester of pregnancy.

When should you take extra care with Amless?

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.
The preparation may cause angioneurotic edema of the face, lips, tongue, throat, larynx, mucous membranes or limbs. If the edema concerns the tongue, throat or larynx, it may interfere with breathing and may be life-threatening. In the event of the first symptoms of edema, stop using the preparation and seek medical help immediately. Hospitalization and appropriate treatment may be necessary. The patient should remain under medical surveillance until the symptoms disappear completely. After the occurrence of angioneurotic edema, the preparation 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. Angioedema may occur at any time during treatment. Angioneurotic edema can also affect the intestines (symptoms are abdominal pain with or without nausea and vomiting), which should be taken into account in case of abdominal pain.
The use of ACE inhibitors is associated with an increased risk of Anaphylactic reactions 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).
Procedures for extracorporeal circulation (hemodialysis, hemofiltration, apheresis of low density LDL lipoproteins), during which blood is exposed to electrically negatively charged surfaces may cause severe anaphylactoid reactions, manifested by facial edema, hypotension, dyspnea, sudden feeling of heat, sometimes a direct threat to life. Before this type of surgery it is necessary to consult a doctor who will recommend other antihypertensive agents or other types of dialysis membranes.
The preparation may cause hematological disorders (decrease in neutrophil counts [neutropenia / agranulocytosis], anemia, thrombocytopenia) especially in persons with impaired renal function, patients with coexisting connective tissue disease (eg lupus erythematosus or scleroderma) and people using other drugs that may cause changes in blood counts (allopurinol, immunosuppressants, corticosteroid s, procainamide, cytostatics). Your doctor will recommend regular blood count monitoring. In the event of any symptoms of infection (e.g.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.
Since the preparation may cause a significant reduction in blood pressure, special care should be taken in people with an increased risk of hypotension after taking the preparation. The increased risk group includes people:
· With a reduced volume of circulating blood, dehydrated or with electrolyte deficiency (eg, taking diuretics, using a low salt diet, subjected to dialysis, diarrhea or vomiting)
· With severe hypertension associated with increased activation of the renin-angiotensin-aldosterone system (RAA).
In the above cases, treatment can only be started under strict medical supervision; during the period of treatment, blood pressure, renal function and blood potassium levels are required. Extreme caution is required in people with ischemic heart disease and cerebrovascular disease (people with coronary artery stenosis or cerebrovascular stenosis) because a significant reduction in blood pressure can cause a heart attack or stroke. Treatment should be started with a low dose.
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), it is necessary that the physician individually adjusts the dosage of each active substance separately. Frequent monitoring of potassium and creatinine in the blood is recommended.
After administration of the preparation in patients with bilateral renal artery stenosis or stenosis of the artery of the only active kidney, an increase in urea and creatinine in the blood may occur. The risk of these disorders is increased in people with renal insufficiency. Renovascular hypertension favors the occurrence of severe hypotension and renal failure.
After application of the preparation in hypertensive patients without previous renal vascular disorders, elevation of urea and creatinine in the blood may occur, especially if the preparation is used in parallel with a diuretic. If you experience such disorders after using a combined preparation, please consult your doctor as they may indicate the development of renal failure. The risk of renal failure particularly affects patients with pre-existing renal dysfunctions (including, for example, renal artery stenosis).
Rarely, the use of the preparation may be associated with the onset of cholestatic jaundice, which can lead to fulminant hepatic necrosis, sometimes fatal. If jaundice or elevated liver enzymes occur, you should immediately consult a doctor because it may be necessary to stop the use of the preparation and initiate appropriate treatment.
In black people, the preparation may be less effective in lowering blood pressure.
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. The use of the preparation increases the risk of significant hypotension during the period of anesthesia. The doctor may recommend stopping the treatment one day before the procedure. Only the doctor may decide to stop using the preparation.
The preparation may cause hyperkalaemia (increase in potassium in the blood).Hyperkalaemia may cause serious arrhythmias, sometimes fatal. Your doctor will monitor the level of potassium in your blood, especially if you are at increased risk for hyperkalaemia (people with kidney failure, after age 70, people with diabetes, dehydrated people, people with heart failure or metabolic acidosis). The use of drugs that may increase the level of potassium in the blood should be avoided, such as potassium supplements, potassium chloride replacers, potassium sparing diuretics or Heparin . If the doctor considers it necessary to take these medicines, he or she will advise you to exercise caution and monitor your blood potassium levels.
The parallel use of lithium salts is not recommended.
In diabetic patients taking oral antidiabetic agents or insulin , your doctor will advise you to monitor your blood Glucose particularly closely, especially during the first month of treatment. There is a risk of hypoglycaemia, an excessive reduction in blood glucose.
In people with liver problems, caution should be exercised because the effect of the amlodipine contained in the preparation may be exacerbated. Liver enzymes should be monitored regularly.
Caution should be exercised in patients with heart failure, especially severe (NYHA grade III and IV); in this group of patients, there is an increased risk of pulmonary edema during the period of application. In patients with congestive heart failure, calcium antagonists, including amlodipine, may increase the risk of cardiovascular events and death.

Does this preparation affect the ability to drive vehicles?
In some people the preparation may cause dizziness, fatigue, weariness or other symptoms that may impair psychophysical fitness and the ability to drive vehicles and operate machines / machines.

Dosage of Amlessa

The preparation is in the form of tablets for oral use. The preparation should be taken once a day, preferably in the morning, before a meal. 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.
Adults: 1 tablet once a day, preferably in the morning, before a meal.
A combined preparation with a fixed content of active substances is not intended to start treatment. Before prescribing the use of a combined preparation, the doctor will gradually adjust the dosage of the individual active substances (ie perindopril and amlodipine).
In patients with impaired renal function and in elderly patients, the concentration of potassium and creatinine in the blood should often be controlled. Do not use the preparation in people with a creatinine clearance less than 60 ml / min. In this group of patients, it is necessary that the physician individually adjust the dosage of each of the active substances used independently.
People with hepatic impairment should be treated with extreme caution; it may be necessary to adjust the dosage by your doctor.
Children and youth:
There are insufficient data on the safety and efficacy of the preparation in children and adolescents. For this reason, the preparation should not be used in this age group.

Can Amless be used 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.
The preparation should not be initiated during pregnancy. If a woman plans to become pregnant she should consult a doctor because 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.
It is not recommended to use the preparation in parallel with:
· Medicines that affect the level of potassium in the blood (potassium salts, potassium-sparing diuretics eg spironolactone, triamteren, amiloride, potassium supplements, trimethoprim, tacrolimus, cyclosporin, heparin) and with potassium substitutes for table salt; these preparations increase the risk of hyperkalemia; if it is necessary to use them, the doctor will recommend frequent monitoring of potassium in the blood
· Lithium; risk of neurotoxic action of lithium; if necessary, such combination treatment should be carefully monitored for the concentration of lithium in the blood
· Estramustine; increased risk of adverse reactions, including angioedema.
Due to the content of perindopril in the preparation, particular caution is required if the preparation is used with any of the following drugs:
· Non-steroidal anti-inflammatory drugs (eg Acetylsalicylic acid , Ibuprofen , Ketoprofen , indometacin, selective COX-2 inhibitors) may reduce the antihypertensive effect of the preparation and lead to renal dysfunction, including acute renal failure and increase in potassium in the blood; caution is especially required in the elderly and in people with impaired renal function; patients should be adequately hydrated and the doctor may recommend monitoring renal function
· Antidiabetic agents (oral preparations, insulin) may cause excessive hypoglycaemia (hypoglycaemia); Take special care and carefully monitor your blood glucose.
Due to the content of amlodipine in the preparation, particular caution is required if the preparation is used with any of the following drugs:
· Preparations that increase the activity of the cytochrome P450 3A4 isoenzyme (such as, for example, rifampicin, St. John's wort, phenobarbital, primidone, fosfentyin, phenytoin and carbamazepine) can reduce amlodipine levels in the blood and reduce its effect; Caution should be exercised because the dosage of amlodipine may need to be adjusted by the doctor
· Preparations that reduce the activity of cytochrome P450 3A4 isoenzyme (such as diltiazem, Verapamil , ketoconazole, itraconazol and other azole antifungals, ritonavir and other protease inhibitors, Erythromycin and other macrolide antibiotics) can inhibit the metabolism of amlodipine and increase its concentration in the blood and significant intensification of its operation; be careful; it may be necessary to adjust the dosage by your doctor.
In addition, special care should be taken if the preparation is used with baclofen, due to the risk of aggravation of antihypertensive effect. Blood pressure and renal function should be monitored. If necessary, your doctor will adjust the dosage of the antihypertensive drug.
Due to the content of perindopril in the preparation, caution should be exercised if the preparation is used with any of the following drugs:
· Diuretics; the use of diuretics may cause a decrease in the volume of circulating blood and electrolyte disturbances and increase the risk of hypotension after starting treatment; if possible, your doctor will advise you to stop using diuretics and adequate hydration and increased supply of electrolytes before taking the medicine
· Sympathomimetics; sympathomimetic drugs may reduce the antihypertensive effect of the preparation
· Gold preparations (e.g. sodium aurotionate); possible occurrence of symptoms such as after administration of nitrates, including facial flushing, nausea, vomiting, hypotension.
In people at higher risk (eg in people with heart failure, in people after myocardial infarction) parallel use of a calcium antagonist (amlodipine) and a beta-blocker (bisoprolol, Metoprolol , Carvedilol ) may cause worsening of heart failure, decreased strength myocardial contraction and hypotension.
In addition, caution should be exercised if the preparation is used with the following drugs, due to the possibility of exacerbating the hypotensive effect and the risk of hypotension:
· Blood pressure-lowering medicines (eg beta-blockers, angiotensin-converting enzyme inhibitors, diuretics) or vasodilators (eg nitroglycerine and other nitrates)
· Alpha receptor blockers (eg prazosin, alfuzosin, Doxazosin , Tamsulosin , terazosin)
· amifostine
· Tricyclic antidepressants, antipsychotics, medicines used under anesthesia.
The use of corticosteroids or tetracosactide may reduce the antihypertensive effect of the preparation.

What side effects can occur?

Like all medicines, including Amless, it can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Side effects that may occur frequently or uncommonly include: hypotension, hypotension-related symptoms (eg dizziness, syncope, balance disorders), headache and dizziness, edema (including swelling of the ankles), fatigue, weakness, malaise , feeling hot and flushing, drowsiness, insomnia, sleep disturbances, mood changes, blurred vision (including double vision), tinnitus, tremors, sensation, tingling and numbness (paresthesia), palpitations, fainting, shortness of breath , bronchospasm, rhinitis, cough, dysgeusia, diarrhea, nausea, vomiting, indigestion, constipation, abdominal pain, weight gain / loss, dry mouth, rash, pruritus, urticaria, hyperhidrosis, alopecia , purpura, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic may cause narrowing of the airways, impede breathing and threaten life), muscle cramps, muscle and joint pain, kidney problems, frequent urination, sexual dysfunction (impotence), gynecomastia. Rarely or very rarely possible: hematological disorders (decrease in white blood cell count [leukopenia], decrease in neutrophil counts [neutropenia / agranulocytosis], thrombocytopenia, hemolytic anemia, hematocrit and hemoglobin decrease), increase in blood glucose, confusion, increased tension muscular (hypertonia), peripheral neuropathy, occasionally extrapyramidal disorders, myocardial ischemia (including angina pectoris or myocardial infarction, secondary to significant hypotension in patients with risk factors), arrhythmia, ischemic stroke (secondary to excessive hypotension in patients with risk factors), vasculitis, eosinophilic pneumonia, gingival hyperplasia, pancreatitis, gastritis, cytolytic or cholestatic hepatitis, jaundice, increased liver enzymes and higher levels of bilirubin in the blood, acute renal failure, severe cutaneous hypersensitivity reactions (exfoliative dermatitis, Stevens and Johnson syndrome, erythema multiforme). In addition, side effects may occur for which their incidence has not been established, such as increased blood creatinine and urea, increased blood potassium (hyperkalemia), decreased blood glucose (hypoglycaemia).

Other preparations on the Polish market containing amlodipine + perindopril

Co-Prestarium (tablets)
Co-Prestarium Initio (tablets)
Prestozek Combi (tablets)
Vilpin Combi (tablets)