|The name of the preparation
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|Ampril 2.5 mg
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:ramipril
The drug is available on prescription
What is Ampril?
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 Ampril contain and how does it work?
The active substance of the preparation is ramipril 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.
Ramipril is absorbed quickly and converted to the active form of ramiprilat in the liver. The maximum concentration of ramipril is obtained within 1 hour and ramiprilat is achieved within the 2 -4 period. hours after taking the drug. The antihypertensive effect starts within 1-2 hours after taking the drug and is the strongest between 3-6. hour. Full development of the antihypertensive effect is achieved after about 3 -4. weeks of use.
When should I use Ampril?
The preparation is indicated:
· In the treatment of hypertension
· In the prevention of cardiovascular diseases - reduction of cardiovascular morbidity and mortality in people with symptomatic cardiovascular disease with atherosclerotic aetiology (ischemic heart disease, stroke or peripheral vascular disease) and in patients with diabetes mellitus and at least one risk factor for cardiovascular disease
· In the treatment of kidney diseases:
on diabetic glomerular nephropathy - the initial stage determined on the basis of microalbuminuria
on diabetic glomerular nephropathy - a symptomatic stage, based on proteinuria, in people with at least one risk factor for cardiovascular disease
on non-diabetic glomerular nephropathy - symptomatic stage, based on proteinuria no less than 3 g per day
· In the treatment of symptomatic heart failure
· Secondary prevention in patients after myocardial infarction - reduction of mortality in the acute phase of myocardial infarction in patients with clinical symptoms of heart failure (the preparation may be included in treatment after at least 48 hours after the onset of myocardial infarction).
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
· There is a significant bilateral renal artery stenosis or one-sided in one active kidney
· There is hypotension or the patient is hemodynamically unstable
· Extracorporeal circulation procedures (hemodialysis, hemofiltration, apheresis of low-density lipoproteins) are used, during which blood is exposed to electrically negatively charged surfaces (this may lead to severe anaphylactoid reactions).
Do not use in parallel with aliskiren in patients with diabetes or with renal impairment (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2
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.
When should you take extra care with Ampril?
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 should not be initiated during pregnancy. If a woman who is using the product plans to become pregnant should consult a doctor who will recommend changing the antihypertensive treatment. If you become pregnant during the period of taking the preparation, you should consult your doctor as soon as possible because immediate discontinuation of the preparation is required. Your doctor may prescribe other antihypertensive agents.
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 increased activation of the renin-angiotensin-aldosterone system (RAA), which may be suspected in case of severe hypertension, congestive heart failure, haemodynamically significant impairment of inflow or outflow from the left ventricle (eg aortic or mitral stenosis / stenosis), unilateral stenosis of the renal artery with the second active kidney, as well as in the case of dehydrated or electrolyte deficient (eg taking diuretics, low salt diets, dialyses, diarrhea or vomiting), people with liver cirrhosis and / or ascites, people undergoing anesthesia or anesthesia;
· With heart failure after a heart attack;
· With an increased risk of myocardial or cerebral ischemia in severe hypotension (eg people with coronary artery stenosis or cerebrovascular narrowing, in whom hypotension could cause a heart attack or stroke).
In the above cases, treatment can only be started under close medical supervision. Because of the increased risk of hypotension, special medical supervision and accurate monitoring and monitoring of blood pressure is required, especially in the initial phase of treatment and each time during dose escalation.
If there is dehydration of the body, a reduction in intravascular volume or electrolyte abnormalities, the doctor will recommend appropriate treatment before starting the preparation.
Inform the doctor about the use of the preparation if you are planning an operation or other procedure requiring anesthesia. usually, the day before the procedure, it is recommended to stop taking the preparation. Remember, only the doctor may decide to stop using the product.
The kidneys should be monitored before and during treatment. In patients with impaired renal function, dosage adjustment is necessary; in these cases, the individual doctor adjusts the dose individually.The risk of renal dysfunction is particularly high in patients with congestive heart failure or after kidney transplantation.
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 hospitalize, to monitor the patient until the symptoms have completely and permanently resolved (at least 12-24 hours) and sometimes to take 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.
The preparation may cause intestinal angioedema (abdominal pain, sometimes nausea and vomiting) which should be taken into account in case of abdominal pain.
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).
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 in people who are at increased risk of hyperkalemia (people with kidney failure, over 70 years of age, have diabetes, are taking medicines to increase the level of potassium in the blood, including potassium or diuretics potassium, dehydrated persons, people with heart failure or metabolic acidosis).
The preparation may cause haematological disorders (decreased neutrophil count [neutropenia], agranulocytosis, thrombocytopenia, anemia, bone marrow suppression). 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 case 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 there is no reduction in the body's resistance.
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.
Combination with other agents acting on the renin-angiotensin-aldosterone system (eg angiotensin II receptor antagonists or aliskiren) is not recommended due to the risk of hypotension, increased blood potassium (hyperkalaemia) and disorders kidney function, including acute renal failure
. If, however, the physician considers such combination treatment to be absolutely necessary, it should be carried out under the supervision of a specialist and kidney function, electrolyte concentration and blood pressure should be closely monitored. In patients with diabetic nephropathy, ACE inhibitors and angiotensin II receptor antagonists should not be used in parallel. The use of a parallel formulation with aliskiren is contraindicated in patients with diabetes mellitus or with renal impairment (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2).
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?
The preparation may cause side effects such as dizziness, symptomatic hypotension, fatigue and other symptoms that may impair psychophysical fitness and ability to concentrate and thus impair the ability to drive vehicles and operate machinery and equipment. The occurrence of these symptoms is particularly likely at the beginning of treatment, during dose escalation and after drug changes.It is not recommended to drive or operate machines / machines for a few hours after taking the first dose and each time the dose is increased.
Dosage of Ampril
The preparation is in the form of tablets for oral use. The product should be taken every day at the same time of the day; can be taken regardless of meals. The tablets should be swallowed whole (do not crush or chew tablets) with liquid. 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.
In people taking diuretics in parallel, there is an increased risk of hypotension. 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. In hypertensive patients receiving diuretic therapy, the starting dose is 1.25 mg per day. It is necessary to control renal function and potassium levels in the blood. Further dosage will be determined individually by a doctor.
Hypertension (monotherapy and combination therapy): initially 2.5 mg 1 once a day, then with behavior 2-4. weekly intervals, the doctor may double the dose; the maximum dose is 10 mg per day. In patients with a strong activation of the renin-angiotensin-aldosterone system, the recommended starting dose is 1.25 mg per day, and treatment can only be started under the close supervision of a physician.
Prophylaxis of cardiovascular disease: initial dose is 2.5 mg 1 once a day, then after 1-2. weeks the doctor may increase the dose to 5 mg a day, and after the next 2 to 3. weeks up to 10 mg once daily. This is the usual maintenance dose.
In patients receiving diuretic therapy, proceed as described above.
Treatment of kidney diseases:
· Diabetic glomerular nephropathy with microalbuminuria: the initial dose is 1.25 mg once daily, then your doctor may increase the dose to 2.5 mg a day after 2 weeks of treatment and then up to 5 mg a day after the next 2 weeks;
· Diabetic glomerular nephropathy in people with at least one cardiovascular risk factor: the starting dose is 2.5 mg once daily, then the doctor may increase the dose to 5 mg daily after 1-2. weeks of treatment and then up to 10 mg a day after the next 2-3 years. weeks. The target dose is 10 mg per day;
· Symptomatic non-diabetic glomerulosclerotic nephropathy found on the basis of proteinuria no less than 3 g / day: the initial dose is 1.25 mg once daily, then your doctor may increase the dose to 2.5 mg daily after 2 weeks of treatment and then up to 5 mg daily after the next 2 weeks.
Symptomatic heart failure: in patients who have been stabilized with a diuretic, the initial dose is 1.25 mg once a day; the doctor will then recommend doubling the dose every 1-2. weeks, up to a maximum dose of 10 mg per day. It is recommended to take the preparation in two divided doses.
Secondary prevention in patients after myocardial infarction with symptoms of heart failure: drug can be taken by clinically and haemodynamically stable patients after 48 hours after the onset of myocardial infarction. The starting dose is 2.5 mg 2 times a day for 3 days; if you do not tolerate this dose, your doctor will prescribe 1.25 mg twice daily for 2 days, followed by 2.5 mg 2 times daily and 5 mg 2 times daily (your doctor will gradually double your daily dose every 1-3 days) . If the dose can not be increased to 2.5 mg twice a day, your doctor will advise you to stop using it.
In patients receiving diuretic therapy, proceed as described above.
There is insufficient data on the treatment of patients with severe heart failure immediately after myocardial infarction. In each case, the physician will decide on whether to start treatment (dose 1.25 mg once daily).
In patients with impaired renal function, an individual dose adjustment is necessary; in individual cases a suitably adjusted dose is determined by a doctor. In this group of patients, treatment can only be carried out under strict medical supervision.
Renal adjustment is necessary in patients with impaired renal function.The doctor will determine the dosage based on the creatinine clearance, a parameter characterizing kidney function. If the creatinine clearance is between 30-60 ml / min, no initial dose adjustment is necessary (2.5 mg / day) and the maximum dose is 5 mg / day; if the creatinine clearance is in the range of 10-30 ml / min, the starting dose is 1.25 mg daily and the maximum dose is 5 mg daily; in patients undergoing hemodialysis, the initial dose is 1.25 mg daily, the maximum dose is 5 mg daily and the preparation should be administered several hours after hemodialysis.
In patients with hepatic impairment, dosage adjustment and treatment should be initiated under close medical supervision. The maximum dose is 2.5 mg per day.
In the elderly, dosage adjustment by the doctor is necessary; a starting dose of 1.25 mg per day may be advantageous. These patients have an increased risk of side effects.
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 Ampril 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 use of the preparation in the first trimester of pregnancy is not recommended. 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. Your doctor will prescribe other antihypertensive drugs during this period.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Contractions with extracorporeal circulation, such as hemodialysis, hemofiltration and low-density lipoprotein apheresis are contraindicated, during which blood is exposed to negatively charged surfaces. This can lead to severe anaphylactoid reactions. If the doctor considers the procedure absolutely necessary, he may use other types of dialyzers or recommend changing antihypertensive drugs.
Parallel use of drugs that affect the level of potassium in the blood (potassium salts, some diuretics and antihypertensive agents, trimethoprim, tacrolimus, cyclosporine, Heparin
) can lead to increased levels of potassium in the blood (hyperkalemia). Your doctor will recommend regular monitoring of potassium levels in your blood.
Antihypertensives and other drugs that can lower blood pressure (eg, diuretics, nitrates, tricyclic antidepressants, anesthetics, baclofen, alfuzosin, Doxazosin
, prazosin, Tamsulosin
, terazosin) and alcohol may increase the antihypertensive effect of the preparation, increasing the risk of hypotension.
In people taking diuretics in parallel there is an increased risk of complications resulting from rapid and significant hypotension. If possible, your doctor will advise you to stop using diuretic therapy 2-3 days before starting the treatment.
Combination with other agents acting on the renin-angiotensin-aldosterone system (eg angiotensin II receptor antagonists or aliskiren) is not recommended due to the risk of hypotension, increased blood potassium (hyperkalaemia) and disorders kidney function, including acute renal failure.
The use of a parallel formulation with aliskiren is contraindicated in patients with diabetes mellitus or with renal impairment (glomerular filtration rate GFR less than 60 ml / min / 1.73 m2).
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 may increase the toxic effects of lithium. The concentration of lithium in the blood should be monitored.
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.
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.
What side effects can occur?
Like all medicines, Ampril can also cause side effects, although it 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.
Common side effects include: headache and dizziness, increase in potassium in the blood (hyperkalemia), symptomatic hypotension, including orthostatic (eg dizziness, syncope, balance disorders), dry persistent cough, bronchitis, paranasal sinusitis , dyspnoea, gastritis, diarrhea, nausea, vomiting, indigestion, epigastric pain, muscle aches and cramps, rash, chest pain, fatigue. Uncommonly possible: myocardial ischemia, including angina pectoris or myocardial infarction, arrhythmias, palpitations, increased heart rate (tachycardia), peripheral edema, changes in blood count (eosinophilia, i.e., increase in eosinophils) , anxiety disorders, anxiety, sleep disorders (drowsiness), mood depression, dizziness associated with labyrinth, tingling and numbness (paresthesia), taste disturbances, blurred vision (including blurred vision), bronchospasm, exacerbation of asthma symptoms, swelling of the membrane mucous nasal cavity, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and life-threatening), angioedema of the intestines, epigastric pain, dry mouth, gastritis , constipation, pancreatitis (rarely a case and fatal), increased pancreatic enzyme activity, increased liver enzymes, decreased appetite, anorexia, joint pain, renal dysfunction (renal failure, changes in urine volume, increased protein excretion in urine, increased creatinine
and urea in the blood), excessive sweating , hot flushes, fever, sexual dysfunction (impotence, decreased libido). Rarely possible: haematological abnormalities (decreased white blood cell count [leukopenia], decreased neutrophil counts [neutropenia], agranulocytosis, anemia, thrombocytopenia), disturbances of consciousness, tremors, balance disorders, conjunctivitis, hearing disorders, tinnitus, vasoconstriction, inflammation vasculitis, cholangitis, cholestatic jaundice, damage to liver cells (hepatocytes), exfoliative dermatitis, urticaria, abnormal nail growth. Very rarely hypersensitivity to light. In addition, possible: bone marrow dysfunction, hemolytic anemia, ischemic stroke
, transient ischemic attack, olfactory disorders, impaired concentration, psychomotor disorders, severe skin reactions (toxic epidermal necrolysis, Stevens and Johnson syndrome, erythema multiforme, pemphigus, exacerbation psoriasis), alopecia, bullous rash or lichenosis, hair loss, decrease in blood sodium, Raynaud's syndrome, aphthous stomatitis, Anaphylactic reactions
, acute liver failure, severe liver failure, hepatitis (occasionally leading to death), gynecomastia .
Other preparations on the Polish market containing ramipril
Ampril 5 mg (tablets)
Ampril 10 mg (tablets)
Piramil 1.25 mg (tablets)
Piramil 2.5 mg (tablets)
Piramil 5 mg (tablets)
Piramil 10 mg (tablets)
Polpril (hard capsules)
Ramipril Accord (hard capsules)
Ramipril Actavis (tablets)
Ramipril Aurobindo (tablets)
Ramipril Billev (tablets)
Ramiprilum 123ratio (tablets)
Ramistad 2.5 (tablets)
Ramistad 5 (tablets)
Ramistad 10 (tablets)
Ramve (hard capsules)
Tritace 2,5 (tablets)
Tritace 5 (tablets)
Tritace 10 (tablets)
Vivace 2.5 mg (tablets)
Vivace 5 mg (tablets)
Vivace 10 mg (tablets)