Instructions for use AMPRILAN


Instructions for use AMPRILAN

The drug is taken orally. It is recommended to swallow the tablet whole, without chewing or crushing, with a sufficient amount of liquid, at the same time every day, regardless of meals.

Adults

In patients taking diuretics,

at the beginning of treatment with Amprilan, arterial hypotension may develop. If possible, diuretic treatment should be discontinued 2-3 days before starting Amprilan therapy. If diuretic treatment is not discontinued in patients with arterial hypertension, Amprilan therapy should be started with a dose of 1.25 mg. Renal function and plasma potassium levels should be monitored. Subsequent doses of Amprilan should be adjusted depending on blood pressure.

Arterial hypertension

The dose should be adjusted individually depending on the patient's condition and blood pressure control.

Amprilan can be used as monotherapy or in combination with other antihypertensive drugs.

Initial dose.

Therapy with Amprilan should be started gradually, with an initial recommended dose of 2.5 mg/day. In patients with a highly activated RAAS, an excessive decrease in blood pressure may be observed after the first dose. These patients are recommended to begin treatment under the supervision of a physician with a dose of 1.25 mg.

Titration and maintenance dose.

The dose can be doubled over an interval of 2 to 4 weeks in order to gradually achieve the target blood pressure level. The maximum permissible dose is 10 mg 1 time / day.

Cardiovascular prevention

Initial dose.

The recommended starting dose of Amprilan is 2.5 mg 1 time/day.

Titration and maintenance dose.

Depending on the tolerability of the drug, the dose should be increased gradually. It is recommended to double the dose after 1 or 2 weeks of therapy and after the next 2 or 3 weeks to increase the maintenance dose to 10 mg 1 time / day.

Treatment of chronic renal failure

Patients with diabetes mellitus and microalbuminuria

Initial dose.

The recommended starting dose of Amprilan is 1.25 mg 1 time/day.

Titration and maintenance dose.

Depending on the tolerability of the drug, the dose should be increased gradually. It is recommended to double the daily dose to 2.5 mg after 2 weeks of therapy and then to 5 mg over the next 2 weeks.

Patients with diabetes mellitus combined with one of the cardiovascular risk factors

Initial dose.

The recommended starting dose of Amprilan is 2 mg 1 time / day.

Titration and maintenance dose.

Depending on the patient’s tolerance of the active substance, the dose should be increased gradually. It is recommended to double the dose after 1 or 2 weeks of therapy to 5 mg and then to 10 mg after and for the next 2 or 3 weeks. The maximum permissible dose is 10 mg/day.

Patients with nondiabetic nephropathy characterized by macroproteinuria ≥3 g/day

Initial dose.

The recommended starting dose of Amprilan is 1.25 mg 1 time/day.

Titration and maintenance dose

. Depending on the tolerability of the drug, the dose should be increased gradually. It is recommended to double the dose after 2 weeks of therapy to 2.5 mg and then to 5 mg over the next 2 weeks.

Symptomatic heart failure

Initial dose.

For patients stabilized on diuretic therapy, the recommended initial dose of Amprilan is 1.25 mg 1 time / day.

Titration and maintenance dose.

The dose of Amprilan should be titrated by doubling every week or two to a maximum dose of 10 mg/day. It is preferable to take the drug 2 times a day.

Secondary prevention after acute myocardial infarction and heart failure

Initial dose.

48 hours after myocardial infarction for clinically and hemodynamically stable patients, the initial dose is 2.5 mg 2 times a day for 3 days. If the initial dose of 2.5 mg is poorly tolerated, then a dose of 1.25 mg 2 times / day should be prescribed for 2 days and further increased to 2.5 mg and 5 mg 2 times / day. If the dose cannot be increased to 2.5 mg 2 times / day, then treatment should be discontinued.

Titration and maintenance dose.

The daily dose should be increased by doubling at intervals of 1-3 days to 5 mg 2 times a day. If possible, the daily dose should be divided into 2 doses daily. If the dose cannot be increased to 2.5 mg 2 times / day, then treatment should be discontinued.

Patients with kidney failure

The daily dose in patients with renal failure should be selected depending on the CC:

  • with CC ≥60 ml/min,
    no adjustment of the initial dose (2.5 mg daily) is required, the maximum daily dose is 10 mg;
  • with CC 30-60 ml/min,
    no adjustment of the initial dose (2.5 mg daily) is required, the maximum daily dose is 5 mg;
  • with CC 10-30 ml/min,
    the initial dose is 1.25 mg daily, the maximum daily dose is 5 mg;
  • in patients with arterial hypertension undergoing hemodialysis
    : because ramipril is poorly dialyzed, the initial dose is 1.25 mg daily, the maximum daily dose is 5 mg. The drug must be taken several hours after hemodialysis.

Patients with liver failure

Patients with liver failure should begin treatment with Amprilan only under medical supervision, the maximum daily dose is 2.5 mg.

Elderly patients

The initial dose should be reduced and increased gradually due to the risk of side effects, especially in very old and frail patients. A reduction in the initial dose of 1.25 mg should be considered.

Use in children

Amprilan is not recommended for use in children and adolescents under 18 years of age.

, because There is insufficient data on safety and effectiveness.

Amprilan®

Before starting treatment with Amprilan®, it is necessary to eliminate hyponatremia and hypovolemia. In patients who have previously taken diuretics, it is necessary to discontinue them or at least reduce their dose 2-3 days before starting Amprilan® (in this case, the condition of patients with CHF should be carefully monitored due to the possibility of decompensation in them with an increase in BCC).

After taking the first dose of the drug, as well as when increasing its dose and/or the dose of diuretics (especially loop diuretics), it is necessary to ensure careful medical monitoring of the patient for at least 8 hours in order to timely take appropriate measures in the event of a pronounced decrease in blood pressure. If Amprilan® is used for the first time or at a high dose in patients with increased RAAS activity, their blood pressure should be carefully monitored, especially at the beginning of treatment, since these patients have an increased risk of a pronounced decrease in blood pressure (see section “With caution”) .

In case of malignant arterial hypertension and heart failure, especially in the acute stage of myocardial infarction, treatment with Amprilan® should only be started in a hospital setting.

In patients with CHF, taking the drug can lead to the development of a pronounced decrease in blood pressure, which in some cases is accompanied by oliguria or azotemia and rarely by the development of acute renal failure.

Caution should be exercised when treating elderly patients, as they may be particularly sensitive to ACE inhibitors. at the beginning of therapy, it is recommended to monitor renal function indicators (see also section “Method of administration and dosage”).

In patients for whom a decrease in blood pressure may pose a particular risk (for example, patients with atherosclerotic narrowing of the coronary or cerebral arteries), treatment should be initiated under strict medical supervision. Caution should be exercised during physical activity and/or hot weather due to the risk of increased sweating and dehydration with the development of arterial hypotension due to a decrease in blood volume and a decrease in sodium content in the blood serum.

It is not recommended to drink alcohol during treatment with Amprilan®. Transient arterial hypotension is not a contraindication for continuing treatment after stabilization of blood pressure. If severe arterial hypotension reoccurs, the dose should be reduced or the drug discontinued.

The simultaneous use of Amprilan® with drugs containing aliskiren or ARA II, leading to double blockade of the RAAS, is not recommended due to the risk of a pronounced decrease in blood pressure, the development of hyperkalemia and deterioration of renal function compared with monotherapy.

The simultaneous use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate to severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients (see Sections “Contraindications” and “Interaction with other drugs”). The simultaneous use of ACE inhibitors with ARA II is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see sections “Contraindications” and “Interaction with other drugs”).

In patients treated with ACE inhibitors. Cases of angioedema of the face, extremities, lips, tongue, pharynx or larynx have been observed. If swelling occurs in the face (lips, eyelids) or tongue, or difficulty swallowing or breathing, the patient should immediately stop taking the drug. Angioedema, localized in the area of ​​the tongue, pharynx or larynx (possible symptoms: difficulty swallowing or breathing), can be life-threatening and requires urgent measures to relieve it: subcutaneous administration of 0.3-0.5 mg or intravenous drip of 0.1 mg of epinephrine (adrenaline) (under the control of blood pressure, heart rate and electrocardiogram (ECG) followed by the use of glucocorticosteroids (intravenous, intramuscular or orally); intravenous administration of antihistamines (H1- and H2-histamine receptor antagonists) is also recommended, and in case of insufficiency of inhibitors C1-esterase enzyme, C1-esterase enzyme inhibitors may be considered in addition to epinephrine (adrenaline).The patient should be hospitalized and monitored until symptoms are completely relieved, but for at least 24 hours.

In patients receiving ACE inhibitors, cases of intestinal angioedema, which was manifested by abdominal pain with or without nausea and vomiting, were observed, in some cases, angioedema of the face was also observed simultaneously. If a patient develops the symptoms described above during treatment with ACE inhibitors, the possibility of developing intestinal angioedema should be considered when making a differential diagnosis.

Treatment aimed at desensitization to insect venom (for example, bees, wasps), and concurrent use of ACE inhibitors can initiate anaphylactic and anaphylactoid reactions (for example, marked decrease in blood pressure, shortness of breath, vomiting, allergic skin reactions), which can sometimes be life-threatening . During treatment with ACE inhibitors, hypersensitivity reactions to insect venom (for example, bees, wasps) develop faster and are more severe. If desensitization to insect venom is necessary, the ACE inhibitor should be temporarily replaced with an appropriate drug of a different class.

Life-threatening, rapidly developing anaphylactoid reactions, sometimes leading to shock, have been described with the use of ACE inhibitors during hemodialysis or hemofiltration using certain high-flux membranes (for example, polyacrylonitrile membranes) (see also membrane manufacturer's instructions). The simultaneous use of Amprilan® and the use of this type of membrane, for example, for emergency hemodialysis or hemofiltration, should be avoided. In this case, it is preferable to use other membranes or discontinue ACE inhibitors. Similar reactions were observed with LDL apheresis using dextran sulfate. Therefore, this method should not be used in patients receiving ACE inhibitors. In patients with impaired liver function, the response to treatment with Amprilan® may be either enhanced or weakened. In addition, in patients with severe liver cirrhosis with edema and/or ascites, significant activation of the RAAS is possible, so special care should be taken when treating these patients (see also section "Dosage and Administration").

Monitoring the content of electrolytes in blood plasma

Hyperkalemia

ACE inhibitors may cause hyperkalemia because they inhibit the release of aldosterone. This effect is usually minor in patients with normal renal function. However, in patients with impaired renal function and/or in patients concomitantly taking drugs containing potassium (including potassium-containing salt substitutes), potassium-sparing diuretics, trimethoprim or co-trimoxazole, also known as trimethoprim + sulfamethoxazole, and in particular aldosterone antagonists or ARBs II, hyperkalemia may develop. The risk group for developing hyperkalemia also includes elderly patients (over 70 years of age), patients with decompensated diabetes mellitus or patients in a state of dehydration, patients with acute heart failure, metabolic acidosis.

Potassium-sparing diuretics and ARB II should be used with caution in patients receiving ACE inhibitors, and serum potassium levels and renal function should be regularly monitored (see section "Interaction with other drugs").

Some patients receiving ramipril experienced SNA ADH with subsequent development of hyponatremia. It is recommended to regularly monitor plasma sodium levels in elderly patients and other patients at risk of developing hyponatremia.

Before surgery (including dental surgery), it is necessary to warn the surgeon/anesthesiologist about the use of ACE inhibitors.

It is recommended to carefully monitor newborns whose mothers used ACE inhibitors during pregnancy. to detect arterial hypotension, oliguria and hyperkalemia. In oliguria, it is necessary to maintain blood pressure and renal perfusion by administering appropriate fluids and vasoconstrictors. These neonates are at risk of developing oliguria and neurological disorders, possibly due to reduced renal and cerebral blood flow due to the reduction in blood pressure caused by ACE inhibitors.

Cough

When using the drug Amprilan®, a dry, unproductive, prolonged cough may occur, which disappears after stopping the use of ACE inhibitors (including ramipril), which must be taken into account in the differential diagnosis of cough during the use of an ACE inhibitor.

Ethnic characteristics

The drug Amprilan®, like other ACE inhibitors. has a less pronounced antihypertensive effect in patients of the Negroid race compared to representatives of other races.

Amprilan® should be prescribed with caution to patients of the Black race due to a higher risk of developing angioedema.

Patients after kidney transplantation

There is insufficient experience with the use of ramipril in patients who have recently undergone kidney transplantation.

Monitoring laboratory parameters before and during treatment with Amprilan

®
(up to 1 time per month in the first 3-6 months of treatment)
Monitoring kidney function (determining serum creatinine concentrations)

When treating with ACE inhibitors, it is recommended to monitor renal function in the first weeks of treatment and subsequently. Particularly careful monitoring is required in patients with acute heart failure and CHF, impaired renal function, after kidney transplantation, patients with renovascular diseases, including patients with hemodynamically significant unilateral renal artery stenosis in the presence of two kidneys (in such patients, even a slight increase in serum creatinine concentration may be indicator of decreased kidney function).

Monitoring of hematological parameters (hemoglobin, number of leukocytes, erythrocytes, platelets, leukocyte formula)

It is recommended to monitor the complete blood count to identify possible leukopenia. More regular monitoring is recommended at the beginning of treatment and in patients with impaired renal function, as well as in patients with connective tissue diseases or in patients simultaneously receiving other drugs that can change the peripheral blood picture (see section "Interaction with other drugs") . Monitoring the number of leukocytes is necessary for the early detection of leukopenia, which is especially important in patients with an increased risk of its development, as well as at the first signs of infection. If neutropenia is detected (the number of neutrophils is less than 2000/μl), discontinuation of treatment with ACE inhibitors is required.

If symptoms due to leukopenia appear (for example, fever, swollen lymph nodes, tonsillitis), urgent monitoring of the peripheral blood picture is necessary. If signs of bleeding appear (tiny petechiae, red-brown rashes on the skin and mucous membranes), monitoring the number of platelets in the peripheral blood is also necessary.

Determination of the activity of “liver” enzymes, the concentration of bilirubin in blood serum

If jaundice or a significant increase in the activity of liver enzymes in the blood plasma appears, treatment with Amprilan® should be stopped and medical supervision of the patient should be provided.

Special information on excipients

Amprilan® contains lactose and is therefore contraindicated in patients with lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Amprilan ND tablets 5mg/25mg No. 10x3

Name

Amprilan ND.

Release forms

Pills.

INN

Ramipril + hydrochlorothiazide.

FTG

Combination antihypertensive agent (ACE blocker + diuretic).

What is the drug and what is it used for?

Amprilan® ND is a combination of two active substances, ramipril and hydrochlorothiazide. Ramipril belongs to a group of drugs called ACE inhibitors (angiotensin-converting enzyme inhibitors) and has the following effects: - suppresses the production of substances in your body that increase blood pressure; - relaxes and dilates blood vessels; - facilitates the work of the heart to move blood throughout the body. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics or water tablets. It stimulates your body to produce more fluid (urine), which lowers your blood pressure. Amprilan® ND is used to treat high blood pressure. The combination has a more pronounced antihypertensive effect and is used in cases where the components of the drug taken separately are not effective enough.

Contraindications

Do not take Amprilan® ND if you are allergic to ramipril, hydrochlorothiazide or any other excipient of the drug (see section “Composition”); - allergy (hypersensitivity) to drugs similar to Amprilan® ND (other ACE inhibitors or sulfonamide derivatives); Symptoms of an allergic reaction may include a rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue. - have ever had a serious allergic reaction called angioedema. Its signs include itching, hives, red spots on the arms, legs and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing; - you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Amprilan® ND may not be suitable for your treatment; - severe liver dysfunction; — the level of certain salts in the blood is disturbed (calcium, potassium, sodium); - kidney diseases in which the blood supply to the kidneys is disrupted (renal artery stenosis); - during the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”); — you are breastfeeding (see section “Pregnancy and breastfeeding”); - if you have diabetes or impaired kidney function and are taking blood pressure medicines containing aliskiren. Do not take Amprilan® ND if any of the above apply to you. If you are unsure, consult your doctor before taking Amprilan® ND.

Special instructions and precautions

Consult your doctor before taking Amprilan® ND: - if you have impaired heart, liver or kidney function; - if you have had significant fluid or salt loss (due to vomiting, diarrhea, excessive sweating, following a low-salt diet, long-term use of diuretics (water pills) or dialysis treatment); - if you are planning treatment to reduce an allergic reaction to bee or wasp stings (desensitization); - if you are planning to have anesthesia, which may be needed for surgery or any dental procedures. You may need to stop taking Amprilan® ND the day before your planned procedure. Consult your doctor! - if you have high levels of potassium in your blood (according to the results of a blood test); - if you are taking medications or have conditions that cause low sodium levels in your blood. Your doctor may order blood tests at regular intervals to check your blood sodium levels, especially if you are older; - if you are taking drugs called mTOR inhibitors (for example, temsirolimus, everolimus, sirolimus) or vildagliptin, as they may increase the risk of developing angioedema, a severe allergic reaction; - if you have vision loss or eye pain, especially if you are at risk of developing glaucoma or are allergic to drugs containing penicillin or sulfonamide; - if you have a collagen disease, such as scleroderma or systemic lupus erythematosus; - if you are taking any of the following medicines used to treat high blood pressure: • an angiotensin II receptor blocker (ARB) (also known as sartans - eg valsartan, telmisartan, irbesartan), particularly if you have kidney disease, diabetes related; • aliskiren. Your doctor may regularly check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood. See also the information under the heading “Do not take Amprilan® ND”. - The active ingredient hydrochlorothiazide may cause an unusual reaction, resulting in decreased visual acuity and eye pain. These may be symptoms of increased pressure in the eyes, which may occur within hours or weeks after taking Amprilan® ND. Without treatment, this condition can lead to vision impairment. You should tell your doctor if you think you are (or may be) pregnant. Amprilan® ND is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see Pregnancy and Breastfeeding section).

Children and teenagers

Amprilan® ND is not recommended for children and adolescents under 18 years of age. This is due to the lack of clinical experience in these age groups. If any of the above apply to you (or you are unsure), consult your doctor before taking Amprilan® ND.

Other drugs and amprilan® nd

Tell your doctor if you are taking, have recently taken, or may be taking any other medications, including over-the-counter (including herbal) medications, because Amprilan® ND may affect the effect of some other medications and other medications may affect the effect of Amprilan® ND. If you are taking any of the following drugs, tell your doctor. They may worsen the effect of Amprilan® ND: - drugs used to relieve pain and reduce inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin). - medications to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, norepinephrine or epinephrine. Your doctor will monitor your blood pressure. If you are taking any of the following drugs, tell your doctor. They may increase the likelihood of adverse reactions when used together with Amprilan® ND: - drugs used to relieve pain and reduce inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin); - drugs that lower potassium levels in the blood. These include medications for constipation, diuretics, amphotericin B (used to treat fungal infections) and ACTH (used to test the effectiveness of adrenal function); — antitumor drugs (chemotherapy); - medicines to treat cardiac dysfunction, including heart rhythm disorders; - drugs to prevent organ rejection after transplantation, such as cyclosporine; - diuretics, for example furosemide; - drugs that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to thin the blood); - anti-inflammatory steroids such as prednisolone; - drugs to replenish calcium deficiency; - allopurinol (used to reduce uric acid levels in the blood); - procainamide (for the treatment of cardiac arrhythmias); - cholestyramine (to reduce the amount of lipids in the blood); - carbamazepine (for the treatment of epilepsy); - trimethoprim and co-trimoxazole (to treat infections caused by bacteria); - mTOR inhibitors (for example, temsirolimus, everolimus, sirolimus) or vildagliptin (for diabetes), as they may increase the risk of angioedema, a severe allergic reaction. If you are taking any of the following drugs, tell your doctor. Amprilan® ND may affect the effectiveness of these drugs: - oral blood sugar-lowering drugs and insulin. Amprilan® ND may lower blood sugar levels. Monitor your blood sugar regularly while taking Amprilan® ND; - lithium (for the treatment of psychiatric diseases). Amprilan® ND may increase lithium levels in the blood. The attending physician should regularly determine the level of lithium in the blood; - medicines to relax muscles; - quinine (for the treatment of malaria); - medicines containing iodine (can be used for x-ray examinations and other imaging methods in a hospital); - penicillin (to treat infections); - blood thinners taken by mouth (oral anticoagulants), such as warfarin. Your doctor may change your dose and/or take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Amprilan® ND” and “Special instructions and precautions”). If any of the above apply to you (or you are unsure), consult your doctor before taking Amprilan® ND. Test results Talk to your doctor before taking this drug: - If you are scheduled to have a parathyroid function test. Amprilan® ND may affect test results. — If you are an athlete and are planning to undergo an anti-doping test. Amprilan® ND may give a false-positive result.

Amprilan® ND with food, drinks and alcohol

Drinking alcohol together with Amprilan® ND may cause dizziness or mental impairment. If you are unsure how much alcohol you can drink while you are taking Amprilan® ND, discuss this with your doctor because Medicines used to lower blood pressure and alcohol may enhance each other's effects. — Amprilan® ND can be taken regardless of meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you are pregnant or may be pregnant. The use of Amprilan® ND is not recommended in the first 12 weeks of pregnancy, and after the 13th week the drug should not be taken, as it can cause severe developmental disorders of the fetus. If you become pregnant while being treated with Amprilan® ND, tell your doctor immediately. If pregnancy is planned, it is recommended to choose alternative treatment methods. You should not take Amprilan® ND while breastfeeding. Consult your doctor before taking any medications.

Driving vehicles and working with machinery

Do not drive or operate machinery until you have determined how Amprilan® ND affects you. You may feel dizzy while taking Amprilan® ND. This effect is most likely to occur at the beginning of treatment or when the dose is increased. If this happens, do not drive or operate machinery.

Important information about some ingredients

Amprilan® ND contains lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

Use of the drug

Always take Amprilan® ND exactly as directed by your doctor. Check with your doctor if you are unsure. Directions for use: Take the drug orally at the same time every day, usually in the morning. — Swallow the tablets whole, without crushing or chewing, with liquid. How many tablets should you take? Treating high blood pressure Your doctor may adjust your dose to achieve the appropriate blood pressure. Elderly patients Your doctor will start treatment with the lowest dose and gradually adjust your treatment. If you take more Amprilan® ND than you should, tell your doctor immediately or go to the nearest emergency room. Do not drive, ask for a ride or call an ambulance. Take the medicine package with you so that the doctor knows exactly what you took. If you forget to take Amprilan® ND Do not take a double dose to make up for the missed dose. If you forget to take your medication at the right time, follow your regular dosing schedule, taking your next dose at the scheduled time. If you have any further questions about the use of this drug, ask your doctor.

Possible adverse reactions

Like all medicines, Amprilan® ND can cause side effects, although not everyone gets them. Stop taking Amprilan® ND and call your doctor right away if you notice any of the following serious side effects: You may need immediate medical attention: - swelling of the face, lips or throat that makes it difficult to swallow or breathe, as well as itching and rashes. This may be a sign of a serious allergic reaction to Amprilan® ND. - severe skin reactions, including rash, mouth ulcers, worsening of an existing skin disease, redness, blistering or peeling of the skin (so-called Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme). Tell your doctor right away if you have any of the following conditions: - fast heart rate, irregular or fast heartbeat (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke. - shortness of breath, cough lasting 2-3 days, loss of appetite. These may be signs of impaired lung function, including inflammation; - easy bruising, prolonged bleeding or any signs of bleeding (for example, bleeding gums), purple spots on the skin that develop more often than usual, infections, sore throat, fever, feeling tired, weak, dizzy or pale skin. These may be signs of impaired hematopoiesis or bone marrow function; - severe pain in the stomach area, radiating to the back. This may be a sign of pancreatitis (inflammation of the pancreas); - fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver disease such as hepatitis (inflammation of the liver) or liver damage. Other side effects Please tell your doctor if any of the following conditions become severe or last longer than a few days. Common (may affect less than 1 in 10 people): - headache, feeling weak, tired; - feeling of dizziness. The occurrence of this effect is more likely at the beginning of treatment or when the dose of Amprilan® ND is increased; - dry irritating cough or bronchitis; - A blood test shows an increase in blood sugar. If you have diabetes, it may get worse; - a blood test shows increased levels of uric acid or lipids in your blood; - painful, red or swollen joints. Uncommon (may affect less than 1 in 100 people): - skin rashes, whether protruding or not protruding above the surface of the skin; - redness of the skin of the face, weakness, hypotension (abnormally low blood pressure), especially if you get up or sit down quickly; - imbalance (vertigo); - itching and unusual sensations on the skin such as numbness, tingling, burning sensation or goose bumps on the skin (paresthesia); - loss or change in taste sensations; - sleep disturbance; - a state of depression, anxiety, feeling of unusual nervousness or anxiety; - nasal congestion, inflammation of the sinuses (sinusitis), shortness of breath; - inflammation of the gums (gingivitis), swelling of the mouth; - redness, itching, swelling or watery eyes; - ringing in the ears; - blurred vision; - hair loss; - chest pain; - muscle pain; - constipation, pain in the stomach or intestines; - upset stomach or nausea; - increased fluid intake and increased frequency of urination during the day; - increased sweating or feeling thirsty; - loss or decreased appetite (anorexia), decreased feeling of hunger; - fast or irregular heartbeat; - swelling of the arms and legs. This may be a sign of fluid retention in the body; - fever; - sexual dysfunction in men; - blood tests showing a decrease in the number of red blood cells, white blood cells, platelets or hemoglobin; - blood tests showing abnormal liver, pancreas or kidney function; - blood tests showing a decrease in potassium levels in the blood. Very rare (may affect less than 1 in 10,000 people): - nausea, incipient diarrhea or heartburn; - red, swollen tongue or dry mouth; - blood tests showing increased levels of potassium in the blood. Frequency not known (frequency cannot be estimated from available data): - concentrated urine (dark color), tenderness or pain, muscle cramps, confusion and seizures, which may be caused by inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible. Other side effects: Please tell your doctor if any of the following side effects become severe or last longer than a few days. - difficulty concentrating, feeling restless or confused; - fingers and toes change color in the cold, when warming up, tingling or pain is felt. It could be Raynaud's syndrome; - enlargement of the mammary glands in men; - blood thickening; - hearing impairment; - dry eyes; - visual perception of objects in yellow; - blurred vision and pain in the eyes (possible signs of acute myopia or closed-angle glaucoma); - dehydration; - swelling, pain and redness in the neck (inflammation of the salivary gland); - swelling in the intestines, called angioedema of the intestines, with symptoms such as abdominal pain, vomiting and diarrhea; - increased photosensitivity; - severe peeling of the skin, itching, pustular rash or other skin reactions, such as a red rash on the face or forehead; - skin rashes or hemorrhages; - spots on the skin and cold extremities; - changes in the nails (for example, softening or peeling of the nail); - musculoskeletal stiffness or inability to move the jaw (tetany); - weakness or muscle cramps; - decreased sexual libido in men or women; - blood in urine. This may be a sign of kidney disease (interstitial nephritis); - increased sugar levels in urine; - increased levels of certain white blood cells (eosinophilia) detected during a blood test; - a blood test indicates a decrease in the amount of formed elements in your blood (pancytopenia); - a blood test showing changes in the levels of salts such as sodium, calcium, magnesium and chlorides in the blood. - slowing or disturbance of reactions; - change in sense of smell; - difficulty breathing or worsening asthma. - severe eye pain, blurred or halos of vision, headache, increased tearing, nausea and vomiting, which may indicate a condition called glaucoma.

Reporting Adverse Reactions

If you experience any unwanted reactions, consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of the drug.

Storage of the drug

Store at a temperature not exceeding 30°C. Keep out of the reach of children. Shelf life: 2 years. Do not use the drug after the expiration date indicated on the package. The expiration date is the last day of the month. Do not throw the drug into the water supply or sewer system. Ask your pharmacist how to dispose of medications that are no longer needed. These measures will protect the environment.

Compound

Active ingredients: 1 tablet contains 5 mg ramipril and 25 mg hydrochlorothiazide. Auxiliary ingredients: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch, sodium stearyl fumarate.

Appearance of the drug and contents of the package

Flat, 5.0 x 10.0 mm, capsule-shaped, beveled edges, white or off-white tablets, embossed with the numbers “2” and “5” on one side and a dividing line between them and on the sides of the tablet. 7 tablets in a blister (OPA/A1/PVC film and aluminum foil). 4 or 12 blisters with an insert in a cardboard box. 10 tablets in a blister (OPA/A1/PVC film and aluminum foil). 3 blisters with an insert in a cardboard box.

Vacation conditions

By doctor's prescription.

Buy Amprilan ND tablet 5mg/25mg in blister pack. in pack No. 10x3 in the pharmacy

Price for Amprilan ND tablet 5mg/25mg in blister pack. in pack №10x3

Instructions for use for Amprilan ND tablet 5mg/25mg in blister pack. in pack №10x3

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