Name:
Amprilan tabl 10mg in a blister pack. No. 10×3
Description:
Amprilan® tablets 1.25 mg: oval, flat tablets of white or almost white color with bevelled edges, without a shell. Amprilan® tablets 2.5 mg: oval, flat tablets of light yellow color with beveled edges, without a shell. Amprilan® tablets 5 mg: oval, flat pink tablets with visible inclusions, with beveled edges, without a shell. Amprilan® tablets 10 mg: oval, flat tablets of white or almost white color with beveled edges, without a shell. 7 tablets in a blister (laminated OPA/aluminum/PVC foil, aluminum foil). 2 blisters with leaflet in a cardboard box. 10 tablets in a blister (laminated OPA/aluminum/PVC foil, aluminum foil). 3 blisters with leaflet in a cardboard box. The main active ingredient mipril Release form Tablets Dosage 10 mg Special instructions Consult your doctor before taking Amprilan®: if you have heart, liver or kidney disease; low salt, long-term use of diuretics (diuretics), dialysis treatment; if you are taking drugs at the same time to reduce allergies to bee or wasp stings (desensitization); if you are going to take pain medication. This may be necessary for a surgical or dental operation. You may need to stop treatment with Amprilan® the day before. Talk to your doctor about this; if you have high levels of potassium in your blood (as determined by a blood test); if you are taking drugs or have conditions that can lower your sodium levels in your blood. Your doctor may order regular blood tests, especially to check your sodium levels in your blood, especially if you are an older person; if you are taking medicines called mTOR inhibitors (eg, temsirolimus, everolimus, sirolimus) or vildagliptin, as these may increase your risk of angioedema a serious allergic reaction if you have a collagenous vascular disease such as scleroderma or systemic lupus erythematosus if you are taking any of the following drugs used to treat high blood pressure: angiotensin II receptor blockers (ARB II) (also known as ” sartans” – for example, valsartan, telmisartan, irbesartan), especially if you have impaired kidney function associated with diabetes; 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 “Contraindications”. You must tell your doctor if you think you are (or are planning to become) pregnant. Amprilan® is not recommended for early pregnancy. The drug should not be taken if you are in the second or third trimester of pregnancy, as this can cause serious harm to your baby (see section “Pregnancy and breast-feeding”). Pharmacological action ACE inhibitor. It is a prodrug from which the active metabolite ramiprilat is formed in the body. It is believed that the mechanism of antihypertensive action is associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin I to angiotensin II, which is a powerful vasoconstrictor. As a result of a decrease in the concentration of angiotensin II, a secondary increase in plasma renin activity occurs due to the elimination of negative feedback on renin release and a direct decrease in aldosterone secretion. Due to the vasodilating effect, it reduces OPSS (afterload), wedge pressure in the pulmonary capillaries (preload) and resistance in the pulmonary vessels; increases cardiac output and exercise tolerance. In patients with signs of chronic heart failure after myocardial infarction, ramipril reduces the risk of sudden death, the progression of heart failure to severe / resistant failure and reduces the number of hospitalizations for heart failure. Ramipril is known to significantly reduce the incidence of myocardial infarction, stroke and cardiovascular death in patients with increased cardiovascular risk due to vascular disease (CHD, previous stroke or peripheral vascular disease) or diabetes mellitus, who have at least one additional risk factor (microalbuminuria , arterial hypertension, increased total cholesterol, low HDL, smoking). Reduces overall mortality and the need for revascularization procedures, slows the onset and progression of chronic heart failure. Both in patients with diabetes mellitus and without it, ramipril significantly reduces the existing microalbuminuria and the risk of developing nephropathy. These effects are observed in patients with both elevated and normal blood pressure. The hypotensive effect of ramipril develops after about 1-2 hours, reaches a maximum within 3-6 hours, lasts at least 24 hours. Pharmacokinetics When taken orally, absorption is 50-60%, food does not affect the degree of absorption, but slows down absorption. Cmax is reached in 2-4 hours. It is metabolized in the liver to form the active metabolite of ramiprilat (6 times more active in inhibiting ACE than ramipril), inactive diketopiperazine and glucuronidated. All formed metabolites, with the exception of ramiprilat, have no pharmacological activity. Plasma protein binding for ramipril is 73%, ramiprilat is 56%. Bioavailability after oral administration of 2.5-5 mg of ramipril – 15-28%; for ramiprilat – 45%. After daily administration of ramipril at a dose of 5 mg / day, a steady-state plasma concentration of ramiprilat is reached by day 4. T1 / 2 for ramipril – 5.1 h; in the phase of distribution and elimination, a drop in the concentration of ramiprilat in the blood serum occurs with T1 / 2 – 3 hours, followed by a transitional phase with T1 / 2 – 15 hours, and a long final phase with very low plasma concentrations of ramiprilat and T1 / 2 – 4- 5 days. T1 / 2 increases in chronic renal failure. Vd of ramipril – 90 l, ramiprilat – 500 l. The kidneys excrete 60%, through the intestines – 40% (mainly in the form of metabolites). In case of impaired renal function, the excretion of ramipril and its metabolites slows down in proportion to the decrease in CC; in case of impaired liver function, the conversion to ramiprilat slows down; in heart failure, the concentration of ramiprilat increases by 1.5-1.8 times. Indications for use The action of Amprilan® is based on: reducing the body’s production of substances that can increase blood pressure; relaxing and dilating blood vessels; facilitating the work of the heart to move blood through the vessels. Amprilan® is intended for: treating high blood pressure (hypertension); reducing the risk of developing heart attack or stroke; reducing the risk of developing kidney disease (whether you have diabetes or not); treating heart disease where it cannot move enough blood through the vessels (heart failure); treating conditions after a heart attack (myocardial infarction) ), complicated by heart failure. Dosage and Administration Take Amprilan® orally at the same time every day. Swallow the tablets whole with plenty of liquid. Do not crush or chew tablets. Treatment of high blood pressure The usual starting dose is 1.25 mg or 2.5 mg once daily. Your doctor may adjust the dose you are taking until your blood pressure is under control. The maximum daily dose is 10 mg once a day. If you are already taking diuretics (water pills), your doctor may cancel or reduce the amount of diuretic you are taking before starting treatment with Amprilan. Reducing the risk of myocardial infarction or stroke The usual starting dose is 2.5 mg once daily. Your doctor may subsequently increase the dose you are taking. The usual dose is 10 mg once a day. Kidney disease risk warnings You can start at 1.25 mg or 2.5 mg once a day. Your doctor may change the dosage. The usual dose is 5 mg or 10 mg once a day. Treatment of heart failure The usual starting dose is 1.25 mg once daily. Your doctor may change the dosage you are taking. The maximum dose is 10 mg per day. It is preferable to divide the dose into two doses per day. Treatment after myocardial infarction The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily. Your doctor may change the dose you are taking. The usual dose is 10 mg per day. It is preferable to divide the dose into two doses per day. Elderly patients Your doctor will reduce your starting dose and adjust your treatment more slowly. Use during pregnancy and lactation If you are pregnant or breastfeeding, suspect that you are pregnant or are planning a pregnancy, consult your doctor before taking Amprilan®. Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking Amprilan® before pregnancy or immediately after you find out that you are pregnant, and will advise you to take another drug instead of Amprilan®. Amprilan® is not recommended for early pregnancy, it should not be taken during pregnancy for more than 3 months, as it can cause serious harm to your baby. Breastfeeding Tell your healthcare provider if you are breastfeeding or about to start breastfeeding. Amprilan® is not recommended for the treatment of mothers who are breastfeeding, and your doctor may suggest a different treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely. Precautions You must tell your doctor if you suspect you are pregnant (or are planning to become pregnant). Amprilan® is not recommended for early pregnancy. The drug should not be taken if you are in the second or third trimester of pregnancy, as this can cause serious harm to your baby (see section “Pregnancy and breast-feeding”). Interactions with other drugs Tell your doctor if you are taking, have recently taken or may start taking any other medicines. Amprilan® may affect the effect of some other drugs. Also, some drugs may affect the work of Amprilan®. Please tell your doctor if you are taking any of the following medicines. They can reduce the effect of Amprilan®: medicines used to relieve pain and inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid), medicines used for low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine, or epinephrine. Your doctor will need to check your blood pressure. Please tell your doctor if you are taking any of the following medicines. They may increase the chance of side effects if you take them with Amprilan®: medicines used to relieve pain and inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetylsalicylic acid), medicines to treat cancer (chemotherapy), temsirolimus (to treat cancer), drugs to prevent organ transplant rejection such as cyclosporine, sirolimus, everolimus (to prevent transplant rejection), diuretics (diuretics) such as furosemide, drugs that can increase the amount potassium in your blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood), hormonal medicines to treat inflammation, such as prednisolone, allopurinol (used to lower blood uric acid levels), procainamide (for disorders heart rate), trimethoprim and cotrimoxazole (for i treat infections caused by bacteria), vildagliptin (used to treat type 2 diabetes). Please tell your doctor if you are taking any of the following medicines. Amprilan® may affect their effectiveness: drugs for the treatment of diabetes, such as oral glucose-lowering drugs and insulin. Amprilan® may lower the amount of sugar in the blood. Check your blood sugar while taking Amprilan®. lithium (for mental illness). Amprilan® may increase the amount of lithium in the blood. The content of lithium in the blood should be carefully monitored by a doctor. If any of the above applies to you (or you are not sure), consult your doctor before taking Amprilan®. Your doctor may need to change your dosage and/or take other precautions: if you are taking an angiotensin II receptor blocker (ARB II) or aliskiren (see also information under the headings “Contraindications” and “Special instructions and precautions”) Amprilan® with food, drink and alcohol Drinking alcohol together with Amprilan may cause dizziness or a state of mental disorder. If you are not sure how much alcohol you can drink while taking Amprilan®, discuss this with your doctor, as drugs used to lower blood pressure and alcohol enhance each other’s effects. Amprilan® can be taken regardless of food intake. Contraindications If you have taken more prescribed dose, seek immediate medical attention. Do not drive! Have someone drive you or call an ambulance. If possible, take the tablets or box with you to show your doctor what you have taken. Composition 1 tablet contains 1.25 mg or 2.5 mg or 5 mg or 10 mg of ramipril. Auxiliary ingredients: Sodium bicarbonate, lactose monohydrate, sodium croscarmellose, pregelatinized starch (Starch 1500), sodium stearyl fumarate. The composition of the 2.5 mg tablets additionally includes the PB22886 Yellow pigment mixture (lactose monohydrate, iron oxide yellow (E172)). The composition of the 5 mg tablets additionally includes a pigment mixture PB24899 Pink (lactose monohydrate, iron oxide red (E172), iron oxide yellow (E172)) . Treatment: in mild cases of overdose – gastric lavage, the appointment of adsorbents and sodium picosulfate (preferably within 30 minutes after ingestion). With a pronounced decrease in blood pressure – intravenous administration of catecholamines, alpha1-adrenergic agonists (norepinephrine, dopamine), angiotensin II (angiotensinamide), the patient should be laid on his back on a surface with a low headboard, if necessary, BCC can be replenished by infusion 0.9 % sodium chloride solution; with bradycardia, a temporary artificial pacemaker can be placed. It is necessary to carefully monitor blood pressure, kidney function and serum potassium levels. The effectiveness of hemodialysis has not been established. Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Amprilan® and contact your doctor immediately if you notice any of the following serious side effects. you may need urgent treatment: Swelling of the face, lips or throat, difficulty swallowing or breathing, and itching and rash. This may be a sign of a severe allergic reaction to Amprilan®. Severe skin reactions, including rash, mouth ulcers, worsening of an existing skin disease, redness, swelling or peeling of the skin (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme). Tell your doctor right away if you experience: fast heart rate, irregular or strong heartbeat (palpitations), chest pain, chest tightness, or more serious conditions, including heart attack and stroke, shortness of breath, or cough. These may be signs of lung disease. bruising, bleeding longer than usual, any signs of bleeding (such as bleeding gums), purple dots and spots on the skin, infections occurring more often than usual, sore throat and fever, feeling tired, weak , dizziness, or pale skin. These signs can signal diseases of the bone marrow. Severe pain in the stomach, radiating to the back. This may be a symptom 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 symptoms 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 symptoms are severe or last more than a few days. Frequent (may affect up to 1 in 10 people) headache or feeling tired; dizziness (more likely to occur at the beginning of treatment with Amprilan® or when the dose is increased); fainting, an abnormal decrease in blood pressure (hypotension), especially if you stand up abruptly or sit up; dry, irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath; stomach or intestinal pain, diarrhea, upset stomach, nausea, or vomiting; rash that rises and above the surface of the skin or is smooth; chest pain; cramps or muscle pain; increased levels of potassium in the blood (based on a blood test). goosebumps (paresthesia) loss or change in taste sensations trouble sleeping depression, restlessness, nervousness or anxiety nasal congestion, difficulty breathing or exacerbation of asthma; swelling in the intestines called “intestinal angioedema” with symptoms such as abdominal pain, vomiting, and diarrhea; heartburn, constipation, or dry mouth; frequent urination during the day; increased sweating; loss or decrease in appetite (anorexia); or irregular heartbeat, swelling of the hands and feet. This may be a sign of fluid retention in the body; hyperemia; blurred vision; joint pain; fever; impotence in men; decreased libido in men or women; an increase in a certain type of white blood cell (eosinophilia), based on a blood test; changes in work liver, pancreas, and kidneys, based on laboratory results. Rare (may affect up to 1 in 1,000 people) trembling and confusion; red, swollen tongue; severe peeling or peeling of the skin, itching, pityriasis rash; changes in the nails ( eg, softening or pulling away of the nail plate from the nail bed); skin rash or bruising; patches of skin and cold extremities; redness, itching, swelling, or watery eyes; hearing loss and tinnitus; feeling faint; a decrease in the number of red blood cells, white blood cells, or platelets or hemoglobin levels based on blood test results. Very rare (may affect up to 1 in 10,000 people) sensitivity to sunlight. Frequency unknown (frequency cannot be estimated from the available data) concentrated urine (dark in color), nausea or vomiting, muscle cramps, confusion and convulsions, which may be caused by abnormal secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible. Other side effects: Please tell your doctor if any of the following symptoms become severe or last more than a few days: difficulty concentrating; swelling of the mouth; blood tests show that there are too few blood cells in the blood; a blood test shows that there is too little sodium in the blood; the fingers and toes change color in the cold, followed by tingling and soreness when warm (Raynaud’s phenomenon); breast enlargement in men; slowing or violation reactions; burning sensation; change in the sense of smell; hair loss. Storage conditions Store at a temperature not exceeding 25 ° C. Store in the original packaging in a place protected from moisture. Keep out of the reach of children. Buy Amprilan tablets 10mg No. 10×3 Price for Amprilan tablets 10mg No. 10×3
INN | RAMIPRIL |
---|---|
The code | 26 410 |
Barcode | 3 838 989 531 423 |
Dosage | 10mg |
Active substance | Ramipril |
Manufacturer | KRKA, d.d., Slovenia, Slovenia |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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