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Hartil Amlo caps 5mg/5mg in bl. in pack. No. 10×3
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Hartil® Amlo capsules 5 mg/5 mg: hard gelatin capsules CONI-SNAP 3, unlabeled, self-closing, with light burgundy opaque base and light burgundy opaque cap. The main active ingredient Ramipril and amlodipine Release form 10 capsules in a blister from a combined cold film: (polyamide / aluminum foil / PVC) And aluminum foil. 3 or 9 blisters are placed in a cardboard box along with instructions for medical use for patients. Dosage 5mg/5mg in bl. in pack. No. 10×3 Indications for use Hartil® Amlo contains two active substances – ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) and amlodipine belongs to a group of medicines called calcium channel blockers. What ramipril does: It reduces your body’s production of substances that can cause high blood pressure. relaxes and dilates your blood vessels. makes it easier for your heart to pump blood throughout your body. Action of amlodipine: relaxes and dilates your blood vessels, which facilitates the passage of blood through the vessels. Hartil® Amlo can be used to treat patients with high blood pressure (hypertension) in whom both drugs taken separately, taken simultaneously in the same doses as in combination, have an adequate effect. Dosage and Administration Always take Hartil® Amlo strictly as prescribed by your doctor. If you are not sure about something, ask your doctor or pharmacist. Dosage regimen – The usual recommended dose is 1 capsule with the dosage of the drug prescribed by the doctor. – Depending on the therapeutic effect, your doctor may change the dose. – The maximum dose is 1 capsule with a dosage of the drug 10/10 mg, once a day. Appointment of the drug in diseases of the liver and kidneys In diseases of the liver and kidneys, the dosage of the drug may be changed. Prescribing the drug to the elderly The doctor will reduce the initial dose of the drug and slow down the selection of the dose of the drug you need. It is not recommended to prescribe Hartil® Amlo to very old and infirm patients. Prescribing the drug to children and adolescents It is not recommended to prescribe Hartil® Amlo to children and adolescents under 18 years of age, since the safety and efficacy of the drug in this group of patients has not been determined. If you think that the therapeutic effect of the drug is too strong or too weak, then you should consult your doctor. It is important to take the capsules without interruption. Do not wait until your medicine runs out, contact your doctor in time to write out the next prescription. If you take more Hartil® Amlo than you need Taking more Hartil® Amlo capsules than you need can cause your blood pressure to drop or dangerously drop. You may feel dizzy, weak, or faint. With a sufficiently severe drop in blood pressure, shock can develop. Your skin may become cold and clammy and you may pass out. Tell your doctor or immediately go to the emergency department of the nearest hospital. Do not drive on the way to the hospital! Ask other people to do it or call an ambulance. Keep the used packaging and keep it with you. Examining it will help your doctor determine exactly what dose you have taken. If you forget to take Hartil® Amlo Do not worry and do not take the forgotten dose. Next time, take the usual dose of the drug at the usual time. You do not need to take a double dose of the drug to make up for the missed dose. If you stop taking Hartil® Amlo, your doctor will determine the duration of treatment you need. Before consulting a doctor, you should not abruptly stop taking or change the dose of the drug taken, as this may provoke a return of your disease. How to use – capsules should be taken orally at the same time of day, every day during the course of treatment, regardless of food intake – capsules should be swallowed whole with liquid – do not take capsules with grapefruit juice – capsules should not be crushed or chewed. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Use during pregnancy and lactation If you are pregnant, breastfeeding, think you are pregnant or are planning to become pregnant, tell your doctor or pharmacist before using this medicine. Pregnancy Hartil® Amlo should not be taken during the first 12 weeks of pregnancy. Starting from the 13th week of pregnancy, the drug is contraindicated. Taking the drug during this period can cause serious disturbances in the development of the fetus. If you become pregnant during the course of treatment with Hartil® Amlo, you should immediately inform your doctor about this. Switching to an appropriate alternative treatment must be completed prior to the planned pregnancy. Breastfeeding Taking Hartil® Amlo during breastfeeding is not recommended. Consult your healthcare professional before taking any medicine if you are pregnant or breastfeeding. Precautions Ask your doctor or pharmacist if you can take the drug in the following cases: – if you are an elderly person; – if you suffer from functional disorders of the heart, liver or kidneys; – if your blood pressure has risen sharply (hypertensive crisis); – if your body’s water-salt balance is disturbed, dehydration due to vomiting, diarrhea, excessive sweating or taking diuretics (diuretics) for a long time, or lack of salt due to being on a low-salt diet or undergoing dialysis; – if you are going to be treated to reduce an allergic reaction to bee or wasp stings (desensitization); – if you have been prescribed painkillers. This can happen when planning a surgical or dental operation. Perhaps, then you will have to stop taking Hartil® Amlo in advance, the day before the scheduled procedure, and consult a doctor for advice; – if you have an elevated level of potassium in the blood (according to the results of a biochemical blood test); – if you are taking medication or have a medical condition that causes low sodium levels in your blood. Your doctor may order regular blood tests to check your sodium levels in your blood, especially if you are older; – if you are prescribed drugs called mTOR (such as tensirolimus, everolimus, sirolimus) or vildagliptin, as these drugs may increase your risk of angioedema, which is a severe allergic reaction; – if you suffer from collagen diseases, such as scleroderma or systemic lupus erythematosus; – if you are taking any of the following blood pressure medicines: – angiotensin-II receptor blockers (ARBs), also known as sartans, eg valsartan, telmisartan, irbesartan, especially if you suffer from kidney disease associated with diabetes; – aliskiren. Your health care provider may need to regularly check your kidney function, blood pressure, and electrolyte (potassium, sodium) levels in your blood. Also read the information in the “Do not take this medicine if you:” section. Be sure to tell your doctor if you are pregnant, think you are pregnant or plan to become pregnant. In the early stages of pregnancy, it is not recommended to take the drug Hartil® Amlo. The drug should not be taken if the gestational age is more than 3 months. Taking the drug during this period can cause serious harm to the fetus (see section “Pregnancy and breastfeeding”). If at least one of the above points concerns you (or you are not sure about this), then before taking Hartil® Amlo, consult your doctor. Children and adolescents under the age of 18 It is not recommended to prescribe Hartil® Amlo to children and adolescents under 18 years of age, since the safety and efficacy of the drug in this group of patients has not been determined. The drug Hartil® Amlo contains dyes: The shell of the capsules 5mg / 5mg and 10mg / 5mg contains a charming red dye (allura red AC-FD&C Red 40 (E-129), and capsules 5mg / 10mg and 10mg / 10mg – azorubine (carmoisine) (E-122) These dyes can cause an allergic reaction. Interactions with other drugs Be sure to tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines). In these cases, Hartil® Amlo may affect the effect of other medicines. In addition, some medicines may affect the action of Hartil® Amlo. Be sure to tell your doctor if you are taking any of the following medicines. They can affect the action of Hartil® Amlo and reduce its effectiveness: – medicines used to relieve symptoms of pain and inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, as well as aspirin); – medicines used to treat patients with low blood pressure, as well as shock, heart failure, asthma or allergies, such as ephedrine, norepinephrine and epinephrine. The doctor should check your blood pressure; – rifampicin (an antibiotic used to treat patients with tuberculosis); – St. John’s wort / Hypericum perforatum (herbal treatment for depression). Be sure to tell your doctor if you are taking any of the following medicines. When taken simultaneously with Hartil® Amlo, they may increase the risk of side effects. Your doctor may need to change the dose of the drug or take other precautions, which are listed below: – medicines used to relieve symptoms of pain and inflammation (for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, as well as aspirin); – medicines prescribed for oncological diseases (during the course of chemotherapy); – drugs that prevent organ rejection after transplantation, such as cyclosporine; – diuretics (water pills) such as furosemide; – medicines that can increase the concentration of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium preparations and potassium-containing table salt substitutes, as well as heparin (a drug that prevents blood clotting); – steroidal anti-inflammatory drugs such as prednisolone; – allopurinol (used to lower the level of uric acid in the blood); – procainamide (a drug for maintaining a normal heart rhythm); – temsirolimus (a medicine used to treat certain cancers); – sirolimus, everolimus (drugs that prevent rejection of transplanted organs); – vildagliptin (a drug used to treat type 2 diabetes); – ketoconazole, itraconazole (used to treat fungal diseases); – erythromycin, clarithromycin (antibiotics used for certain bacterial infections); – ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV-infected patients); – verapamil, diltiazem (used to treat a number of heart conditions and high blood pressure); – trimethoprim and cotrimoxazole (antibiotics to treat certain bacterial infections); – tacrolimus (a medicine to control the immune system in organ transplants); – medicines angiotensin II receptor blockers (ARBs) or aliskiren (see also the information in the sections “Do not take Hartil® Amlo in the following cases” and “Precautions for medical use”). Be sure to tell your doctor if you are taking any of the following medicines – Hartil® Amlo may affect them by changing how they work: – medicines for diabetes, such as insulin and oral glucose-lowering medicines. Hartil® Amlo may reduce blood sugar levels. When taking Hartil® Amlo, you should constantly monitor your blood sugar levels. – preparations containing lithium (drugs for the treatment of mental disorders). Hartil® Amlo may increase the level of lithium in the blood. The content of lithium in your blood should be constantly monitored by a doctor. – cyclosporine (a drug that inhibits the function of the immune system). – simvastatin (a drug used to lower blood cholesterol levels). If at least one of the above points concerns you (or you are not sure about this), then before taking Hartil® Amlo, consult your doctor. Taking Hartil® Amlo at the same time as food and drink – Drinking alcohol while taking Hartil® Amlo may cause you to feel uncertain, dizzy. If you have a question about how much alcohol you can consume while taking Hartil® Amlo, then discuss this issue with your doctor. Alcohol and drugs used to lower blood pressure can increase each other’s sedative effects. – Grapefruit and grapefruit juice are not recommended for patients taking Hartil® Amlo, as this can increase the level of amlodipine (one of the active ingredients) in the blood, leading to an unpredictable increase in the antihypertensive effect (a sharp drop in blood pressure) of Hartil® Amlo. – You can take Hartil® Amlo before and after meals. Contraindications – if you are allergic to ramipril, amlodipine (active substances), any other calcium channel blocker or ACE inhibitors, as well as to any of the excipients of Hartil® Amlo, listed in the “Composition” section; Signs of an allergic reaction may include a rash, reddening of the skin, difficulty swallowing, or trouble breathing; – if you have severe vasoconstriction that prevents the outflow of blood from the left ventricle (for example, narrowing of the aortic heart valve) or cardiogenic shock (a condition in which the heart is unable to pump the necessary amount of blood); – if you have ever had a severe allergic reaction called angioedema (angioneurotic edema), the signs of which are itching, allergic rash (urticaria), red marks on the arms, legs and neck, swelling of the throat and tongue, swelling around the eyes and lips difficulty breathing and swallowing; – if you are prescribed dialysis or any other type of blood filtration. In this case, taking Hartil® Amlo, depending on the equipment used or the type of membranes, may be ineffective or unsafe for you; – if you suffer from kidney disease, in which the blood flow to your kidney is reduced (renal artery stenosis); – if you have abnormally low or unstable blood pressure. In this case, your attending physician must give his opinion; – if you have heart failure after a myocardial infarction; – if you are in the 2nd and 3rd trimester of pregnancy; – if you suffer from diabetes, impaired kidney function or if you are being treated with blood pressure lowering medicines containing aliskiren. Do not take Hartil® Amlo if at least one of the conditions described above applies to you. If you are not sure about this, then before taking Hartil® Amlo, consult your doctor. Active ingredient: one 5 mg/5 mg capsule contains 5 mg ramipril and 5 mg amlodipine (in the form of 6.95 mg amlodipine besylate), 5 mg/10 mg contains 5 mg ramipril and 10 mg amlodipine (in the form of 13.9 mg amlodipine besylate), 10mg/5mg contains 10mg ramipril and 5mg amlodipine (as 6.95mg amlodipine besylate) and 10mg/10mg contains 10mg ramipril and 10mg amlodipine (as 13.9mg amlodipine besylate) respectively. Excipients: crospovidone, hypromellose, microcrystalline cellulose, glycerol dibehenate. The composition of the capsule CONI-SNAP-3 (5 mg / 5 mg): brilliant blue (E-133), charming red (E-129), titanium dioxide (E-171), gelatin. The composition of the capsule CONI-SNAP-0 (5 mg / 10 mg): titanium dioxide (E-171), iron oxide red (E-172), carmoisine (E-122), indigo carmine + FD and C blue 2 (E-132 ), gelatin. The composition of the capsule CONI-SNAP-0 (10 mg / 5 mg): titanium dioxide (E-171), iron oxide red (E-172), brilliant blue (E-133), charming red (E-129), gelatin. The composition of the capsule CONI-SNAP-0 (10 mg / 10 mg): carmoisine (E-122), indigo carmine + FD and C blue 2 (E-132), titanium dioxide (E-171), gelatin. Side effects Hartil® Amlo, like all medicines, can cause side effects, although not everyone gets them. If you experience any of the serious side effects listed below, you should stop taking Hartil® Amlo and consult a doctor immediately – You may need urgent medical attention: – swelling of the face, lips or throat, accompanied by difficulty in swallowing or breathing, as well as itching and rash. This may be a sign of a severe allergic reaction to taking Hartil® Amlo; – severe skin reactions, including rash, mouth ulcers, exacerbation of pre-existing skin conditions, redness, blistering or stratification of the skin (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme). Call your doctor right away if you experience: – an increase in heart rate, irregular or increased heartbeat (palpitations), chest pain, chest tightness, or more serious problems, including heart attack and stroke; – shortness of breath or cough – this may be a sign of impaired respiratory function; – frequent bruising of the skin, bleeding that lasts longer than usual, any other signs of bleeding (such as bleeding from the gums), purple spots on the skin, or more frequent infections than usual, sore throat and fever, feeling tired, fainting, dizziness, or pale skin. This may be a sign of disorders in the circulatory system or bone marrow; – severe pain in the abdomen, which can spread to the back area – this may be a sign of pancreatitis (inflammation of the pancreas); – fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). This may be a sign of liver disease, such as hepatitis (inflammation of the liver), or damage to the liver tissue. Other side effects: Call your doctor if any of the following side effects get worse or last more than a few days. The frequency parameters used below are defined as follows: Common: Occurs in 1 to 10 patients in 100 Uncommon: Occurs in 1 to 10 patients in 1,000 Rare: Occurs in 1 to 10 patients in 10,000 Very rare: Occurs less frequently than in 1 patient in 10,000 frequency unknown – cannot be determined from the available data Common side effects – drowsiness (especially at the beginning of treatment); – feeling of a strong heartbeat; – redness of the face (hot flashes); – headache or feeling tired, weak; – dizziness. This occurs, most often, at the beginning of the course of Hartil® Amlo therapy or when switching to higher doses of the drug; – visual impairment (including double vision); – impaired bowel function, including diarrhea and constipation; – fainting, hypotension (abnormally low blood pressure), especially when you stand or sit down quickly; – difficult dry cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath; – pain in the abdomen (in the stomach or in the intestines), diarrhea, indigestion, nausea, vomiting; – rash on the skin, with or without blistering; – pain in the chest; – muscle cramps or pain; – fainting; – elevated levels of potassium in the blood (detected as a result of a blood test). Uncommon side effects – mood changes, insomnia; – shiver; – ringing in the ears; – sneezing/runny nose caused by inflammation of the nasal mucosa (rhinitis); – hair loss; – rash (exanthema); – itching, changes in skin color; – increased need to urinate, especially at night, difficulty urinating, more frequent urge to urinate; – deterioration of kidney function; – pain, feeling unwell; – backache; – increase or decrease in body weight; – discomfort and enlargement of the mammary glands in men; – imbalance with dizziness and a sensation of rotation (vertigo); – itching and unusual skin sensations such as numbness, tingling, stinging, burning or goosebumps on the skin (paresthesia), loss of sensation in the skin (hypesthesia); – loss or change in taste sensations; – sleep disorders; – depression, anxiety, increased nervousness or agitation; – nasal congestion, exacerbation of asthma; – the occurrence of intestinal edema (called angioedema of the intestine), expressed by symptoms of abdominal pain, vomiting and diarrhea; – heartburn, feeling of dryness in the mouth; – accumulation of gases in the stomach (gastritis); – increase in the amount of urine excreted during the day; – increased sweating; – decrease or loss of appetite (anorexia); – increased heart rate, slow heart rate or arrhythmia; – swelling of the hands and feet. This may be a sign that your body is holding on to excess fluid; – blurred vision; – pain in the joints; – fever; – sexual impotence in men, decreased sexual desire in men and women; – an increase in the number of certain white blood cells (eosinophilia) detected by a blood test; – changes in the function of the liver, pancreas and kidneys, revealed as a result of blood tests and biochemical tests; – myocardial infarction. Rare side effects – a state of uncertainty or confusion; – redness and swelling of the tongue; – pronounced stratification or peeling of the skin, itching, rough skin rash; – nail disease (for example, weakening or separation of the nail from the nail bed); – skin rash or bruising; – spots on the skin or cold extremities; – redness of the eyes, itching, swelling of the eyes or watery eyes; – hearing disorders; – a decrease in the number of red blood cells (erythrocytes), white blood cells (leukocytes) and platelets (platelets), as well as a decrease in hemoglobin levels, detected as a result of blood tests. Very rare side effects (recorded in less than 1 patient out of 10,000) – high blood sugar; – inflammation of the pancreas; – inflammation of the liver, yellowing of the skin (jaundice); – increased sensitivity to sunlight (photosensitivity); – gingival hyperplasia (growth of gum tissue); – muscle stiffness, trembling or impaired movement; – increased muscle tone; – inflammation of blood vessels. Other side effects reported (frequency unknown) Call your doctor if any of the side effects listed below get worse or last more than a few days. – violation of concentration; – swelling of the mouth; – inflammation of the oral mucosa with the formation of small ulcers; – a decrease in the number of blood cells detected during blood tests; – a decrease in the concentration of sodium in the blood, revealed during biochemical analyzes; – discoloration of the fingers and toes in the cold, and when exposed to heat, a painful tingling sensation (Raynaud’s syndrome); – slowing down or violation of psychomotor reactions; – burning sensation; – impaired sense of smell; – psoriasis; – increased levels of antibodies to cell nuclei (blood test); – concentrated, dark-colored urine, muscle spasm, feeling unwell and seizures due to the syndrome of inappropriate secretion of antidiuretic hormone. If you experience these symptoms, contact your doctor immediately; – trembling, rigid posture, mask-like face, slow movements and unbalanced shuffling gait. Reporting side effects If you experience any side effects, including those not mentioned in this leaflet, please contact your doctor or pharmacist. By reporting side effects, you help provide more information about the safety of this drug. Storage conditions Store at a temperature not exceeding 30 ° C, out of the reach of children. Buy Hartil Amlo capsules 5mg / 5mg No. 10×3 Price for Hartil Amlo capsules 5mg / 5mg No. 10×3
INN | RAMIPRIL + AMLODIPINE |
---|---|
The code | 62 948 |
Barcode | 5 995 327 146 812 |
Dosage | 5mg/5mg |
Active substance | Ramipril/amlodipine |
Manufacturer | Egis Pharmaceuticals PLC, Hungary |
Importer | LLC "GrandPharm", Minsk, 220004, Minsk, Timiryazeva st., 4, office 1H, office 7; "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, office 1; SOOO "Brititrade", 223021, Minsk district, Shchomyslitsky s / s, 18 |
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