Amprilan ND tablets 5mg/25mg №10×3

NameAmprilan ND. Forms of release Tablets. MHNRamipril + hydrochlorothiazide. FTGHypotensive combined means (APF blocker + diuretic). What the drug is and what it is used for Amprilan® ND is a combination of two active substances, ramipril and hydrochlorothiazide. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) and has the following effects: – Suppresses your body’s production of substances that increase blood pressure; – relaxes and dilates blood vessels; – facilitates the work of the heart to promote blood throughout the body. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, or diuretic tablets. It stimulates the 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 auxiliary ingredient 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, 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 some salts (calcium, potassium, sodium) is disturbed in the blood; – kidney disease, in which the blood supply to the kidneys is disturbed (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 not sure, check with 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, diarrhoea, excessive sweating, following a low-salt diet, long-term use of diuretics (diuretics) or dialysis treatment); – if you are going to be treated to reduce an allergic reaction to bee or wasp stings (desensitization); – if you are scheduled for anesthesia, which may be necessary for surgery or any dental procedures. You may need to stop taking Amprilan® ND the day before your scheduled intervention. Consult with your doctor! – if you have an elevated level 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 sodium levels in your blood, especially if you are an older person; – if you are taking drugs called mTOR inhibitors (eg temsirolimus, everolimus, sirolimus) or vildagliptin, as these may increase your risk of angioedema, a severe allergic reaction; – if you experience vision loss or eye pain, especially if you are at risk of developing glaucoma or are allergic to medicines containing penicillin or sulfonamides; – 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 – for example, valsartan, telmisartan, irbesartan), in particular if you have kidney disease associated with 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 “Do not take Amprilan® ND”. – The active ingredient hydrochlorothiazide may cause an unusual reaction resulting in reduced visual acuity and eye pain. These may be symptoms of increased pressure in the eyes, which can occur within hours or weeks after taking Amprilan® ND. Without treatment, this condition can lead to visual impairment. You must tell your doctor if you think you are pregnant (or if you are likely to 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 section “Pregnancy and breast-feeding”). Children and adolescents 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 applies to you (or you are not sure), check with your doctor before taking Amprilan® ND. Other medicines and Amprilan® ND Tell your doctor if you are taking, have recently taken or may have taken any other medicines, including OTC (including herbal preparations), as Amprilan® ND may affect the effect of some other medicines, and others drugs may affect the effect of Amprilan® ND. Tell your doctor if you are taking any of the following medicines. They can worsen the effect of Amprilan® ND: – drugs used to relieve pain and reduce inflammation (eg non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin). – drugs to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, norepinephrine or epinephrine. Your doctor will monitor your blood pressure. Tell your doctor if you are taking any of the following medicines. They may increase the likelihood of adverse reactions when combined 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 the level of potassium in the blood. These include drugs for constipation, diuretics, amphotericin B (used to treat fungal infections) and ACTH (used to test the effectiveness of adrenal function); – anticancer drugs (chemotherapy); – medicines for the treatment of cardiac dysfunction, including heart rhythm disturbances; – drugs that prevent organ rejection after transplantation, such as cyclosporine; – diuretics, such as furosemide; – drugs that increase the level of potassium 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 compensate for the lack of calcium; – allopurinol (used to lower the level of uric acid in the blood); – procainamide (for the treatment of heart rhythm disturbances); – cholestyramine (to reduce the amount of lipids in the blood); – carbamazepine (to treat epilepsy); – trimethoprim and co-trimoxazole (to treat infections caused by bacteria); – mTOR inhibitors (eg temsirolimus, everolimus, sirolimus) or vildagliptin (to treat diabetes), as they may increase the risk of angioedema, a severe allergic reaction. Tell your doctor if you are taking any of the following medicines. Amprilan® ND may affect the effectiveness of these drugs: – drugs for the treatment of diabetes, lowering blood sugar levels, intended for oral administration, and insulin. Amprilan® ND may lower blood sugar levels. Check your blood sugar regularly while taking Amprilan® ND; – lithium (for the treatment of psychiatric diseases). Amprilan® ND may increase the level of lithium in the blood. The attending physician should regularly determine the level of lithium in the blood; – medicines to relax the muscles; – quinine (to treat malaria); – medicines containing iodine (can be used for X-ray studies and other imaging methods in a hospital); – penicillin (to treat infections); – Oral blood thinners (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 information under the headings “Do not take Amprilan® ND” and “Special instructions and precautions”). If any of the above applies to you (or you are not sure), check with your doctor before taking Amprilan® ND. Test results Talk to your doctor before taking this medicine: – If you are scheduled to have a parathyroid test. Amprilan® ND may affect test results. – If you are an athlete and are planning to take an anti-doping test. Amprilan® ND may give a false positive result. Amprilan® ND with food, drink and alcohol Drinking alcohol together with Amprilan® ND may cause dizziness or mental confusion. If you are not sure how much alcohol you can drink while you are taking Amprilan® ND, talk to your doctor about this. drugs used to lower blood pressure and alcohol may enhance each other’s effects. – Amprilan® ND can be taken with or without food. Pregnancy and breastfeedingIf you are pregnant or breastfeeding, think you are pregnant or have the possibility of pregnancy. The use of the drug 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 fetal developmental disorders. If you become pregnant while being treated with Amprilan® ND, tell your doctor immediately. When a planned pregnancy is recommended to choose alternative methods of treatment. You should not take Amprilan® ND while breastfeeding. Consult with your doctor before taking any medications. Driving and operating machinery Do not drive or operate machinery until you have determined how Amprilan® ND affects you. You may feel dizzy while taking Amprilan® ND. The occurrence of this effect is most likely at the beginning of treatment or when the dose is increased. If this occurs, do not drive or operate machinery. Important information about some of the ingredients Amprilan® ND contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Use of the drugAlways take Amprilan® ND exactly as directed by your doctor. Check with your doctor if you are unsure. How to 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 to take Treatment of high blood pressure Your doctor may adjust the dose of the drug to achieve the appropriate pressure. Elderly Patients The doctor will start treatment at the lowest dose and will gradually adjust your treatment. If you have taken Amprilan® ND more than you should Tell your doctor immediately or go to the nearest emergency room. Do not drive, ask to be driven or call an ambulance. Take the package of the drug with you so that the doctor knows exactly what you have taken. If you forget to take Amprilan® ND Do not take a double dose to make up for the missed one. If you forget to take your medicine at the correct time, follow your regular dosing schedule by taking your next dose at the scheduled time. If you have any further questions on the use of this drug, ask your doctor. Possible side effects Like all medicines, Amprilan® ND can cause side effects, although not everyone gets them. Stop taking Amprilan® ND and contact your doctor immediately if you notice any of the following serious side effects: you may need urgent medical attention: – swelling of the face, lips or throat that makes swallowing or breathing difficult, 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 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 (such as bleeding gums), purple spots on the skin that develop more often than usual, infections, sore throat, fever, tiredness, weakness, dizziness or pale skin. These may be signs of impaired hematopoiesis or bone marrow function; – Severe pain in the stomach, 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 damage to the liver. Other side effects Please tell your doctor if any of the following become severe or last more than a few days. Common (may affect up to 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 with an increase in the dose of Amprilan® ND; – dry irritating cough or bronchitis; – A blood test shows an increase in the amount of sugar in the blood. If you have diabetes, it may get worse; – a blood test shows an increase in the level of uric acid or lipids in your blood; Painful, reddened or swollen joints. Uncommon (may affect up to 1 in 100 people): – skin rashes that are raised or not raised 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 goosebumps on the skin (paresthesia); – loss or change in taste sensations; – sleep disturbance; – a state of depression, anxiety, feeling unusually nervous or anxious; – nasal congestion, inflammation of the sinuses (sinusitis), shortness of breath; – inflammation of the gums (gingivitis), swelling of the mouth; – redness, itching, swelling or tearing of the eyes; – ringing in the ears; – blurred vision; – hair loss; – chest pain; – muscle pain; – constipation, pain in the stomach or intestines; – indigestion or nausea; – increased fluid intake and increased frequency of urination during the day; – increased sweating or feeling thirsty; – loss or decrease in appetite (anorexia), reduced feeling of hunger; – fast or irregular heartbeat; – swelling of the hands and feet. This may be a sign of fluid retention in the body; – fever; – violation of sexual function 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 that show a decrease in the level of potassium in the blood. Very rare (may affect up to 1 in 10,000 people): – nausea, incipient diarrhea or heartburn; – reddened swollen tongue or dry mouth; – blood tests that show an increase in the level of potassium in the blood. Frequency not known (frequency cannot be estimated from the available data): – concentrated urine (dark color), tenderness or soreness, muscle cramps, confusion and convulsions, 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 get severe or last more than a few days. – impaired concentration, a feeling of anxiety or confusion; – fingers and toes change color when cold, tingling or sore when warmed. It could be Raynaud’s syndrome; – an increase in the mammary glands in men; – thickening of the blood; – hearing impairment; – dry eyes; – visual perception of objects in yellow color; – deterioration of vision and pain in the eyes (possible signs of acute myopia or angle-closure glaucoma); – dehydration; – swelling, pain and redness in the neck (inflammation of the salivary gland); – swelling in the intestines, called “angioneurotic edema of the intestines”, with symptoms such as abdominal pain, vomiting and diarrhea; – increased photosensitivity; – severe skin peeling, itching, pustular rash or other skin reactions such as a red rash on the skin of the face or forehead; – skin rashes or hemorrhages; – spots on the skin and cold extremities; – changes in the nails (for example, softening or detachment of the nail); – musculoskeletal stiffness or inability to move the jaw (tetany); – muscle weakness or cramps; – decreased sexual libido in men or women; – blood in the urine. This may be a sign of kidney disease (interstitial nephritis); – increased sugar levels in the urine; – an increase in the level of certain white blood cells (eosinophilia) found 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 down or impaired reactions; – change in sense of smell; – Difficulty breathing or exacerbation of asthma. – severe eye pain, blurred or haloed vision, headache, increased tearing, nausea and vomiting, which may indicate a condition called glaucoma. Reporting Adverse Reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in this package insert. By reporting adverse reactions, you help to get 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 expiry date which is stated on the package. The expiry date is the last day of the month. Do not dispose of the drug in the water supply or sewerage. Ask your pharmacist how to dispose of drugs you no longer need. These measures will help protect the environment. Composition Active ingredients: 1 tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide. Auxiliary ingredients: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, pregelatinized starch, sodium stearyl fumarate. The appearance of the drug and the contents of the package Flat, 5.0 x 10.0 mm, capsule-shaped, with beveled edges, white or almost 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 leaflet in a cardboard box. 10 tablets in a blister (OPA/A1/PVC film and aluminum foil). 3 blisters with a leaflet in a cardboard box. Conditions of releaseAccording to a doctor’s prescription. Buy Amprilan ND tablets 5mg/25mg No. 10×3