Lorista ND tablets p/o 100mg/25mg №10×6

NameLorista nd. Release form Film-coated tablets. Dosage 100 mg + 25 mg. Pack quantity: 28 pcs. ManufacturerKrka dd. INN Losartan + hydrochlorothiazide. FTGHypotensive combined agent (angiotensin II receptor blocker + diuretic). What it is and what it is used for Lorista® ND is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to relax, which in turn lowers blood pressure. Hydrochlorothiazide acts on the kidneys, causing them to pass more water and salt. It also helps lower blood pressure. Lorista® ND is intended for the treatment of arterial hypertension (high blood pressure). Do not take this medicine if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (see Composition section); – if you are allergic to other sulfonamide derivatives (eg other thiazides, certain antibacterials such as co-trimoxazole; ask your doctor if you are not sure); – if you are more than 3 months pregnant (it is also better to avoid taking the drug in the early stages of pregnancy – see the Pregnancy section); – if you have severe liver dysfunction; – if you have severe kidney dysfunction or if your kidneys do not produce urine; – if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected with treatment; – if you suffer from gout; – if you have diabetes or impaired kidney function and are being treated with a blood pressure medicine containing aliskiren. Special instructions and precautions Talk to your doctor before taking Lorista® ND. You must tell your doctor if you think you are (or might become) pregnant. Lorista® ND is not recommended in early pregnancy and is contraindicated if the pregnancy is more than 3 months, as the baby may be seriously harmed if the drug is used at this time (see section “Pregnancy”). It is very important to tell your doctor before you start taking Lorista® ND: – if you have previously had swelling of your face, lips, throat or tongue; – if you are taking diuretics (water pills); – if you are on a low salt diet; – if you have had severe vomiting and/or diarrhea; – if you have heart failure; – if you have impaired liver function (see section “Do not take this medicine”); – if you have narrow arteries in your kidneys (renal artery stenosis), have only one functioning kidney, or have recently had a kidney transplant; – if you have narrowing of the arteries (atherosclerosis) or angina pectoris (chest pain due to poor heart function); – if you have “aortic or mitral valve stenosis” (narrowing of the heart valves) or “hypertrophic cardiomyopathy” (a disease that causes thickening of the heart muscle); – if you suffer from diabetes; – if you have gout; – if you have or have had allergic conditions, asthma or a condition that causes joint pain, rash and fever (systemic lupus erythematosus); – if you have high calcium levels or low potassium levels, or are on a diet low in potassium; – if you need anesthesia (even at the dentist) or before surgery, or if tests are planned to check the function of the parathyroid gland, you must tell the doctor that you are taking Lorista® ND tablets; – if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal glands, caused by abnormalities in the gland); – if you are taking any of the following medicines used to treat high blood pressure: – an ACE inhibitor (eg enalapril, lisinopril, ramipril), in particular 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 “Do not take this drug.” Children and adolescents There is no experience with the use of Lorista® ND in children and adolescents. Therefore, the drug should not be given to children and adolescents. Lorista® ND contains lactose and quinoline yellow (E104) If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The dye quinoline yellow can have a negative effect on activity and attention in children. Other drugs Tell your doctor if you are taking, have recently taken or may take any other medicines. Diuretics such as hydrochlorothiazide contained in Lorista ND may interact with other drugs. Lithium-containing products should not be taken with Lorista ND without close medical supervision. It is wise to take special precautions (such as blood tests) if you are taking potassium supplements, potassium-containing salt substitutes or potassium-sparing drugs, other diuretics (“diuretic pills”), certain laxatives, gout medications, heart rate control medications, or treatment of diabetes mellitus (oral drugs or insulin). Your doctor may adjust your dose and/or take other precautions if you are taking ACE inhibitors or aliskiren (see also information under the headings “Do not take this drug” and “Special instructions and precautions”). It is also important to tell your doctor if you are taking: – other drugs to lower blood pressure; – steroids; – drugs for the treatment of cancer; – painkillers; – preparations for the treatment of fungal infections; – drugs for the treatment of arthritis; – resins used to treat high cholesterol, such as cholestyramine; – drugs that relax muscles; – sleeping pills; – opioid drugs such as morphine; – pressor amines such as adrenaline or other drugs from the same group; – oral agents for the treatment of diabetes mellitus or insulin. Please also tell your doctor that you are taking Lorista® ND if you are going to have an x-ray procedure using iodinated contrast agents. Lorista® ND with food and drink It is not recommended to drink alcohol while taking Lorista® ND: alcohol and Lorista® ND may enhance each other’s effects. Dietary salt in excess amounts may counteract the effect of Lorista® ND. Lorista® ND can be taken with or without food. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your healthcare professional before taking this medicine. Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will tell you to stop taking Lorista® ND before you become pregnant, or as soon as you know you are pregnant, and prescribe you another drug. Lorista® ND is not recommended in early pregnancy and should not be taken during pregnancy for more than 3 months, as taking the drug can cause serious harm to the baby. Breastfeeding Tell your healthcare provider if you are breastfeeding or about to start breastfeeding. Lorista® ND is not recommended while breastfeeding and your doctor may choose a different treatment for you if you wish to breastfeed. Driving and operating machines When you start taking Lorista® ND, you should not perform tasks that require special attention (such as driving a car or operating dangerous machinery) until you know how the drug works for you. How to use the drugAlways take Lorista® ND exactly as directed by your doctor. Check with your doctor if you are unsure. Your doctor will decide on the appropriate dose of the drug, depending on your condition and whether you are taking other drugs. It is important to continue taking Lorista® ND at all times as directed by your doctor to maintain smooth control of your blood pressure. High blood pressure The usual dose for most patients with high blood pressure is 1 lorista® H tablet (50 mg losartan/12.5 mg hydrochlorothiazide) per day to control blood pressure over a 24-hour period. The dose can be increased to 2 tablets of Lorista® N (50 mg losartan/12.5 mg hydrochlorothiazide) per day or up to 1 tablet of Lorista® ND (100 mg losartan/25 mg hydrochlorothiazide) per day. The maximum daily dose is 2 tablets Lorista® N (50 mg losartan/12.5 mg hydrochlorothiazide) or 1 tablet Lorista® ND (100 mg losartan/25 mg hydrochlorothiazide). If you take more Lorista® ND than you should In case of an overdose, contact your doctor immediately for medical attention. Overdose can cause low blood pressure, fast or strong heartbeat (palpitations), slow heart rate, changes in blood composition, and dehydration. If you forget to take Lorista® ND Try to take your medicine every day as directed by your doctor. Do not take a double dose to make up for a 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. The use of Lorista® ND in elderly patients works equally well and is tolerated by most elderly and young adult patients. Most older patients require the same dose as younger patients. Possible side effects Like all medicines, Lorista® ND can cause side effects, although not everybody gets them. A severe allergic reaction (rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty in swallowing or breathing) is a serious but rare side effect that may affect up to 1 in 1,000 people. You may need urgent medical attention or hospitalization. The following adverse reactions have been reported: Common (may affect up to 1 in 10 people): – cough, upper respiratory tract infection, nasal congestion, sinusitis; – diarrhea, abdominal pain, nausea, dyspepsia; – muscle pain or cramps, leg pain, back pain; – insomnia, headache, dizziness; – weakness, fatigue, chest pain; – elevated potassium levels (which can cause abnormal heart rhythms), decreased hemoglobin levels; – changes in kidney function, including renal failure; Too low blood sugar (hypoglycemia). Uncommon (may affect up to 1 in 100 people): – anemia, red or brownish patches on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the arms and legs and stomach pain), bruising , a decrease in the level of leukocytes, a violation of blood clotting, a decrease in the number of platelets; – loss of appetite, increased uric acid levels or aggravation of gout, increased blood sugar levels, abnormal levels of electrolytes in the blood; – anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment; – a feeling of goosebumps or tingling, pain in the limbs, trembling, migraine, fainting; blurred vision, burning eyes, conjunctivitis, blurred vision, seeing things in yellow; – ringing, buzzing, roaring or clicking in the ears, vertigo; – low blood pressure, which may be due to a change in position (feeling dizzy or weak when standing up), chest pain (angina pectoris), abnormal heartbeat, cerebrovascular events (transient mini-stroke), heart attack, fast or strong heartbeat (palpitations ); – inflammation of the blood vessels, which is often associated with a skin rash or bruising; – sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty in breathing), nosebleeds, runny nose, nasal congestion; – constipation, flatulence, indigestion, stomach cramps, vomiting, dry mouth, inflammation of the salivary gland, toothache; – jaundice (yellowing of the eyes and skin), inflammation of the pancreas; – urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, redness, sweating, hair loss; – pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness; – frequent urination, including at night, abnormal kidney function, including inflammation of the kidneys, urinary tract infection, sugar in the urine; – decreased sexual desire, impotence; – swelling of the face, localized swelling (edema), fever. Rare (may affect up to 1 in 1,000 people): Inflammation of the liver (hepatitis), abnormal liver function test results. Frequency unknown (frequency cannot be determined from the available data) – influenza symptoms; – unexplained muscle pain accompanied by dark urine (rhabdomyolysis); – low sodium levels in the blood (hyponatremia); – general poor health (malaise); – Taste disorder (dysgeusia). 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 drugDoes not require special storage conditions. Keep out of the reach of children. Shelf life 5 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 1 film-coated tablet contains: Active ingredients: 100 mg of losartan potassium and 25 mg of hydrochlorothiazide Auxiliary ingredients: pregelatinized starch, microcrystalline cellulose, lactose monohydrate, magnesium stearate, hypromellose, macrogol 4000, quinoline yellow dye (E104), titanium dioxide ( E171), talc. Appearance of the drug and contents of the package Yellow, oval, slightly biconvex film-coated tablets. 7 tablets in a blister (PVC/PVDC film and aluminum foil). 4 blisters with a leaflet in a cardboard box. 14 tablets in a blister (PVC/PVDC film and aluminum foil). 2 or 4 blisters with a leaflet in a cardboard box. 10 tablets in a blister (PVC/PVDC film and aluminum foil). 3 or 6 blisters with leaflet in a cardboard box. Conditions of release By prescription. Buy Lorista ND tablets p/o 100mg/25mg No. 10×6