Valsakor n 80 tablets p/o 80mg/12.5mg №15×2

Name Valsakor n 80. Release form Tablets. INN Valsartan + hydrochlorothiazide. FTGHypotensive combined agent (angiotensin II receptor blocker + diuretic). What it is and what it is used for Valsacor® N 80 film-coated tablets contain two active substances, valsartan and hydrochlorothiazide. These two substances help control high blood pressure (BP). – Valsartan belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance in your body that increases vascular tone, thereby causing an increase in blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases. – Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as diuretics). Hydrochlorothiazide increases urine output, which also lowers blood pressure. Valsacor® H 80 is indicated for the treatment of hypertension in patients whose blood pressure is not controlled by valsartan or hydrochlorothiazide monotherapy. High blood pressure (BP) puts more stress on the heart and arteries. Left untreated, damage to blood vessels in the brain, heart, and kidneys can result, as well as stroke, heart failure, or kidney failure. High blood pressure increases the risk of myocardial infarction. Lowering blood pressure generally reduces the risk of developing these diseases. Do not take this medicine if you are allergic to valsartan, hydrochlorothiazide, other sulfonamides (substances chemically similar to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in the Composition section); – if your pregnancy is more than 3 months old (it is recommended to avoid the use of Valsacor® H 80 in the early stages of pregnancy, see section “Pregnancy”); – if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis), leading to a buildup of bile in the liver (cholestasis); – if you have severe kidney disease; – if you do not pass urine (anuria); – if you are on hemodialysis; – if you have low levels of potassium or sodium in your blood, or if you have high calcium levels that cannot be corrected by 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. If any of the above apply to you, do not take Valsacor® H 80 and talk to your doctor. Special instructions and precautions Before taking the drug Valsacor® H 80, consult your doctor: – if you are taking medicines that increase the level of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs, and heparin. It may be necessary to check the amount of potassium in the blood at regular intervals; – if you have low levels of potassium in your blood; – if you have diarrhea or severe vomiting; – if you are taking high doses of diuretics (diuretic tablets); – if you have heart failure; – if you have a narrowing of the renal artery; – if you have recently undergone a kidney transplant (received a new kidney); – if you suffer from hyperaldosteronism. This is a disease in which the adrenal glands produce too much of the hormone aldosterone. If this applies to you, the use of Valsacor® H 80 is not recommended; – if you have kidney or liver disease; – if you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema while taking medicines (including ACE inhibitors), tell your doctor. If these symptoms occur while taking Valsacor N® 80, stop taking Valsacor N® 80 immediately and never take it again. See section “Possible adverse reactions”. – if you have a fever, rash and joint pain, which may be signs of systemic lupus erythematosus (an autoimmune disease also called SLE). – if you have diabetes, gout, high cholesterol or triglycerides in the blood; – if you have ever had an allergic reaction to other blood pressure lowering medicines of this class (including ACE inhibitors), or if you have allergies or asthma; – if you experience decreased vision or pain in your eyes. These may be signs of increased intraocular pressure and may occur within a few hours or weeks after taking Valsacor® H 80. If left untreated, this can lead to permanent loss of vision. If you have previously had an allergy to penicillin or a sulfonamide, your risk of developing this disease may be higher; – because taking this medicine may make the skin more sensitive to sunlight; – if you have had skin cancer or suddenly develop a skin lesion during treatment. The use of hydrochlorothiazide, especially long-term use of high doses, may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer). If you are taking Valsacor® H 80, you must protect your skin from exposure to sunlight and ultraviolet rays. – if you are taking any of the following medicines used to treat hypertension: – an ACE inhibitor (eg enalapril, lisinopril, ramipril), in particular if you have kidney disease associated with diabetes; – aliskiren. If any of the above apply to you, tell your doctor. During the treatment period, the attending physician may check kidney function, measure blood pressure and the level of electrolytes (including potassium) in the blood at regular intervals. See also the information under the heading “Do not take Valsacor® N 80”. You must tell your doctor if you think you are (or are planning to become) pregnant. Valsacor® N 80 is not recommended in early pregnancy, and is contraindicated in pregnancy over 3 months, as the drug can cause serious harm to the baby when taken at this stage of pregnancy (see section “Pregnancy and breastfeeding”). Children and adolescents The use of Valsacor® H 80 in children and adolescents (under 18 years of age) is not recommended. Valsacor® H 80 contains lactose If you have an intolerance to some sugars, tell your doctor before taking this medicine. Other drugs Tell your doctor if you are taking, have recently taken or may start taking any other medicines. The effect of the treatment may be changed when Valsacor® H 80 is taken together with certain other drugs. It may be necessary to change the dose, take special precautions, or, in some cases, stop taking one of the drugs. This applies to the following medicines: – lithium, a drug used to treat certain types of mental illness; – medicines or substances that increase the level of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs, and heparin; – medicines that can lower the level of potassium in your blood. These include diuretics (water pills), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G; – drugs that can cause ventricular arrhythmia “torsades de pointes” (irregular heartbeat). These include antiarrhythmic drugs (medicines used to treat heart problems) and some antipsychotics. – medicines that can lower blood sodium levels, such as antidepressants, antipsychotics, antiepileptics; – drugs for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone; – supplements containing vitamin D and calcium; – medicines for the treatment of diabetes (insulins and oral preparations such as metformin); – other drugs that reduce blood pressure, including methyldopa; – medicines that increase blood pressure, such as epinephrine or noradrenaline; – digoxin or other digitalis glycosides (medicines used to treat heart problems); – medicines that can raise blood sugar levels, such as diazoxide or beta-blockers; – cytotoxic drugs (used to treat cancer, such as methotrexate or cyclophosphamide); – pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX2) blockers and acetylsalicylic acid > 3 g; – medicines that relax the muscles, such as tubocurarine; – anticholinergic drugs (drugs used to treat various conditions such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease and as an aid to anesthesia); – amantadine (a medicine used to treat Parkinson’s disease and to treat or prevent certain diseases caused by viruses); – cholestyramine and colestipol (medicines used primarily to treat elevated blood lipids); – cyclosporine, a medicine used in organ transplants to protect against transplant rejection; – alcohol, sleeping pills and anesthetics (drugs with hypnotic or analgesic effect, used, for example, during surgery); – iodine-containing contrast agents (drugs used for contrast studies; – ACE inhibitors or aliskiren (see also information under the headings “Do not take the drug” and “Special instructions and precautions.” Valsacor® N 80 with food, drink and alcohol Valsacor® N 80 can be taken with or without food.Avoid alcohol until you have talked to your doctor.Alcohol may cause a decrease in blood pressure and/or increase your risk of dizziness or weakness.Pregnancy and breastfeedingIf you are pregnant or breastfeeding, think you are pregnant, or plan to become pregnant, before using the drug, consult your doctor – You must tell your doctor if you think you are pregnant (or plan to become pregnant) Your doctor will advise you to stop taking Valsacor® H 80 if you are planning a pregnancy, or as soon as you know about pregnancy and suggest other treatment Valsacor® H 80 is not recommended n 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. – Tell your doctor if you are breastfeeding or planning to breastfeed. Valsacor® H 80 is not recommended for mothers who are breastfeeding and your healthcare provider may choose a different treatment if you wish to continue breastfeeding, especially if your baby is new or born prematurely. Driving and using machines Before you start driving or operating machines that require concentration, you should know exactly how Valsacor® N 80 affects you. When taking Valsacor® H 80, as with other drugs that reduce blood pressure, in rare cases, dizziness or an effect on concentration may occur. Using the drug Always take the drug in full accordance with the recommendations of your doctor. This will help you get better treatment results and reduce the risk of side effects. You should consult your doctor if you are not sure. People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This highlights the importance of seeing a doctor, even if you feel well. Your doctor will tell you exactly how many Valsacor® H 80 tablets you need to take. Your doctor may increase or decrease the dose of the drug depending on your response to treatment. – The usual dose of Valsacor® H 80 is one tablet per day. – Do not change your dose or stop taking your tablets without consulting your doctor. – Take the drug regularly, preferably in the morning, at the same time every day. – You can take Valsacor® H 80 tablets with food or on an empty stomach. – Take the tablet with a glass of water. If you have taken more Valsacor® H 80 than you should. If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately. If you accidentally take too many tablets, contact your doctor or hospital immediately. If you forget to take Valsacor® H 80 Do not take a double dose to make up for the missed one. If you forget to take a dose, take it as soon as you remember. However, if this time is close to your next dose, skip the forgotten dose. If you stop taking Valsacor® N 80 Stopping treatment with Valsacor® N 80 may make your condition worse. Do not stop taking the drug without consulting your doctor. If you have any further questions on the use of this drug, ask your doctor. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Some symptoms require immediate medical attention: You should contact your doctor immediately if you experience symptoms of angioedema: – swelling of the face, tongue or throat – difficulty swallowing or breathing – hives. If you experience any of these symptoms, stop taking Valsacor® and contact your doctor immediately (see also section 2 “Special instructions and precautions”). Other side effects include: Uncommon (may affect up to 1 in 100 people): – Cough – Low blood pressure – Dehydration (thirst, dry mouth, infrequent urination, dark urine, dry skin) – muscle pain , – fatigue, – tingling or numbness, – blurred vision, – tinnitus (eg, hissing, buzzing). Very rare (may affect up to 1 in 10,000 people): – Dizziness, – Diarrhea, – Joint pain. Frequency not known (frequency cannot be estimated from the available data): – Difficulty breathing – Decrease in urine volume – Low blood sodium levels (which can cause fatigue, confusion, and in severe cases, muscle twitching and/or convulsions). – Increased levels of potassium in the blood (which can cause muscle weakness, muscle spasms and abnormal heart rhythms), – Low levels of white blood cells in the blood (with symptoms of fever, sore throat or mouth ulcers due to infection, weakness). – Elevated blood bilirubin (which in severe cases can cause yellowing of the skin and eyes), – Elevated blood urea and creatinine (which can indicate impaired kidney function), – Elevated blood uric acid (which in severe cases can cause gout), – Fainting (loss of consciousness). The following is the frequency of side effects reported for valsartan or hydrochlorothiazide alone: Valsartan Uncommon (may affect up to 100 people) – Dizziness, – Abdominal pain. Frequency unknown (frequency cannot be estimated from the available data): Skin rash with or without itching with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms, red spots, fever, itching (signs of inflammation of the blood vessels), – low blood platelets (sometimes with unusual bleeding or bruising), – increased blood potassium levels (which can, in rare cases, cause muscle spasms and heart rhythm disturbances), – Allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness), – Edema, mainly of the face and throat, rash, itching; – Increased liver enzymes – Decreased hemoglobin and red blood cell count (which leads to anemia in severe cases) – Kidney failure – Decreased sodium levels in the blood (which can cause fatigue and confusion, and in severe cases cases of muscle twitching and/or convulsions). Hydrochlorothiazide Very common (may affect more than 1 in 10 people): – Low blood potassium, – Elevated blood lipids. Common (may affect up to 1 in 10 people) – Low blood sodium – Low blood magnesium – High blood uric acid – Itchy rash and other rashes – Decreased appetite – Mild nausea and vomiting, – Fainting when standing up, – Inability to achieve or maintain an erection. Rare (may affect up to 1 in 1,000 people): – Swelling and blistering of the skin (due to increased skin sensitivity to the sun), – Increased blood calcium levels, – Increased blood glucose levels; – The appearance of sugar in the urine, – Worsening of metabolic disorders in patients with diabetes mellitus, – Constipation, diarrhea, discomfort in the stomach or intestines, liver disease, which can cause yellowing of the skin and eyes; – Heart rhythm disturbances – Headache – Sleep disturbances – Depressed mood – Low platelets (sometimes with bleeding or bruising) – Dizziness – Tingling or numbness – Blurred vision. Very rare (may affect up to 1 in 10,000 people): – Inflammation of blood vessels with symptoms such as rash, purplish red spots, fever (vasculitis), – Rash, itching, hives, difficulty breathing or swallowing, dizziness (reactions hypersensitivity), – Severe skin diseases that are accompanied by a rash, redness and peeling of the skin, blistering of the lips, eyes or mouth, fever (toxic epidermal necrolysis), – Rash on the face, joint pain, muscle damage, fever (red lupus), – Severe pain in the stomach (pancreatitis), – Difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory failure, including pneumonitis and pulmonary edema), – Fever, sore throat, frequent infections (agranulocytosis), – Pale skin, tiredness, shortness of breath, dark urine (hemolytic anemia), – Fever, sore throat or mouth ulcers due to infection (leukopenia), – Confusion, tiredness, muscle twitching and spasms, rapid breathing (hypochloremic alkalosis). Frequency unknown (frequency cannot be estimated from the available data): – Cancer of the skin and lips (non-melanoma skin cancer); – Weakness, bruising, frequent infections (aplastic anemia), – Decrease in urine volume (possible signs of kidney damage or kidney failure), – Decreased visual acuity or eye pain due to high pressure (possible signs of acute angle-closure glaucoma), – Rash , redness of the skin, blisters on the lips, eyes or mouth, peeling of the skin, fever (possible signs of erythema multiforme), – Muscle spasms, – Fever (hyperthermia), – Weakness (asthenia). 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. Store in original packaging to protect from light and moisture. 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. Active ingredient: 1 film-coated tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide. Excipients: lactose monohydrate, microcrystalline cellulose, povidone K 25, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose 2910, titanium dioxide, E 171, iron oxide yellow, E 172, iron oxide red, E 172, macrogol 4000. Appearance of the drug and the contents of the packageOval, biconvex tablets, film-coated pink. 14 film-coated tablets in a PVC/PE/PVDC blister with aluminum foil. 1,2, blister with leaflet in a cardboard box. 15 film-coated tablets in a PVC/PE/PVDC blister with aluminum foil. 2.4 blisters with leaflet in a cardboard box. Conditions of releaseBy prescription. Buy Valsacor n 80 tablets p/o 80mg/12.5mg No. 15×2 5mg №15×2