Valsacor tablets p/o 80mg №15×2

Name Walsacor. Release form Film-coated tablets. Dosage 160 mg. Pack quantity: 30 pcs. ManufacturerKrka dd. INN Valsartan. FTG angiotensin II receptor antagonist. What it is and what it is used for Valsacor® belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure (BP). Angiotensin II is a substance in your body that increases vascular tone, thereby causing an increase in blood pressure. Valsacor® works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases. Valsacor® film-coated tablets 80 mg and 160 mg can be used for three different indications: Treatment of high blood pressure in adults and children aged 6 to 18 years High blood pressure (BP) increases the workload on the heart and arteries. Left untreated, this can lead to damage to blood vessels in the brain, heart, and kidneys, 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. Treatment of adult patients after a recent heart attack (myocardial infarction) “Recently suffered” in this case means a period of 12 hours to 10 days. Treatment of symptomatic heart failure in adult patients Valsacor® can be used to treat symptomatic heart failure in adult patients. Valsacor® is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines for treating heart failure) cannot be used or the drug can be used in addition to ACE inhibitors when other medicines for treating heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid retention. This occurs when the heart muscle cannot pump enough blood to keep blood moving throughout the body. Do not take this medicine if you are allergic to valsartan or any of the other ingredients of this medicine (listed in the Composition section); – if you have severe liver disease; – if you are more than 3 months pregnant (it is recommended to avoid taking Valsacor® in early pregnancy, see Pregnancy section); – concomitant use of Valsacor® and drugs that reduce blood pressure and contain aliskiren is contraindicated if you have diabetes mellitus or kidney failure. If any of the above apply to you, do not take Valsacor® Special instructions and precautions Talk to your doctor before taking Valsacor®: – if you have liver disease; – if you have a serious kidney disease or are on dialysis; – if you have a narrowing of the renal artery; – if you have recently undergone a kidney transplant (received a new kidney); – if you are being treated after a myocardial infarction or heart failure. Your doctor may test kidney function; – if you have any other serious heart disease other than heart failure or myocardial infarction; – if you have ever had swelling of the tongue and face caused by an allergic reaction called angioedema while taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur while taking Valsacor®, stop taking it immediately and never start again. See also the section “Possible adverse reactions); – if you are taking medicines that increase the level of potassium in your 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 are under 18 years of age and are taking Valsacor® in combination with other drugs that inhibit the renin-angiotensin-aldosterone system (drugs that lower blood pressure). Your doctor may check kidney function and blood potassium levels at regular intervals; – if you suffer from aldosteronism. (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® is not recommended; – if you have lost a lot of fluids (dehydration) due to diarrhea, vomiting or high doses of a diuretic (diuretic tablets); – 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 you are taking ACE inhibitors with certain other heart failure medicines that are mineralocorticoid receptor (AMP) antagonists (eg spironolactone, eplerenone) or beta-blockers (eg metoprolol). During treatment, the attending physician may check kidney function, measure blood pressure and electrolyte levels (including potassium) in the blood at regular intervals. See also the information under the heading “Do not take this drug.” You must tell your doctor if you think you are (or are planning to become) pregnant. Valsakor® is not recommended in early pregnancy, and is contraindicated for more than 3 months of pregnancy, because. the drug can cause serious harm to the baby if taken at this stage of pregnancy (see section “Pregnancy and breast-feeding”). If any of the above apply to you, tell your doctor before you start taking Valsacor®. Valsacor 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® is taken in conjunction with certain other drugs. It may be necessary to change the dose, take special precautions, or, in some cases, stop taking one of the medicines. This applies to both prescription and over-the-counter drugs, especially: – other drugs that lower blood pressure, especially diuretics (water pills); – drugs that increase the level of potassium in the blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing drugs, and heparin; – a specific group of pain medications called non-steroidal anti-inflammatory drugs (NSAIDs); – some antibiotics (rifamycin group), drugs used to protect against transplant rejection (cyclosporine) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may enhance the effect of Valsacor®; – lithium, a drug used to treat certain types of mental illness; – ACE inhibitors or aliskiren (see also information under the headings “Do not take this drug” and “Special instructions and precautions”. Additionally: – if you are taking treatment after a myocardial infarction, the combination with ACE inhibitors (drugs to treat heart attack) is not recommended – if you are taking treatment after a myocardial infarction, a triple combination with ACE inhibitors and other drugs for the treatment of myocardial infarction known to be mineralocorticoid receptor (AMP) antagonists (eg spironolactone, eplerenone) or beta-blockers (eg metoprolol). Valsacor® with food, drink and alcoholValsacor® can be taken with or without food.Pregnancy and breast-feedingIf you are pregnant or breastfeeding, think you may become pregnant, or are planning to become pregnant, consult your doctor before using this medicine. if you think you are pregnant (or are planning to become pregnant), your doctor will advise stop taking Valsacor® immediately if you are planning a pregnancy, or as soon as you know you are pregnant, and suggest other treatment. Valsakor® is not recommended during the first trimester and is contraindicated in the second and third trimester of pregnancy, because taking Valsacor during this period can cause serious harm to your child. – Tell your doctor if you are breastfeeding or planning to breastfeed. Valsacor® is not recommended for mothers who are breastfeeding, and your doctor may choose a different type of treatment if you want to continue breastfeeding, especially if your baby was just born or was born prematurely. Driving vehicles and working with mechanisms Before you start driving vehicles or working with mechanisms that require concentration of attention, you should know exactly how Valskor® affects you. When taking Valsacor®, as with other drugs that lower 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. Adult patients with high blood pressure The recommended dose of valsartan is 80 mg per day. In some cases, the doctor may increase the dose (for example, to 160 mg or 320 mg) and prescribe a combination of Valsacor® with other drugs (for example, diuretics). Children and adolescents (aged 6-18 years) with high blood pressure The usual dose for patients weighing up to 35 kg is 40 mg of valsartan once a day. The usual starting dose for patients weighing 35 kg or more is 80 mg of valsartan once daily. In some cases, the doctor may increase the dose (for example, up to 160 mg or up to a maximum of 320 mg). Adult patients after a recent heart attack Treatment is usually started no later than 12 hours after a heart attack, usually with the lowest dose of 20 mg twice a day. The 20 mg dose is provided by dividing the tablet with a 40 mg dosage. Your doctor will increase this dose gradually over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on individual tolerance. Valsacor® may be used in conjunction with other drugs to treat a heart attack. Your doctor will prescribe the appropriate treatment for you. Adult patients with heart failure Treatment usually begins with 40 mg twice daily. Your doctor will increase this dose gradually over several weeks to a maximum dose of 160 mg twice daily. The final dose depends on individual tolerance. Valsacor® can be used in conjunction with other drugs for the treatment of heart failure. Your doctor will prescribe the appropriate treatment for you. Valsacor® can be taken with or without food. Swallow Valsacor® tablets with a glass of water. Take Valsacor® at about the same time each day. If you have taken more Valsacor® 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® 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® Stopping treatment with Valsacor® 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: – Symptoms of angioedema (specific allergic reaction) such as swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, hives, itching. If you experience any of these symptoms, stop taking Valsacor® and contact your doctor immediately (see also section “Special Instructions and Precautions”). Other side effects include: Common (may affect up to 1 in 10 people): – Dizziness – Low blood pressure with or without symptoms such as dizziness and fainting when standing up – Decreased kidney function (a sign of kidney failure). Uncommon (may affect up to 1 in 100 people): – Angioedema (see section “Some symptoms require immediate medical attention”) – Sudden loss of consciousness (syncope) – Feeling of spinning (vertigo) – Severe decrease in kidney function (a sign of acute renal failure), – Muscle spasms, abnormal heart rhythm (signs of hyperkalemia), – Shortness of breath, difficulty breathing when lying down, swelling of the feet and legs (signs of heart failure), – Headache, – Cough, – Abdominal pain, – Nausea, – Diarrhea, – Fatigue, – Weakness. Frequency unknown (frequency cannot be estimated from the available data): – Allergic reactions with rash, itching and urticaria; fever symptoms, joint swelling and pain in the joints, muscle pain, swollen lymph nodes and/or flu-like symptoms (serum sickness symptoms), – purplish red spots, fever, itching (signs of an inflammation of the blood vessels called vasculitis), – Unusual bleeding or bruising (signs of thrombocytopenia), – Muscle pain (myalgia), – Fever, sore throat, or mouth ulcers due to infection (symptoms of low levels of white blood cells called neutropenia), – Decreased hemoglobin levels and reduced proportion of red blood cells in the blood (which leads to anemia in severe cases), – Increased levels of potassium in the blood (which can, in rare cases, cause muscle spasms and heart rhythm disturbances), – Increased levels of liver enzymes (which may indicate liver damage), including an increase in blood bilirubin (which can cause yellowing of the skin and eyes in severe cases), – an increase in blood urea and an increase in serum creatinine edema (which may indicate impaired kidney function), – Decreased sodium levels in the blood (which can cause fatigue and confusion, and in severe cases, muscle twitching and/or convulsions). The frequency of some side effects may vary depending on your condition. For example, side effects such as dizziness and decreased kidney function were observed less frequently in patients treated for hypertension than in patients treated for heart failure or after a recent myocardial infarction. Side effects in children and adolescents are similar to those seen in adults. 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 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. Composition Active ingredient: 1 film-coated tablet contains 80 mg or 160 mg of valsartan. Excipients: lactose monohydrate, microcrystalline cellulose, povidone K 25, sodium croscarmellose, colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose 6cp, titanium dioxide (E 171), iron oxide red (E 172), macrogol 4000. Film-coated tablets , 160 mg additionally contain iron oxide yellow (E 172). Appearance of the preparation and contents of the package Film-coated tablets 80 mg tablets: round, biconvex tablets with beveled edges, scored on one side, pink film-coated. The risk is designed to divide the tablet into two equal parts. Tablets 160 mg: oval, biconvex tablets with a score on one side, brownish-yellow film-coated. The risk is designed to divide the tablet into two equal parts. 7 film-coated tablets in a blister pack ((PVC/PE/PVDC)/aluminum foil). 2 or 4 blisters with leaflet in a cardboard box. 10 film-coated tablets in a blister pack ((PVC/PE/PVDC)/aluminum foil). 3 blisters with leaflet in a cardboard box. 14 film-coated tablets in a blister pack ((PVC/PE/PVDC)/aluminum foil). 1 or 2 blisters with leaflet in a cardboard box. 15 film-coated tablets in a blister pack ((PVC/PE/PVDC)/aluminum foil). 2 or 4 blisters with leaflet in a cardboard box. Conditions of release By prescription. Buy Valsacor tablets p/o 80mg No. 15×2