Amlessa tablets 8mg/5mg №10×3

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Amlessa tab. 8mg/5mg in a blister. in pack. No. 10×3
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Tablets 4 mg / 5 mg: round, slightly biconvex tablets of white or almost white color with beveled edges. Tablets 4 mg / 10 mg: capsular, biconvex tablets of white or almost white color with a notch on one side. The notch is not intended to divide the tablet into equal parts, while it can be used to break the tablet in order to facilitate its swallowing. Tablets 8 mg / 5 mg: round, biconvex tablets of white or almost white color with bevelled edges. Tablets 8 mg / 10 mg: round, biconvex tablets of white or almost white color with bevelled edges and a notch on one side. The tablet can be divided into equal parts. Excipients: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, calcium chloride hexahydrate, sodium bicarbonate, anhydrous colloidal silicon dioxide, magnesium stearate. The main active ingredient Amlodipine + perindopril Release form: 10 tablets in a blister (OPA/aluminum/PVC//aluminum foil). blister with leaflet in a cardboard box. Dosage Always follow your doctor’s instructions when taking Amlessa. If you doubt the correctness of the reception, consult your doctor. Your doctor will prescribe the appropriate dose for you. The usual dose is 1 tablet per day. Special instructionsConsult your doctor before you start taking Amlessa: – if you suffer from hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies blood to the kidneys), – if you suffer from other heart diseases, – if you have impaired liver function, – if you have impaired kidney function or if you are undergoing dialysis, – if you suffer from collagenosis (a systemic connective tissue disease) such as systemic lupus erythematosus or scleroderma, – if you have diabetes. – if you are on a low-salt diet or are taking salt substitutes containing potassium (it is very important that your blood potassium levels are balanced) – if you are taking any of the following medicines, your risk of angioedema is increased: racecadotril (used for diarrhea treatment), sirolimus, everolimus, temsirolimus, and other drugs belonging to a class of so-called MPM inhibitors (used to prevent rejection of transplanted organs). Pharmacological actionDrugs that affect the renin-angiotensin system. ACE inhibitors in combination with calcium channel blockers. ATX code: C09BB04. Pharmacokinetics Amlessa is a combination of two active ingredients: perindopril and amlodipine. Perindopril is an ACE inhibitor (angiotensin-converting enzyme). Amlodipine is a calcium antagonist (and belongs to a class of drugs called dihydropyridines). They have a combined effect, dilating and relaxing blood vessels, which facilitates the passage and pumping of blood. Amlessa is indicated for the treatment of high blood pressure (hypertension) and/or stable coronary heart disease (a condition where the pumping of blood to the heart is reduced or blocked). Patients taking perindopril and amlodipine can take Amlessa, which contains both components, instead of separate tablets. Dosage and Administration When taking Amlessa, always strictly follow your doctor’s instructions. If you doubt the correctness of the reception, consult your doctor. Your doctor will prescribe the appropriate dose for you. The usual dose is 1 tablet per day. Amlessa is usually prescribed to patients already taking perindopril and amlodipine as separate tablets. Tablets are recommended to be taken once a day, in the morning, before meals, washed down with water, preferably at the same time every day. The use of grapefruit and grapefruit juice can lead to an increase in the level of the active component of amlodipine in the blood, which can cause an unpredictable increase in the effect (lowering pressure) from taking Amlessa. Therefore, the use of grapefruit juice and grapefruit is not recommended for patients taking Amlessa. If you forget to take Amlessa It is important to take the drug every day, as regular use makes the treatment more effective. However, if you forget to take a dose of Amlessa, take your next dose at the usual time. Do not double the dose to make up for a missed one. If you stop taking Amlessa Since Amlessa is intended for long-term use, you should talk to your doctor before you stop taking it. If you have any further questions about taking the drug, contact your doctor. Use during pregnancy and lactation If you are pregnant or breastfeeding, suspect you are pregnant or are planning to become pregnant, consult your healthcare professional before taking this medicine. Your doctor will advise you to stop taking Amlessa before pregnancy or, if pregnancy is confirmed, and prescribe you another drug. Taking Amlessa is not recommended in early pregnancy and is contraindicated if the gestational age is more than 3 months, since taking the drug in the second and third trimester of pregnancy can cause serious harm to the baby. Breastfeeding Tell your doctor if you are breastfeeding. Amlessa is not recommended for breastfeeding mothers. Your doctor should prescribe another type of treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely. Precautions Your health care provider may periodically check your kidney function, blood pressure, and the amount of electrolytes (eg, potassium) in your blood. Let your doctor know if you think you are (or might become) pregnant. Amlessa is not recommended in the early stages of pregnancy. The drug should also not be taken if the duration of pregnancy exceeds 3 months, since at this time the drug can cause serious harm to the child (see section “Pregnancy and lactation”). If you are taking Amlessa, you should also tell your doctor about the following: – if you are going to have anesthesia or major surgery – if you have had diarrhea or vomiting recently – if you are undergoing LDL apheresis (hardware removal of cholesterol from the blood) – if You are about to undergo desensitization to desensitize yourself to the allergic effects of bee or wasp stings. Interactions with other drugs If you are taking, have recently taken or may take other medicines, tell your doctor. Avoid concomitant use of Amlessa with the following drugs: lithium (used to treat mania or depression), estramustine (used to treat cancer), potassium-sparing diuretics (spironolactone, triamterene), potassium supplements, or potassium-containing salt substitutes. The therapeutic effect of Amlessa may be affected by the use of other drugs. Be sure to tell your doctor if you are taking any of the following drugs, as special care must be taken when taking them: other drugs for treating high blood pressure, including diuretics (drugs that increase the amount of urine passed by the kidneys), non-steroidal anti-inflammatory drugs (eg. , ibuprofen) for pain relief or high doses of acetylsalicylic acid, diabetes medications (eg insulin), drugs to treat mental disorders such as depression, anxiety, schizophrenia, etc. (eg tricyclic antidepressants, antipsychotics, imipramine-like drugs, antipsychotics), immunosuppressants (drugs that lower the body’s defenses) used to treat autoimmune disorders or after transplantation (eg, cyclosporine), allopurinol (to treat gout), procainamide (to treat irregular heart rhythms), vasodilators s, including nitrates, heparin (anti-clotting drugs), ephedrine, norepinephrine or epinephrine (drugs used to treat low blood pressure, shock, or asthma), baclofen, or dantrolene (infusion), which are used to treat muscle stiffness associated with certain conditions , for example, with multiple sclerosis; certain antibiotics such as rifampicin, erythromycin, clarithromycin, antiepileptics such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone, itraconazole, ketoconazole (drugs used to treat fungal infections), alpha-blockers used to treat prostate enlargement, such like prazosin, alfuzosin, doxazosin, tamsulosin, terazosin, amifostine (used to prevent or reduce side effects caused by other medicines or radiation therapy used to treat cancer), corticosteroids (which are used to treat a variety of conditions including severe asthma and rheumatoid arthritis ), gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis), drugs most commonly used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other drugs s belonging to the class of so-called MPM inhibitors). See section “Special Instructions and Precautions for Use”, tacrolimus (used to control your body’s immune response, allows your body to accept a transplant), simvastatin (a drug that lowers cholesterol), ritonavir, indinavir, nelfinavir (called protease inhibitors, used for treating HIV infection), St. John’s wort (St. if you are taking an angiotensin II receptor blocker (ARB) or aliskiren. Release form 10 tablets in a blister (OPA/aluminum/PVC//aluminum foil). blister with leaflet in a cardboard box. Contraindications Do not take Amlessa: – if you are hypersensitive to perindopril erbumine (tert-butylamine) or any other ACE inhibitor, amlodipine besilate or any other calcium antagonist drug or any other component of Amlessa; – if your pregnancy is more than 3 months. It is preferable to avoid taking the drug also in early pregnancy; – if you have had symptoms such as wheezing, swelling of the face or tongue, intense itching or a large skin rash while taking other ACE inhibitors, or if any of your family members have had such symptoms (this phenomenon is called angioedema); – with cardiogenic shock (a condition in which your heart cannot pump enough blood to the body), with aortic stenosis (narrowing of the aortic valve) or unstable angina (chest pain that may occur at rest); – with very low blood pressure (severe hypotension); – in heart failure (when the heart cannot pump blood properly, resulting in difficulty breathing or peripheral edema) after a heart attack. – if you have diabetes mellitus or impaired kidney function and you are taking blood pressure lowering drugs that contain aliskiren Composition 4 mg/5 mg tablets: each tablet contains 4 mg of perindopril erbumine (corresponding to 3.34 mg of perindopril) and 5 mg of amlodipine ( in the form of besylate). 4 mg/10 mg tablets: Each tablet contains 4 mg of perindopril erbumine (corresponding to 3.34 mg of perindopril) and 10 mg of amlodipine (as besylate). 8 mg/5 mg tablets: Each tablet contains perindopril erbumine 8 mg (corresponding to perindopril 6.68 mg) and amlodipine 5 mg (as besylate). 8 mg/10 mg tablets: Each tablet contains perindopril erbumine 8 mg (corresponding to perindopril 6.68 mg) and amlodipine 10 mg (as besylate). Excipients: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, calcium chloride hexahydrate, sodium bicarbonate, anhydrous colloidal silicon dioxide, magnesium stearate. Overdose If you have taken too many tablets, contact the nearest emergency room or tell your doctor immediately. The most likely symptom in the event of an overdose is a drop in blood pressure, which can make you feel dizzy or faint. If this happens, lie down and elevate your legs, this may relieve your condition. Side effects Like all medicines, Amlessa can cause side effects, although not everyone gets them. Stop taking this drug and tell your doctor right away if you notice the following: Tinnitus (ringing in the ears) (Common: may affect up to 1 in 10 people) Foamy or dark urine, swelling, excessive thirst, or any of the following symptoms that would indicate kidney problems (Uncommon: may affect up to 1 in 100 people) Symptoms that indicate a blood disorder, such as fever, sore throat, fatigue, unexplained bruising, bleeding, mouth ulcers (Very rare: may occur in 1 in 10,000 people) Inflammation of the pancreas, which can lead to severe pain in the abdomen or back, making you feel very unwell (Very rare: may affect up to 1 in 10,000 people) Symptoms suggestive of abnormal liver function, such as yellowing of the skin, nausea, stomach pain (Very rare: may affect up to 1 in 10,000 people) Gastrointestinal disorders (nausea, vomiting, abdominal pain, indigestion or indigestion, diarrhea, constipation) (may affect up to 1 in 10 people) Swelling of the face, lips, mouth, tongue and throat, difficulty breathing (angioedema) (Uncommon: may affect up to 1 in 100 people) Severe dizziness or loss of consciousness due to low blood pressure (Common: may develop in 1 in 10 people) Unusually fast or abnormal heartbeat (Uncommon: may affect up to 1 in 100 people), chest pain (angina) or heart attack (Very rare: may affect up to 1 in 10,000 people) Weakness of arms or legs, or speech problems that could indicate a possible stroke (Very rare: may affect up to 1 in 10,000 people) Sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (Uncommon: may affect up to 1 in 100 people) skin reactions, including severe skin rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions (Very rare: may occur in 1 in 10,000 people) Other side effects include: PERINDOPRIL Common: may affect up to 1 in 10 people Headache, dizziness, vertigo, tingling sensation, blurred vision, cough, shortness of breath (dyspnea), allergic reactions (such as skin rash, itching ), muscle cramps, weakness, taste disturbances Uncommon: may affect up to 1 in 100 people Mood swings, sleep disturbances, dry mouth, severe itching or skin rash, red spots on the skin, erectile dysfunction, increased sweating, increased eosinophils (a type of white blood cell), tachycardia (rapid heartbeat), myalgia (muscle pain), chest pain, malaise (feeling generally unwell/malaise), peripheral edema (swelling of the ankles), fever, laboratory changes (high potassium in the blood, reversible after discontinuation of the drug, low sodium levels, hypoglycemia (low blood sugar) in the case of patients with diabetes mellitus, an increase in the level of urea in the blood, as well as an increase in the level of creatinine in the blood). Rare: may affect up to 1 in 1,000 people Laboratory changes (elevated liver enzymes, elevated serum bilirubin), worsening of psoriasis Very rare: may affect up to 1 in 10,000 people nose or runny nose), sudden kidney failure Not known: frequency cannot be estimated from available data Vasculitis (inflammation of the blood vessels) often with skin rash AMLODIPINE Very common: may affect more than 1 in 10 people Edema (fluid retention) Common: may develop in 1 in 10 people Headache (especially early in treatment), dizziness, drowsiness, palpitations (palpitations), flushing, blurred vision, double vision, muscle cramps, ankle swelling Uncommon: may affect up to 1 in 100 people mood, anxiety, depression, insomnia, trembling, taste disturbances, loss of consciousness, numbness, or tingling sensation in the limbs; loss of pain, low blood pressure, sneezing/runny nose caused by inflammation of the nasal mucosa (rhinitis), cough, dry mouth, vomiting, hair loss, increased sweating, itchy skin, red spots on the skin, discoloration of the skin, urination disorders, increased urge to urinate, at night, increased frequency of urination, impotence, male breast discomfort or enlargement, pain, feeling unwell, muscle pain, back pain, weight gain or loss Rare: may affect up to 1 in 1,000 people Confusion consciousness Very rare: may affect up to 1 in 10,000 people Excessive blood sugar (hyperglycemia), nerve problems that can cause weakness, tingling and numbness, swollen gums, bloating (gastritis), increased muscle tone, inflammation of the blood vessels (often with skin rash), sensitivity to light, disorders associated with muscle rigidity, tremors and/or impaired movement Frequency not known: often it cannot be estimated from the available data Trembling, rigid position, masked face, slow movements, unbalanced walking Reports of suspected adverse reactions If you experience any side effects, tell your doctor. This also applies to any possible side effects not even listed in this package insert. By reporting adverse reactions, you can help gather information about the safety of Amlessa. Storage conditionsStore at a temperature not exceeding 30 °C. Store in original packaging to protect from light and moisture. Keep out of the reach of children. Buy Amlessa tablets 8mg/5mg No. 10×3 Price for Amlessa tablets 8mg/5mg No. 10×3