|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Actelsar||tablets; 40 mg; 28 tabl.||Actavis Polska||14.25||
|Actelsar||tablets; 80 mg; 28 tabl.||Actavis Polska||27.01||
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The drug from the group of angiotensin II receptor antagonists, which, like all preparations in this group, limits the action of angiotensin II, a substance that causes vasoconstriction and aldosterone-stimulating release.
The active substance is telmisartan belonging to a group of medicines called angiotensin II receptor antagonists or sartans. The common mechanism of action of drugs in this group is the blocking of angiotensin II receptors which prevents them from binding to angiotensin II and inhibits its action (drugs from this group are often indicated by the abbreviation ARB, which comes from the English nameAngiotensin II Receptor Blockers). Agiotensin II plays an important role in the pathophysiology of hypertension. The effect of angiotensin II is vasoconstriction and the increase in the release of aldosterone, which leads to increased blood pressure. The effect of telmisartan, like other sartans, effectively counteracts the effects of angiotensin II and leads to a reduction in blood pressure. Unlike drugs from the angiotensin-converting enzyme inhibitors, sartans do not exacerbate the effects of bradykinin-dependent, for example, cough. Sartans are used as medicines to lower blood pressure and to treat and prevent diseases of the cardiovascular system. In patients with heart failure , they reduce vascular resistance, which improves hemodynamic conditions, increases exercise capacity and improves the clinical condition. They have a protective effect on the kidneys, slow down the rate of development associated with high blood pressure and diabetes renal dysfunction.
Telmisartan lowers blood pressure without affecting the heart rate. Lowering blood pressure occurs gradually within 3 hours after taking a single dose of telmisartan and persists for more than 24 hours. Full development of antihypertensive action usually requires 4-8 weeks of application.
The preparation is indicated in adults:
• to treat spontaneous hypertension
• to reduce the incidence of cardiovascular morbidity in individuals with overt atherosclerotic disease (ischemic heart disease, stroke, peripheral arterial disease) and in patients with type 2 diabetes with documented target organ related complications.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
The preparation is contraindicated in people with severe hepatic impairment and in people with biliary obstructive disorders.
The concomitant use of the preparation with aliskiren is contraindicated in people with diabetes mellitus or renal dysfunction.
The preparation is contraindicated in the second and third trimester of pregnancy and during breastfeeding. It is not recommended during the first trimester of pregnancy.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
In people with mild or moderate hepatic impairment, caution is required. The doctor will determine the individual dose. The use of the preparation is contraindicated in case of severe hepatic dysfunction, disorders in the outflow of bile, stagnation of bile (the preparation is excreted mainly in the bile).
The use of drugs acting on the renin-angiotensin-aldosterone system, including the preparation, in patients with bilateral renal artery stenosis or stenosis of the artery of the sole active kidney is associated with an increased risk of severe hypotension and renal failure.
Caution should be exercised in patients with impaired renal function; your doctor will recommend regular monitoring of potassium and creatinine in your blood, parameters that characterize your kidneys. There are no data on the use of the preparation in patients after kidney transplantation.
Caution should be exercised because the preparation, especially after the first dose, may cause symptomatic hypotension, especially in patients with circulating, dehydrated or sodium deficient blood volume (eg, people who have previously received high doses of diuretics, low salt diets) after diarrhea or vomiting). Before starting treatment, electrolyte deficits should be leveled and adequate hydration should be ensured.
Combination with angiotensin-converting enzyme (ACE) inhibitors is not recommended due to the risk of hypotension, syncope, increase in potassium in the blood (hyperkalemia) and renal dysfunction, including acute renal failure . If the physician considers such combination treatment to be necessary, the renal function should be closely monitored.
In patients at higher risk of renal dysfunction, in which renal function depends on the activity of the renin-angiotensin-aldosterone system (eg in patients with severe heart failure, bilateral renal artery stenosis or renal artery stenosis of the sole active kidney) use of drugs acting on the renin-angiotensin-aldosterone system may be associated with a risk of sudden decreases in blood pressure, oliguria, increased urea and creatinine in the blood, and rarely, acute renal failure. Caution should be exercised and treatment should be under special medical supervision.
It is not recommended to use the preparation in patients with primary hyperaldosteronism, because the effect of the preparation in this group of patients is not effective.
Caution should be used if the preparation is used in patients with impaired left ventricular outflow (aortic or mitral stenosis), hypertrophic cardiomyopathy).
In diabetic patients taking antidiabetic medicines, hypoglycaemia may occur during treatment. Blood Glucose monitoring should be monitored. It may be necessary for your doctor to adjust the dosage of antidiabetic medicines.
Use of the preparation, like the use of other drugs acting on the renin-angiotensin-aldosterone system, may cause hyperkalaemia (increase in potassium in the blood). Hyperkalaemia may cause serious arrhythmias and may lead to life-threatening conditions. In people at increased risk of hyperkalemia, your doctor will advise you to closely monitor your potassium levels.
The group of increased risk of hyperkalemia include:
• elderly people, people with diabetes, people with kidney failure
• people taking concomitant preparations and / or medicines that increase the level of potassium in the blood, including: potassium salts, potassium sparing diuretics, Heparin , angiotensin-converting enzyme or angiotensin-receptor blockers, non-steroidal anti-inflammatory drugs, trimethoprim, immunosuppressive drugs such as cyclosporin or tacrolimus
• dehydrated persons, with decompensated heart failure, metabolic acidosis, as well as patients with deterioration of renal function, including sudden deterioration of renal function, eg in the course of infectious diseases, disintegration of cells eg in the course of acute limb ischemia or muscle disintegration transversely streaked or after extensive trauma).
In black people, the preparation may be less effective in lowering blood pressure.
Caution should be exercised in people with ischemic heart disease or cerebrovascular disease (people with coronary artery stenosis or narrowing of the cerebral vessels) because a significant reduction in blood pressure can result in a heart attack or stroke.
Additional information about the other ingredients of the preparation:
• the preparation contains sorbitol (E420); in the case of fructose intolerance, this preparation should not be used.
Does this preparation affect the ability to drive vehicles?
The preparation may occasionally cause dizziness, drowsiness or other symptoms that may impair psychophysical fitness and the ability to drive vehicles and operate machinery and equipment.
The preparation is in the form of tablets. It is intended for oral use. The tablets can be taken with or without food, with liquid. The tablets should be removed from the blister just before use. Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.
Primary hypertension: 40 mg once daily; some patients will need 20 mg once a day; if necessary, your doctor will increase the dose to 80 mg once daily or will recommend the use of hydrochlorothiazide (a diuretic) in parallel. Full antihypertensive effect of the preparation is obtained after 4 -8. weeks of treatment.
Decreased incidence of cardiovascular cases: 80 mg once daily. Close blood pressure monitoring is recommended, especially during the initial treatment period. It may be necessary for the doctor to adjust the dosage of antihypertensive drugs.
There is no need to adjust the starting dose in patients with mild or moderate renal impairment. In patients with severely impaired renal function and in patients undergoing hemodialysis, the doctor will recommend a reduction of the initial dose to 20 mg once daily.
In patients with mild or moderate hepatic impairment, dosage adjustment by the physician is necessary; the dose should not exceed 40 mg once daily. The use of the preparation is contraindicated in case of severe liver dysfunction or disturbance of bile outflow.
Elderly patients do not need to adjust their dosage.
There are insufficient data on the safety and efficacy of the preparation in children and adolescents up to 18 years of age.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine.
The preparation should not be used during the first trimester of pregnancy.The use of the preparation in the second and third trimester of pregnancy is contraindicated. If a woman plans to become pregnant she should consult a doctor because it is recommended to change the way of antihypertensive treatment. If you suspect or confirm pregnancy during the period of taking the preparation, you should consult a doctor as soon as possible because immediate discontinuation of the preparation is required. Your doctor will prescribe other antihypertensive agents.
Do not use the product during breast-feeding.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Parallel use of drugs that affect the level of potassium in the blood (potassium salts, potassium supplements, potassium sparing diuretics, such as, for example, spironolactone, triamterene, amiloride, eplerenone, immunosuppressants, such as tacrolimus, cyclosporine, ACE inhibitors, angiotensin II receptor antagonists, trimethoprim, heparin, non-steroidal anti-inflammatory drugs) and potassium chloride substitutes may lead to increased levels of potassium in the blood (hyperkalemia). The parallel use of telmisartan with the preparations mentioned above is not recommended. If it is necessary to use them, the doctor will recommend regular monitoring of potassium in the blood.
The preparation, like angiotensin-converting enzyme (ACE inhibitors), may increase the toxic effects of lithium salts. The simultaneous use of lithium is not recommended, and if necessary, combination therapy should be used with caution and control of the concentration of lithium in the blood.
Non-steroidal anti-inflammatory drugs (eg Acetylsalicylic acid , Ibuprofen , Ketoprofen , indomethacin) may reduce the antihypertensive effect of the preparation and may cause renal dysfunction and increase in potassium in the blood. Adequate hydration and regular renal function should be ensured. Caution should be exercised, especially in elderly patients.
Diuretics (eg Furosemide , hydrochlorothiazide) may cause a decrease in blood volume and increase the risk of hypotension after treatment with telmisartan.
Other antihypertensive agents may increase the hypotensive effect of the preparation. Drugs that can lower blood pressure (eg barbiturates, opioid analgesics, antidepressants, antipsychotics, baclofen, amifostine) increase the risk of hypotension.
Parallel alcohol consumption increases the risk of hypotension.
Generally used corticosteroid s reduce the antihypertensive effect of the preparation.
Like all medicines, Actelsar can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Uncommonly possible: upper respiratory tract infections (inflammation of the throat and sinuses), urinary tract infections (including cystitis), anemia, hyperkalemia, depression, insomnia, fainting, dizziness, decreased heart rate (bradycardia), symptoms caused by hypotension arterial, including orthostatic hypotension (eg dizziness, weakness, balance disorders), shortness of breath, cough, abdominal pain, diarrhea, indigestion, bloating, nausea, vomiting, pruritus, rash, chest pain, weakness, profuse sweating pain and muscle cramps, backache, kidney problems including acute renal failure, increased blood creatinine. Rare: sepsis, sometimes leading to death, eosinophilia (increased eosinophil count, eosinophils), thrombocytopenia, hypoglycemia in patients with diabetes, anxiety, drowsiness, visual disturbances, increased heart rate (tachycardia), joint pain, limb pain, symptoms Flu-like, tendon pain (symptoms similar to tendonitis), dry mouth, gastritis, liver dysfunction, increased liver enzymes, increased uric acid in the blood, decreased hemoglobin, hypersensitivity and Anaphylactic reactions , angioneurotic edema (edema face, lips, language,throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and threaten life), eczema, drug eruption, erythema, severe skin changes (toxic melanosis). Very rarely interstitial lung disease.
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