|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Actelsar HCT||tablets; 12.5 mg + 80 mg (1 tablet contains: 80 mg telmisartan, 12.5 mg hydrochlorothiazide); 28 tabl.||Actavis Polska||31.55||
|Actelsar HCT||tablets; 25 mg + 80 mg (1 tablet contains: 80 mg telmisartan, 25 mg hydrochlorothiazide); 28 tabl.||Actavis Polska||31.55||
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
A medicine that reduces blood pressure. Combined preparation containing an angiotensin II receptor antagonist (telmisartan) and a diuretic agent (hydrochlorothiazide).
It is a combined preparation containing 2 active substances, telmisartan and hydrochlorothiazide. Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists or sartans. The common mechanism of action of drugs in this group is blocking angiotensin II receptors which prevents their binding to angiotensin II and inhibits its action (drugs from this group are often indicated by the abbreviation ARB, which is derived from the English name Angiotensin 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.
The other active substance is hydrochlorothiazide, a diuretic thiazide diuretic that increases the volume of urine output. It inhibits the return of sodium ions in the kidney tubules, resulting in increased sodium excretion in the urine and increasing the volume of excreted water. Increased sodium excretion is accompanied by increased excretion of potassium, Magnesium and chlorine, while Calcium excretion decreases. The loss of potassium in the urine is less pronounced in the presence of telmisartan. The action of thiazides also leads to vasodilatation and reduction of vascular resistance.
The antihypertensive effect of the preparation is stronger than when each component is used alone. Full antihypertensive effect is achieved within 4-8 days. weeks from the start of the preparation.
It is indicated for the treatment of essential hypertension in adults who do not achieve sufficient blood pressure reduction with telmisartan alone.
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 or sulfonamides. You can not use the preparation if you are present:
• severe liver problems
• cholestasis (cholestasis) and obstruction of the bile ducts
• severe kidney problems (creatinine clearance less than 30 ml / min)
• refractory hypokalemia (decrease in potassium in the blood), hypercalcemia (increased level of calcium in the blood).
Parallel use of aliskiren is contraindicated in people with diabetes or impaired renal function.
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.
People should be treated with caution in patients with hepatic impairment (unrelated to cholestasis) or progressive liver disease. Even small disturbances of water and electrolyte balance may contribute to the occurrence of hepatic coma. The preparation is contraindicated in the presence of severe hepatic impairment, obstruction of the bile ducts or cholestasis (telmisartan is mainly excreted in the bile).
The use of the preparation in patients with bilateral renal artery stenosis or stenosis of the artery of the only 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 regularly assess potassium levels and parameters that characterize your kidneys, including creatinine and uric acid in your blood. There is no data on the use of the preparation in patients after recent kidney transplantation. In the case of severe renal failure (creatinine clearance less than 30 ml / min), the use of the preparation is contraindicated.
Caution should be exercised because the preparation (especially after taking the first dose) may cause symptomatic hypotension, especially in people with circulating, dehydrated or sodium deficient blood volume (eg, people who have previously received high doses of diuretics, using a low-salt diet) after diarrhea or vomiting). Before starting treatment, electrolyte deficits should be leveled and adequate hydration should be ensured.
Combination of various drugs acting on the renin-angiotensin-aldosterone system is not recommended. Therefore, it is not recommended to use the ACE inhibitor or aliskiren in parallel due to the increased risk of side effects, including renal dysfunction, hyperkalemia, syncope and stroke. 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 (such as eg telmisartan) may be associated with the risk of oliguria, increased urea and creatinine in the blood and acute renal failure . Caution should be exercised and treatment should be under special medical supervision. Regular monitoring of creatinine and urea in the blood is necessary.
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 exercised in the case of impaired left-ventricular blood flow (occurrence of aortic or mitral stenosis, hypertrophic cardiomyopathy).
Hydrochlorothiazide reduces Glucose tolerance. During the period of application, patients with diabetes should be careful and carefully monitor glucose. The preparation may reduce the effectiveness of oral antidiabetic agents and insulin and may need to be adjusted by the doctor. The preparation may reveal latent diabetes.
Hydrochlorothiazide may cause an increase in blood lipids (cholesterol and triglycerides).
Due to the content of the thiazide diuretic, elevated levels of uric acid in the blood (hyperuricemia) and, in rare cases, an increase in the frequency of gout attacks may occur. The content of telmisartan in the preparation causes a decrease in uric acid and may prevent hyperuricaemia induced by hydrochlorothiazide.
The hydrochlorothiazide contained in the preparation may affect the water-electrolyte balance and cause deficiencies of sodium, potassium, magnesium and chlorine. During the period of application, the doctor will recommend regular monitoring of the concentration of these ions. Disorders of potassium in the blood (both hypokalemia and hyperkalemia) can cause serious arrhythmias. In patients with swelling during hot weather, a shortage of sodium in the blood may occur. The product reduces the excretion of calcium in the urine and may cause a slight increase in blood calcium (hypercalcemia). Significant hypercalcemia may be the result of unrecognized hyperparathyroidism. In the case of significant hypercalcemia, tests to assess parathyroid function should be performed. Before performing parathyroid function tests, the preparation should be discontinued (only after consultation with a doctor and on his recommendation).
If you experience symptoms such as: dry mouth, increased thirst, weakness, lethargy, drowsiness, restlessness, convulsions, confusion, muscle aches and cramps, muscle fatigue, hypotension, oliguria, increased heart rate (tachycardia), nausea or vomiting, you should consult your doctor, because these symptoms may indicate a disturbance of fluid and electrolyte balance.
Due to the content of thiazide diuretic, the preparation may cause hypokalaemia (decrease in potassium in the blood). However, telmisartan contained in the preparation prevents hypokalemia caused by a thiazide diuretic. The risk of hypokalemia is greater in patients with cirrhosis of the liver, with increased diuresis and in patients receiving corticosteroid s or ACTH. Your doctor will recommend regular monitoring of potassium levels in your blood. On the other hand, the content of telmisartan may cause hyperkalaemia (increased potassium in the blood), especially in people with renal insufficiency, heart failure and in patients with diabetes. Parallel use of drugs that may increase potassium levels in the blood, such as, for example, potassium supplements, potassium chloride replacers, potassium sparing diuretics or Heparin requires careful attention and is only possible with the doctor's explicit recommendation.
In black people, the preparation may be less effective in lowering blood pressure.
Caution should be exercised in people with ischemic heart disease and cerebrovascular disease (people with coronary artery stenosis or cerebrovascular stenosis) because a significant reduction in blood pressure may result in a heart attack or stroke.
Hydrochlorothiazide may cause hypersensitivity reactions, regardless of whether there has been an allergy or bronchial asthma in the past. Hydrochlorothiazide contained in the preparation may cause Lupus Erythematosus or exacerbate its symptoms.
During the use of thiazide diuretics, skin hypersensitivity reaction to light (rash, fever, vasculitis) may occur. If it occurs, please consult your doctor, as it may be necessary to stop using the product. If it is necessary to resume therapy in the future, skin protection should be protected against solar and UV radiation.
Hydrochlorothiazide, a sulphonamide, may cause temporary myopia and acute glaucoma with a closing angle of perception (sudden decrease in visual acuity, eye pain). Untreated glaucoma can lead to permanent loss of vision.
Does this preparation affect the ability to drive vehicles?
The preparation may occasionally cause dizziness, fatigue, 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 tablet can be taken with or without food, with liquid. 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.
The doctor will individually adjust the dosage. The fixed dose of the preparation should be taken once a day. Actelsar HCT (80 mg / 12.5 mg) is used in patients whose blood pressure is not controlled by telmisartan 80 mg. If necessary, your doctor may also increase the daily dose to 1 tablet of Actelsar HCT (80 mg + 25 mg) once a day.
In people with impaired renal function, the doctor will recommend periodic monitoring of their activities. If the creatinine clearance is less than 30 ml / min, the use of the preparation is contraindicated.
People with mild or moderate hepatic impairment should not exceed 1 tablet of the preparation (40 mg + 12.5 mg) once daily. Be careful. The use of the preparation in patients with severe hepatic impairment is contraindicated.
Elderly patients usually do not need to adjust their dosage.
Do not use the preparation in children and adolescents up to 18 years of age, due to the lack of data on the safety and efficacy of the preparation in this age group.
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.
Medicines from the group of sartans and hydrochlorothiazide may have a detrimental effect on pregnancy, fetus and newborn development. The use of the preparation in the second and third trimester of pregnancy is contraindicated; in the first trimester of pregnancy, the use of the preparation is not recommended.
The preparation should not be initiated during pregnancy. If a woman who is using the product plans to become pregnant should consult a doctor who will recommend changing the 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. If necessary, your doctor will prescribe other antihypertensive agents.
The use of the preparation is contraindicated during breast-feeding.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Because of the risk of renal dysfunction, including acute renal failure, the concomitant use of the angiotensin-converting enzyme (ACE) or aliskiren-ACE inhibitor should be limited to individual cases where renal function is monitored.
The preparation may increase concentration and exacerbate 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 blood levels of lithium should be closely monitored.
Parallel use of the preparation with drugs that cause potassium loss (eg corticosteroids, tetracosactis, amphotericin B, carbenoxolone, ACTH, penicillin G, salicylic acid and its derivatives, laxatives, some diuretics) may increase the risk of hypokalaemia (decreases in potassium in the blood) and intensify her. If it is necessary to use these substances, the level of potassium in the blood should be monitored.
It is not recommended to use telmisartan in parallel with products that increase the concentration of potassium. Parallel use of these drugs (potassium salts, some diuretics and antihypertensive agents, e.g.spironolactone, triamterene, amiloride, eplerenone, potassium supplements, trimethoprim, tacrolimus, cyclosporin, heparin) and potassium-containing salt substitutes can lead to increased levels of potassium in the blood (hyperkalemia). If it is necessary to use them, the doctor will recommend regular monitoring of potassium in the blood.
If the preparation is used in parallel with the following drugs that can cause serious type-heart rhythm disturbancestorsade de pointes caution should be exercised because of the risk of hypokalemia (regular monitoring of potassium in the blood and ECG is recommended). Hypokalemia increases the risk of arrhythmiastorsade de pointes:
• class Ia and III antiarrhythmics (such as quinidine, hydroquinidine, disopyramide, Amiodarone , sotalol, dofetilide, ibutilide)
• some antipsychotics: phenothiazine derivatives (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazole), benzamides (amisulpiride, sulpiride, sultopride, thiapride), butyrophenone derivatives (stoperydol, Haloperidol )
• other medicines: bepridil, cisapride, difemanil, Erythromycin (intravenously), halofantrine, ketanserin, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine (intravenously).
The preparation may cause hypokalaemia or hypomagnesaemia, which intensifies the toxicity of cardiac glycosides. In patients using cardiac glycosides, caution should be exercised and potassium levels should be monitored and ECG examinations performed.
The preparation may increase the effect of other antihypertensive drugs (eg beta-blockers, calcium antagonists) or medicines that may lower blood pressure (eg some antidepressants, hypnotics, sedatives, barbiturates, antipsychotics, opioids, baclofen, amifostine). Antihypertensive effects and hypotension, including orthostatic hypotension, may occur.
The preparation may reduce the effectiveness of oral antidiabetic agents and insulin and may need to be adjusted by the doctor. You should monitor your blood glucose.
The concomitant use of Metformin increases the risk of lactic acidosis.
Bile acid medications (cholestyramine, colestipol) may reduce the absorption of the preparation from the gastrointestinal tract.
Non-steroidal anti-inflammatory drugs (e.g. Acetylsalicylic acid , Ibuprofen , Ketoprofen , indometacin, selective COX-2 inhibitors) 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.
The preparation may reduce the effect of catecholamines (eg adrenaline, norepinephrine) on the muscularis arteries.
The preparation may increase the effect of skeletal muscle relaxants (eg tubocurarines).
As the preparation may increase the concentration of uric acid in the blood, it may be necessary to adjust the doses of medicines used to treat gout (probenecid, sulfinpyrazone, Allopurinol ). It is also possible to intensify hypersensitivity reactions to allopurinol.
Thiazide diuretics may increase serum calcium. The parallel use of calcium supplements or vitamin D may further increase hypercalcemia. If it is necessary to use calcium supplements, the concentration of calcium in the blood should be closely monitored.
Hydrochlorothiazide may increase the hyperglycemia associated with the use of beta-blockers and diazoxide.
Anticholinergics (eg atropine, biperiden) may increase the effect of diuretics by reducing intestinal peristalsis.
Hydrochlorothiazide may increase the risk of side effects that are the nipple of amantadine.
The preparation may increase the toxic effect on the bone marrow of cytotoxic medicines such as cyclophosphamide and Methotrexate .
Baclofen and amifostine may increase the antihypertensive effect of the preparation.
Hydrochlorothiazide may influence the results of parathyroid function tests due to its effect on calcium metabolism.
Like all medicines, Actelsar HCT 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.
Common side effects commonly include: dizziness, anxiety, fainting, paresthesia (sensory disturbances such as pricking or tingling), arrhythmia, hypotension (including orthostatic), dyspnoea, diarrhea, dry oral mucosa , bloating, muscle aches, back pain, chest pain, sexual dysfunction, decrease in potassium in the blood (hypokalaemia). Rarely possible: bronchitis, pharyngitis, sinusitis, exacerbation or activation of systemic lupus erythematosus, increase in uric acid in the blood, decrease in blood sodium, depression, insomnia, sleep disturbances, blurred vision, blurred vision, respiratory distress syndrome (in including pneumonia, pulmonary edema), abdominal pain, constipation, indigestion, vomiting, liver dysfunction, angioneurotic edema (swelling of the face, lips, tongue, throat, larynx in sporadic cases that may cause narrowing of the airways, impede breathing and constitute a life hazard) , erythema, pruritus, rash, urticaria, hyperhidrosis, joint pain, pain in the extremities, flu-like symptoms, increased blood creatinine, increased liver enzymes.
It is also possible to rule out side effects previously reported for each component of the preparation used independently. Side effects associated with the use of telmisartan include: upper respiratory tract infections, urinary tract infections (including cystitis), sepsis, sometimes leading to death, eosinophilia (increased eosinophil counts, eosinophils), anemia, thrombocytopenia (decreased platelet count) ), hypersensitivity reactions and Anaphylactic reactions , hyperkalemia, arrhythmia, eczema, eruptions, tendon pain (symptoms similar to tendonitis), osteoarthritis, indigestion, weakness, kidney problems (including acute renal failure), decreased hemoglobin.
Side effects associated with hydrochlorothiazide include: loss of appetite, nausea, vomiting, constipation, diarrhea, discomfort in the gastrointestinal tract, salivary gland inflammation, pancreatitis, intrahepatic cholestasis (jaundice), urinary glucose excretion, renal interstitial nephritis, renal dysfunction , kidney failure, hypokalemia, hyponatraemia, increase in blood glucose, increase in uric acid in the blood, haematological abnormalities (haemolytic anemia, marked granulocyte decline, [reduced leukopenia], decrease in platelet count [thrombocytopenia] , sometimes with purpura, suppression of bone marrow function), depression, sleep disorders, headaches, dizziness, blurred vision, yellow vision, necrotizing vasculitis, respiratory failure with inflammation and pulmonary edema, rarely reacting anaphylactic, fever, hypersensitivity reactions (urticaria, rash), hypersensitivity to light and very rarely toxic necrosis, lupus-like skin reactions, activation of cutaneous form of Lupus Erythematosus.
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