Index of drugs

Treatment of mild and moderate spontaneous hypertension. The compound drug is indicated for use by patients who can not be adequately controlled on blood pressure only with zofenopril.

1 tabl powl. contains 30 mg of zofenopril Calcium and 12.5 mg of hydrochlorothiazide; drug contains lactose.

Hypersensitivity to zofenopril, other ACE inhibitors, hydrochlorothiazide, other sulphonamide derivatives or to any of the excipients. Angioedema associated with treatment with ACE inhibitors. Congenital or idiopathic angioedema. Severe hepatic failure. Severe renal failure (creatinine clearance <30 ml / min). Bilateral renal artery stenosis or unilateral renal artery stenosis for the sole active kidney. II and III trimester of pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (glomerular filtration rate, GFR <60 ml / min / 1.73 m²).

The use of the preparation in the first trimester of pregnancy is not recommended. Use in the second and third trimester of pregnancy is contraindicated. Zofenopril used in the second and third trimester of pregnancy is toxic to fetal development (deterioration of renal function, oligohydramnios, delayed ossification of the skull) and newborn (renal failure, hypotension, hyperkalemia) - when exposure to the drug occurred from the second trimester of pregnancy, it is recommended an ultrasound examination of the fetus skull and kidneys; children whose mothers took the drug during pregnancy should be closely monitored for hypotension. Hydrochlorothiazide in the second and third trimester may interfere with fetal-placental blood flow and may cause fetal and neonatal effects such as jaundice, electrolyte disturbances and thrombocytopenia. Hydrochlorothiazide should not be used in the treatment of gestational edema, gestational hypertension or pre-eclampsia and in the treatment of essential hypertension in pregnant women. It is not recommended to take a combined medicine while breastfeeding, especially when breastfeeding a newborn or premature baby. If the drug is used during breastfeeding, the dose should be as low as possible.

Common: dizziness, headache, cough. Uncommon: infection, bronchitis, sore throat, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypokalemia, hyperkalemia, hyperuricaemia, insomnia, drowsiness, syncope, increased tension, angina pectoris, atrial fibrillation, myocardial infarction, palpitations, sudden redness, hypotension, hypertension , dyspnoea, nausea, indigestion, gastritis, gingivitis, dry mouth, abdominal pain, angioedema, psoriasis, acne, dry skin, pruritus, urticaria, back pain, polyuria, weakness, flu-like illness, peripheral edema, erectile dysfunction , increase in creatinine, abnormal liver function tests. The following undesirable effects specific to the individual active substances used as monotherapy can occur during the use of a combination drug.zofenopril - often: dizziness, headache, cough, nausea, vomiting, tiredness; uncommon: rash, muscle cramps, weakness; rare: angioneurotic edema. The following side effects have been observed in association with treatment with ACE inhibitors - agranulocytosis, pancytopenia, haemolytic anemia in patients deficient in glucose-6-phosphate dehydrogenase, paresthesia, dysgeusia, imbalance, severe hypotension, occurrence or worsening of renal failure (also in acute renal failure) kidney), increase in urea and creatinine in the blood (especially in the case of renal failure, severe heart failure and renovascular hypertension), decrease in hemoglobin, hematocrit, platelet count and leukocytes,increase in liver enzymes and bilirubin in the blood, angioedema involving the face and tissues of the mouth and throat (in individual cases, deaths due to airway obstruction); rarely: depression, mood change, sleep disturbances, confusion, blurred vision, tinnitus, sudden redness, shortness of breath, sinusitis, rhinitis, inflammation of the tongue, bronchitis, bronchospasm, abdominal pain, diarrhea, constipation, dry mouth, allergic reactions and symptoms of hypersensitivity (including pruritus, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis eruptions, alopecia, symptoms may be accompanied by: fever, muscle pain, arthralgia, eosinophilia and / or increasing the titre of antinuclear antibodies), excessive perspiration, muscle pain, urination disorders, erectile dysfunction; very rare: hypoglycaemia, angioedema of the small intestine, peripheral edema, chest pain; isolated cases: tachycardia, palpitations, arrhythmia, angina pectoris, myocardial infarction (in combination with hypotension), pancreatitis, intestinal obstruction, cholestatic jaundice, hepatitis; frequency unknown: abnormal secretion of antidiuretic hormone.hydrochlorothiazide: leukopenia, neutropenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow failure, anaphylactic reactions, anorexia, dehydration, gout, diabetes, metabolic alkalosis, hyperuricaemia, electrolyte disturbances (including hyponatremia, hypokalemia, hypomagnesaemia, hypochloraemia, hypercalcemia) , hyperglycemia, hyperamylasemia, apathy, confusion, depression, nervousness, anxiety, sleep disorders, convulsions, disturbances of consciousness, coma, headache, dizziness, paresthesia, paralysis, vision in yellow, blurred vision, myopia (worsening), decreased secretion tears, dizziness, dysrhythmia, palpitations, orthostatic hypotension, thrombosis, embolism, shock, pneumonia, interstitial lung disease, pulmonary edema, dry mouth, nausea, vomiting, discomfort in the stomach area, diarrhea, constipation, pain stomach, not well paralytic, flatulence, salivary gland inflammation, pancreatitis, cholestatic jaundice, cholecystitis, pruritus, purpura, urticaria, hypersensitivity reactions to light, rash, cutaneous lupus erythematosus, necrotizing vasculitis, toxic epidermal necrolysis, muscle spasms, muscle pain , kidney problems, acute renal failure, interstitial nephritis, glucosuria, erectile dysfunction, asthenia, fever, tiredness, increased thirst, changes in the electrocardiogram, increased cholesterol in the blood, increased triglycerides in the blood.

Orally. Adults: 1 tabl. once a day. It is recommended that individual doses of the individual active substances (ie zofenopril and hydrochlorothiazide) be adjusted before the start of the co-administration. If clinically warranted, a direct change from monotherapy to compound treatment may be considered.Special groups of patients. Elderly patients with normal creatinine clearance do not need to change the dosage. In patients with mild renal impairment (CCr> 45 ml / min), no dosage adjustment is necessary; it is not recommended to use the drug in patients with CCr <45 ml / min; use in patients with CCr <30 ml / min is contraindicated; in patients undergoing dialysis, the use is not recommended. In patients with mild or moderate hepatic impairment, where a 30 mg dose of zofenopril alone has been reached, the same dosage regimen may be used as for patients with normal hepatic function; in patients with severe hepatic insufficiency, the use of the drug is contraindicated.