Tritace Plus tablets 10 mg/12.5 mg 28 pcs.

One tablet contains (active ingredients):

• ramipril – 10 mg;
• hydrochlorothiazide – 12.5 mg.

Excipients: hydroxypropylmethylcellulose, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide (E 172), yellow iron oxide (E 172).

• hypersensitivity to the active substance ramipril or other ACE inhibitors (angiotensin-converting enzyme), hydrochlorothiazide, other thiazide diuretics, sulfonamides or to any of the excipients included in the preparation;
• history of angioedema (hereditary, idiopathic or previously suffered from the use of ACE inhibitors or angiotensin II receptor antagonists);
• arterial hypotension or hemodynamically unstable conditions;
• concomitant use with sacubitril/valsartan;
• simultaneous use of ACE inhibitors and extracorporeal treatments that lead to contact of blood with negatively charged surfaces (such use may lead to severe anaphylactic reactions); such extracorporeal treatments include dialysis or hemofiltration using certain membranes with high hydraulic permeability (e.g. polyacrylonitrile) and low-density lipoprotein apheresis using dextran sulfate;
• significant bilateral renal artery stenosis or unilateral renal artery stenosis of a single kidney;
• severe renal impairment (creatinine clearance <30 ml/minute) in patients not undergoing hemodialysis;
• clinically significant electrolyte imbalances, which may worsen during treatment;
• Hypokalemia or hypercalcemia resistant to treatment may occur;
• refractory hyponatremia;
• symptomatic hyperuricemia (gout);
• anury;
• severe liver dysfunction, hepatic encephalopathy;
• pregnancy and pregnancy planning;
• breastfeeding period;
• simultaneous use of the drug “Tritace Plus 10 mg / 12.5 mg” with drugs containing aliskiren in patients with diabetes mellitus or renal dysfunction (glomerular filtration rate (GFR) <60 ml / minute / 1.73 m ^2);
• concomitant use with angiotensin II receptor antagonists in patients with diabetic nephropathy.

For oral use. To achieve the recommended dose, tablets with the appropriate content of active ingredients are used.

It is recommended to take the drug once a day at the same time, preferably in the morning.

The drug can be taken before, during, and after meals, as food intake does not affect the bioavailability of the drug. The tablets should be swallowed whole with water. They should not be chewed or crushed.

Adults: The dose should be adjusted individually, depending on the patient’s characteristics and blood pressure levels. The use of a fixed combination of ramipril and hydrochlorothiazide is generally recommended only after titration of the doses of each of its individual components.

Treatment should be started at the lowest possible dose. If necessary, the dose can be gradually increased until the target blood pressure is reached. The maximum daily dose is 10 mg ramipril and 25 mg hydrochlorothiazide per day.

Children

The drug is not recommended for use in children, as there is insufficient data on its efficacy and safety for such patients.

Drivers

Studies on the effect of the drug on the ability to drive and use machines have not been conducted. Some side effects (for example, symptoms of low blood pressure, such as dizziness) may impair the patient’s ability to concentrate and react, which is risky in situations where these qualities are especially important (for example, when driving a car or operating other mechanisms).

This is especially true when starting treatment or switching to other medications. After taking the first dose or a subsequent dose increase, it is undesirable to drive or operate other machinery for several hours.

Symptoms of overdose are persistent diuresis, excessive peripheral vasodilation (with pronounced hypotension, shock), bradycardia, electrolyte imbalance, renal failure, cardiac arrhythmias, impaired consciousness, including coma, epileptic seizures, cerebral convulsions, paresis and paralytic intestinal obstruction. Overdose of hydrochlorothiazide can lead to acute urinary retention in patients predisposed to this (for example, with prostatic hyperplasia), tachycardia, weakness, dizziness, muscle spasms, polyuria, oliguria, anuria, hypokalemia, hyponatremia, hypochloremia, alkalosis, increased blood urea nitrogen (mainly renal failure). The patient’s condition should be carefully monitored.

Treatment is symptomatic and supportive. Treatment includes primary detoxification (gastric lavage, administration of adsorbents), as well as measures aimed at restoring stable hemodynamics, including the administration of alpha-1 adrenoceptor agonists or angiotensin II (angiotensinamide). Ramiprilat, the active metabolite of ramipril, is poorly removed by hemodialysis.

The safety profile of ramipril + hydrochlorothiazide includes data on side effects resulting from hypotension and/or volume depletion due to increased diuresis. The active substance ramipril may cause persistent cough, while the active substance hydrochlorothiazide may disrupt glucose, fat and uric acid metabolism. Both substances have an irreversible effect on plasma potassium levels. Severe adverse reactions include angioedema or anaphylactoid reactions, impaired liver or kidney function, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.

Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.

Shelf life – 3 years.