Roxipre is indicated for replacement therapy in severe hypertension and the presence of one of the following factors: primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia), mixed dyslipidemia (type IIb) or heterozygous familial hypercholesterolemia, in adults whose condition is adequately controlled with rosuvastatin, perindopril and indapamide, when used simultaneously in the same doses as in the combination.
Composition
Active ingredient: rosuvastatin (as rosuvastatin calcium), perindopril tert-butylamine and indapamide.
1 tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium), 4 mg of perindopril tert-butylamine and 1.25 mg of indapamide or
20 mg of rosuvastatin (as rosuvastatin calcium), 4 mg of perindopril tert-butylamine and 1.25 mg of indapamide, or
10 mg rosuvastatin (as rosuvastatin calcium), 8 mg perindopril tert-butylamine and 2.5 mg indapamide, or
20 mg of rosuvastatin (as rosuvastatin calcium), 8 mg of perindopril tert-butylamine and 2.5 mg of indapamide.
Excipients: microcrystalline cellulose (type 112 and type 200, low moisture), crospovidone (type A), colloidal anhydrous silicon dioxide, magnesium stearate.
Film coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172).
Contraindication
Associated with rosuvastatin
Hypersensitivity to rosuvastatin. Active liver disease, including of unknown etiology, persistent elevation of serum transaminases and elevation of any serum transaminase more than 3 times the upper limit of normal. Myopathy. Concomitant use of cyclosporine. Pregnancy and lactation. Also contraindicated in women of reproductive age not using appropriate contraception.
Method of application
Administer orally.
The recommended dose is 1 tablet per day, preferably in the morning before meals.
Fixed-dose combinations are not appropriate for initial therapy.
Before switching to Roxiper, patients who are simultaneously using the same stable doses of monocomponents should be monitored. The dose of Roxiper should be determined based on the doses of the individual components before switching to the combination.
If a dosage change is necessary for any active substance of the fixed combination for any reason (e.g. diagnosed concomitant disease, change in patient condition or drug interaction), the individual components should be re-administered to determine the dose.
Features
Pregnant women
The use of ACE inhibitors is not recommended during the first trimester of pregnancy.
Children
Roxipres should not be used in children and adolescents, as the efficacy and tolerability of the medicinal product in children and adolescents have not been established.
Drivers
Roxiper does not affect the ability to drive.
Overdose
The most likely adverse reaction in case of overdose is hypotension, sometimes associated with nausea, vomiting, convulsions, dizziness, drowsiness, confusion, oliguria, which may progress to anuria (due to hypovolemia). Disturbances of water-salt balance (low sodium and potassium levels) may occur.
Side effects
The most common adverse reactions observed during use:
Perindopril: dizziness, headache, paresthesia, vertigo, visual disturbances, tinnitus, hypotension, cough, shortness of breath, abdominal pain, constipation, diarrhea, taste perversion (dysgeusia), dyspepsia, nausea, vomiting, itching, skin rash, muscle cramps, asthenia. Indapamide: hypersensitivity reactions, mainly dermatological, in patients prone to allergic and asthmatic reactions and maculo-papular rashes.
Interaction
When lithium is used concomitantly with ACE inhibitors, reversible increases in serum lithium concentrations and signs of toxicity have been observed. Concomitant use of thiazide diuretics further increases the risk of lithium toxicity when using ACE inhibitors. The combination of indapamide and lithium is not recommended, but if combination therapy is necessary, careful monitoring of serum lithium levels should be performed.
Storage conditions
Store in the original package in order to protect from light. The medicinal product does not require any special temperature storage conditions. Keep out of the reach of children.
Shelf life: 3 years.
