Mertenil tablets are used for the following indications:
Treatment of hypercholesterolemia: adults, adolescents and children over 10 years of age with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when diet and other non-pharmacological measures (e.g. exercise, weight reduction) are inadequate; in homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatments (e.g. low-density lipoprotein apheresis) or when such treatment is inappropriate; prevention of cardiovascular events: prevention of major cardiovascular events in patients estimated to be at high risk of a first cardiovascular event, in addition to correction of other risk factors.
Composition
Active ingredient: rosuvastatin;
1 tablet contains 5 mg, 10 mg or 20 mg of rosuvastatin, which is equivalent to 5.2 mg, 10.4 mg or 20.8 mg of rosuvastatin calcium;
Excipients: lactose, microcrystalline cellulose, magnesium hydroxide, crospovidone, magnesium stearate film coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc.
Contraindication
Hypersensitivity to rosuvastatin or any of the excipients of the drug; liver disease in the active phase, including of unknown etiology, with a persistent increase in the activity of hepatic transaminases, as well as an increase in the level of any transaminase in the blood serum by more than 3 times relative to the upper limit of normal; severe renal impairment (creatinine clearance <30 ml/min); myopathy; simultaneous administration of cyclosporine; pregnancy and breastfeeding, as well as women of reproductive age who do not use reliable contraception; hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption.
The 40 mg dose is contraindicated in patients with factors predisposing to the development of myopathy/rhabdomyolysis. Such factors include:
moderately severe renal impairment (creatinine clearance <60 ml/min); hypothyroidism; personal or family history of hereditary muscle diseases; history of myotoxicity while taking other HMG-CoA reductase inhibitors or fibrates; alcohol abuse; conditions that may lead to increased plasma concentrations of rosuvastatin; belonging to the Mongoloid race; simultaneous use of fibrates.
Method of application
Before starting treatment, the patient should be placed on a standard cholesterol-lowering diet and should continue to follow it during treatment. The dose should be individualized, depending on the goal of therapy and the patient's response to treatment, guided by the recommendations of current generally accepted guidelines.
The drug Mertenil can be taken at any time of the day, regardless of meals.
Application features
Pregnant women
Contraindicated.
Children
The use of the drug in children should only be carried out by a specialist.
Drivers
With caution.
Overdose
There is no specific treatment for overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures should be taken as necessary. Liver function and CK levels should be monitored. Hemodialysis is unlikely to be effective.
Side effects
Adverse events observed with Mertenil are usually mild and transient. In controlled clinical trials, less than 4% of patients receiving Mertenil withdrew from the study due to adverse reactions.
Below are the most frequent adverse reactions to rosuvastatin according to clinical studies and extensive post-marketing experience.
Endocrine disorders: common (≥ 1/100 to < 1/10) - diabetes mellitus.
Nervous system: common (≥ 1/100 to < 1/10) - headache, dizziness.
Gastrointestinal: common (≥ 1/100 to < 1/10) - constipation, nausea, abdominal pain.
Musculoskeletal and connective tissue disorders: common (≥ 1/100 to < 1/10) - muscle pain.
Interaction
During the period of co-administration of the drug Mertenil and cyclosporine, the AUC values of rosuvastatin were on average approximately 7 times higher than those observed in healthy volunteers. Mertenil is contraindicated in patients who are simultaneously receiving cyclosporine.
Storage conditions
Store in the original packaging to protect from light.
The medicinal product does not require special temperature storage conditions.
Keep out of reach of children.
Shelf life - 3 years.
