rosuvastatin – Krestor tablets are covered.pl.ob. 10 mg 126 pcs

Description

Description

coated tablets, 10 tablets, round, 10 mg: 10 tablets: .

Latin name

CRESTOR

Release form

film-coated tablets

Pharmacological action

Mechanism of action Rosuvastatin is a selective, competitive inhibitor of HMG-CoA reductase, an enzyme, converting 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a cholesterol precursor. The main target of the action of rosuvastatin is the liver, where the synthesis of cholesterol (cholesterol) and the catabolism of low density lipoproteins (LDL) are carried out. Rosuvastatin increases the number of hepatic LDL receptors on the cell surface, increasing the uptake and catabolism of LDL, which in turn leads to inhibition of the synthesis of very low density lipoprotein

(VLDL), thereby reducing the total amount of LDL and VLDL.

Krestor ® reduces elevated concentrations of LDL cholesterol (LDL-C), total cholesterol, triglycerides (TG), increases the concentration of high-density lipoprotein cholesterol (HDL-C), and also reduces the concentration of apolipoprotein B (ApoV), cholesterol-non-HDL CS-VLDLP, TG-VLDLP and increases the concentration of apolipoprotein AI (ApoA-I) (see tables 1 and 2), reduces the ratio of cholesterol-LDL / cholesterol-HDL, total cholesterol / cholesterol-HDL and cholesterol-non-HDL / cholesterol-HDL and the ratio of ApoV / ApoA-I. The therapeutic effect develops within one week after the start of therapy with Krestor ®, after 2 weeks of treatment reaches 90% of the maximum possible effect.

The maximum therapeutic effect is usually achieved by the 4th week of therapy and is maintained with regular use of the drug. Table 1. Dose-dependent effect in patients with primary hypercholesterolemia (type IIa and IIb according to Fredrickson) (average adjusted percentage change compared to the initial value). Dose Number of patients with cholesterol-LDL cholesterol Total cholesterol-cholesterol-HDL-C 20 mg 17 -55 -40 8 -23 -51 -46 5 40 mg 18 -63 -46 10 -28 -60 -54 0 Table 2. Dose-dependent effect in patients with hypertriglyceridemia (type IIb and IV according to Fredrickson) (average percentage change compared to the initial value). Dose Number of patients with TG cholesterol-LDL cholesterol Total cholesterol cholesterol-HDL cholesterol non-HDL cholesterol cholesterol-high cholesterol TG-lponp Placebo 26 1 5 1 -3 2 2 6 10 mg 23 -37 -45 -40 8 -49 -48 -39 20 mg 27 -37 -31 -34 22 -43 -49 -40 40 mg 25 -43 -43 -40 17 -51 -56 -48

Clinical efficacy Crestor ® is effective in adult patients with hypercholesterolemia with or without hypertriglyceridemia, regardless race, gender or age, including in patients with diabetes mellitus and familial hypercholesterolemia. In 80% of patients with type IIa and IIb hypercholesterolemia according to Fredrickson (the average initial concentration of LDL-C is about 4.8 mmol / L) when taking the drug at a dose of 10 mg, the concentration of LDL-C reaches less than 3 mmol / L. In patients with heterozygous familial hypercholesterolemia receiving Krestor ® at a dose of 20-80 mg, a positive dynamics of the lipid profile was observed (study involving 435 patients). After titration to a daily dose of 40 mg (12 weeks of therapy), a decrease in the concentration of LDL-C by 53% is noted. In 33% of patients, an LDL-C concentration of less than 3 mmol / L is achieved. In patients with homozygous familial hypercholesterolemia taking Krestor ® at a dose of 20 mg and 40 mg, the average decrease in LDL-C concentration is 22%.

In patients with hypertriglyceridemia with an initial concentration of TG from 273 to 817 mg / dl who received Krestor ® at a dose of 5 mg to 40 mg once a day for 6 weeks, the concentration of TG in the blood plasma was significantly reduced (see table 2). An additive effect is observed in combination with fenofibrate in relation to the concentration of triglycerides and with nicotinic acid in lipid lowering doses in relation to the concentration of HDL-C (see also the section œSpecial Instructions ). In a METEOR study in 984 patients aged 45 “70 years with a low risk of developing coronary heart disease (CHD) (a 10-year risk on the Framingham scale of less than 10%), an average LDL cholesterol concentration of 4.0 mmol / L (154.5 mg / dl) and subclinical atherosclerosis (which was evaluated by the thickness of the carotid artery intima-media complex – TCIM) studied the effect of rosuvastatin on the thickness of the intima-media complex. Patients received rosuvastatin at a dose of 40 mg / day or placebo for 2 years.

Rosuvastatin therapy significantly slowed the progression rate of maximum TCIM for 12 segments of the carotid artery compared with placebo with a difference of -0.0145 mm / year [95% confidence interval from -0.0196 to -0.0093 p <0.001]. Compared with the initial values, in the rosuvastatin group, a decrease in the maximum TCIM by 0.0014 mm / year (0.12% / year (unreliable difference)) was noted compared with an increase of this indicator by 0.0131 mm / year (1.12 % / year (p <0.001)) in the placebo group. To date, no direct relationship between a decrease in TCIM and a decrease in the risk of cardiovascular events has been demonstrated. The METEOR study was conducted in patients with a low risk of coronary heart disease, for whom a dose of Crestor ® 40 mg is not recommended. A dose of 40 mg should be used in patients with severe hypercholesterolemia and a high risk of cardiovascular disease (CVD). Results of the JUPITER study (The rationale for the use of statins for primary prevention: an interventional study evaluating rosuvastatin) in 17802 patients showed that rosuvastatin significantly reduced the risk of cardiovascular complications (252 in the placebo group compared to 142 in the rosuvastatin group) (p noted after the first 6 months of drug use There was a statistically significant decrease of 48% in the combined criterion, including death from cardiovascular causes , Stroke and myocardial infarction (hazard ratio: 0.52, 95% confidence interval 0,40-0,68, p <0.001) a 54% reduction in the occurrence of fatal or non-fatal myocardial infarction (risk ratio: 0.46, 95%, confidence interval 0.30-0.70) and by 48% - fatal or non-fatal stroke. Total mortality decreased by 20% in the rosuvastatin group (risk ratio: 0.80, 95%, confidence interval 0.67-0.97, p = 0.02). The safety profile in patients taking 20 mg rosuvastatin was generally similar to the safety profile in the placebo group. Indications ² ў Primary Fredrickson hypercholesterolemia (type IIa, including familial heterozygous hypercholesterolemia) or mixed hypercholesterolemia (type IIb) as a supplement to diet, when diet and other non-drug methods of treatment are insufficient (for example, physical body mass) . ² ў Family homozygous hypercholesterolemia as a supplement to diet and other lipid lowering therapy (eg, LDL apheresis), or in cases where such therapy is not effective enough. ² ў Hypertriglyceridemia (type IV according to Fredrickson) as a supplement to the diet. ² ў To slow the progression of atherosclerosis as a supplement to the diet in patients who are shown therapy to reduce the concentration of total cholesterol and LDL-C. ² ў Primary prevention of major cardiovascular complications (stroke, heart attack, arterial revascularization) in adult patients without clinical signs of coronary artery disease, but with an increased risk of its development (over 50 years old for men and over 60 years old for women, increased concentration of C-reactive protein ( 2 mg / l) in the presence of at least one of the additional risk factors, such as arterial hypertension, low concentration of HDL-C, smoking, family history of early onset of coronary heart disease). Contraindications For 10 mg tablets: hypersensitivity to rosuvastatin or any of the components of the preparation liver disease in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times compared with the upper limit of normal) severe disorders kidney function (CC less than 30 ml / min.) myopathy concurrent use of cyclosporine in women: pregnancy, lactation, lack of adequate methods of contraception for patients, predispositions prone to the development of myotoxic complications lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the drug contains lactose) Precautions For 10 mg tablets: There is a risk of myopathy / rhabdomyolysis – renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and a previous history of muscle toxicity when using other HMG-CoA reductase inhibitors or fibrates excessive alcohol consumption over the age of 65 years, conditions in which there is an increase in the plasma concentration of rosuvastatin race (Asian race) simultaneous administration with fibrates ( see Pharmacokinetics section) history of liver disease sepsis arterial hypotension extensive surgery, trauma, severe metabolic, endocrine or electrolyte disturbances or uncontrolled seizures. Use during pregnancy and lactation Krestor ® is contraindicated in pregnancy and lactation. Women of reproductive age should use adequate methods of contraception. Since cholesterol and other cholesterol biosynthesis products are important for the development of the fetus, the potential risk of inhibiting HMG-CoA reductase exceeds the benefits of using the drug in pregnant women. In case of pregnancy during therapy, the drug should be discontinued immediately. There are no data on the excretion of rosuvastatin with breast milk, therefore, during the period of breastfeeding, the drug should be discontinued (see section Contraindications). Composition Each tablet contains the active substance: 10 rosuvastatin in the form of calcium rosuvastatin. Excipients: lactose monohydrate 89.50 mg microcrystalline cellulose 29.82 mg calcium phosphate 10.90 mg crospovidone 7.50 mg magnesium stearate 1.88 mg monohydrate hypo lactose tablets: lactose tablets: lactose 1, 26 mg triacetin (glycerol triacetate) 0.36 mg titanium dioxide 1.06 mg dye iron oxide red 0.02 mg. Dosage and administration Inside, do not chew or grind the tablet, swallow whole, washed down with water. The drug can be prescribed at any time of the day, regardless of food intake. Before starting treatment with Krestor ®, the patient should start to follow a standard hypocholesterolemic diet and continue to follow it during treatment. The dose of the drug should be selected individually depending on the goals of therapy and the therapeutic response to treatment, taking into account current recommendations on the target concentration of lipids. Recommended starting dose for patients starting to take the drug, or for patients transferred from taking other HMG-CoA reductase inhibitors, should be 5 or 10 mg of the drug Crestor ® 1 time per day. When choosing an initial dose, you should be guided by an individual concentration of cholesterol and take into account the possible risk of cardiovascular complications, and it is also necessary to assess the potential risk of side effects. If necessary, the dose can be increased to a larger after 4 weeks (see section “Pharmacodynamics”). Due to the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug (see section “Side effects”), increasing the dose to 40 mg after an additional dose is higher than the recommended initial dose for 4 weeks therapy can be performed only in patients with severe degree of hypercholesterolemia and with a high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia), who did not achieve the desired result of therapy when taking a dose of 20 mg, and who will be under the supervision of a specialist (see section “Special instructions”). Especially careful monitoring of patients receiving the drug in a dose of 40 mg is recommended. A dosage of 40 mg is not recommended for patients who have not previously consulted a doctor. After 2-4 weeks of therapy and / or with an increase in the dose of the Krestor ® preparation, monitoring of lipid metabolism is necessary (dose adjustment is necessary if necessary). Elderly Patients No dose adjustment required. Patients with renal failure In patients with mild or moderate renal failure, dose adjustment is not required. In patients with severe renal failure (CC less than 30 ml / min.), The use of the drug Krestor ® is contraindicated. The use of the drug in a dose of 40 mg is contraindicated in patients with moderate impaired renal function (CC less than 30-60 ml / min.) (See the section “Special Instructions” and “Pharmacodynamics”). For patients with moderate impaired renal function, an initial dose of 5 mg is recommended. Patients with hepatic insufficiency Krestor ® is contraindicated in patients with liver diseases in the active phase (see section “Contraindications”). Special Populations. Ethnic groups When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, an increase in systemic concentration of rosuvastatin among Japanese and Chinese was noted (see section “Special Instructions”). This fact should be taken into account when prescribing Crestor ® to these patient groups. When prescribing doses of 10 and 20 mg, the recommended initial dose for patients of the Mongoloid race is 5 mg. Administration of the drug in a dose of 40 mg is contraindicated for patients of the Mongoloid race (see section “Contraindications”). Genetic polymorphism. Carriers of genotypes SLC01B1 (OATP1B1) c.521CC and ABCG2 (BCRP) c.421AA showed an increase in exposure (AUC) to rosuvastatin compared to carriers of genotypes SLC01B1 c.521TT and ABCG2 c.421CC. For patients carriers of c.521CC or c.421AA genotypes, the recommended maximum dose of Crestor ® is 20 mg once a day (see Pharmacokinetics sections, œSpecial Instructions and œInteraction with other medicinal products and other types of drug interaction ). Patients predisposed to myopathy. Administration of the drug in a dose of 40 mg is contraindicated in patients with factors that may indicate a predisposition to the development of myopathy (see section “Contraindications”). When prescribing doses of 10 and 20 mg, the recommended initial dose for this group of patients is 5 mg (See section “Contraindications”). Concomitant therapy Rosuvastatin binds to various transport proteins (in particular, OATP1B1 and BCRP). When used together with Crestor ® medications (such as cyclosporine, some HIV protease inhibitors, including the combination of ritonavir with atazanavir, lopinavir and / or tipranavir), increasing the concentration of rosuvastatin in plasma due to interaction with transport proteins, the risk of myopathy (including rhabdomyolysis) may increase (see sections “Special instructions” and “Interaction with other drugs and other types of drug interaction”). Read the instructions for use of these drugs before prescribing them together with Crestor ®. In such cases, you should evaluate the possibility of prescribing alternative therapy or temporarily stopping the use of the drug Krestor ®. If the use of the above drugs is necessary, you should evaluate the ratio of the benefit and risk of concomitant therapy with Crestor ® and consider the possibility of reducing its dose (see section œInteraction with other drugs and other types of drug interaction ). Side effects Side effects observed with Krestor ® are usually mild and resolve on their own. As with other HMG-COL reductase inhibitors, the incidence of side effects is mainly dose-dependent. The frequency of adverse effects is presented as follows: often (> 1/100, <1/10) infrequently (> 1/1000, <1/100) rarely (> 1/10000, <1/1000) very rarely (<1 / 10000), daily frequency (cannot be calculated according to available data). Immune system Rarely: hypersensitivity reactions, including angioedema Endocrine system Often: type 2 diabetes mellitus From the central nervous system Often: headache, dizziness From the digestive tract Often: constipation, nausea, abdominal pain Rarely: pancreatitis From the skin side Infrequently: itching, rash, urticaria From the musculoskeletal system Frequently: myalgia Rarely: myopathy (including myositis), rhabdomy Others Often: asthenic syndrome From the urinary system Proteinuria may be detected in patients treated with Crestor ®. Changes in the amount of protein in the urine (from the absence or trace amounts to ++ or more) are observed in less than 1% of patients receiving 10-20 mg of the drug, and in approximately 3% of patients receiving 40 mg of the drug. A slight change in the amount of protein in the urine was observed when taking a dose of 20 mg. In most cases, proteinuria decreases or disappears during therapy and does not mean the occurrence of acute or progressive existing kidney disease. From the musculoskeletal system When using the drug Krestor ® in all dosages and, especially when taking doses of the drug in excess of 20 mg, the following effects on the musculoskeletal system were reported: myalgia, myopathy (including myositis), in rare cases – rhabdomyolysis with acute renal failure or without it. A dose-dependent increase in creatine phosphokinase (CPK) activity is observed in a small number of patients taking rosuvastatin. In most cases, it was mild, asymptomatic and temporary. In the case of increased activity of CPK (more than 5 times compared with the upper limit of normal), therapy should be suspended (see section “Special instructions”). From the liver When using rosuvastatin, a dose-dependent increase in the activity of œliver transaminases is observed in a small number of patients. In most cases, it is insignificant, asymptomatic and temporary. Laboratory indicators When using the drug Krestor ®, the following changes in laboratory parameters were also observed: an increase in the concentration of glucose, bilirubin, the activity of gamma-glutamyl transpeptidase, alkaline phosphatase, and dysfunction of the thyroid gland. Post-marketing use The following side effects have been reported in the post-marketing use of Crestor ®: From the hemopoietic system of Unspecified frequency: thrombocytopenia From the alimentary canal Very rarely: jaundice, hepatitis Rarely: increased activity of œliver transaminases of Unspecified frequency: diarrhea From the musculoskeletal system Very rarely: arthralgia of Unspecified frequency: immuno-mediated necrotizing myopathy of the central side srd rarely: memory loss or impairment Unspecified frequency: peripheral neuropathy Respiratory system Unspecified frequency: cough, shortness of breath Urinary systems Very rare: hematuria From the skin and subcutaneous fat Undetermined frequency: Stevens-Johnson syndrome From the reproductive system and breast Unspecified frequency: gynecomastia Other Unspecified frequency: peripheral edema The following side effects were reported with some statins: depression, sleep disturbances, including insomnia and œnightmare dreams, sexual dysfunction, hyperglycemia, increased concentration of glycosylated hemoglobin. Isolated cases of interstitial lung disease have been reported, especially with prolonged use of drugs (see section “Special instructions”). Drug Interaction Effect of other drugs on rosuvastatin Transport protein inhibitors: rosuvastatin binds to some transport proteins, in particular OATP1B1 and BCRP. The concomitant use of drugs that are inhibitors of these transport proteins may be accompanied by an increase in the plasma concentration of rosuvastatin and an increased risk of myopathy (see Table 3 and section œAdministration and doses and œSpecial instructions ). Cyclosporine: when co-administered with rosuvastatin and cyclosporine, the AUC of rosuvastatin was, on average, 7 times higher than that observed in healthy volunteers (see Table 3). Does not affect the plasma concentration of cyclosporine. Crestor ® is contraindicated in patients receiving cyclosporine (see Contraindications). Human immunodeficiency virus (HIV) protease inhibitors: Although the exact mechanism of interaction is unknown, co-administration of HIV protease inhibitors can lead to a significant increase in exposure to rosuvastatin (see Table 3). Pharmacokinetic study on the concomitant use of 20 mg of rosuvastatip with the combination drug, containing two HIV protease inhibitors (400 mg lopinavir / 100 mg ritonavir) in healthy volunteers resulted in approximately twice and fivefold increases in rosuvastatin AUC (0-24) and C max, respectively. Therefore, concomitant administration of rosuvastatin and HIV protease inhibitors is not recommended (see section œAdministration and dosage , œSpecial instructions , table 3). Gemfibrozil and other hypolipidemic agents: co-administration of rosuvastatin and gemfibrozil results in a 2-fold increase in the maximum concentration of rosuvastatin in the blood plasma and rosuvastatin AUC (see section œSpecial instructions ). Based on the specific interaction data, no pharmacokinetically significant interaction with fenofibrate is expected, a pharmacodynamic interaction is possible. Gemfibrozil, fenofibrate, other fibrates and lipid-lowering doses of nicotinic acid increased the risk of myopathy when co-administered with HMG-CoA reductase inhibitors, possibly due to the fact that they may cause myopathy when used in monotherapy (see Special Instructions). At simultaneous administration of the drug with gemfibrozil, fibrates, nicotinic acid in lipid-lowering doses (more than 1 g / day), patients are recommended an initial dose of the drug 5 mg, a dose of 40 mg is contraindicated when co-administered with fibrates (see “Contraindications”, ” Method of administration and dosage “,” Special instructions “). Ezetimibe: co-administration of Crestor ® at 10 mg and ezetimibe at 10 mg was accompanied by an increase in rosuvastatin AUC in patients with hypercholesterolemia (see Table 3). An increased risk of side effects due to the pharmacodynamic interaction between Crestor ® and ezetimibe cannot be ruled out. Antacids: the simultaneous administration of rosuvastatin and suspensions of antacids containing magnesium and aluminum hydroxide results in a decrease in the plasma concentration of rosuvastatin by about 50%. This effect is less pronounced if antacids are administered 2 hours after taking rosuvastatin. The clinical significance of such interaction has not been studied. Erythromycin: concomitant administration of rosuvastatin and erythromycin results in a 20% decrease in rosuvastatin AUC and a rosuvastatin Cmax of 30%. Such interaction may result from increased intestinal motility caused by the intake of erythromycin. Cytochrome P450 iso-fermeites: results from in vivo and in vitro studies showed that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes. In addition, rosuvastatin is a weak substrate for these isoenzymes. Therefore, interaction of rosuvastatin with other drugs at the level of metabolism with the participation of cytochrome P450 isoenzymes is not expected. No clinically relevant interaction of rosuvastatin with fluconazole (an inhibitor of CYP2C9 and CYP3A4 isoenzymes) and ketoconazole (an inhibitor of CYP2A6 and CYP3A4 isoforms) was noted. Fusidic acid: no studies have been performed to study the interaction of rosuvastatin and fusidic acid. As with other statins, post-marketing reports of rhabdomyolysis with rosuvastatin and fusidic acid have been reported. Patients should be closely monitored. If necessary, temporary withdrawal of rosuvastatin is possible. Interaction with medicinal products requiring dose adjustment of rosuvastatin (see Table 3) The dose of the drug Crestor ® should be adjusted as necessary when combined with medicinal products that increase exposure to rosuvastatin. You should read the instructions for use of these drugs before their appointment together with the drug Krestor ®. If the exposure is expected to increase by 2 times or more, the starting dose of Krestor ® should be 5 mg once daily. The maximum daily dose of Krestor ® should also be adjusted so that the expected exposure to rosuvastatin does not exceed that for the 40 mg dose taken without the concomitant administration of rosuvastatin drug. For example, the maximum daily dose of Krestor ® when co-administered with gemfibrozil is 20 mg (increase in exposure by 1.9 times), with ritonavir / atazanavir – 10 mg (increase in exposure by 3.1 times). Table 3. Effect of concomitant therapy on exposure to rosuvastatin (AUC, data are presented in descending order) – results of published clinical studies Concomitant therapy regimen Reception of rosuvastatin 75 mg AUC, twice a day, 6 months 10 mg once daily, 10 days Increase 7.1 times Atazanavir 300 mg / ritonavir 100 mg once daily, 8 days 10 mg once Increase 3.1 times Simeprevir 152 mg once daily, 7 days 10 mg once Increase 2.8 times Lopinavir 400 mg / ritonavir 100 mg twice daily, 17 days 20 mg once daily, 7 days Increase 2, 1 time Clopidogrel 300 mg (loading dose), then 75 mg after 24 h 20 mg once Increase twice Gemfibrozil 600 mg twice daily, 7 days 80 mg once Increase 1.9 times Eltrombopag 75 mg once daily . 10 days 10 mg once Increase 1.6 times Darunavir 600 mg / ritonavir 100 mg 2 times a day, 7 days 10 mg 1 time a day, 7 days Increase 1.5 times Tipranavir 500 mg / ritonavir 200 mg 2 times daily, 11 days 10 mg once Increased 1.4 times Dronedarope 400 mg 2 times daily. No data Increase 1.4 times Itraconazole 200 mg once daily, 5 days 10 mg or 80 mg once Increase 1.4 times Ezetimibe 10 mg once daily, 14 days 10 mg once daily, 14 days Increase 1.2 times Fosamprenavir 700 mg / ritonavir 100 mg 2 times a day, 8 days 10 mg once Unchanged Aleglitazar 0.3 mg. 7 days 40 mg, 7 days No changes Silymarin 140 mg 3 times a day. 5 days 10 mg once Without changes Fenofibrate 67 mg 3 times a day, 7 days 10 mg, 7 days Without changes Rifampin 450 mg once a day. 7 days 20 mg once without changes Ketoconazole 200 mg 2 times a day, 7 days 80 mg once without changes Fluconazole 200 mg once a day, 11 days 80 mg once without changes Erythromycin 500 mg 4 times a day, 7 days 80 mg once a 28% reduction in Baikalin 50 mg 3 times a day, 14 days 20 mg once a 47% decrease Effect of rosuvastatin on other drugs Vitamin K antagonists: initiation of rosuvastatin therapy or dose increase in patients receiving concomitant antagonists To (for example, warfarin), can lead to magnify International Normalized Attitude (MHO). Withdrawing rosuvastatin or reducing the dose of the drug can lead to a decrease in MHO. MHO monitoring is recommended in such cases. Oral contraceptives / hormone replacement therapy: co-administration of rosuvastatin and oral contraceptives increases the ethinylestradiol AUC and norgestrel AUC by 26% and 34%, respectively. This increase in plasma concentration should be taken into account when selecting the dose of oral contraceptives. Pharmacokinetic data on the concomitant use of the drug Crestor ® and hormone replacement therapy are absent, therefore, it is impossible to exclude a similar effect when using this combination. However, such a combination was widely used during clinical trials and was well tolerated by patients. Other medicines: no clinically relevant interaction of rosuvastatin with digoxin is expected. Overdose When co-administered with multiple daily doses, the pharmacokinetic parameters of rosuvastatin do not change. There is no specific treatment for overdose with rosuvastatin. Symptomatic treatment and interventions aimed at maintaining the functions of vital organs and systems are recommended for overdose. Control of liver function and CPF level is required. Hemodialysis is unlikely to be effective. Storage conditions At a temperature not exceeding 30 ° C, out of the reach of children. Expiration At a temperature not exceeding 30 ° C, out of the reach of children. Active ingredient Rosuvastatin dosage form dosage form tablets AstraZeneca, Britain