Rosuvastatin Canon - instructions for use, dose, side effects, contraindications

active substance: rosuvastatin calcium 10.4 mg, calculated as rosuvastatin 10 mg; Excipients: calcium hydrophosphate dihydrate 44.2 mg, corn pregelatinized corn starch 41.8 mg, magnesium stearate 1 mg, povidone 7 mg, microcrystalline cellulose 35.6 mg;

composition of film shell: Selekoate AQ-01032 red - 4 mg, including: hypromellose (hydroxypropylmethylcellulose) 1.6 mg, macrogol-400 (polyethylene glycol 400) 0.4 mg, macrogol-6000 (polyethylene glycol 6000) 0.4 mg, titanium dioxide 1.2 mg, lacquer Aluminum based on the dye crimson [Ponso 4R] 0.4 mg.

Dosage of 20 mg

active substance: rosuvastatin calcium 20.8 mg, calculated as rosuvastatin 20 mg; Excipients: calcium hydrogen phosphate dihydrate 66.3 mg, corn pregelatinized corn starch 57.5 mg, magnesium stearate 1.5 mg, povidone 10.5 mg, microcrystalline cellulose 53.4 mg;

composition of film shell: Selekoate AQ-01032 red - 6 mg, including: hypromellose (hydroxypropylmethylcellulose) 2.4 mg, macrogol-400 (polyethylene glycol 400) 0.6 mg, macrogol-6000 (polyethylene glycol 6000) 0.6 mg, titanium dioxide 1.8 mg, lacquer Aluminum based on the dye crimson [Ponso 4R] 0.6 mg.

The dosage of 40 mg

active substance: rosuvastatin calcium 41.6 mg, calculated as rosuvastatin 40 mg; Excipients: calcium hydrogen phosphate dihydrate 101 mg, corn starch pregelatinized starch 80.3 mg, magnesium stearate 2.5 mg, povidone> 13.4 mg, microcrystalline cellulose 81.2 mg;

composition of film shell: Selekoate AQ-01032 red 10 mg, including: hypromellose (hydroxypropylmethylcellulose) 4 mg, macrogol-400 (polyethylene glycol 400) 1 mg, macrogol-6000 "(polyethylene glycol 6000) 1 mg, titanium dioxide 3 mg, lacquer aluminum based on the dye crimson [Ponso 4 R] 1 mg.

Description:

Dosage of 10 mg:

- tablets are round, biconcave with a risk, covered with a film shell of red color. On the cross-section - the core is almost white.

Dosages of 20 mg and 40 mg:

Round tablets, biconvex, covered with a film coat of red color. On the cross-section - the core is almost white.

Pharmacotherapeutic group:lipid-lowering agent - HMG-CoA reductase inhibitor

ATX: & nbsp

C.10.A.A Inhibitors of HMG-CoA reductase

C.10.A.A.07 Rosuvastatin

Pharmacodynamics:The hypolipidemic drug, a selective competitive inhibitor of HMG-CoA reductase that converts 3-hydroxy-3-metilglutarilKoA to mevalonate, a precursor of cholesterol (LDL). The main target of the action is the liver, where the synthesis of cholesterol and catabolism of low-density lipoproteins (LDL) is carried out. Inhibits the activity of HMG-CoA reductase (90% of rosuvastatin circulates in the blood). Increases the number of LDL receptors on the hepatocyte surface, increasing the catabolism of LDL and seizure that results in inhibition of the synthesis of very low density lipoproteins (VLDL), reducing the total amount of VLDL and LDL. Reduces the concentration of LDL-C, neLPVP-cholesterol (low density lipoprotein) VLDL-cholesterol, total cholesterol, triglycerides (TG), VLDL-triglycerides, apolipoprotein B (apoB), the ratio LPNPHS-HDL-C, total, LDL / HS- HDL, CS-non-HDL / HDL-C, Apov / ApoA-1, increases the concentration of 'cholesterol-HDL, ApoA-1. Therapeutic effect develops within 1 week after initiation of therapy; in 2 weeks reaches 90% of the maximum possible effect,maximum therapeutic effect * is usually achieved by the 4th week of therapy and is maintained with regular intake of the drug. Effective in adults with hypercholesterolemia, p. or without hypertriglyceridemia (regardless of race, sex or age), including in patients with diabetes mellitus and familial hypercholesterolemia. Additive effect is noted in combination with fenofibrate (in terms of decrease, TG concentration) and nicotinic acid in lipid-lowering doses (in terms of reducing the concentration of HDL-C).

Pharmacokinetics:

Absorption and distribution

The maximum concentration of rosuvastatin in the blood plasma is reached approximately 5 hours after ingestion. Absolute bioavailability is approximately 20%. It is metabolized primarily by the liver, which is the main site for the synthesis of cholesterol and the metabolism of LDL-C. The volume distribution of rosuvastatin is approximately 134 liters. Approximately 90% of rosuvastatin binds to blood plasma proteins, mainly albumin.

Metabolism

It is subject to limited metabolism (about 10%). Rosuvastatin is a non-core substrate for metabolism by isoenzymes of the cytochrome P450 system. The main isoenzyme involved in the metabolism of rosuvastatin is isoenzyme CYP2C9. Isozymes CYP2C19, CYP3A4, CYP2D6 are less involved in metabolism. The main metabolites identified are N-desmethylrozvastatin and lactone metabolites. Nis less than 50% less active than rosuvastatin, lactone metabolites are pharmacologically inactive. More than 90% of the pharmacological activity of inhibiting the circulating HMG-CoA reductase is provided by rosuvastatin, the rest - by its metabolites.

Excretion

About 90% of the dose of rosuvastatin is excreted unchanged through the intestine (including absorbed and unabsorbed rosuvastatin). The rest is excreted by the kidneys. Plasma half-life (T1 / 2) is approximately 19 hours (does not change with increasing dose of the drug). The average geometric plasma clearance is 50 l / h. As with other inhibitors of HMG-CoA reductase, a membrane cholesterol transporter involved in the hepatic elimination of rosuvastatin plays an important role in the hepatic elimination of rosuvastatin. The systemic exposure of rosuvastatin increases in proportion to the dose.Pharmacokinetic parameters do not change with daily intake.

Special patient groups

Age and gender

Sex and age do not have a clinically significant effect on the pharmacokinetics of rosuvastatin.

Ethnic groups

Pharmacokinetic studies showed approximately a twofold increase in the median AUC (area under the concentration-time curve) and Cm(maximum concentration in blood plasma) of rosuvastatin in patients of Asian race (Japanese, Chinese, Filipinos, Vietnamese and Koreans) compared with Caucasians; Hindus show an increase in median AUC and Cmah 1,3 times. Pharmacokinetic analysis did not reveal clinically significant differences in pharmacokinetics among Caucasians and representatives of the Negroid race.

Renal insufficiency

In patients with mild to moderate renal failure, the plasma concentration of rosuvastatin or N- desmethyl-rosuvastatin does not change significantly. In patients with severe renal insufficiency (creatinine clearance (CK) less than 30 ml / min.), The concentration of rosuvastatin in blood plasma is 3 times higher, and the concentration N- desmethyl-rosuvastatin is 9 times higher than in healthy volunteers.The concentration of rosuvastatin in blood plasma in patients on hemodialysis is approximately 50% higher than in healthy volunteers.

Liver failure

There was no increase in T1 / 2 rosuvastatin in patients with a score of 7 or lower on the Child-Pugh scale. In 2 patients with scores of 8 and 9 on the Child-Pugh scale, an increase in the half-life was observed, at least 2-fold. The experience with rosuvastatin in patients with a score above 9 on the Child-Pugh scale is not available.

Genetic polymorphism

Inhibitors of HMG-CoA reductase, including rosuvastatin canon, bind to transport proteins of OATP1B1 (polypeptide-transport of organic anions, involved in the capture of statins of hepatocyte) and BCRP (efflux conveyor). In carriers of genotypes SLCO1B1 (OATP1B1) p.521NC and ABCG2 (BCRP) p.421AA there was an increase in exposure (AUC) to rosuvastatin and 1.6 and 2.4 times, respectively, compared with carriers of genotypes SLCO1B1 p.521TT and ABCG2 p.421S.

Indications:

Primary hypercholesterolemia according to Fredriksen (type IIa, including familial heterozygous hypercholesterolemia) or mixed gipercholesterinemia (type IIb) as a supplement to the diet, when the diet and other non-pharmacological methods of treatment (physical exercises, weight loss) are insufficient.

- Family homozygous hypercholesterolemia as a supplement to diet and other lipid-lowering therapy (eg, LG1NP-apheresis), or in cases when such therapy is not effective enough.

- Hypertriglyceridemia (type IV according to Fredriksen) as a supplement to the diet.

- 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.

Primary prevention of major cardiovascular complications

(stroke, myocardial infarction, arterial revascularization) in adult patients without clinical signs of coronary artery disease, but with an increased risk of its development (age over 50 for men and over 60 for women, an elevated concentration of C-reactive protein (more than 2 mg / L) if there is at least one of additional risk factors, such as hypertension, low concentration of HDL-C, smoking, family history of early onset of CHD).

Contraindications:

For tablets 10 mg and 20 mg:

- increased sensitivity to rosuvastatin or any of the components of the drug;

- 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 the upper limit of normal);

- severe renal dysfunction (creatinine clearance (CK) less than 30 ml / min);

- myopathy;

- simultaneous administration of cyclosporine;

- in women: pregnancy, lactation, lack of adequate contraceptive methods;

- patients who are predisposed to the development of myotoxic complications;

- children's age till 18 years.

For tablets 40 mg:

- hypersensitivity to rosuvastatin or any of the components

preparation;

- simultaneous administration of cyclosporine;

- in women: pregnancy, lactation, lack of adequate methods of contraception;

- liver diseases in the active phase, including a persistent increase in serum transaminase activity and any increase in serum transaminase activity (more than 3 times the upper limit of the norm);

patients with risk factors for myopathy / rhabdomyolysis, namely:

- renal failure of moderate severity (CC less than 60 ml / min);

- hypothyroidism;

- personal or family anamnesis of muscular diseases;

- myotoxicity on the background of taking other inhibitors of HMG-CoA reductase or fibrates in anamnesis;

- excessive use of alcohol;

- conditions that can lead to an increase in the plasma concentration of rosuvastatin;

- simultaneous reception of fibrates;

- patients of the Asian race;

- children's age till 18 years.

Carefully:

For tablets 10 mg and 20 mg:

The presence of a risk of myopathy / rhabdomyolysis - renal failure, hypothyroidism, personal or family history of hereditary muscle diseases and a previous history of muscle toxicity with the use of other inhibitors of HMG-CoA reductase or fibrates; alcohol addiction; age over 65; conditions in which there was an increase in the plasma concentration of rosuvastatin; racial affiliation (Asian race-Japanese and Chinese); simultaneous application with fibrates; liver disease in history; sepsis; arterial hypotension; extensive surgical interventions, trauma, severe metabolic, endocrine or electrolyte disorders, or uncontrolled convulsive seizures.

For tablets 40 mg:

Renal insufficiency of low severity (QC more than 60 ml / min); age over 65years; liver disease in history; sepsis; arterial hypotension; extensive surgical interventions, trauma, severe metabolic, endocrine or electrolyte disorders, or uncontrolled convulsive seizures.

Patients with hepatic insufficiency

Data or experience of the drug in patients with a score above 9 on the Child-Pugh scale is not available.

Pregnancy and lactation:

Rosuvastatin is contraindicated in pregnancy and lactation.

Women of reproductive age should apply adequate methods, contraception. Since cholesterol and substances synthesized from cholesterol are important for fetal development, the potential risk of inhibiting HMG-CoA reductase exceeds the benefit of using the drug in pregnancy.

In case of diagnosing pregnancy during therapy, taking the drug should be stopped immediately.

Data on the allocation of rosuvastatin to breast milk are not available, therefore, during the period of breastfeeding, the drug should be discontinued.

Dosing and Administration:

Inside, the tablet can not be chewed and chopped, swallowed whole, washed down with enough water, you can take any time, any day, regardless of food intake.If you need to take the drug at a dose of 5 mg, you should divide the tablet with a dosage of 10 mg.

Before starting therapy with Rosuvastatin Canon, the patient should begin to follow the standard hypocholesterolemic diet and continue to observe it during treatment. The dose of the drug should be selected individually depending on the purpose of therapy and the therapeutic response to treatment, taking into account the current recommendations for target levels of lipids.

The recommended initial dose for patients starting to take the drug or for patients transferred from other HMG-CoA reductase inhibitors should be 5 mg (1/2 tablet of 10 mg) or 10 mg of rosuvastatin canon once a day.

When taking a drug with gemfibrozil, fibrates, nicotinic acid at a dose of more than 1 g / day, the recommended initial dose of the drug is 5 mg (1/2 tablet of 10 mg).

When choosing the initial dose should be guided by an individual cholesterol level and take into account the possible risk of cardiovascular complications, as well as the potential risk of side effects.If necessary, the dose may be increased to greater after 4 weeks.

In connection with the possible development of side effects when taking a dose of 40 mg, compared with lower doses of the drug, increasing the dose to 40 mg, after additional doses above the recommended initial dose for 4 weeks of therapy, can only be carried out in patients with severe 'the degree of hypercholesterolemia and the 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 which will be monitored cha. It is recommended especially careful monitoring of patients receiving the drug in a dose of 40 mg.

It is not recommended to use a dose of 40 mg in patients who have not previously consulted a doctor. After 2-4 weeks of therapy and / or with an increase in the dose of the drug, control of lipid metabolism parameters is necessary (if necessary, dose correction is required).

Elderly patients

No dose adjustment is required.

Patients with renal insufficiency

In patients with mild or moderate renal insufficiency, dose adjustment is not required.Contraindicated the use of all dosages of the drug in patients with severe renal failure. (SC less than 30 ml / min). Contraindicated use of the drug in a dose of 40 mg to patients with moderate renal dysfunction (CC less than 60 ml / min). Patients with moderate impairment of renal function are recommended an initial dose of 5 mg (1/2 tablet of 10 mg).

Patients with hepatic insufficiency.

Rosuvastatin is contraindicated in patients with liver disease in the active phase. Radel "Contraindications").

The experience of using the drug in patients with hepatic insufficiency above 9 on the Child-Pugh scale is absent.

Special Populations

When studying the pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, there was an increase in the systemic concentration of rosuvastatin among Japanese and Chinese. It should be taken into account when using this drug Rosuvastatin. The canon of this, a group of patients. When using 10 mg and 20 mg doses, the recommended initial dose for patients of the Asian race is 5 mg (1/2 tablet by 10 mg). Contraindicated use of the drug in a dose of 40 mp in patients of the Asian race.

Patients who are predisposed to myopathy

Contraindicated use of the drug in a dose of 40 mg in patients with factors indicating a predisposition to the development of myopathy. When using 10 mg and 20 mg doses, the recommended initial dose for this group of patients is 5 mg (1/2 tablet of 10 mg).

When used with gemfibrozilom the dose of the drug should not exceed 10 mg / day.

Side effects:

Classification of the incidence of side effects is as follows:

very often> 1/10

often from> 1/100 to <1/10

infrequently from> 1/1000 to <1/100

rarely from> 1/10000 to <1/1000

very rarely from <1/10000, including individual messages "

unspecified frequency - the frequency can not be calculated from the available data. The frequency of side effects depends on the dose of the drug taken.

From the central nervous system: often - headache, dizziness, asthenic syndrome; very rarely - polyneuropathy, memory loss.

From the digestive system: often - constipation, nausea, abdominal pain; rarely - pancreatitis; very rarely - jaundice, hepatitis; the frequency of unspecified diarrhea.

From the respiratory system: Unspecified frequency - cough, shortness of breath.

From the musculoskeletal system: often - myalgia; rarely - myopathy (including myositis), rhabdomyolysis with or without acute renal failure; very rarely - arthralgia.

From the urinary system: proteinuria (less than 1% of cases - for doses of 10 mg and 20 mg, 3% cases - for a dose of 40 mg); Unspecified frequency - peripheral edema; very rarely - hematuria.

From the endocrine system: diabetes mellitus type 2.

Allergic reactions: rarely - hypersensitivity reactions, including angioedema; infrequently - itchy skin, rash, hives; Unspecified frequency - Stevens-Johnson syndrome.

Laboratory indicators: transient dose-dependent increase, activity

Creatine phosphokinase (CK) (with an increase in activity of CK more than 5 times compared with the upper limit of the norm, therapy should be temporarily suspended);

reversible transient dose-dependent increase in the activity of "liver" transaminases;

increase in glucose concentration, bilirubin, gamma- glutamyltranspeptidase, alkaline phosphatase, changes in the level of thyroid hormones.

Some of the inhibitors of HMG-CoA reductase (statins) reported the following side effects: depression, sleep disorders, including insomnia and nightmarish dreams, sexual dysfunction.Single cases of interstitial lung disease, especially prolonged use of drugs, have been reported.

Overdose:With the simultaneous administration of several daily doses, the pharmacokinetic parameters of rosuvastatin do not change. Treatment of overdose is symptomatic, control of liver function and activity of CKF is necessary; there is no specific antidote, hemodialysis is ineffective.

Interaction:

Cyclosporine: with simultaneous application of rosuvastatin and cyclosporine AUC rosuvastatin is an average of 7 times higher than that seen in healthy volunteers. Joint application with rosuvastatin results in an increase in Cmah in blood plasma 11 times. Does not affect the plasma concentration of cyclosporine .. Antagonists of vitamin K: the initiation of rosuvastatin therapy or an increase in the dose of the drug in patients receiving both vitamin K antagonists (for example, warfarin), can lead to an increase in prothrombin time (International Normalized Ratio - MHO). The cancellation of rosuvastatin or a decrease in the dose of the drug may lead to a decrease MHO (monitoring is recommended MHO). Gemfibrozil and other lipid-lowering drugs: joint application rosuvastatin and gemfibrozil leads to an increase of 2 times Cmah and AUC rosuvastatin. Based on the data on the specific interaction, no pharmacokinetically significant interaction with fenofibrates is expected, possibly pharmacodynamic interaction.

Gemfibrozil, fenofibrate, other fibrates and lipid-lowering doses of nicotinic acid (large doses or equivalent 1 g per day) increase the risk of myopathy with simultaneous use with HMG-CoA reductase inhibitors, possibly due to the fact that they can cause myopathy and when used in monotherapy . With the simultaneous administration of the drug with gemfibrozilom, fibrates, nicotinic acid in a dose of more than 1 g / day patients are recommended the initial dose of the drug is 5 mg (1/2 tablet of 10 mg).

Ezetimab: The simultaneous use of rosuvastatin and ezetimibe was not accompanied by a change AUC and Cmah both drugs.

HIV protease inhibitors: despite the fact that the exact mechanism of interaction is unknown, the joint administration of HIV protease inhibitors can lead to a significant increase in exposure to rosuvastatin.A pharmacokinetic study on the simultaneous use of 20 mg rosuvastatin with a combined preparation containing two HIV protease inhibitors (400 mg lopinavir / 100 mg ritonavir) in healthy volunteers resulted in approximately a two- and five-fold increase AUC (o-24) and Cmrosuvastatin, respectively. Therefore, simultaneous administration of rosuvastatin and inhibitors, HIV protease in the treatment of patients with human immunodeficiency virus (HIV) is not recommended.

Antacids: simultaneous application of rosuvastatin and suspensions of antacids containing aluminum and magnesium hydroxide leads to a decrease in the plasma concentration of rosuvastatin by approximately 50%. This effect is less pronounced if antacids are administered 2 hours after rosuvastatin administration. The clinical significance of such an interaction has not been studied.

Erythromycin: simultaneous application of rosuvastatin- and erythromycin leads to a decrease AUC rosuvastatin on 20% and Cmah on 30%. Such interaction can arise as a result of increased intestinal motility caused by the intake of erythromycin.

Peroral contraceptives / hormone replacement therapy: simultaneous use of rosuvastatin and oral contraceptives increases AUC ethinylestradiol and AUC norgestrel by 26% and 34%, respectively. Such an increase in plasma concentration should be taken into account when choosing a dose of oral contraceptives. Pharmacokinetic data on simultaneous use of rosuvastatin and hormone replacement therapy are absent, therefore, it is impossible to exclude a similar effect when using this combination.

Other medicines: no clinically significant interaction between rosuvastatin and digoxin is expected.

Cytochrome P450: research results in vivo and in vitro showed that rosuvastatin is neither an inhibitor nor an inducer of cytochrome P450 isoenzymes .. In addition, rosuvastatin is a non-core substrate for these isoenzymes. There was no clinically significant interaction between rosuvastatin and fluconazole (inhibitor of isoenzymes CYP2C9 and CYP3A4) and ketoconazole (inhibitor of isoenzymes CYP2A6 and CYP3A4). Joint use of rosuvastatin. and itraconazole (isoenzyme inhibitor CYP3 A4) increases AUC rosuvastatin by 28% (it is clinically insignificant). Thus, the interaction associated with metabolism through the cytochrome P450 system is not expected.

Special instructions:

Before the start of therapy and throughout the treatment period, a standard lipid-lowering diet should be followed. During treatment, every 2-4 weeks, the lipid profile should be monitored and, if necessary, adjusted the dose of the drug.

When rosuvastatin is used in all doses, and in particular at a dose exceeding 20 mg, short-term proteinuria can be observed. In patients taking the drug at a dose of 40 mg, it is recommended to monitor the indicators of kidney function. In patients receiving rosuvastatin in a dose exceeding 20 mg, there may be myalgia, myopathy, rarely rhabdomyolysis. Determination of the activity of CKD should not be performed after intensive physical exertion or in the presence of other possible causes of increase in CK, which may lead to incorrect interpretation of the results. With an increase in CK 5 times higher than the upper limit of the norm, a second measurement should be made after 5-7 days.Do not start therapy if the repeated test confirms the initial increased activity of CK more than 5 times compared with the upper limit of the norm.

In patients at risk of developing myopathy / rhabdomyolysis, the risk-to-benefit ratio of therapy should be considered and clinical observation performed throughout the treatment course.

The patient should be informed of the need to report immediately to the doctor if there is an unexpected occurrence of "muscle aches, muscle weakness, or spasms, especially in combination with malaise and fever;" "These patients should monitor the activity of CK." The therapy should be discontinued if the activity of CK is increased by more than in 5 times in comparison with the upper limit of the norm, or if the muscular symptoms are pronounced and cause daily discomfort (even if the activity of CK is 5 times less compared to the upper limit If symptoms disappear and CPK activity returns to normal, consideration should be given to re-administering the drug or other HMG-CoA reductase inhibitors in smaller doses under close medical supervision.Routine monitoring of CKK in the absence of symptoms of rhabdomyolysis is not advisable.

An increase in the incidence of myositis and myopathy was reported in patients taking other HMG-CoA reductase inhibitors in combination with fibrin acid derivatives, including gemfibrozil, ciclosporin, nicotinic acid in lipid-lowering doses, azole antifungal agents, HIV protease inhibitors and macrolide antibiotics. Gemfibrozil increases the risk of myopathy when combined with certain HMG-CoA reductase inhibitors. Thus, simultaneous use of rosuvastatin and gemfibrozil is not recommended. A balance of risk and possible benefit should be carefully weighed in the combined use of rosuvastatin and fibrates or nicotinic acid in lipid-lowering doses.

It is recommended to perform the determination of liver function indices before the beginning of therapy and after 3 months; after the start of therapy. If the activity of "hepatic" transaminases in the blood serum, 3 times higher than the upper limit of the norm, the dose of the drug should be reduced or stopped.

When a combination of hypercholesterolemia and hypothyroidism or nephrotic syndrome, therapy for major diseases should be performed prior to the initiation of treatment with rosuvastatin; An increase in the plasma concentration of rosuvastatin in patients of the Asian race compared with patients of the Caucasian race was noted.

In patients with a glucose concentration of 5.6 to 6.9 mmol / L, rosuvastatin was associated with an increased risk of developing type 2 diabetes mellitus.

Women of reproductive age should apply adequate methods of contraception.

During the treatment period, dizziness and weakness may occur, so care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated 10 mg, 20 mg and 40 mg.

Packaging:

For 7, 10, 30 tablets (for dosages of 10 mg and 20 mg) or 7, 10 tablets (for a dosage of 40 mg) in a polyvinyl chloride film, PVC / PVDC film, PVC / G1XTFE films or aluminum foil foil and foil aluminum printed varnished.

1, 2, 4, 8, contour cell packs 7 tablets or 1, 2, 3, 6 contour cell packs of 10 tablets, or 1, 2 blisters but 30 tablets with instruction but the application is placed in a wad of cardboard.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001216

Date of registration:16.11.2011

Date of cancellation:2016-11-16

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Information update date: & nbsp02.06.2016

Illustrated instructions

Instructions

Rosuvastatin Canon (Rosuvastatin Canon)