Expiration date: 08/2025

The composition and form of issue: 

Tablets, film-coated 1 tablet contains active substance: 

rosuvastatin (as rosuvastatin calcium) 5, 10, 20 or 40 mg

excipients: lactose monohydrate microcrystalline calcium phosphate crospovidone magnesium stearate 

shell tablets: lactose monohydrate hypromellose triacetin (glycerol triacetate) titanium dioxide dye iron oxide yellow (PL. 5 mg) or iron oxide red (table. 10, 20, 40 mg) 

blistere in 14 PCs the paper cartons 2 blister packs (tab. for 5, 20 mg), or blistere in 7 or 14 PCs. in cardboard pack 1 or 2 blisters, respectively (table. 10 mg), or blistere 7 PC., in a cardboard bundle 4 blisters (table. 40 mg).

Description pharmaceutical form:

Tablets 5 mg: round, biconvex, film-coated yellow color, engraved ZD4522 and 5 on one side.

Tablets 10 mg: round, biconvex, film-coated pink, engraved ZD4522 and 10 on one side.

Tablet 20 mg: round, biconvex, film-coated pink, engraved ZD4522 20 on one side.

Pills 40 mg: oval, biconvex, film-coated pink, engraved ZD4522 on one side and 40 on the other.

Indications:

• primary hypercholesterolemia Fredrickson's (type IIa, including family heterozygous hypercholesterolemia) hypercholesterolemia or mixed (type IIb) as an adjunct to diet when diet and other non-pharmacological treatments (e.g. exercise, weight reduction) are inadequate
  
• family homozygous hypercholesterolemia as an adjunct to diet and other lepidotrigla therapy (eg, LDL-apheresis), or in cases where such treatment is not effective enough
  
• hypertriglyceridemia (type IV according to Fredrickson) as a Supplement to the diet.
  
• for slowing the progression of atherosclerosis as an adjunct to diet in patients who have shown therapy for reducing the concentration of total cholesterol (TC) and cholesterol-LDL.
  
• primary prevention of major cardiovascular complications (stroke, infarction, arterial revascularization) in adults without clinical signs of CHD, but with an increased risk of its development (age older than 50 years for men and over 60 for women, elevated C-reactive protein concentration (&ge2 mg/l) in the presence of at least one of additional risk factors such as hypertension, low concentration of HDL-C, Smoking, family history of early CHD).
  

Contraindications:

For the drug Crestor in a daily dose of 5, 10 and 20 mg:

• hypersensitivity to rosuvastatin or any component of the drug
  
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption (product contains lactose)
  
• children up to age 18 years
  
• liver disease in the active phase, including a persistent increase in serum transaminases and any increase in transaminaz in the serum (more than 3 times compared with CAH)
  
• expressed by the human kidney (Cl creatinine less than 30 ml/min)
  
• myopathy
  
• concomitant use of cyclosporine
  
• in women: pregnancy, lactation, inadequate contraceptive methods
  
• patients predisposed to the development myotoxicity complications.
  

For the drug Crestor in a daily dose of 40 mg:

• hypersensitivity to rosuvastatin or any component of the drug
  
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption (product contains lactose)
  
• children up to age 18 years
  
• concomitant use of cyclosporine
  
• in women: pregnancy, lactation, inadequate contraceptive methods
  
• liver disease in the active phase, including a persistent increase in serum transaminases and any increase in transaminaz in the serum (more than 3 times compared with CAH) patients with risk factors for myopathy/rhabdomyolysis, namely:
  
• renal failure of moderate severity (Cl creatinine less than 60 ml/min)
  
• hypothyroidism
  
• personal or family history of muscle disease
  
• myotoxicity on a background of reception of other inhibitors of HMG-COA reductase inhibitors or fibrates in history
  
• excessive alcohol consumption
  
• condition, which can lead to increased plasma concentrations of rosuvastatin
  
• concurrent administration of fibrates
  
• patients of the Mongoloid race.
  

With caution

For the drug Crestor in a daily dose of 5, 10 and 20 mg: the risk of myopathy/rhabdomyolysis — renal impairment, hypothyroidism, personal or family history of hereditary muscular diseases and previous history of muscular toxicity with other inhibitors of HMG-COA reductase inhibitors or fibrates excessive alcohol use age over 65 years, which is marked by an increase in plasma concentrations of rosuvastatin race (Mongoloid race) co-administration with fibrates liver disease history of sepsis with arterial hypotension, extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disorders or uncontrolled seizures.

For the drug Crestor in a daily dose of 40 mg: renal failure a low degree of impairment (Cl creatinine more than 60 ml/min) age older than 65 years of liver disease history of sepsis, arterial hypotension, extensive surgical interventions, injuries, severe metabolic, endocrine or electrolyte disorders or uncontrolled seizures.

Patients with hepatic insufficiency

Data or experience with the drug in patients with more than 9 points on a scale child-Pugh missing (see "Special instructions").

Application in pediatric practice

The efficacy and safety of the drug in children under 18 years not installed. The experience of the drug in pediatric practice limited to a small number of children (8 years and older) family homozygous hypercholesterolemia. Currently not recommended Crestor children up to 18 years.

Application of pregnancy and breast-feeding:

Crestor is contraindicated in pregnancy and lactation.

Women of childbearing age should use adequate methods of contraception.

Since cholesterol and other products of cholesterol biosynthesis are important for the development of the fetus, the potential risk of inhibition of HMG-COA reductase is greater than the benefit derived from the use of the drug in pregnant women.

In case of pregnancy during therapy, the drug should be discontinued immediately.

Data concerning the allocation of rosuvastatin in breast milk are not available therefore in the period of breast-feeding, the drug should be discontinued (see section "Contraindications").

Side effects:

Common to all dosages of the drug Crestor

Side effects observed while taking the drug Crestor, usually expressed slightly and are themselves. As the use of other inhibitors of HMG-COA reductase inhibitor, the incidence of side effects is mainly dose-dependent nature.

The incidence of adverse effects as follows:

often (> 1/100, <1/10) uncommon (>1/1000, <1/100) rare (>1/10 000, <1/1 000) very rare (<1/10 000), including individual messages.

Immune system: rarely — hypersensitivity reactions, including angioedema.

CNS: frequently — headache, dizziness.

From the digestive tract: often — constipation, nausea, abdominal pain, rarely — pancreatitis.

With the skin: rarely — itching, rash, hives.

From the side of musculoskeletal system: often — myalgia, rarely — myopathy (including myositis), rhabdomyolysis.

Other: often — asthenic syndrome.

From the side of urinary system: in patients receiving Crestor, may reveal proteinuria. Change the amount of protein in the urine (absence or trace quantities to ++ or more) occur less than 1% of the patients receiving 10-20 mg of the drug, and approximately 3% of patients receiving 40 mg of drug. A slight change in the amount of protein in the urine was observed after the oral dose of 20 mg. In most cases, proteinuria decreases or disappears during therapy and does not mean the occurrence of acute or progression of existing renal diseases.

From the side of musculoskeletal system: in applying the drug Crestor at all doses and in particular when taking doses exceeding 20 mg, reports the following effects in the musculoskeletal system: myalgia, myopathy (including myositis), in rare cases rhabdomyolysis with acute renal failure.

A dose-dependent increase in the activity of creatine phosphokinase (CPK) was observed in a small number of patients taking rosuvastatin. In most cases it was insignificant, asymptomatic and transient. In the case of increasing the activity of KFK (more than 5 times compared with CAH) therapy should be suspended (see "Special instructions").

The liver: the use of rosuvastatin observed a dose-dependent increase in liver transaminases in a small number of patients. In most cases this is not significant, asymptomatic and temporary.

Laboratory findings: in applying the drug Crestor was also observed following changes in laboratory parameters: increased concentrations of glucose, bilirubin, activity of gamma-glutamyl transpeptidase, alkaline phosphatase, disorders of thyroid function.

For the dosage of the drug Crestor 5 mg, optionally

Endocrine system: often — diabetes mellitus type 2.

Post-marketing use.

Common dosages

It was reported the following side effects in post-marketing use of the drug Crestor:

From the digestive tract: rarely — jaundice, hepatitis, rarely — increase in liver transaminases unspecified frequency — diarrhea.

From the side of musculoskeletal system: very rarely — artralgia.

CNS: rarely — polyneuropathy, memory loss.

From the side of urinary system: rarely — hematuria.

On the part of the skin and subcutaneous fat: unspecified frequency — Stevens-Johnson syndrome.

Other: unspecified frequency — peripheral edema.

In the application of certain statins was reported the following side effects: depression, sleep disturbances, including insomnia and nightmares, sexual dysfunction. It was reported about rare cases of interstitial lung disease, especially with long-term use of the drug (see "Special instructions").

For the dosage of the drug Crestor 5 mg, optionally

The respiratory system: unspecified frequency — cough, shortness of breath.

Method of application and dose:

Inside, without chewing or crushing the pill by swallowing whole with plenty of water. The drug may be administered at any time of the day regardless of the meal.

Before the start of drug therapy Crestor patient should begin to follow standard cholesterol-lowering diet and continue to observe her during treatment. The dose should be chosen individually depending on the goals of therapy and therapeutic response to treatment, taking into account the current recommendations for target levels of lipids.

The recommended initial dose for patients who start taking the drug or for patients transferred from the reception of other inhibitors of HMG-COA reductase, should be 5 or 10 mg drug Crestor 1 per day. When selecting the starting dose should be guided by the individual content of cholesterol and to take into account the possible risk of cardiovascular complications, and to assess the potential risk of side effects. If necessary, the dose may be increased to greater over 4 weeks.

In connection with the possible development of side effects when taking doses of 40 mg compared with lower doses of the drug (see section "Side effects"), increasing the dose to 40 mg after an additional dose above the recommended starting dose over 4 weeks of treatment can be carried out only in patients with severe hypercholesterolemia and high risk of cardiovascular complications (especially in patients with familial hypercholesterolemia) who have not achieved the desired outcome of therapy at the dose of 20 mg and who will be under the supervision of a specialist (see the section "Special instructions"). Especially advised careful monitoring of patients receiving the drug in a dose of 40 mg.

Not recommended administration of a dose of 40 mg patients not previously applied to the doctor. After 2-4 weeks of therapy and/or with increasing doses of the drug Crestor is necessary to control lipid metabolism (if necessary, dose adjustment is required).

Elderly patients

No dose adjustment is required.

Patients with renal insufficiency

In patients with renal insufficiency mild or moderate severity dose adjustment is not required. In patients with severe renal insufficiency (Cl creatinine less than 30 ml/min) of the drug Crestor is contraindicated. The drug is contraindicated in the dose of 40 mg for patients with moderate renal impairment (Cl creatinine 30-60 ml/min) (see section "Special instructions"). Patients with moderate renal impairment, the recommended initial dose of 5 mg.

Patients with hepatic insufficiency

Crestor is contraindicated in patients with liver disease in the active phase (see section "Contraindications").

A special population. Ethnic groups

In the study of pharmacokinetic parameters of rosuvastatin in patients belonging to different ethnic groups, the marked increase in systemic concentrations of rosuvastatin among Japanese and Chinese (see "Special instructions"). You should consider this fact when administering the drug Crestor these groups of patients. When assigning doses 10 and 20 mg the recommended starting dose for patients of the Mongoloid race is 5 mg. Contraindicated use of the drug at a dose of 40 mg patients of the Mongoloid race (see "Contraindications").

Patients predisposed to myopathy

Contraindicated use of the drug at a dose of 40 mg patients with factors that may indicate a predisposition to the development of myopathy (see section "Contraindications"). When assigning doses 10 and 20 mg the recommended initial dose for this group of patients is 5 mg (see section "Contraindications")

Overdose:

While receiving multiple daily doses pharmacokinetic parameters of rosuvastatin are not changed.

Treatment: specific treatment of overdose of rosuvastatin are there. In case of overdose recommended symptomatic treatment and measures aimed at maintaining the functions of vital organs and systems. Requires monitoring of liver function and CPK level. It is unlikely that dialysis will be effective.

Special instructions:

Common to all dosages of the drug Crestor

Renal effects

Patients receiving high doses of the drug Crestor (mainly 40 mg) was observed tubular proteinuria, which in most cases were transient. This proteinuria was not indicative of acute kidney disease or the progression of kidney disease. In patients receiving the drug at a dose of 40 mg, it is recommended to monitor indicators of kidney function during treatment.

From the musculoskeletal system

In applying the drug Crestor at all doses and in particular when taking doses exceeding 20 mg, reports the following effects in the musculoskeletal system: myalgia, myopathy, and in rare cases rhabdomyolysis.

Determination of creatine phosphokinase

Determination of activity of KFK should not be after intense exercise or if there are other possible reasons for the increased activity of KFK, which may lead to misinterpretation of the results. If the initial activity of CPK significantly increased (5 times higher than the ULN), 5-7 days should be measured again. You should not start the therapy if the second test confirms the initial activity of KFK (above more than 5 times compared with CAH).

Before therapy

In appointing the drug Crestor, as with other inhibitors of HMG-COA reductase inhibitors, caution should be exercised in patients with existing risk factors for myopathy/rhabdomyolysis (see section "caution"), it is necessary to consider the balance of risk and potential benefits of therapy and to conduct clinical observation.

During therapy

Should inform the patient about the need for an immediate message to the doctor about the cases of sudden occurrence of muscle pain, muscle weakness or cramps, especially in combination with malaise and fever. These patients should determine the activity of KFK. Therapy should be discontinued if the CPK activity increased significantly (more than 5 times compared with CAH), or if symptoms from muscles are pronounced and cause daily discomfort (even if ck activity less than 5 times compared with CAH). If the symptoms disappear, and the activity of CPK returns to normal, you should consider re-appointment of the drug Crestor or other inhibitors of HMG-COA reductase in smaller doses with careful monitoring of the patient.

Routine monitoring of CPK in the absence of symptoms is inappropriate.

There were no signs of increased exposure to skeletal muscles when taking the drug Crestor and concomitant therapy. However, there is a reported increase in the incidence of myositis and myopathy in patients taking other inhibitors of HMG-COA reductase inhibitor in combination with fibrin acid derivatives, including gemfibrozil, ciclosporin, nicotinic acid, azole antifungal agents, protease inhibitors and macrolide antibiotics. Gemfibrozil increases risk of myopathy when used together with some inhibitors of HMG-COA reductase. Thus, not recommended simultaneous application of the drug Crestor® and gemfibrozil. Must be carefully weighed the risks and potential benefits in a joint application of the drug Crestor and fibrates or lepidosperma doses of nicotinic acid. Contraindicated taking the drug Crestor at a dose of 40 mg together with fibrates. (see "Contraindications").

Within 2-4 weeks after the start of treatment or when the dose of the drug Crestor is necessary to control lipid metabolism (if necessary, dose adjustment is required).

Liver

Recommended definition of indicators of liver function before therapy and 3 months after initiation of therapy. Taking the drug Crestor, discontinue or reduce the dose if transaminases activity in blood serum in 3 times the VGN.

In patients with hypercholesterolemia due to hypothyroidism or nefroticski syndrome therapy major diseases should be carried out before starting treatment with the drug Crestor.

A special population. Ethnic groups

During pharmacokinetic studies among Chinese and Japanese patients was an increase in systemic concentrations of rosuvastatin compared with figures obtained among patients-Caucasians (see sections "Method of application and dosage").

HIV protease inhibitors

Does not recommend the combined use of the drug with inhibitors of HIV protease.

Lactose

The drug should not be used in patients with lactase deficiency, galactose intolerance and glucose-galactose malabsorption.

Effects on ability to drive and other mechanisms. There were no studies on the effects of the drug Crestor on the ability to drive vehicles and use machinery. Use caution when driving or work requiring high concentration and psychomotor speed reactions (during treatment may occur dizziness).

For the dosage of the drug Crestor 5 mg, optionally

Interstitial lung disease

In the application of certain statins, especially for a long time, it was reported about rare cases of interstitial lung disease. Symptoms can be shortness of breath, non-productive cough and deterioration in General health (fatigue, weight loss and fever). In cases of suspected interstitial lung disease, discontinue statin therapy.

Diabetes mellitus type 2

In patients with concentration of glucose from 5.6 to 6.9 mmol/l therapy drug Crestor was associated with an increased risk of developing diabetes type 2.

Review:

Before using the drug you must read the instructions for use.