Simvastatin (Tablets) Instructions for Use
ATC Code
C10AA01 (Simvastatin)
Active Substance
Simvastatin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Hypolipidemic agent
Pharmacotherapeutic Group
Hypolipidemic agent – HMG-CoA reductase inhibitor
Pharmacological Action
A hypolipidemic agent, obtained synthetically from a fermentation product of Aspergillus terreus, is an inactive lactone that undergoes hydrolysis in the body to form a hydroxy acid derivative.
The active metabolite inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes the initial reaction of mevalonate formation from HMG-CoA.
Since the conversion of HMG-CoA to mevalonate is an early stage in cholesterol synthesis, the use of simvastatin does not cause the accumulation of potentially toxic sterols in the body.
HMG-CoA is easily metabolized to acetyl-CoA, which is involved in many synthesis processes in the body.
It causes a decrease in the plasma levels of triglycerides (TG), low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), and total cholesterol (in cases of heterozygous familial and non-familial forms of hypercholesterolemia, and in mixed hyperlipidemia when elevated cholesterol is a risk factor).
It increases the level of high-density lipoproteins (HDL) and reduces the LDL/HDL ratio and the total cholesterol/HDL ratio.
The onset of the effect is within 2 weeks from the start of administration, the maximum therapeutic effect is achieved after 4-6 weeks. The effect persists with continued treatment; upon discontinuation of therapy, cholesterol levels gradually return to the initial level.
Pharmacokinetics
The absorption of simvastatin is high.
After oral administration, Cmax in plasma is reached in approximately 1.3 – 2.4 hours and decreases by 90% after 12 hours.
Plasma protein binding is about 95%.
It is metabolized in the liver, has a first-pass effect through the liver (hydrolyzed to form an active derivative: beta-hydroxy acid, other active as well as inactive metabolites have been detected).
The T1/2 of active metabolites is 1.9 hours. It is excreted mainly in the feces (60%) as metabolites. About 10-15% is excreted by the kidneys in an inactive form.
Indications
Hypercholesterolemia
- Primary hypercholesterolemia (type IIa and IIb) when a low-cholesterol diet and other non-drug measures (physical activity and weight reduction) are ineffective in patients with an increased risk of coronary atherosclerosis;
- Combined hypercholesterolemia and hypertriglyceridemia, not corrected by a special diet and physical activity.
Coronary heart disease
- For the prevention of myocardial infarction, to reduce the risk of death, to reduce the risk of cardiovascular events (stroke or transient ischemic attacks), to slow the progression of coronary atherosclerosis, to reduce the risk of revascularization procedures.
ICD codes
| ICD-10 code | Indication |
| E78.0 | Pure hypercholesterolemia |
| E78.1 | Pure hyperglyceridemia |
| E78.2 | Mixed hyperlipidemia |
| G45 | Transient cerebral ischemic attacks [TIAs] and related syndromes |
| I21 | Acute myocardial infarction |
| I25.1 | Atherosclerotic heart disease |
| I61 | Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type) |
| I63 | Cerebral infarction |
| ICD-11 code | Indication |
| 5C80.00 | Primary hypercholesterolemia |
| 5C80.1 | Hypertriglyceridemia |
| 5C80.2 | Mixed hyperlipidemia |
| 8B00.Z | Intracerebral hemorrhage of unspecified site, unspecified |
| 8B10.Z | Transient ischemic attack, unspecified |
| 8B11 | Cerebral ischemic stroke |
| BA41.Z | Acute myocardial infarction, unspecified |
| BA52.Z | Atherosclerosis of coronary arteries, site unspecified |
| EB90.21 | Tuberous xanthoma |
| EB90.22 | Eruptive xanthoma |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Tablets
Before starting treatment with simvastatin, the patient should be prescribed a standard hypocholesterolemic diet, which must be followed throughout the entire course of treatment.
Simvastatin should be taken orally once a day in the evening, with a sufficient amount of water.
The time of taking the drug should not be associated with food intake.
The recommended dose of simvastatin for the treatment of hypercholesterolemia ranges from 10 to 80 mg once a day in the evening.
The recommended initial dose of the drug for patients with hypercholesterolemia is 10 mg.
The maximum daily dose is 80 mg.
Dose adjustments (titration) should be made at intervals of 4 weeks.
In most patients, the optimal effect is achieved when taking the drug in doses up to 20 mg/day.
In patients with homozygous hereditary hypercholesterolemia, the recommended daily dose of simvastatin is 40 mg once a day in the evening or 80 mg in 3 divided doses (20 mg in the morning, 20 mg in the afternoon, and 40 mg in the evening).
In the treatment of patients with coronary heart disease (CHD) or at high risk of developing CHD, effective doses of simvastatin are 20-40 mg/day.
Therefore, the recommended initial dose in such patients is 20 mg/day.
Dose adjustments (titration) should be made at intervals of 4 weeks; if necessary, the dose can be increased to 40 mg/day.
If the LDL level is less than 75 mg/dL (1.94 mmol/L), the total cholesterol level is less than 140 mg/dL (3.6 mmol/L), the dose of the drug must be reduced.
In elderly patients and in patients with mild or moderate renal impairment, no changes in the dosage of the drug are required.
In patients with chronic renal failure (creatinine clearance less than 30 ml/min) or those taking cyclosporine, danazol, gemfibrozil or other fibrates (except fenofibrate), niacin in lipid-lowering doses (> 1 g/day) in combination with simvastatin, the maximum recommended dose of simvastatin should not exceed 10 mg/day.
For patients taking amiodarone or verapamil simultaneously with simvastatin, the daily dose of simvastatin should not exceed 20 mg.
Adverse Reactions
Digestive system: abdominal pain, constipation, flatulence, nausea, diarrhea, pancreatitis, vomiting, hepatitis, increased activity of liver enzymes, alkaline phosphatase and creatine phosphokinase (CPK) may occur.
Nervous system and sensory organs: asthenic syndrome, headache, dizziness, insomnia, muscle cramps, paresthesia, peripheral neuropathy, blurred vision, taste disturbance.
Allergic and immunopathological reactions: angioedema, polymyalgia rheumatica, vasculitis, thrombocytopenia, increased ESR, fever, arthritis, urticaria, photosensitivity, skin hyperemia, flushing, dyspnea, lupus-like syndrome, eosinophilia.
Dermatological reactions: rarely skin rash, itching, alopecia, dermatomyositis.
Musculoskeletal system: myopathy, myalgia, muscle cramps, weakness; rarely – rhabdomyolysis.
Other: anemia, palpitations, acute renal failure (due to rhabdomyolysis), decreased potency.
Contraindications
- Active liver disease, persistent increase in liver enzyme activity of unclear etiology;
- Skeletal muscle diseases (myopathy);
- Age under 18 years (efficacy and safety not established);
- Hypersensitivity to simvastatin or other components of the drug (including hereditary lactose intolerance), as well as to other drugs of the statin class (HMG-CoA reductase inhibitors) in the medical history.
Use with caution in patients who abuse alcohol, in patients after organ transplantation who are receiving therapy with immunosuppressants (due to an increased risk of rhabdomyolysis and renal failure); in conditions that can lead to the development of severe renal failure, such as arterial hypotension, severe acute infectious diseases, severe metabolic and endocrine disorders, water and electrolyte imbalances, surgical interventions (including dental) or trauma; in patients with decreased or increased skeletal muscle tone of unclear etiology; epilepsy.
Use in Pregnancy and Lactation
Simvastatin is contraindicated in pregnant women. There are several reports of abnormalities in newborns whose mothers took Simvastatin. Women of childbearing potential taking Simvastatin should avoid conception. If pregnancy occurs during treatment, Simvastatin should be discontinued, and the woman should be warned about the potential hazard to the fetus.
Data on the excretion of simvastatin in breast milk are not available. If it is necessary to prescribe simvastatin during breastfeeding, it should be taken into account that many drugs are excreted in breast milk, and there is a risk of developing severe reactions, therefore breastfeeding is not recommended while taking the drug.
Use in Hepatic Impairment
Contraindications: active liver disease, persistent increase in liver enzyme activity of unclear etiology.
Use in Renal Impairment
In patients with mild or moderate renal impairment, no changes in the dosage of the drug are required.
In patients with chronic renal failure (creatinine clearance less than 30 ml/min) or those taking cyclosporine, danazol, gemfibrozil or other fibrates (except fenofibrate), niacin in lipid-lowering doses (> 1 g/day) in combination with simvastatin, the maximum recommended dose of simvastatin should not exceed 10 mg/day.
Pediatric Use
Contraindication: age under 18 years (efficacy and safety not established).
Geriatric Use
In elderly patients, no changes in the dosage of the drug are required.
Special Precautions
At the beginning of simvastatin therapy, a transient increase in liver enzyme levels is possible.
Before starting therapy and then regularly, liver function tests should be performed (monitor liver enzyme activity every 6 weeks for the first 3 months, then every 8 weeks for the remainder of the first year, and then once every six months), and also when increasing doses, a liver function test should be performed.
When increasing the dose to 80 mg, the test should be performed every 3 months.
If there is a persistent increase in transaminase activity (3 times above the initial level), simvastatin should be discontinued.
Simvastatin, like other HMG-CoA reductase inhibitors, should not be used when there is an increased risk of developing rhabdomyolysis and renal failure (against the background of severe acute infection, arterial hypotension, planned major surgery, trauma, severe metabolic disorders).
Discontinuation of hypolipidemic agents during pregnancy does not significantly affect the results of long-term treatment of primary hypercholesterolemia.
Since HMG-CoA reductase inhibitors inhibit cholesterol synthesis, and cholesterol and other products of its synthesis play a significant role in fetal development, including the synthesis of steroids and cell membranes, Simvastatin may have an adverse effect on the fetus when administered to pregnant women (women of reproductive age should avoid conception). If pregnancy occurs during treatment, the drug must be discontinued, and the woman should be warned about the potential hazard to the fetus.
The use of simvastatin is not recommended in women of childbearing potential who are not using contraception.
In patients with reduced thyroid function (hypothyroidism) or in the presence of certain kidney diseases (nephrotic syndrome) with elevated cholesterol levels, therapy for the underlying disease should be conducted first.
Simvastatin should be prescribed with caution to persons who abuse alcohol and/or have a history of liver disease.
Before starting and during treatment, the patient must be on a hypocholesterolemic diet.
Concomitant intake of grapefruit juice may increase the severity of side effects associated with simvastatin intake, so their simultaneous use should be avoided.
Simvastatin is not indicated in cases where there is hypertriglyceridemia of types I, IV and V.
Treatment with simvastatin can cause myopathy, leading to rhabdomyolysis and renal failure.
The risk of this pathology increases in patients receiving one or more of the following drugs simultaneously with simvastatin: fibrates (gemfibrozil, fenofibrate), cyclosporine, nefazodone, macrolides (erythromycin, clarithromycin), antifungal agents from the azole group (ketoconazole, itraconazole) and HIV protease inhibitors (ritonavir).
The risk of developing myopathy is also increased in patients with severe renal failure.
All patients starting therapy with simvastatin, as well as patients who need to increase the dose of the drug, should be warned about the possibility of myopathy and the need to immediately consult a doctor in case of unexplained pain, muscle tenderness, lethargy or muscle weakness, especially if this is accompanied by malaise or fever. Therapy with the drug should be stopped immediately if myopathy is diagnosed or suspected.
To diagnose the development of myopathy, it is recommended to regularly measure CPK levels.
During treatment with simvastatin, an increase in serum CPK levels is possible, which should be taken into account in the differential diagnosis of chest pain. The criterion for drug withdrawal is an increase in serum CPK levels more than 10 times the upper limit of normal. In patients with myalgia, muscle weakness and/or a marked increase in CPK activity, treatment with the drug is discontinued.
The drug is effective both as monotherapy and in combination with bile acid sequestrants.
In case of missing a current dose, the drug should be taken as soon as possible.
If it is time for the next dose, the dose should not be doubled.
Patients with severe renal failure should be treated under the control of renal function.
The duration of the drug use is determined individually by the attending physician.
Effect on ability to drive vehicles and operate machinery
No adverse effects of simvastatin on the ability to drive a car or operate machinery have been reported.
Overdose
In none of the few known cases of overdose (maximum dose taken 450 mg) were any specific symptoms identified.
Treatment: induce vomiting, take activated charcoal. Symptomatic therapy. Liver and kidney functions, serum CPK levels should be monitored.
If myopathy with rhabdomyolysis and acute renal failure develops (a rare but severe side effect), the drug should be discontinued immediately and the patient should be given a diuretic and sodium bicarbonate (intravenous infusion). Hemodialysis is indicated if necessary.
Rhabdomyolysis can cause hyperkalemia, which can be eliminated by intravenous administration of calcium chloride or calcium gluconate, infusion of glucose with insulin, the use of potassium ion exchangers or, in severe cases, by hemodialysis.
Drug Interactions
Cytostatics, antifungal agents (ketoconazole, itraconazole), fibrates, high doses of nicotinic acid, immunosuppressants, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone increase the risk of developing myopathy.
Cyclosporine or danazol: the risk of developing myopathy/rhabdomyolysis increases with the concomitant administration of cyclosporine or danazol with high doses of simvastatin.
Other hypolipidemic agents capable of causing myopathy: the risk of developing myopathy increases with the concomitant administration of other hypolipidemic agents that are not potent inhibitors of CYP3A4 but are capable of causing myopathy during monotherapy. Such as gemfibrozil and other fibrates (except fenofibrate), as well as niacin (nicotinic acid) in a dose of > 1 g/day.
Amiodarone and verapamil: the risk of developing myopathy increases with the concomitant use of amiodarone or verapamil with high doses of simvastatin.
Diltiazem: the risk of developing myopathy slightly increases in patients receiving diltiazem simultaneously with simvastatin at a dose of 80 mg.
Simvastatin potentiates the effect of oral anticoagulants (e.g., phenprocoumon, warfarin) and increases the risk of bleeding, which requires monitoring of blood coagulation parameters before starting treatment, and also quite frequently during the initial period of therapy. Once a stable level of prothrombin time or International Normalized Ratio (INR) is achieved, further monitoring should be performed at intervals recommended for patients receiving anticoagulant therapy. When changing the dosage or discontinuing simvastatin, prothrombin time or INR should also be monitored according to the above scheme.
Simvastatin therapy does not cause changes in prothrombin time and the risk of bleeding in patients not taking anticoagulants. It increases the plasma level of digoxin.
Cholestyramine and colestipol reduce bioavailability (simvastatin can be used 4 hours after taking these drugs, while an additive effect is noted).
Grapefruit juice contains one or more components that inhibit CYP3A4 and can increase the plasma concentration of drugs metabolized by CYP3A4. The increase in the activity of HMG-CoA reductase inhibitors after consuming 250 ml of juice per day is minimal and has no clinical significance. However, consumption of large volumes of juice (more than 1 liter per day) while taking simvastatin significantly increases the level of inhibitory activity against HMG-CoA reductase in the plasma. Therefore, it is necessary to avoid consuming large quantities of grapefruit juice.
Storage Conditions
Store in a place inaccessible to children at a temperature from 15°C (59°F) to 25°C (77°F).
Shelf Life
Shelf life – 2 years.
Dispensing Status
The drug is dispensed by prescription.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Film-coated tablets, 10 mg: 10, 30, 50, or 100 pcs.
Film-coated tablets, 20 mg: 10, 30, 50, or 100 pcs.
Film-coated tablets, 40 mg: 10, 30, 50, or 100 pcs.
Film-coated tablets, 80 mg: 10, 30, 50, or 100 pcs.
Marketing Authorization Holder
Aurobindo Pharma, Ltd. (India)
Dosage Forms
 |
Simvastatin | Film-coated tablets, 10 mg: 10, 30, 50, or 100 pcs. |
| Film-coated tablets, 20 mg: 10, 30, 50, or 100 pcs. | ||
| Film-coated tablets, 40 mg: 10, 30, 50, or 100 pcs. | ||
| Film-coated tablets, 80 mg: 10, 30, 50, or 100 pcs. |
Dosage Form, Packaging, and Composition
| Film-coated tablets | 1 tab. |
| Simvastatin | 10 mg |
10 pcs. – blister (1) – cardboard packs.
10 pcs. – blister (3) – cardboard packs.
10 pcs. – blister (5) – cardboard packs.
10 pcs. – blister (10) – cardboard packs.
| Film-coated tablets | 1 tab. |
| Simvastatin | 20 mg |
10 pcs. – blister (1) – cardboard packs.
10 pcs. – blister (3) – cardboard packs.
10 pcs. – blister (5) – cardboard packs.
10 pcs. – blister (10) – cardboard packs.
| Film-coated tablets | 1 tab. |
| Simvastatin | 40 mg |
10 pcs. – blister (1) – cardboard packs.
10 pcs. – blister (3) – cardboard packs.
10 pcs. – blister (5) – cardboard packs.
10 pcs. – blister (10) – cardboard packs.
| Film-coated tablets | 1 tab. |
| Simvastatin | 80 mg |
10 pcs. – blister (1) – cardboard packs.
10 pcs. – blister (3) – cardboard packs.
10 pcs. – blister (5) – cardboard packs.
10 pcs. – blister (10) – cardboard packs.
Film-coated tablets, 10 mg: 20 pcs.
Coated tablets, 20 mg: 20 pcs.
Marketing Authorization Holder
Hemofarm, A.D. (Serbia)
Contact Information
HEMOFARM A.D. (Serbia)
Dosage Forms
|
Simvastatin | Film-coated tablets, 10 mg: 20 pcs. |
| Coated tablets, 20 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets white, round, biconvex, with a score on one side.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: lactose, pregelatinized starch, microcrystalline cellulose, talc (magnesium hydrosilicate), magnesium stearate, butylated hydroxyanisole.
Coating composition: hypromellose (hydroxypropylcellulose), hypromellose, titanium dioxide (E171), talc (magnesium hydrosilicate).
10 pcs. – blisters (2) – cardboard packs.
Coated tablets white, round, biconvex, with a score on one side.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: lactose, pregelatinized starch, microcrystalline cellulose, talc (magnesium hydrosilicate), magnesium stearate, butylated hydroxyanisole.
Coating composition: hypromellose (hydroxypropylcellulose), hypromellose, titanium dioxide (E171), talc (magnesium hydrosilicate).
10 pcs. – blisters (2) – cardboard packs.
Film-coated tablets, 10 mg: 28 or 30 pcs.
Film-coated tablets, 20 mg: 28 or 30 pcs.
Film-coated tablets, 40 mg: 14 or 28 pcs.
Marketing Authorization Holder
Polpharma Pharmaceutical Works, Sa (Poland)
Dosage Forms
|
Simvastatin | Film-coated tablets, 10 mg: 28 or 30 pcs. |
| Film-coated tablets, 20 mg: 28 or 30 pcs. | ||
| Film-coated tablets, 40 mg: 14 or 28 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets brownish-pink, oval, with a biconvex surface, with a score on one side; the core on the cross-section is white or almost white.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, butylated hydroxyanisole, ascorbic acid, citric acid, colloidal anhydrous silicon dioxide, talc, magnesium stearate.
Film coating composition: hypromellose (Pharmacoat 606), hypromellose (Methocel E15LV Premium), iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171), talc, povidone.
10 pcs. – blisters (3) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
Film-coated tablets brownish-orange, oval, with a biconvex surface; the core on the cross-section is white or almost white.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, butylated hydroxyanisole, ascorbic acid, citric acid, colloidal anhydrous silicon dioxide, talc, magnesium stearate.
Film coating composition: hypromellose (Pharmacoat 606), hypromellose (Methocel E15LV Premium), iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171), talc, povidone.
10 pcs. – blisters (3) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
Film-coated tablets dark pink, oval, with a biconvex surface; the core on the cross-section is white or almost white.
| 1 tab. | |
| Simvastatin | 40 mg |
Excipients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, butylated hydroxyanisole, ascorbic acid, citric acid, colloidal anhydrous silicon dioxide, talc, magnesium stearate.
Film coating composition: hypromellose (Pharmacoat 606), hypromellose (Methocel E15LV Premium), iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171), talc, povidone.
7 pcs. – blisters (2) – cardboard packs.
7 pcs. – blisters (4) – cardboard packs.
Film-coated tablets, 20 mg: 10, 20, 28, 30, 40, or 50 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 20 mg: 10, 20, 28, 30, 40, or 50 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is from white to almost white with a brownish tint.
| 1 tab. | |
| Simvastatin (calculated as 100% substance) | 20 mg |
Excipients: microcrystalline cellulose 102 – 30 mg, crospovidone XL-10 – 6 mg, ascorbic acid – 5 mg, citric acid – 2.5 mg, magnesium stearate – 2 mg, potato starch – 1 mg, butylated hydroxytoluene – 0.04 mg, lactose monohydrate – to make an uncoated tablet weighing 200 mg.
Coating composition: film coating mixture “Opadry® 20A180003 white” [hypromellose 2910 – 30%, hypromellose – 30%, talc – 20%, titanium dioxide – 20%] – 5 mg – to make a coated tablet weighing 205 mg.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets, 10 mg: 20, 30, 40, 60, or 90 pcs.
Film-coated tablets, 40 mg: 20, 30, 40, 60, or 90 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Forms
|
Simvastatin | Film-coated tablets, 10 mg: 20, 30, 40, 60, or 90 pcs. |
| Film-coated tablets, 40 mg: 20, 30, 40, 60, or 90 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white or white with a yellowish tint.
| 1 tab. | |
| Simvastatin (calculated as 100% substance) | 10 mg |
Excipients: microcrystalline cellulose 102 – 15 mg, crospovidone XL-10 – 3 mg, ascorbic acid – 2.5 mg, citric acid – 1.25 mg, magnesium stearate – 1 mg, potato starch – 0.5 mg, butylated hydroxytoluene – 0.02 mg, lactose monohydrate – to make an uncoated tablet weighing 100 mg.
Coating composition: film coating mixture “Opadry® 20A180003 white” – 2.5 mg [hypromellose 2910 – 30%, hypromellose – 30%, talc – 20%, titanium dioxide – 20%]; to make a coated tablet weighing 102.5 mg.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is almost white or white with a yellowish tint.
| 1 tab. | |
| Simvastatin (calculated as 100% substance) | 40 mg |
Excipients: microcrystalline cellulose 102 – 60 mg, crospovidone XL-10 – 12 mg, ascorbic acid – 10 mg, citric acid – 5 mg, magnesium stearate – 4 mg, potato starch – 2 mg, butylated hydroxytoluene – 0.08 mg, lactose monohydrate – to make an uncoated tablet weighing 400 mg.
Coating composition: film coating mixture “Opadry® 20A180003 white” – 10 mg [hypromellose 2910 – 30%, hypromellose – 30%, talc – 20%, titanium dioxide – 20%]; to make a coated tablet weighing 410 mg.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
Film-coated tablets, 10 mg: from 7 to 500 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Or
Ozon Pharm, LLC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 10 mg: from 7 to 500 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, with a score; the core on the cross-section is white or almost white.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: lactose monohydrate (milk sugar) – 56.48 mg, microcrystalline cellulose (MCC-101) – 14.5 mg, corn starch – 10 mg, povidone K25 – 3 mg, magnesium stearate – 1 mg, butylated hydroxyanisole – 0.02 mg.
Film coating composition: hypromellose – 1.65 mg, titanium dioxide – 0.9 mg, macrogol-4000 – 0.45 mg.
From 7 to 50 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets, 20 mg: from 7 to 500 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Or
Ozon Pharm, LLC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 20 mg: from 7 to 500 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: lactose monohydrate (milk sugar) – 112.96 mg, microcrystalline cellulose (MCC-101) – 29 mg, corn starch – 20 mg, povidone K25 – 6 mg, magnesium stearate – 2 mg, butylated hydroxyanisole – 0.04 mg.
Film coating composition: hypromellose – 3.3 mg, titanium dioxide – 1.8 mg, macrogol-4000 – 0.9 mg.
From 7 to 50 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets, 40 mg: from 7 to 500 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon Pharm, LLC (Russia)
Or
Ozon, LLC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 40 mg: from 7 to 500 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Simvastatin | 40 mg |
Excipients: lactose monohydrate (milk sugar) – 225.92 mg, microcrystalline cellulose (MCC-101) – 58 mg, corn starch – 40 mg, povidone K25 – 12 mg, magnesium stearate – 4 mg, butylated hydroxyanisole – 0.08 mg.
Film coating composition: hypromellose – 6.6 mg, titanium dioxide – 3.6 mg, macrogol-4000 – 1.8 mg.
From 7 to 50 pcs. – contour cell blisters (from 1 to 10 pcs.) – cardboard packs.
Film-coated tablets, 10 mg: 20 or 30 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Simvastatin | Film-coated tablets, 10 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets green, round, biconvex; the cross-section shows two layers – a white or almost white core and a green film coating.
| 1 tab. | |
| Simvastatin (calculated as 100% substance) | 10 mg |
Excipients: lactose monohydrate – 55.95 mg, corn starch – 24.47 mg, microcrystalline cellulose – 42.91 mg, methylcellulose – 1.25 mg, butylated hydroxyanisole – 0.02 mg, ascorbic acid – 2.5 mg, citric acid – 1.5 mg, magnesium stearate – 1.4 mg.
Coating composition: opadry (green) – 6 mg (polyvinyl alcohol, partially hydrolyzed – 44%, talc – 20%, macrogol 3350 – 12.35 mg, soy lecithin – 3.5%, coloring pigment (green) – 20.15%, titanium dioxide (E171) – 17.77%, aluminum lake based on yellow quinoline (E132) – 1.3%, aluminum lake based on indigo carmine (E132) – 1%, aluminum lake based on yellow sunset (E110) – 0.08%).
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
Film-coated tablets, 20 mg: 20 or 30 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Simvastatin | Film-coated tablets, 20 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets green in color, round, biconvex; the cross-section shows two layers – a white or almost white core and a green film coating.
| 1 tab. | |
| Simvastatin (calculated as 100% substance) | 20 mg |
Excipients: lactose monohydrate – 111.9 mg, corn starch – 48.94 mg, microcrystalline cellulose – 85.82 mg, methylcellulose – 2.5 mg, butylated hydroxyanisole – 0.04 mg, ascorbic acid – 5 mg, citric acid – 3 mg, magnesium stearate – 2.8 mg.
Coating composition Opadry (green) – 12 mg (partially hydrolyzed polyvinyl alcohol – 44%, talc – 20%, macrogol 3350 – 12.35 mg, soy lecithin – 3.5%, coloring pigment (green) – 20.15%, titanium dioxide (E171) – 17.77%, aluminum lake based on quinoline yellow (E132) – 1.3%, aluminum lake based on indigo carmine (E132) – 1%, aluminum lake based on sunset yellow FCF (E110) – 0.08%).
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
Film-coated tablets, 10 mg: 20, 30, 50, 100, 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 8000, 10000, or 12000 pcs.
Marketing Authorization Holder
ZiO-Health CJSC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 10 mg: 20, 30, 50, 100, 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 8000, 10000, or 12000 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Simvastatin | 10 mg |
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (100) – cardboard boxes.
10 pcs. – contour cell blisters (200) – cardboard boxes.
10 pcs. – contour cell blisters (300) – cardboard boxes.
10 pcs. – contour cell blisters (400) – cardboard boxes.
10 pcs. – contour cell blisters (500) – cardboard boxes.
1000 pcs. – polymer jars (1) – cardboard boxes.
1000 pcs. – polymer jars (2) – cardboard boxes.
1000 pcs. – polymer jars (3) – cardboard boxes.
1000 pcs. – polymer jars (4) – cardboard boxes.
1000 pcs. – polymer jars (5) – cardboard boxes.
1000 pcs. – polymer jars (6) – cardboard boxes.
2000 pcs. – polymer jars (1) – cardboard boxes.
2000 pcs. – polymer jars (2) – cardboard boxes.
2000 pcs. – polymer jars (3) – cardboard boxes.
2000 pcs. – polymer jars (4) – cardboard boxes.
2000 pcs. – polymer jars (5) – cardboard boxes.
2000 pcs. – polymer jars (6) – cardboard boxes.
500 pcs. – polymer jars (1) – cardboard boxes.
500 pcs. – polymer jars (2) – cardboard boxes.
500 pcs. – polymer jars (3) – cardboard boxes.
500 pcs. – polymer jars (4) – cardboard boxes.
500 pcs. – polymer jars (5) – cardboard boxes.
500 pcs. – polymer jars (6) – cardboard boxes.
Film-coated tablets, 20 mg: 20, 30, 50, 100, 200, 300, 400, 500, 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 8000, 10000, or 12000 pcs.
Marketing Authorization Holder
ZiO-Health CJSC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 20 mg: 20, 30, 50, 100, 200, 300, 400, 500, 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 8000, 10000, or 12000 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Simvastatin | 20 mg |
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (100) – cardboard boxes.
10 pcs. – contour cell blisters (200) – cardboard boxes.
10 pcs. – contour cell blisters (300) – cardboard boxes.
10 pcs. – contour cell blisters (400) – cardboard boxes.
10 pcs. – contour cell blisters (500) – cardboard boxes.
1000 pcs. – polymer jars (1) – cardboard boxes.
1000 pcs. – polymer jars (2) – cardboard boxes.
1000 pcs. – polymer jars (3) – cardboard boxes.
1000 pcs. – polymer jars (4) – cardboard boxes.
1000 pcs. – polymer jars (5) – cardboard boxes.
1000 pcs. – polymer jars (6) – cardboard boxes.
2000 pcs. – polymer jars (1) – cardboard boxes.
2000 pcs. – polymer jars (2) – cardboard boxes.
2000 pcs. – polymer jars (3) – cardboard boxes.
2000 pcs. – polymer jars (4) – cardboard boxes.
2000 pcs. – polymer jars (5) – cardboard boxes.
2000 pcs. – polymer jars (6) – cardboard boxes.
500 pcs. – polymer jars (1) – cardboard boxes.
500 pcs. – polymer jars (2) – cardboard boxes.
500 pcs. – polymer jars (3) – cardboard boxes.
500 pcs. – polymer jars (4) – cardboard boxes.
500 pcs. – polymer jars (5) – cardboard boxes.
500 pcs. – polymer jars (6) – cardboard boxes.
Film-coated tablets, 20 mg: 20 or 30 pcs.
Marketing Authorization Holder
Novosibkhimpharm, JSC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 20 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Simvastatin | 20 mg |
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
Coated tablets, 40 mg: 20 or 30 pcs.
Marketing Authorization Holder
Novosibkhimpharm, JSC (Russia)
Dosage Form
|
Simvastatin | Coated tablets, 40 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Simvastatin | 40 mg |
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
Coated tablets, 10 mg: 30 pcs.
Marketing Authorization Holder
Novosibkhimpharm, JSC (Russia)
Dosage Form
|
Simvastatin | Coated tablets, 10 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
| Coated tablets | 1 tab. |
| Simvastatin | 10 mg |
10 pcs. – contour cell blisters (3) – cardboard packs.
Film-coated tablets, 20 mg: 20 or 30 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Simvastatin | Film-coated tablets, 20 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Coated tablets from light pink to pink in color, round, biconvex.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: ascorbic acid, lactose (milk sugar), potato starch, butylated hydroxytoluene, citric acid, pregelatinized starch, magnesium stearate.
Coating composition hypromellose, hydroxypropyl cellulose, talc, titanium dioxide, acid red 2C dye for pharmaceutical purposes.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
Film-coated tablets, 10 mg: 28 pcs.
Film-coated tablets, 20 mg: 28 pcs.
Film-coated tablets, 40 mg: 28 pcs.
Marketing Authorization Holder
Alkaloid AD Skopje (Republic of North Macedonia)
Dosage Forms
|
Simvastatin Alkaloid | Film-coated tablets, 10 mg: 28 pcs. |
| Film-coated tablets, 20 mg: 28 pcs. | ||
| Film-coated tablets, 40 mg: 28 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets greyish-pink in color, round, biconvex, with a score on one side.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: ascorbic acid, citric acid monohydrate, butylated hydroxytoluene, microcrystalline cellulose, lactose monohydrate, pregelatinized starch, povidone K25, magnesium stearate.
Coating composition Opadry II pink (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol-3000, talc, iron oxide red [pigment 30], iron oxide yellow [pigment 10]).
7 pcs. – contour cell blisters (4) – cardboard packs.
Film-coated tablets greyish-pink in color, round, biconvex, with a score on one side.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: ascorbic acid, citric acid monohydrate, butylated hydroxytoluene, microcrystalline cellulose, lactose monohydrate, pregelatinized starch, povidone K25, magnesium stearate.
Coating composition Opadry II pink (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol-3000, talc, iron oxide red [pigment 30], iron oxide yellow [pigment 10]).
14 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets greyish-pink in color, round, biconvex, with a score on one side.
| 1 tab. | |
| Simvastatin | 40 mg |
Excipients: ascorbic acid, citric acid monohydrate, butylated hydroxytoluene, microcrystalline cellulose, lactose monohydrate, pregelatinized starch, povidone K25, magnesium stearate.
Coating composition Opadry II pink (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol-3000, talc, iron oxide red [pigment 30], iron oxide yellow [pigment 10]).
14 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets, 10 mg: 28 pcs.
Marketing Authorization Holder
Alkaloid AD (Macedonia)
Labeled By
KANONPHARMA PRODUCTION, CJSC (Russia)
Dosage Form
|
Simvastatin Alkaloid | Film-coated tablets, 10 mg: 28 pcs. |
Dosage Form, Packaging, and Composition
| Film-coated tablets | 1 tab. |
| Simvastatin | 10 mg |
7 pcs. – contour cell blisters (4) – cardboard packs.
Film-coated tablets, 20 mg: 28 pcs.
Marketing Authorization Holder
Alkaloid AD (Macedonia)
Labeled By
KANONPHARMA PRODUCTION, CJSC (Russia)
Dosage Form
|
Simvastatin Alkaloid | Film-coated tablets, 20 mg: 28 pcs. |
Dosage Form, Packaging, and Composition
| Film-coated tablets | 1 tab. |
| Simvastatin | 20 mg |
7 pcs. – contour cell blisters (4) – cardboard packs.
14 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets, 10 mg: 30 pcs.
Film-coated tablets, 20 mg: 30 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Forms
|
Simvastatin Renewal | Film-coated tablets, 10 mg: 30 pcs. |
| Film-coated tablets, 20 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow-brown in color, round, biconvex; slight surface roughness is allowed; the cross-section shows a white or almost white core.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, ascorbic acid, citric acid monohydrate, magnesium stearate, butylated hydroxyanisole.
Film coating composition: Opadry® 20A230058 orange (hypromellose, hypromellose, titanium dioxide, talc, iron oxide red, iron oxide yellow).
10 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets yellow-brown in color, round, biconvex; slight surface roughness is allowed; the cross-section shows a white or almost white core.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, ascorbic acid, citric acid monohydrate, magnesium stearate, butylated hydroxyanisole.
Film coating composition: Opadry® 20A230058 orange (hypromellose, hypromellose, titanium dioxide, talc, iron oxide red, iron oxide yellow).
10 pcs. – contour cell blisters (3) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
Film-coated tablets, 10 mg: 28 or 84 pcs.
Film-coated tablets, 20 mg: 28 or 84 pcs.
Film-coated tablets, 40 mg: 28 or 84 pcs.
Marketing Authorization Holder
Sanofi Russia JSC (Russia)
Manufactured By
Zentiva, k.s. (Czech Republic)
Dosage Forms
|
Simvastatin Sanofi | Film-coated tablets, 10 mg: 28 or 84 pcs. |
| Film-coated tablets, 20 mg: 28 or 84 pcs. | ||
| Film-coated tablets, 40 mg: 28 or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from white to almost white, oblong, biconvex, with a score on both sides and with the engraving “SVT” and “10” on one side.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: anhydrous lactose – 74.5 mg, pregelatinized corn starch – 10 mg, microcrystalline cellulose – 5 mg, talc – 1 mg, magnesium stearate – 0.5 mg, butylated hydroxyanisole – 0.02 mg.
Film coating composition: hypromellose – 0.76 mg, hypromellose – 0.76 mg, titanium dioxide – 0.69 mg, talc – 0.28 mg.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (6) – carton packs.
Film-coated tablets from white to almost white, oblong, biconvex, with a score on both sides and with the engraving “SVT” and “20” on one side.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: anhydrous lactose – 149 mg, pregelatinized corn starch – 20 mg, microcrystalline cellulose – 10 mg, talc – 2 mg, magnesium stearate – 1 mg, butylated hydroxyanisole – 0.04 mg.
Film coating composition: hypromellose – 1.65 mg, hypromellose – 1.65 mg, titanium dioxide – 1.5 mg, talc – 0.6 mg.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (6) – carton packs.
Film-coated tablets from white to almost white, oblong, biconvex, with a score on both sides and with the engraving “SVT” and “40” on one side.
| 1 tab. | |
| Simvastatin | 40 mg |
Excipients: anhydrous lactose – 298 mg, pregelatinized corn starch – 40 mg, microcrystalline cellulose – 20 mg, talc – 4 mg, magnesium stearate – 2 mg, butylated hydroxyanisole – 0.08 mg.
Film coating composition: hypromellose – 3.06 mg, hypromellose – 3.06 mg, titanium dioxide – 2.78 mg, talc – 1.11 mg.
14 pcs. – blisters (2) – carton packs.
14 pcs. – blisters (6) – carton packs.
Film-coated tablets, 10 mg: 10, 20, 28, 30, or 42 pcs.
Marketing Authorization Holder
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Simvastatin-Ferein | Film-coated tablets, 10 mg: 10, 20, 28, 30, or 42 pcs. |
Dosage Form, Packaging, and Composition
| Film-coated tablets | 1 tab. |
| Simvastatin | 10 mg |
10 pcs. – contour cell blisters (3) – carton packs.
10 pcs. – contour cell blisters (2) – carton packs.
10 pcs. – contour cell blisters (1) – carton packs.
10 pcs. – plastic bottles (1) – carton packs.
10 pcs. – polymer jars (1) – carton packs.
14 pcs. – contour cell blisters (1) – carton packs.
14 pcs. – contour cell blisters (2) – carton packs.
14 pcs. – contour cell blisters (3) – carton packs.
20 pcs. – plastic bottles (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
30 pcs. – plastic bottles (1) – carton packs.
Film-coated tablets, 10 mg: 14, 20, 28, 30, 60, or 84 pcs.
Marketing Authorization Holder
Severnaya Zvezda, CJSC (Russia)
Dosage Form
|
Simvastatin-SZ | Film-coated tablets, 10 mg: 14, 20, 28, 30, 60, or 84 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to yellow, round, biconvex; on the cross-section – white or almost white.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: ascorbic acid – 2.5 mg, potato starch – 20 mg, lactose monohydrate – 90 mg, microcrystalline cellulose – 10 mg, butylated hydroxyanisole – 0.02 mg, citric acid – 1.2 mg, magnesium stearate – 1.28 mg, colloidal silicon dioxide (aerosil) – 2 mg, talc – 1 mg.
Coating composition: Opadry II (partially hydrolyzed polyvinyl alcohol – 1.6 mg, talc – 0.592 mg, macrogol (polyethylene glycol 3350) – 0.808 mg, titanium dioxide (E171) – 0.8748 mg, iron oxide yellow (E172) – 0.0012 mg, aluminum lake based on quinoline yellow (E104) – 0.1204 mg, aluminum lake based on sunset yellow FCF (E110) – 0.0028 mg, aluminum lake based on indigo carmine (E132) – 0.0008 mg.
10 pcs. – contour cell blisters (3) – carton packs.
20 pcs. – dark glass jars (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
20 pcs. – polymer bottles (1) – carton packs.
30 pcs. – dark glass jars (1) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
30 pcs. – polymer bottles (1) – carton packs.
Film-coated tablets, 20 mg: 10, 20, or 30 pcs.
Marketing Authorization Holder
Severnaya Zvezda, CJSC (Russia)
Dosage Form
|
Simvastatin-SZ | Film-coated tablets, 20 mg: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to yellow, round, biconvex; on the cross-section – white or almost white.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: ascorbic acid – 5 mg, potato starch – 40 mg, lactose monohydrate – 180 mg, microcrystalline cellulose – 20 mg, butylated hydroxyanisole – 0.04 mg, citric acid – 2.4 mg, magnesium stearate – 2.56 mg, colloidal silicon dioxide (aerosil) – 4 mg, talc – 2 mg.
Coating composition: Opadry II (partially hydrolyzed polyvinyl alcohol – 3.2 mg, talc – 1.184 mg, macrogol (polyethylene glycol 3350) – 1.616 mg, titanium dioxide (E171) – 1.7496 mg, iron oxide yellow (E172) – 0.0024 mg, aluminum lake based on quinoline yellow (E104) – 0.2408 mg, aluminum lake based on sunset yellow FCF (E110) – 0.0056 mg, aluminum lake based on indigo carmine (E132) – 0.0016 mg.
10 pcs. – contour cell blisters (3) – carton packs.
20 pcs. – dark glass jars (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
20 pcs. – polymer bottles (1) – carton packs.
30 pcs. – dark glass jars (1) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
30 pcs. – polymer bottles (1) – carton packs.
Film-coated tablets, 40 mg: 20 or 30 pcs.
Marketing Authorization Holder
Severnaya Zvezda, CJSC (Russia)
Dosage Form
|
Simvastatin-SZ | Film-coated tablets, 40 mg: 20 or 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light yellow to yellow, round, biconvex; on the cross-section – white or almost white.
| 1 tab. | |
| Simvastatin | 40 mg |
Excipients: ascorbic acid – 10 mg, potato starch – 80 mg, lactose monohydrate – 360 mg, microcrystalline cellulose – 40 mg, butylated hydroxyanisole – 0.08 mg, citric acid – 4.8 mg, magnesium stearate – 5.12 mg, colloidal silicon dioxide (aerosil) – 8 mg, talc – 4 mg.
Coating composition: Opadry II (partially hydrolyzed polyvinyl alcohol – 6.4 mg, talc – 2.368 mg, macrogol (polyethylene glycol 3350) – 3.232 mg, titanium dioxide (E171) – 3.4992 mg, iron oxide yellow (E172) – 0.0048 mg, aluminum lake based on quinoline yellow (E104) – 0.4816 mg, aluminum lake based on sunset yellow FCF (E110) – 0.0112 mg, aluminum lake based on indigo carmine (E132) – 0.0032 mg.
10 pcs. – contour cell blisters (3) – carton packs.
20 pcs. – dark glass jars (1) – carton packs.
20 pcs. – polymer jars (1) – carton packs.
20 pcs. – polymer bottles (1) – carton packs.
30 pcs. – dark glass jars (1) – carton packs.
30 pcs. – polymer jars (1) – carton packs.
30 pcs. – polymer bottles (1) – carton packs.
Film-coated tablets, 10 mg: 30 pcs.
Film-coated tablets, 20 mg: 30 pcs.
Film-coated tablets, 40 mg: 30 pcs.
Marketing Authorization Holder
Teva Pharmaceutical Industries, Ltd. (Israel)
Manufactured By
Teva Pharmaceutical Works, Private Limited Company (Hungary)
Dosage Forms
|
Simvastatin-Teva | Film-coated tablets, 10 mg: 30 pcs. |
| Film-coated tablets, 20 mg: 30 pcs. | ||
| Film-coated tablets, 40 mg: 30 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from light pink to slightly yellowish-brown, oval, with the engraving “10” on one side.
| 1 tab. | |
| Simvastatin | 10 mg |
Excipients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, ascorbic acid, citric acid monohydrate, butylated hydroxyanisole, magnesium stearate.
10 pcs. – blisters (3) – carton packs.
Film-coated tablets from yellowish-brown to light brown, oval, with the engraving “20” on one side.
| 1 tab. | |
| Simvastatin | 20 mg |
Excipients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, ascorbic acid, citric acid monohydrate, butylated hydroxyanisole, magnesium stearate.
10 pcs. – blisters (3) – carton packs.
Film-coated tablets from pink to pink with a slight brownish tint, oval, with the engraving “40” on one side.
| 1 tab. | |
| Simvastatin | 40 mg |
Excipients: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, ascorbic acid, citric acid monohydrate, butylated hydroxyanisole, magnesium stearate.
10 pcs. – blisters (3) – carton packs.
![Simvastatin [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Simvastatin [Tablets] 2")