Atomax - instructions for use, doses, side effects, contraindications

Excipients: calcium carbonate 36.00 mg; lactose 36.00 mg; cellulose microcrystalline 12.16 mg; croscarmellose sodium 13.00 mg; Povidone K-30 3.00 mg; magnesium stearate 1.00 mg; shell: hypromellose 1.41 mg; talc 0.17 mg; titanium dioxide 0.29 mg; triacetin 0.13 mg.

For one tablet 20 mg:

active substance: atorvastatin calcium trihydrate 21.66 mg, calculated as atorvastatin 20.00 mg;

Excipients: calcium carbonate 50.00 mg; lactose 48.34 mg; corn starch 30.00 mg; croscarmellose sodium 11.00 mg; Povidone K-30 5.00 mg; magnesium stearate 4,00 mg; silicon dioxide colloid 3.00 mg; crospovidone 7.00 mg; shell: hypromellose 3.04 mg; talc 0.29 mg; titanium dioxide 0.46 mg; triacetin 0.21 mg.

Description:

Round biconvex tablets, covered with a film membrane of almost white color, with a risk on one side. The core is from white to almost white.

Pharmacotherapeutic group:Hypolipidemic agent - inhibitor of HMG-CoA reductase

ATX: & nbsp

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

C.10.A.A.05 Atorvastatin

Pharmacodynamics:

Lipid-lowering drug. Atorvastatin - a selective competitive inhibitor of HMG-CoA reductase, a key enzyme that converts 3-hydroxy-3-methylglutarylcoenzyme A into mevalonic acid, a precursor of steroids, including cholesterol. In the liver, triglycerides and cholesterol are included in very low density lipoproteins (VLDL), enter the blood plasma and transport to peripheral tissues. Low density lipoproteins (LDL) are formed from VLDL, which are catabolized by interaction with high-affinity LDL receptors. Atorvastatin It reduces the plasma concentration of cholesterol and lipoproteins by inhibiting HMG-CoA reductase in the liver and by increasing the number of "liver" LDL receptors on the cell surface, which leads to increased trapping and catabolism of LDL-cholesterol.

Reduces the formation of cholesterol-LDL and the number of small particles of LDL. It causes a pronounced and persistent increase in the activity of LDL receptors, and also has a beneficial effect on the quality of circulating LDL. Effectively reduces the concentration of cholesterol-LDL in patients with homozygous hypercholesterolemia, which usually can not be treated with other lipid-lowering agents. Atorvastatin in a dose of 10-80 mg reduces the concentration of total cholesterol by 30-46%, LDL cholesterol by 41-61%, apolipoprotein B by 34-50% and triglycerides by 14-33%. The results of treatment are similar in patients with heterozygous familial hypercholesterolemia, non-familial forms of hypercholesterolemia and mixed hyperlipidemia, incl. in patients with non-insulin-dependent diabetes mellitus.

Atorvastatin reduces concentration total cholesterol, cholesterol-LDL, cholesterol-VLDL, apolipoprotein B, triglycerides and cholesterol, not included in the composition of HDL, and increases the concentration of HDL-cholesterol in patients with isolated hypertriglyceridemia. Atorvastatin reduces the concentration of intermediate density lipoprotein cholesterol the patients with disbetalipoproteinemia.

In connection with the decrease in the level of total cholesterol, LDL cholesterol and apolipoprotein B, the risk of cardiovascular complications decreases and, accordingly, the risk of death decreases.

Atorvastatin and some of its metabolites are pharmacologically active. The primary target organ of atorvastatin is the liver, where it is carried out, the synthesis of cholesterol and the clearance of LDL. The dynamics of cholesterol-LDL concentration correlates better with the dose of atorvastatin than with its concentration in the blood plasma. The dose of atorvastatin should be selected taking into account the therapeutic effect.

Pharmacokinetics:

Suction. Atorvastatin quickly absorbed after ingestion. The maximum concentration in the blood plasma (Cmah) is achieved in 1-2 hours. The concentration of atorvastatin in blood plasma in women is different (Cmah about 20% higher, AUC - 10% lower) from that in men in the absence of clinically significant differences ininfluence on the lipid profile. The degree of absorption and concentration of atorvastatin in Plasma increase in proportion to the dose. Absolute bioavailability is about 14%, and systemic bioavailability of inhibitory activity against HMG-CoA-reductase is about 30%. Low systemic bioavailability is due to presystemic metabolism in the mucosa of the gastrointestinal tract and / or metabolism during the "primary" passage through the liver.

Food reduces the rate and extent of absorption of atorvastatin (by 25% and 9% respectively), as evidenced by the results of the determination of Cmand the area under the concentration-time curve (AUC), but the concentration of LDL cholesterol when taking atorvastatin on an empty stomach and during meals decreases to the same extent. After taking atorvastatin in the evening, its concentration in the blood plasma is lower (Cmah and AUC about 30%) than after taking in the morning, but the degree of decrease in the concentration of LDL cholesterol does not depend on the time of taking the drug during the day.

Distribution. The average volume of distribution is about 38 g / l. Degree of binding with blood plasma proteins - 98%.The ratio of atorvastatin concentration in erythrocytes / plasma is 0.25, indicating a low penetration of atorvastatin into erythrocytes.

Metabolism. Metabolized mainly in the liver with the participation of cytochrome P450 isoenzymes CYP3A4 (to a greater extent), CYP3A5 and CYP3A7 with the formation of pharmacologically active metabolites of ortho- and para-hydroxylated derivatives and beta-oxidation products. In vitro the inhibitory effect of ortho- and para-hydroxylated metabolites on HMG-CoA reductase is comparable to that of atorvastatin. Inhibitory activity against HMG-CoA reductase in plasma approximately on 70% is caused by active metabolites. Research in vitro showed that atorvastatin is a weak inhibitor CYP3A4.

Excretion. Atorvastatin and its metabolites are excreted, mainly with bile. Atorvastatin not subject to severe intestinal hepatic recirculation. The half-life (T1 / 2) is about 14 hours. The inhibitory activity against HMG-CoA reductase is maintained for 20-30 hours, which is explained by the presence of active metabolites. After ingestion, less than 2% of the dose is detected in the urine.

Special patient groups

Patients of advanced age. The concentration of atorvastatin in the blood plasma in patients older than 65 years is higher (Cmah about 40%, AUC about 30%) than in younger patients. However, there were no differences in safety, efficacy, or achievement of the goals of lipid-lowering therapy in elderly and younger patients.

Patients with impaired renal function. The renal dysfunction does not affect the concentration of atorvastatin in the blood plasma or its effect on the lipid profile, in this regard, dose adjustment in patients with impaired renal function is not required. Studies in patients with renal failure at terminal stages were not carried out. Atorvastatin is not excreted during hemodialysis due to intensive binding to blood plasma proteins.

Patients with hepatic insufficiency. The concentration of atorvastatin is significantly increased (Cmah and AUC approximately 16 and 11 times, respectively) in patients with alcoholic liver cirrhosis (7-9 on the Child-Pugh scale).

Indications:

- In combination with a diet to reduce elevated levels of total cholesterol, cholesterol-LDL, apolipoprotein B and triglycerides,and increase in HDL cholesterol in patients with primary hypercholesterolemia, heterozygous familial and non-family hypercholesterolemia, and combined (mixed) hyperlipidemia (types IIa and IIb according to Fredrickson's classification).

- In combination with diet for treatment patients with elevated serum triglyceride levels (Fredrickson type IV) and patients with disbetalipoproteinemia (type III according to Fredrickson classification), in which diet therapy does not give an adequate effect.

- To reduce the levels of total cholesterol and LDL-cholesterol in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological treatments are not effective enough.

Contraindications:

- Hypersensitivity to the main and / or auxiliary components of the drug.

- Active liver disease or increased activity of "liver" transaminases in blood plasma (more than 3 times compared with the upper limit of the norm) of an unknown genesis.

- Hepatic failure (5-6 and 7-9 on the Child-Pugh scale).

- Reproductive age in women who do not use reliable methods of contraception.

- Pregnancy.

- Breastfeeding period.

- Age to 18 years (effectiveness and safety not established).

- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the preparation contains lactose).

Carefully:

Alcohol abuse; liver disease in history; severe electrolyte imbalance; endocrine and metabolic disorders; arterial hypotension; severe acute infection (sepsis); uncontrolled epilepsy; extensive surgical interventions; injuries; diseases of skeletal muscles; combined use with cyclosporine, HIV protease inhibitors (saquinavir, lopinavir, indinavir, ritonavir, nelfinavir), erythromycin clarithromycin, antifungal agents from the azole group (itraconazole, ketoconazole, fluconazole), nefazodone, fibrolic acid derivatives (gemfibrozil), nicotinic acid in lipid-lowering doses, ezetimibe (in connection with an increased risk of myopathy).

Pregnancy and lactation:

Atomax® is contraindicated in pregnancy.

Animal tests revealed an adverse effect of atorvastatin on the fetus.Controlled studies involving pregnant women were not conducted.

Women of reproductive age during treatment should apply reliable methods of contraception. The patient should be informed of the potential risk to the fetus, as well as the need to stop taking Atomax®, at least 1 month before the planned pregnancy. In case of pregnancy in The time of treatment should be stopped immediately.

Atomax® is contraindicated in breastfeeding. It is not known whether atorvastatin with breast milk. If necessary use of Atomax® during lactation breastfeeding should be discontinued.

Dosing and Administration:

Inside, regardless of the time of eating, at any time of the day. It is recommended to take the drug every day at the same time.

When prescribing Atomax®, the patient should be recommended a standard hypocholesterol diet, which he must follow throughout the treatment period.

The initial dose is 10 mg once a day. The maximum daily dose of Atomax® is 80 mg.A dose in the range from 10 mg to 80 mg once a day is selected taking into account the initial concentration of cholesterol-LDL, the purpose of therapy and the individual effect on the therapy. A significant therapeutic effect develops after 2 weeks of taking the drug, the maximum effect is achieved after 4 weeks (so the dose should not be changed earlier than 4 weeks after starting the drug) and remains with long-term treatment.

If you miss a dose of the next dose of Atomax®, you should not double the next dose.

Primary hypercholesterolemia and combined (mixed) hyperlipidemia,

In most cases, it may be sufficient to administer the drug Atomax® at a dose of 10 mg once a day.

Homozygous familial hypercholesterolemia

The range of doses of atorvastatin is the same as for other forms of hyperlipidemia. In most patients, the optimal therapeutic effect (reduction of cholesterol-LDL by 18-45%) is observed at a dose of 80 mg - 1 time per day or divided into 3 doses during the day: 20 mg, 20 mg and 40 mg. The drug Atomax® is used as an adjunct to other methods of treatment (plasmapheresis) or as the main treatment if therapy with other methods is impossible.

Special patient groups

Patients of advanced age. Atorvastatin at a dose of up to 80 mg / day and in patients over the age of 65 years, there was no difference in safety, efficacy, or achievement of lipid-lowering therapy goals compared with younger patients.

Patients with impaired renal function. Correction of the dose is not required.

Patients with impaired liver function. In connection with the slowing down of atorvastatin removal from the body, the drug is administered with caution under constant monitoring clinical and laboratory indicators of liver function. When detecting significant deviations, the dose of Atomax® should be reduced or canceled.

Use in combination with other medicines

In patients receiving concomitant therapy ciclosporin, the maximum daily dose of the drug Atomax® should not exceed 10 mg.

If it is necessary to use together with diltiazem, Atomax® should be taken at the lowest effective dose.

In patients receiving clarithromycin, erythromycin, itraconazole, ketoconazole, fluconazole, ritonavir, saquinavir, lopinavir, nelfinavir, the maximum daily dose of Atomax® should not exceed 20 mg.

Side effects:

The frequency of the listed side effects is indicated in accordance with the WHO classification: very often more than 10%; often more than 1% and less than 10%; infrequently - more than 0.1% and less than 1%; rarely - more than 0.01% and less than 0.1%; very rarely - less than 0.01%, including individual cases; frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the central and peripheral nervous system: often - insomnia / sleep disorders, headache, asthenic syndrome; infrequent - malaise, dizziness, amnesia (loss or loss of memory), paresthesia, nightmares, peripheral neuropathy, hypoesthesia; frequency is unknown - depression.

From the sense organs: infrequent - noise or ringing in the ears, blurred vision; very rarely - visual disturbances, deafness, perversion of taste.

On the part of the organs of hematopoiesis: infrequently - thrombocytopenia.

From the respiratory system: often - nasopharyngitis, sore throat; very rarely - interstitial lung diseases (with prolonged use).

From the digestive system: often - abdominal pain, constipation, flatulence, dyspepsia, nausea, diarrhea; infrequently anorexia, vomiting, pancreatitis, discomfort; rarely - hepatitis, cholestatic jaundice; very rarely - liver failure.

From the side of the musculoskeletal system: often - myalgia, arthralgia, pain in the extremities, bursitis; infrequently - myopathy, muscle cramps, neck pain, back pain; rarely - myositis, rhabdomyolysis, muscle weakness; very rarely a rupture of the tendon.

Allergic reactions: often - rash, itchy skin, anaphylaxis; infrequently, urticaria; very rarely angioedema, bullet rash, polymorphic exudative erythema (including Stevens-Johnson syndrome), Lyell's syndrome.

Laboratory indicators: often - increased activity of serum creatine phosphokinase (CK), "hepatic" transaminases alanine aminotransferase (ALT) and aspartate aminotransferase (ACT); infrequently - hypo- or hyperglycemia; rarely - leukocyturia; frequency is unknown - hyperglycemia, increased concentration of glycosylated hemoglobin.

Other: often - increased fatigue; infrequently - weight gain, impotence, secondary renal failure, alopecia,chest pain; rarely - peripheral edema; frequency unknown - sexual dysfunction, gynecomastia, immuno-mediated necrotizing myopathy.

Overdose:

Treatment: There is no specific antidote, symptomatic therapy is performed.

Hemodialysis is ineffective.

Interaction:

When combined use of atorvastatin with a number of drugs - ciclosporin, HIV protease inhibitors (indinavir, saquinavir, lopinavir, ritonavir, nelfinavir), erythromycin, clarithromycin, antifungal. preparations from the group of azoles (itraconazole, ketoconazole, fluconazole), nefazodone, derivatives of fibroic acid (gemfibrozil), a nicotinic acid in lipid-lowering doses, ezetimibe - concentration Atorvastatin in the blood plasma increases, which increases risk of myopathy, in rare cases - rhabdomyolysis with acute renal failure.

Because the atorvastatin is metabolized predominantly by isoenzyme CYP3A4 cytochrome P450, the simultaneous use of atorvastatin with inhibitor preparations or isoenzyme substrates CYP3A4 can lead to an increase in the concentration of atorvastatin in the blood plasma.The degree of interaction and the effect of potentiation are determined by the variability of the effect on CYP3A4. Atorvastatin and its metabolites are substrates of the transport protein OATP1B1.

Inhibitors of transport protein OATP1B1 when combined, can increase bioavailability atorvastatin.

Inhibitors CYP3A4

Cyclosporin (substrate CYP3A4, inhibitor of the transporter OATP1B1). The combined use of atorvastatin 10 mg and cyclosporine at a dose of 5.2 mg / kg / day led to an increase in the concentration of atorvastatin in blood plasma by 7.7 times. If a joint application is necessary, the maximum daily dose of atorvastatin should not exceed 10 mg.

Erythromycin, clarithromycin. With simultaneous use of atorvastatin and erythromycin (500 mg 4 times / day) or clarithromycin (500 mg 2 times / day), there was a significant increase in the concentration of atorvastatin in the blood plasma. If necessary joint use with these drugs, the maximum daily dose of atorvastatin should not exceed 20 mg.

Inhibitors of proteases. Simultaneous use of atorvastatin with protease inhibitors, known as isoenzyme inhibitors CYP3A4, was accompanied by an increase concentrations of atorvastatin in blood plasma (when combined with erythromycin, an increase in Cmah atorvastatin by 40%).

HIV protease inhibitors. Against the backdrop of concomitant use with atorvastatin, a combination of HIV protease inhibitorsatorvastatin 40 mg and ritonavir + saquinavir 400 mg 2 times / day; atorvastatin 20 mg and lopinavir 400 mg + ritonavir 100 mg 2 times / day) there was a significant increase AUC atorvastatin. Simultaneous use of atorvastatin in a dose of 10 mg and nelfinavir mesylate 1250 mg 2 times a day was accompanied by an increase in the concentration of atorvastatin in blood plasma (an increase AUC by 74% and Cmah on 122%). If it is necessary to use together with these drugs, the maximum daily dose of atorvastatin should not exceed 20 mg.

Diltiazem. The combined use of atorvastatin in a dose of 40 mg with diltiazem in a dose of 240 mg resulted in an increase AUC atorvastatin by 50%. If necessary, a joint application with diltiazem atorvastatin should be taken at the lowest effective dose.

Verapamil, amiodarone. Joint application can lead to an increase concentrations of atorvastatin.

Cimetidine. Clinically significant interaction of atorvastatin with cimetidine was not detected.

Itraconazole. The combined use of atorvastatin in doses of 20 mg and 40 mg and itraconazole at a dose of 200 mg resulted in a 2.5-3-fold increase AUC. Atorvastatin, If necessary, combined with azole antifungal agents, the maximum daily dose of Atomax® should not exceed 20 mg.

Grapefruit juice contains components that inhibit CYP3A4. Excessive consumption of grapefruit juice (more than 1.2 l / day) can lead to a significant increase in the concentration of atorvastatin in the blood plasma.

Inductors CYP3A4

The use of atorvastatin in conjunction with isozyme inducing drugs CYP3A4 (eg, phenytoin, efavirenz, rifampicin, St. John's wort perforated) can lead to a decrease in the concentration of atorvastatin in blood plasma and inadequate efficacy. Due to the dual mechanism of interaction from rifampicin (inducer FROMYP3A4 and hepatocyte transport protein inhibitor OATP1B1), simultaneous use of atorvastatin and rifampicin is recommended,because delayed administration of atorvastatin after taking rifampicin leads to a significant decrease in the concentration of atorvastatin in the blood plasma.

Other concomitant therapy

Antipyrine (phenazone). Atorvastatin does not affect the pharmacokinetics of phenazone, so the interaction with other drugs metabolized by the same isoenzymes of cytochrome P450, not expected.

Antacids. Simultaneous reception of a suspension containing magnesium hydroxides and aluminum, led to a decrease in the concentration of atorvastatin in the blood plasma by about 35%, but the degree of decrease in the cholesterol-LDL content did not change.

Kolestipol. With the simultaneous use of colestipol, the concentration of atorvastatin in the blood plasma decreased by about 25%, but the lipid-lowering effect of the combination of these drugs was superior to that of each drug alone. Colestipol can weaken the absorption of atorvastatin, so between the intake of medications should be maintained interval of at least 2 hours.

Gemfibrozil. Concomitant use of gemfibrozil 600 mg 2 times / day was accompanied by an increase in the concentration of atorvastatin by 24%.

Digoxin. When re-ingesting digoxin in a dose of 0.25 mg and atorvastatin at a dose of 10 mg the equilibrium concentrations of digoxin in the blood plasma did not change; atorvastatin at a dose of 80 mg / day caused an increase in the concentration of digoxin by about 20%. Patients receiving digoxin in combination with atorvastatin in high doses, require appropriate monitoring.

Azithromycin. With the simultaneous use of atorvastatin at a dose of 10 mg / day and azithromycin at a dose of 500 mg once a day, the concentration of atorvastatin in the blood plasma did not change.

Oral contraceptives. When combined use of atorvastatin and oral contraceptive containing norethisterone and ethinyl estradiol, there was a significant increase AUC norethisterone and ethinylestradiol (approximately 30% and 20%, respectively). This effect must be taken into account when choosing an oral contraceptive for a woman receiving atorvastatin.

Hormone replacement therapy with estrogen. There is no evidence of a cynically significant interaction with the simultaneous administration of atorvastatin and hormone replacement therapy with estrogens.

Warfarin. When combined with atorvastatin in the first days of treatment, it is possible to increase the effect of warfarin on blood coagulation indices (reduction of prothrombin time). After 15 days of therapy, the prothrombin time returns to the initial, determined before the start of joint use of drugs.

Amlodipine. With the simultaneous use of atorvastatin in a dose of 80 mg and amlodipine at a dose of 10 mg, the pharmacokinetics of atorvastatin in the equilibrium state did not change. No obvious changes in blood pressure or heart rate were observed.

Hinapril. The combined use of quinapril 80 mg and atorvastatin 10 mg did not significantly alter the pharmacokinetic profile of atorvastatin.

Special instructions:

Before starting therapy with Atomax® it is necessary to try to achieve control of hypercholesterolemia with diet, increase physical activity, reduce body weight in obese patients and treat other conditions.

Action on the liver

As with the use of other lipid-lowering agents from the class of HMG-CoA reductase inhibitors, against the background of therapy with Atomax®, activity of "hepatic" transaminases in the blood serum. Before the start of therapy, 6 weeks and 12 weeks after the start of the use of the drug Atomax® or after each increasing the dose, and periodically (for example, every 6 months) throughout the treatment period, it is necessary to monitor the biochemical parameters of liver function. The liver function should also be investigated when there are clinical signs of liver damage. Patients who have an increased activity of "liver" transaminases, should be under control before their normalization. If the increase in activity of alanine aminotransferase or aspartate aminotransferase is more than 3 times in comparison with the upper limit of the norm is maintained, it is recommended reduction of dose or cancellation of the drug Atomax®.

Atomax® should be used with caution in patients who consume significant amounts of alcohol and / or have a history of liver disease. Active liver disease, or persistent increase in activity "hepatic" transaminases unclear genesis serve as a contraindication to the administration of the drug Atomax®.

Action on skeletal muscles

Treatment with atorvastatin can cause myopathy.The diagnosis of myopathy (pain or weakness in the muscles in combination with an increase in creatine phosphokinase activity by more than 10 times compared with the upper limit of the norm) should be assumed in patients with advanced myalgia, tenderness or weakness of the muscles and / or a marked increase in the activity of CK. Patients should be warned About, what they should immediately inform the doctor about the occurrence of unexplained pain or weakness in the muscles, especially if they are accompanied by malaise or fever.

Therapy with Atomax® should be discontinued if there is a pronounced increase activity of creatine phosphokinase or in the presence of confirmed or suspected myopathy. Risk of myopathy when treated with other HMG-CoA reductase inhibitors increased with the simultaneous use of cyclosporine, fibrates, erythromycin, nicotinic acid in lipid-lowering doses (more than 1 g) or azole antifungal agents. Many of these drugs inhibit the metabolism mediated by the cytochrome P450 isoenzyme CYP3A4, and / or transport of medicinal products. CYP3A4 - the main isoenzyme involved in the biotransformation of atorvastatin.With the appointment of the drug Atomax® in combination with fibrates, erythromycin, clarithromycin, immunosuppressive agents, nefazodone, azole antifungal agents or nicotine. acid in lipid-lowering doses (more than 1 g), the physician should carefully weigh the expected benefits of treatment and the possible risk. It should be regularly observed patients with the purpose of identifying pain or weakness in the muscles, especially during the first months of therapy and during the period of increasing the dose of any of these drugs. If necessary, their joint use should consider the possibility of using lower initial and maintenance doses of these agents. In patients who constantly take Atomax® at a dose of 40 mg or 80 mg, it is necessary to reduce the daily dose of the drug to 20 mg during the concomitant use of clarithromycin, erythromycin or azole antifungal agents, or temporarily interrupt therapy with statin. It is recommended to interrupt therapy with atorvastatin for the duration of treatment with fusidic acid preparations. If necessary, a joint application with diltiazem atorvastatin should be taken at the lowest effective dose.In such situations, periodic monitoring of the activity of creatine phosphokinase is recommended, although such monitoring does not prevent the development of severe myopathy.

When using atorvastatin, as well as other inhibitors of HMG-CoA reductase, rare cases of rhabdomyolysis with acute renal failure due to myoglobinuria are described. Therapy with Atomax® should be temporarily discontinued or completely eliminated if there is evidence of possible myopathy or the presence of a risk factor for developing renal failure against rhabdomyolysis (for example, severe acute infection, arterial hypotension, extensive surgical intervention, trauma, severe metabolic, endocrine and electrolyte disturbances, uncontrolled convulsions).

Effect on the ability to drive transp. cf. and fur:

Information about the adverse effect of atorvastatin on the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions is not present.

In connection with the possibility of developing dizziness against the background of treatmentbe careful when driving vehicles and working with mechanisms until you find out the individual reaction to taking the drug.

Form release / dosage:

The tablets covered with a film membrane, 10 mg, 20 mg.

Packaging:

10 tablets in a planar cell package (blister) made of aluminum foil.

When packaged and / or packaged at LLC "MAKIZ-PHARMA" or LLC "Hemofarm"

10 tablets in contour acrylic packaging from polyvinylchloride film and aluminum foil printed lacquered or in contour cell packaging from foil of aluminum printed lacquered and aluminum foil, laminated with polyvinylchloride and polyamide film.

3, 4 or 5 contour squares (blisters) together with instructions for use in a pack 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 printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001346

Date of registration:28.09.2011 / 25.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Manufacturer: & nbsp

HETERO DRUGS Limited India

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp20.09.2017

Illustrated instructions

Instructions

Atomax® (Atomax®)