Tulip - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate 34,80 mg / 34,80 mg; croscarmellose sodium 19.20 mg / 19.20 mg; giprolose 2.00 mg / 2.00 mg; polysorbate 80 2.60 mg / 2.60 mg; magnesium oxide heavy 26.00 mg / 26.00 mg; silicon colloid dioxide 1.20 mg / 1.20 mg; magnesium stearate 1.00 mg / 1.00 mg; cellulose microcrystalline up to 250,00 mg / 250,00 mg;

shell composition: hypromellose 2.976 mg / 2.976 mg; giprolose 0.744 mg / 0.744 mg; titanium dioxide 1,380 mg / 1,368 mg; macrogol 6000 0.600 mg / 0.600 mg; talc 0.300 mg / 0.300 mg; iron oxide yellow E 172 - / 0.012 mg.

Description:

Tablets 10 mg: white or almost white, round biconvex tablets covered with a film sheath, engraved “HLA 10 "on one side. View of the break: white tablets.

Tablets of 20 mg: light yellow, round biconvex tablets, film-coated, engraved “HLA 20 "on one side. View of the break: white tablets.

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:

Atorvastatin is a selective competitive inhibitor of HMG-CoA reductase, an enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A into mevalonic acid, a precursor of sterols, including cholesterol.

Triglycerides (TG) and cholesterol are included in the composition of very low density lipoproteins (VLDL) in liver synthesis, enter the blood plasma and transport to peripheral tissues. Lipoproteins of low density (LDL) are formed from VLDL during the interaction with receptors of LDL.

Studies have shown that increasing concentrations of total cholesterol, LDL and apolipoprotein B (Apo-B) in blood plasma contributes to the development of atherosclerosis and are part of a group of risk factors for cardiovascular disease, while an increase in the concentration of high-density lipoprotein (HDL) reduces the risk of developing cardiovascular diseases.

Atorvastatin reduces the concentration of cholesterol and lipoproteins in the blood plasma by inhibiting the HMG-CoA reductase, the synthesis of cholesterol in the liver, and the increase in the number of "liver" LDL receptors on the cell surface, which leads to an increase in the capture and catabolism of LDL (according to preclinical research).

Atorvastatin reduces the synthesis and concentration of cholesterol-LDL, total cholesterol, Apo-B in patients with homozygous and heterozygous familial hypercholesterolemia, primary hypercholesterolemia and mixed hyperlipidemia.

It also causes a decrease in the concentration of cholesterol-VLDL and TG and an increase in the concentration of cholesterol-HDL and apolipoprotein A-1 (Apo-A).

In patients with dysbetalipoproteinemia, the concentration of lipoproteins of intermediate cholesterol density - the low-density lipoprotein cholesterol - decreases. Atorvastatin in doses of 10 and 20 mg reduces the concentration of total cholesterol by 29 and 33%, LDL by 39 and 43%, Apo-B by 32 and 35% and TG by 14 and 26%, respectively; causes an increase in the concentration of cholesterol-HDL and Apo-A.

Dose-dependently reduces the concentration of LDL in patients with homozygous familial hypercholesterolemia, resistant to therapy with other lipid-lowering drugs.

Does not have a carcinogenic and mutagenic effect.

The therapeutic effect develops 2 weeks after the initiation of therapy, reaches a maximum after 4 weeks, and persists throughout the treatment period.

Pharmacokinetics:

Absorption and distribution

Absorption is high. The maximum concentration in the blood plasma (Cmah) after oral administration is achieved after 1 to 2 hours. Cmah Women are 20% higher, the area under the curve "concentration-time" (AUC) - 10% lower than in men, which has no clinical significance. FROMmah In patients with alcoholic liver cirrhosis (class B on the Child-Pugh scale) 16 times, and AUC - 11 times higher than normal.

Eating somewhat reduces the speed and degree of absorption of the drug (by 25% and 9% %, respectively), but the degree of decrease in LDL cholesterol when taking atorvastatin does not depend on food intake.

After oral administration of atorvastatin in the evening, its concentration in the blood plasma is lower (Cmah and AUC approximately 30%) than after taking in the morning hours, whereas a decrease in the concentration of LDL cholesterol does not depend on the time of day of taking the drug. A linear relationship between the degree of absorption and the dose of the drug has been revealed.

Bioavailability is 14%, the systemic bioavailability of inhibitory activity against HMG-CoA reductase is about 30%. Low systemic bioavailability is due to presystemic metabolism in the gastrointestinal tract (GIT) and the effect of "primary transmission" through the liver.

The average volume of distribution is 381 liters, communication with plasma proteins is 98%. The ratio of atorvastatin concentration in erythrocytes / plasma is about 0.25, which indicates a poor penetration of atorvastatin into erythrocytes.

Metabolism and excretion

Atorvastatin is metabolized predominantly in the liver by isozymes CYP3A4, CYP3A5 and CYP3A7 with the formation of pharmacologically active metabolites (ortho- and para-hydroxylated derivatives, beta-oxidation products). In vitro ortho- and para-hydroxylated metabolites have an inhibitory effect on HMG-CoA reductase, comparable to that of atorvastatin.The inhibitory effect of the drug against HMG-CoA reductase is approximately 70% determined by the activity of circulating metabolites, which persists for about 20 to 30 hours, due to their presence.

Research results in vitro suggest that isoenzyme CYP3A4 The liver plays an important role in the metabolism of atorvastatin. This is confirmed by an increase in the concentration of atorvastatin in blood plasma with the simultaneous administration of erythromycin, which is an inhibitor of this isoenzyme.

Research in vitro They also showed that atorvastatin is a weak isoenzyme inhibitor CYP3A4.

It is derived mainly through the intestine after hepatic and / or extrahepatic metabolism (the drug is not subjected to severe intestinal hepatic recirculation). The half-life (T1 / 2) is 14 hours. T1/2 inhibitory activity of HMG-CoA reductase is 20 to 30 hours. Less than 2% of the ingested dose is determined in urine.

It is not excreted during hemodialysis due to intensive binding to blood plasma proteins.

FROMmah and AUC of the drug in elderly patients (> 65 years) by 40 and 30%, respectively, higher than in young patients, but this does not affect the degree of lowering LDL cholesterol.

Impaired renal function does not affect the concentration of the drug in the blood plasma, the degree of decrease in LDL cholesterol.

Indications:

A drug Tulip® applies:

- in combination with a hypocholesterolemic diet to reduce increased concentrations of total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides, and increased cholesterol-HDL concentrations in patients with primary hypercholesterolemia, heterozygous familial and non-family hypercholesterolemia, and combined (mixed) hyperlipidemia (type IIa and IIb according to Fredrickson's classification), when diet therapy and other non-pharmacological treatments are not effective enough;

- to reduce the concentration of total cholesterol and cholesterol / LDL in patients with homozygous familial hypercholesterolemia, when diet therapy and other non-pharmacological treatments are not effective enough;

- primary prevention of cardiovascular complications in patients without clinical signs of ischemic heart disease, but having several risk factors for its development: age over 55, nicotine dependence, arterial hypertension, diabetes,retinopathy, albuminuria, low concentrations of Hc-HDL in the blood plasma, genetic predisposition, incl. against dyslipidemia;

- secondary prophylaxis of cardiovascular complications in patients with coronary heart disease in order to reduce the total death rate, myocardial infarction, stroke, re-hospitalization for angina pectoris and the need for revascularization.

Contraindications:

- hypersensitivity to atorvastatin and other auxiliary components of the drug;

- liver disease in the active stage or an increase in the serum activity of "liver" transaminases in blood plasma of unknown origin (more than 3 times compared with the upper limit of the norm);

- pregnancy and the period of breastfeeding;

- age under 18 years (effectiveness and safety not established);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (as the composition contains lactose).

Carefully:Alcohol abuse, liver disease in the history, diseases of the muscular system (in the anamnesis from the use of other representatives of the group HMG-CoA-reductase inhibitors),severe violations of water electrolyte balance, endocrine (hyperthyroidism) and metabolic disorders, arterial hypotension, diabetes mellitus, severe acute infections (sepsis), uncontrolled epilepsy, extensive surgical interventions, traumas, aggressive lipid-lowering therapy (atorvastatin in a dose of 80 mg) in the secondary prevention of stroke in patients with hemorrhagic or lacunar stroke in history.

Pregnancy and lactation:

A drug Tulip® contraindicated for use during pregnancy. Because cholesterol and substances synthesized from cholesterol are important for fetal development, the potential risk of inhibiting HMG-CoA reductase exceeds the benefit of using the drug during pregnancy.

In case of diagnosing pregnancy during drug therapy Tulip®, his reception should be terminated as soon as possible, and the patient is warned about the potential risk to the fetus.

A drug Tulip® can be used in women of reproductive age only if the probability of pregnancy is very low, and the patient is informed of the possible risk to the fetus during treatment.Women of reproductive age during drug treatment Tulip® should apply reliable methods of contraception.

Atorvastatin is excreted into breast milk, therefore it is contraindicated for use during breastfeeding, when it is necessary to administer the drug Tulip® during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Before starting the preparation Tulip® the patient should be recommended a standard hypocholesterolemic diet, which he must continue to observe during the entire period of therapy with the drug. It is recommended to apply the drug Tulip® inside regardless of the time of food intake. Dose of the drug Tulip® varies from 10 mg to 80 mg per day, and is adjusted to the initial concentration of LDL cholesterol, the purpose of therapy and an individual therapeutic response to the therapy.

For most patients, the initial dose is 10 mg once a day at the beginning of treatment, after 2-4 weeks of therapy and / or after increasing the dose of the drug Tulip® it is necessary to monitor the concentration of lipids in the blood plasma and, if necessary, adjust the dose of the drug.The maximum daily dose is 80 mg / day.

Primary (heterozygous hereditary and polygenic) hypercholesterolemia (type IIa) and mixed hyperlipidemia (type IIb)

In most cases, it may be sufficient to apply a dose of 10 mg of the drug Tulip® 1 time per day. If necessary, it is possible to gradually increase the dose to 80 mg, depending on the patient's reaction at an interval of 2-4 weeks, since the therapeutic effect is observed after 2 weeks, and the maximum therapeutic effect after 4 weeks. With prolonged treatment, this effect persists.

Homozygous hereditary hypercholesterolemia

A drug Tulip® used in most cases at a dose of 80 mg / day.

Prevention of cardiovascular disease

Tulip® apply in a dose of 10 mg once a day. If not achieved the optimal concentration of LDL in the plasma is possible to increase the dose of the drug up to 80 mg per day, depending on the patient's reaction with an interval 2-4 weeks.

Dose adjustment Tulip® in patients with impaired renal function and in elderly patients not required.

In patients with impaired liver function slowing the withdrawal of atorvastatin from the body,therefore it is recommended to apply it with caution in the regular monitoring of the activity of "liver" transaminases: aspartate aminotransferase (ACT) and alanine aminotransferase (ALT). If the observed increase in activity ACT or ALT more than 3 times compared with the upper limit of the norm (VGN) is preserved, it is recommended to reduce the dose or drug withdrawal Tulip®.

Side effects:

According to the World Health Organization (WHO) undesirable effects are classified according to their frequency of development as follows: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000), including individual messages; frequency is unknown - according to available data, establish frequency of occurrence is not seemed possible.

From the side immune systems often: allergic reactions; rarely: anaphylaxis.

From the central and peripheral nervous system: often: headache; infrequently: dizziness, sleep disturbances, including insomnia and nightmarish dreams, asthenic syndrome, weakness, paresthesia, hypoesthesia, a violation of taste sensitivity, loss or loss of memory; rarely: peripheral neuropathy.

From the side of the digestive system tract: often: constipation, flatulence, indigestion, nausea, diarrhea; infrequently: anorexia, vomiting, pancreatitis, hepatitis, abdominal pain, belching; rarely: Cholestatic jaundice (including obstructive jaundice); rarely: hepatic failure.

From the side of the locomotor system apparatus and connective tissue: often: myalgia, arthralgia, "Swelling" joints, joint pain, back pain, muscle spasm; infrequently: pain in the muscles of the neck, muscle weakness; rarely: myopathy, myositis, rhabdomyolysis, tendinopathy (sometimes complicated by a rupture of the tendon); frequency is unknown: immuno-mediated necrotizing myopathy.

From the sense organs infrequently: noise in the ears, blurred vision; rarely: impaired vision; rarely: loss of hearing.

From the skin and subcutaneous fat: infrequently: urticaria, skin rash and itching, alopecia; rarely: angioedema, Bullous rash, polymorphic exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the side of metabolism: often: hyperglycemia; infrequently: hypoglycemia, weight gain.

From the hematopoiesis: infrequently: thrombocytopenia.

From the respiratory system: often: nasopharyngitis, sore throat, nosebleed.

Laboratory indicators: often: increased activity serum creatinine phosphokinase (CK), increased activity "hepatic" transaminases; infrequently: leukocyturia; frequency is unknown: rise concentration of glycosylated hemoglobin.

Other: infrequently: increased fatigue, a violation of potency, secondary renal failure, fever, chest pain, peripheral edema; rarely: gynecomastia, diabetes mellitus.

There are separate reports on the development of atonic fasciitis (communication with the use of atorvastatin is not exactly established) frequency is unknown: depression, interstitial disease lungs (especially with prolonged therapy), sexual dysfunction.

Overdose:

There is no specific antidote for overdose treatment.

In case of an overdose, symptomatic treatment should be given. Hemodialysis is ineffective (because the drug is significantly associated with blood plasma proteins).

Interaction:

The risk of myopathy during treatment with HMG-CoA reductase inhibitors increases with simultaneous use with cyclosporine, erythromycin, clarithromycin, immunosuppressive, antifungal agents (azole derivatives) due to a possible increase concentration of atorvastatin in serum.

When used simultaneously with inhibitors of HIV proteases - indinavir, ritonavir - the risk of myopathy increases.

A similar interaction is possible with simultaneous use of atorvastatin with fibrates and nicotine acid at lipid-lowering doses (more than 1 g / day).

Inhibitor inhibitors CYP3A4

Since atorvastatin is metabolized by isoenzyme CYP3A4, co-administration Tulip® with inhibitors of this isoenzyme may lead to an increase in the concentration of atorvastatin in the blood plasma. The degree of interaction and the effect of increasing the concentration of atorvastatin are determined variability of exposure to isoenzyme CYP3A4.

Inhibitors of transport protein OATP1B1

Atorvastatin and its metabolites are substrates of the transport protein OATP1B1. Inhibitors of OATP1B1 (for example, ciclosporin) may increase the bioavailability of atorvastatin. Thus, the use of atorvastatin in a dose of 10 mg and cyclosporine at a dose of 5.2 mg / kg / day leads to an increase the concentration of atorvastatin in blood plasma is 7.7 times.

Erythromycin / clarithromycin

With simultaneous application Atorvastatin 10 mg and erythromycin (500 mg 4 times daily) or clarithromycin (500 mg twice daily) that inhibit the cytochrome isoenzyme CYP3A4, there is an increase concentrations of atorvastatin in the blood plasma (by 40% - with erythromycin and 56% - with clarithromycin).

Inhibitors of proteases

Simultaneous application Atorvastatin with protease inhibitors, known as inhibitors of the cytochrome isoenzyme CYP3A4, is accompanied by an increase concentrations of atorvastatin in blood plasma (with simultaneous use with erythromycin FROMmOh atorvastatin is increased by 40%).

Diltiazem

Joint application Atorvastatin 40 mg with diltiazem in a dose of 240 mg leads to an increase in the concentration of atorvastatin in the blood plasma.

Cimetidine

Clinically significant the interaction of atorvastatin with cimetidine was not revealed. Itraconazole

Simultaneous application Atorvastatin at doses of 20 mg to 40 mg and itraconazole at a dose of 200 mg conducts a 3-fold increase in the value AUC atorvastatin.

Grapefruit juice

Because grapefruit juice contains one or more components that inhibit the isoenzyme CYP3A4, its excessive use (more than 1.2 liters per day for 5 days) can cause an increase in concentration atorvastatin in the blood plasma.

Inductors of isoenzyme CYP3A4

Joint application atorvastatin with isoenzyme inducers CYP3A4 (eg, efavirenz or rifampicin) can lead to a decrease in the concentration of atorvastatin in the blood plasma. Due to the dual mechanism of interaction with rifampicin (inductor isoenzyme CYP3A4 and an inhibitor of the hepatocyte transport protein OATP1B1), simultaneous use is not recommended atorvastatin and rifampicin, since delayed administration of atorvastatin after rifampicin administration leads to a significant reduction concentrations of atorvastatin in blood plasma.

Antacids

With simultaneous administration of atorvastatin and a suspension containing magnesium and aluminum hydroxides, the concentration Atorvastatin in plasma is reduced by about 35%, but the degree of decrease in concentration LDL cholesterol does not change.

Fenazone

Atorvastatin does not affect the pharmacokinetics of phenazone, therefore interaction with other drugs metabolized by the same isoenzymes is not expected.

Kolestypol

The lipid-lowering effect of the combination with colestipol exceeds that for each drug alone, despite a decrease in concentration atorvastatin by 25% with its simultaneous application with colestipol.

Fusidic acid

There have been no studies on the interaction of atorvastatin and fusidic acid. As in the case of other statins, in post-marketing research joint application atorvastatin and fusidic acid reported side effects on muscles, including rhabdomyolysis. The mechanism of interaction is unknown. Such patients require careful follow-up and, possibly, a temporary discontinuation of atorvastatin.

Colchicine

Although no studies have been conducted on the interaction of atorvastatin and colchicine, cases have been reported myopathies in a joint application with colchicine, and with Caution should be exercised at the same time that atorvastatin and colchicine are administered.

Digoxin

With the repeated use of digoxin and atorvastatin at a dose of 10 mg, the equilibrium concentrations of digoxin in the blood plasma do not change. However, when using digoxin in combination with atorvastatin in a dose of 80 mg / day. the concentration of digoxin in the blood plasma increases by approximately 20%. Patients receiving digoxin in combination with atorvastatin, control of digoxin concentration in blood plasma is required.

Azithromycin

With the simultaneous use of atorvastatin in a dose of 10 mg 1 time / day and azithromycin at a dose of 500 mg 1 time / day, the concentration of atorvastatin in the blood plasma does not change.

Oral contraceptives

With simultaneous application atorvastatin and an oral contraceptive containing norethisterone and ethinyl estradiol, a significant rise AUC norethisterone and ethinyl estradiol by approximately 30% and 20%, respectively, which should be considered when choosing an oral contraceptive.

Terfenadine

Atorvastatin with simultaneous application with terfenadine does not have a clinically significant effect on the pharmacokinetics of terfenadine.

Warfarin

Patients who take long-term warfarin, atorvastatin in a dose of 80 mg per day somewhat shortens prothrombin time in the first days of joint application. This effect disappears after 15 days of simultaneous application of these drugs. Although the cases of clinically significant changes in anticoagulant effect was reported very rarely, prothrombin time in patients taking coumarin anticoagulants before and often enough at the beginning of atorvastatin treatment to ensure no significant changes prothrombin time. As soon as a stable prothrombin time, it can be checked at intervals, usual for patients, taking coumarin anticoagulants. When changing the dose or discontinuing treatment, these measures should be repeated. There was no association between the use of atorvastatin and bleeding or a change in prothrombin time in patients not taking anticoagulants.

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 does not change.

Other lipid-lowering drugs

With simultaneous use of atorvastatin with other lipid-lowering drugs (for example, ezetimibe, gemfibrozil, a derivative of fibroic acid) in lipid-lowering doses increased risk of developing rhabdomyolysis.

Other concomitant therapy

With the simultaneous use of atorvastatin with antihypertensive agents and estrogens (as a substitute therapy) clinically significant no interaction was found.

Special instructions:

Effects on the liver

As with the use of other inhibitors of HMG-Co-reductase (statins), with drug therapy Tulip® possibly moderate (more than 3 times higher than the upper limit of the norm (VGN)) increased serum activity "hepatic" transaminases: ACT and ALT.

Before the start of therapy, at 6 weeks and 12 weeks after starting the drug Tulip® or after increasing its dose, it is necessary to control indicators liver function (ACT, ALT). The liver function follows monitor also when there are clinical signs of liver damage. In case of increased activity ACT and ALT, their Activity should be monitored until it normalizes. Tulip® should be used with caution in patients who abuse alcohol and / or having a history of liver disease (see "With caution"). Diseases of the liver in the active stage or increase in the activity of "hepatic" transaminases of blood plasma of unknown origin are contraindication for the use of the drug Tulip® (see section "Contraindications").

Prevention of stroke with the help of intensive lipid-lowering of therapy (SPARCL).

In a retrospective analysis of the various subspecies of stroke in patients with coronary heart disease (CHD) who recently suffered a stroke or transient ischemic attack (TIA), a higher risk of hemorrhagic stroke in patients, host atorvastatin at a dose of 80 mg per compared with placebo. Especially high risk was observed in patients who underwent hemorrhagic stroke or lacunar infarction at the time of the start of the study. For patients who have had hemorrhagic stroke or lacunar infarction and receiving atorvastatin in a dose of 80 mg, the risk / benefit ratio is ambiguous, and should be carefully monitored. appraise potential risk of development hemorrhagic stroke before treatment.

Action on skeletal muscles

When using the drug Tulip® possibly the development of myalgia. Diagnosis of myopathy (pain and weakness in muscles in combination with an increase more than 10 times the activity of CKD in comparison with HHI) is possible in patients with diffuse myalgia, tenderness or weakness of muscles and / or a marked increase in CKK activity. Drug therapy Tulip® should be discontinued in the event of a marked increase in the activity of CK or in the presence of confirmed or suspected myopathy.

When using other inhibitors of HMG-Co-reductase (statins) possible increased risk Myopathy with simultaneous application with cyclosporine, fibrates, erythromycin, nicotinic acid in lipid-lowering doses (more than 1 g / day) or azole antifungal preparations.

Applying the drug Tulip® in combination with fibrates, erythromycin, immunosuppressants, azole antifungal agents or nicotinic acid in lipid-lowering doses (more than 1 g / day), it is necessary to weigh the expected benefit and risk of drug treatment Tulip®.

Very rarely reported cases of immunosupplemented necrotizing myopathy during or after treatment with statins, including atorvastatin.

Immuno-mediated necrotizing myopathy is clinically characterized muscle weakness in the upper limbs and an increase in the concentration of CFC of the blood plasma, persisting despite the cessation of statin treatment.

If necessary combination therapy should consider use of these drugs in lower initial and maintenance doses.

Recommended periodic control of the activity of CK. Joint application atorvastatin and fusidic acid is not recommended, therefore, a temporary discontinuation of therapy should be considered atorvastatin during the administration of fusidic acid.

Patients should be warned that you should immediately consult a doctor if you have unexplained pain or muscle weakness, especially if they are accompanied by malaise or fever!

When using the drug Tulip® as well as other inhibitors of HMG-Co-reductase (statins), rare cases of rhabdomyolysis with acute renal failure are described, caused by myoglobinuria.

When there are symptoms of possible myopathy or the presence of a risk factor for developing kidney failure in the background rhabdomyolysis (eg, severe acute infection, arterial hypotension, extensive surgical intervention, trauma, metabolic and endocrine disorders and uncontrolled convulsions) drug therapy Tulip® should be suspended or completely canceled.

Interstitial lung disease

It was reported about extremely rare cases of development interstitial lung disease with the use of certain statins, especially with prolonged therapy. Clinical manifestations include shortness of breath, a non-productive cough, and a deterioration in overall health (fatigue, weight loss and fever). In case of suspected development of interstitial lung disease, treatment with statins should be discontinued.

Diabetes

Data from some studies suggest that the use of statins as a class can lead to increased blood glucose levels, and in some patients with an increased risk of developing diabetes in the future can cause a level hyperglycemia, which requires a standard antidiabetic therapy. However, this risk is insignificant in comparison with a decrease in the risk of vascular risk when taking statins, and therefore should not be the reason for the abolition of statin treatment. Patients in risk group (with fasting glucose 5,6-6,9 mmol / l, body mass index> 30 kg / m², an elevated level triglycerides, increased arterial pressure) must be controlled, both clinically and biochemically, in accordance with national standards medical care.

Effect on the ability to drive transp. cf. and fur:During treatment with Tulip®, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated 10 mg and 20 mg.

Packaging:For 10 tablets (10 or 20 mg) is placed in a blister of A1 / A1 foil. For 3, 6 or 9 blisters are placed in a cardboard box together with instructions for medical use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Shelf life:

3 years

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015755 / 01

Date of registration:02.06.2009

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp21.04.2015

Illustrated instructions

Instructions

Tulip® (Tulip®)