Lescola Forte - instructions for use, dose, side effects, contraindications

Active substanceFluvastatinFluvastatin

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Lescola® Forte

pills inwards

Novartis Pharma AG Switzerland

Dosage form: & nbsptablets of prolonged action, film-coated

Composition:

1 tablet of 80 mg contains:

active substance: fluvastatin sodium 84.24 mg;

Excipients: cellulose microcrystalline 111.27 mg, hypromellose 97.50 mg, giprolose 16.25 mg, potassium hydrogen carbonate 8.42 mg, povidone K-30 4.88 mg, magnesium stearate 2.44 mg;

film coating: Opadrai (mixture for film coating, coating, yellow): iron dye oxide yellow (CI No. 77492, E 172), macrogol 8000, titanium dioxide, hypromellose.

Description:

Round biconvex with beveled edges of yellow tablets. On one side of the tablet there is an inscription "LE", on the other side - "NVR".

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

ATX: & nbsp

C.10.A.A.04 Fluvastatin

Pharmacodynamics:

Fluvastatin, synthetic lipid-lowering drug, is a competitive inhibitor of the enzyme HMG-CoA reductase, which is responsible for the conversion of HMG-CoA into mevalonate, a precursor of sterols, in particular cholesterol (Xc). Fluvastatin inhibits the synthesis of cholesterol in the liver.

It is basically a racemate of two erythroenantiomers, one of which has pharmacological activity.With inhibition of cholesterol synthesis and a decrease in its content in liver cells, it increases in compensation the formation of receptors for low density lipoprotein (LDL), as well as their capture by hepatocytes, which leads to a decrease in the concentration of cholesterol in the blood plasma.

Treatment of patients with primary hypercholesterolemia or mixed dyslipidemia drug at a dose of 80 mg / day for 24 weeks leads to a significant decrease in the concentrations of total XC by 23%, X-LDL by 34%, apo-B by 26%, triglycerides (TG) by 19%; to increase the concentration of high-density lipoproteins (X-HDL) by 9%. In patients with initially low HDL-C values (<35 mg / dL), the increase in this indicator may be higher (up to 14%).

Clinical effect is observed after 2 weeks of treatment, reaches maximum expression within 4 weeks from the beginning of treatment and remains with constant therapy.

In patients with primary mixed dyslipidemia IIb type in the classification of Fredrickson in the treatment of fluvastatin at a dose of 80 mg per day, there is a decrease in the concentration of TG in the blood plasma by 25% (with an initial value of 200 to 400 mg / dL).

In patients with ischemic heart disease (CHD) with concomitant hypercholesterolemia (Xc-LDL 115-190 mg / dL),the use of fluvastatin 40 mg / day for 2.5 years causes a significant slowdown in the progression of coronary atherosclerosis (according to angiographic data).

The use of fluvastatin in patients with IHD at different concentrations of total XC significantly reduces the risk of developing the first serious cardiovascular event (sudden death from cardiovascular disease, suffered myocardial infarction, the need for revascularization procedures and coronary bypass) for 4 years. This positive effect is especially pronounced in patients with diabetes mellitus and multiple lesions of the coronary arteries. Therapy with the drug reduces by 31% the risk of myocardial infarction and / or sudden death from cardiovascular pathology.

It was shown that the concentration of total XC decreased by an average of 23.6%, Xc-LDL by 30.5%, and TG by 5.2% and increased HDL-C by 5% with fluvastatin for two years in children and adolescents older than 9 years with heterozygous familial hypercholesterolemia with:

- the initial concentration of LDL-C> 190 mg / dl (4.9 mmol / l);

- the initial concentration of LDL-C> 160 mg / dL (4.1 mmol / L) and the presence of one or more risk factors (early coronary heart disease in relatives, smoking, increased blood pressure,confirmed concentration of HDL-C is below 35 mg / dL, diabetes mellitus);

- of the initial concentration of LDL-C> 160 mg / dL (4.1 mmol / L), TG <600 mg / dL, and the established DNA-deficiency of the LDL-C receptor.

The use of fluvastatin in children and adolescents older than 9 years does not lead to disruption of growth, development and puberty.

Fluvastatin has not been used to treat children and adolescents under the age of 9 years.

The presented pharmacodynamic features of fluvastatin obtained as a result of clinical studies can not be used to assess the possible consequences of early onset of therapy with lipid-lowering means in children.

Fluvastatin is effective when used as a monotherapy.

There are data confirming the efficacy and safety of fluvastatin when combined with nicotinic acid (in lipid-lowering doses), colstiraamine or fibrate.

Pharmacokinetics:

Suction

When administered orally in the form of a solution fluvastatin absorbed quickly and completely (98%). After ingestion of the drug tablets, fluvastatin absorption is 60% slower than conventional dosage forms (capsules), with an average retention time of fluvastatin in the blood plasma increased by approximately 4 hours.After eating, the rate of absorption of fluvastatin decreased somewhat. Significant differences in lipid-lowering the effects of fluvastatin on appointment with food intake or 4 hours after it were not observed.

Distribution

Bioavailability of the drug is 24%. Visible volume of fluvastatin distribution (V_z/f) is equal to 330 liters. More than 98% of circulating fluvastatin binds to blood plasma proteins, and the degree of binding does not depend on the concentration of fluvastatin itself, or on the content of warfarin, salicylic acid and glyburide in the blood plasma.

Metabolism

Fluvastatin is metabolized mainly in the liver. After taking the drug in the blood, it is mainly circulated fluvastatin and pharmacologically inactive metabolite - N-Disisopropylpropionic acid.

Hydroxylated metabolites have a pharmacological activity, however they do not enter the systemic circulation.

The fluvastatin biotransformation pathways are not associated with cytochrome P450, therefore the fluvastatin metabolism remains practically unchanged under the action of drugs affecting cytochrome P450. Fluvastatin inhibits only isoenzyme CYP2C9 despite possible competition between fluvastatin and isoenzyme substrates CYP2C9, such as diclofenac, phenytoin, tolbutamide and warfarin, according to clinical studies, drug interaction is unlikely.

Excretion

It is excreted primarily through the intestine (93%) and about 6% by the kidneys, with the unchanged fluvastatin accounting for less than 2%. The calculated value of the plasma clearance (CL/f) fluvastatin in humans is 1.8 ± 0.8 l / min. The values of equilibrium plasma concentrations suggest no cumulation of fluvastatin after its administration at a dose of 80 mg per day. After a single administration of 80 mg of the drug on an empty stomach, the half-life of fluvastatin was 7.0 ± 3.8 hours. When fluvastatin is prescribed during supper or 4 hours after dinner, significant differences in the area under the concentration-time curve (AUC) was not revealed.

The concentration of fluvastatin in the blood plasma does not depend from the floor or age of the patient.

However, there was a more pronounced effect of fluvastatin among women and elderly patients.

Fluvastatin has a high degree of presystemic metabolism, is excreted through the biliary tract. There is a possibility of cumulation of the drug in patients with hepatic insufficiency.

Indications:

Adults (from 18 years and older):

- primary hypercholesterolemia and mixed dyslipidemia (type IIa and IIb by Fredrickson classification) in combination with diet therapy;

- coronary atherosclerosis in patients c ischemic heart disease and primary hypercholesterolemia, including an insignificant (for slowing the progression of the disease);

- secondary prevention of major cardiovascular events (sudden death from cardiovascular pathology, post-infarction myocardial and coronary revascularization) in patients with ischemic disease after percutaneous transluminal balloon angioneuroplasty.

Children and adolescents (over 9 years):

- heterozygous familial hypercholesterolemia in combination with dietotherapy.

Contraindications:

- Hypersensitivity to fluvastatin or any inactive drug ingredient;

- active liver disease or persistent increase in serum transaminase activity of unclear etiology;

- age younger than 18 years, except for indications: heterozygous familial hypercholesterolemia in combination with diet therapy - age younger than 9 years;

- pregnancy, the period of breastfeeding;

- use in women reproductive age that do not enjoy reliable methods of contraception.

Carefully:

Care should be taken:

- when prescribed to patients with a history of liver disease or abusing alcohol;

- when appointing patients with a predisposition to rhabdomyolysis, as well as with hereditary muscle diseases, cases of muscle toxicity with the use of other hypolipidemic drugs in the anamnesis.

Liver function

Post-marketing cases of hepatic insufficiency with a fatal outcome and without a fatal outcome are described with the use of some statins, including Lescola® Forte. Although there is no causal relationship with Lescola® Forte, patients should be advised to immediately report any potential symptoms or signs of liver failure (including nausea, vomiting, decreased appetite, jaundice, impaired brain function, a tendency to bruising , bleeding) with the subsequent consideration of the issue ofthe cessation of therapy.

Pregnancy and lactation:

Since the inhibitors of HMG-CoA- reductase inhibit the synthesis of cholesterol and, probably, other biologically active substances - the derivatives of cholesterol, when prescribing these drugs to pregnant women they can harm the fetus. Therefore, the use of Lescola® Forte is contraindicated in pregnancy and the period of breastfeeding.

Women of childbearing age should use adequate methods of contraception. If pregnancy occurs during treatment with the drug of this pharmacological group, treatment should be discontinued.

Contraindicated the use of Lescola® Forte in breastfeeding.

Dosing and Administration:

Tablets Lesco ® Forte can be taken once a day, regardless of food intake. The Lescola® Forte tablet should be swallowed whole with a glass of water. Since the maximum lipid-lowering effect of the drug develops by week 4, the first revision of the dose of the drug is carried out depending on the effect achieved, with an interval of not less than 4 weeks. The therapeutic effect of the drug Lescola® Forte persists with its long-term use.

Adults

Before starting treatment with Lescola® Forte, the patient should be transferred to a standard hypocholesterol diet. The diet should be followed and during the entire treatment period.

The initial recommended dose of the drug is 80 mg (1 tablet) 1 time per day.

The initial dose should be selected individually, taking into account the initial concentration of cholesterol / LDL and the stated goal of therapy.

For patients with coronary heart disease after angioeoplastic surgery, the recommended initial dose is 80 mg per day.

Children and adolescents older than 9 years with heterozygous familial hypercholesterolemia

Children and adolescents older than 9 years within 6 months prior to the initiation of therapy with Lescola® Forte and throughout the treatment period should adhere a standard hypocholesterol diet.

The recommended initial dose of the drug is 80 mg (1 tablet) 1 time per day. In mild cases of the disease, a dose of fluvastatin 20 mg (1 capsule of Lescola® 20 mg) may be sufficient. Initial doses should be selected individually according to the baseline concentration of X-LDL and the goals of treatment.

The use of fluvastatin simultaneously with nicotinic acid in lipid-lowering doses (≥1 g / day), colestyramine or fibrates in children and adolescents has not been studied.

Patients with impaired renal function

Because the fluvastatin is excreted mainly by the liver and only less than 6% of the dose received in the body is excreted by the kidneys, in patients with impaired renal function of any severity, there is no need to correct the dose of the drug.

Patients with impaired hepatic function

Contraindicated the use of Lescola® Forte with active liver disease or persistent increase in the activity of transaminases (creatine phosphokinase (CK), aspartate aminotransferase (ACT), alanine aminotransferase (ALT) of unknown etiology.

Patients aged ≥65 years

The efficacy and good tolerability of fluvastatin has been demonstrated for patients aged over 65 years and younger than this age. In the age group over 65, the response to treatment was more pronounced, and no evidence of a worse tolerability was obtained. Thus, there is no need to change the dose of Lescola® Forte given age.

Side effects:

The undesirable phenomena listed below are listed by frequency, starting with the most frequent. The incidence of undesirable reactions was estimated as follows: "very often" occurring ≥ 1/10, "often" - ≥ 1/100, <1/10, "infrequently" - ≥ 1/1000, <1/100, "rarely" - ≥ 1/10 000, <1/1000, "very rarely" - <1/10 000, including individual messages. Within the limits of each group allocated according to the frequency of occurrence, adverse reactions are distributed in order of decreasing their severity.

Among the observed side effects of the drug, the most frequently observed minor symptoms from the gastrointestinal tract, insomnia and headache.

Disturbances from the blood system and lymphatic system: rarely - thrombocytopenia.

Immune system disorders: rarely - hypersensitivity (skin rash, hives), very rarely - anaphylactic reactions.

Disorders of the psyche: often - insomnia.

Impaired nervous system: often - headache; rarely - paresthesia, dysesthesia, hypoesthesia, possibly related to the underlying disease.

Vascular disorders: rarely - vasculitis.

Disturbances from the digestive tract: often - nausea, abdominal pain, indigestion; rarely - pancreatitis.

Disorders from the liver and bile ducts: very rarely hepatitis.

Disturbances from the skin and subcutaneous tissues: very rarely - angioedema, swelling of the face and other skin reactions (eczema, dermatitis, bullous exanthema).

Disturbances from the musculoskeletal and connective tissue: rarely - myalgia, muscle weakness, myopathy; rarely - rhabdomyolysis, lupus-like syndrome, myositis.

Laboratory and instrumental data: often - increased activity of CKK and activity of transaminases in blood serum.

Based on spontaneous messages received in the post-registration period, revealed the following undesirable phenomena, the frequency of which can not be established:

Violations of the genitals and mammary gland: erectile dysfunction.

Application Safety Profile fluvastatin in children and adolescents older than 8 years with heterozygous familial hypercholesterolemia, which was evaluated in two clinical trials, did not differ from that established for adults.In both clinical studies, children and adolescents had normal processes of growth and sexual development.

Changes in liver function in the blood serum are associated with inhibitors of HMG-CoA reductase and other lipid-lowering agents.

A confirmed increase in the activity of hepatic transaminases in the serum to values more than 3 times higher than the upper limit of the norm was observed in a small number of patients (1-2%).

A marked increase in the activity of CK, in the form of a 5-fold excess of the upper limit of the norm, was registered in a small number of patients (0.3-1%).

In the postmarketing study of the use of some statins, the following adverse effects were reported: loss or loss of memory, depression, sleep disturbances, including insomnia and nightmarish dreams, sexual dysfunction, gynecomastia, hyperglycemia,

Concentrations of glycosylated hemoglobin, single cases of interstitial lung disease (especially with prolonged use), cases of immuno-mediated necrotizing myopathy, thrombocytopenia.

Overdose:

In placebo-controlled studies In 40 patients with hypercholesterolemia who received Lescola® Forte at a dose of 320 mg per day for 2 weeks, good tolerability was noted. Currently there is no specific treatment for overdose of Lescola® Forte.

In case of an accidental drug overdose, symptomatic treatment and all necessary measures ensuring the maintenance of vital body functions are indicated. It is necessary to monitor the parameters, liver function and serum CKK activity.

Interaction:

Effect of food on fluvastatin

There are no significant differences in hypolipidemic action fluvastatin, given together with an evening meal or after 4 hours.

Because the fluvastatin does not interact with substances that are substrates for the isoenzyme CYP3A4, its interaction is not expected with grapefruit juice.

The effect of various drugs on fluvastatin

Fibric acid derivatives (fibrates) and nicotinic acid at lipid-lowering doses (≥1 g / day)

With the simultaneous administration of fluvastatin with bezafibrate, gemfibrozil,ciprofibrate or nicotinic acid in lipid-lowering doses (≥1 g / day), no clinically significant changes in the bioavailability of fluvastatin or other lipid-lowering agents have been observed. However, since simultaneous use of other HMG-CoA reductase inhibitors with any of the above drugs has been associated with an increased risk of myopathy, such combinations should be used with caution.

Itraconazole and erythromycin

Simultaneous administration of fluvastatin and such potent inhibitors of isoenzyme CYP3A4 as itraconazole and erythromycin has a slight effect on the bioavailability of fluvastatin. Since the isoenzyme CYP ZA4 does not play any significant role in fluvastatin metabolism, it can be expected that other inhibitors of this isoenzyme (ketoconazole, ciclosporin) will not affect the bioavailability of fluvastatin.

Fluconazole

The administration of fluvastatin to healthy volunteers who previously received fluconazole (inhibitor of isoenzyme CYP2C9), led to an increase AUC and maximum concentration (C_max) of fluvastatin in blood plasma by 84% and 44%, respectively.Although no clinical evidence of a change in the safety profile of fluvastatin has been obtained in patients receiving the previous 4-day treatment with fluconazole, caution should be exercised when they are used together.

Cyclosporin

In clinical studies in patients after kidney transplantation who received stable maintenance doses of cyclosporine, there was no clinically significant increase in the bioavailability of fluvastatin, given in a daily dose of up to 40 mg. In another study, when the drug was administered at a dose of 80 mg patients after kidney transplantation, who received stable maintenance doses of cyclosporine, there was an increase AUC and C_mOh fluvastatin in 2 times, in comparison with indicators of healthy volunteers. Despite the fact that the increase AUC and C_mOh fluvastatin were not clinically significant, caution should be exercised when using this combination.

Bile acid sequestrants

Fluvastatin should be administered no earlier than 4 hours after taking the resin (eg, colestyramine) to avoid binding fluvastatin.

Rifampicin (rifampin)

When fluvastatin is prescribed to healthy volunteers who have previously received rifampicin, a decrease in the bioavailability of fluvastatin by about 50% was noted. Although the change in the activity of fluvastatin has not been shown to be effective for patients receiving long-term treatment with rifampicin (eg, for tuberculosis), nevertheless, appropriate fluvastatin dose adjustment may be required to achieve the desired hypolipidemic effect,

H₂-gistamine receptor blockers and proton pump inhibitors

Simultaneous administration of fluvastatin with cimetidine, ranitidine or omeprazole increases the bioavailability of fluvastatin, which, however, has no clinical significance. Although studies on the interaction of fluvastatin with other drugs of these pharmacological groups have not been conducted, nevertheless, any significant effect of these drugs on the bioavailability of fluvastatin is unlikely.

Phenytoin

The effect of phenytoin on the pharmacokinetic parameters of fluvastatin is very slight, therefore dose adjustment fluvastatin is not required.

Cardiovascular drugs

There were no clinically significant pharmacokinetic interactions with the simultaneous use of fluvastatin with propranolol, digoxin, losartan, clopidogrel or amlodipine, so when using such combinations it is not required monitoring the concentration of these preparations in blood plasma and correction of their doses.

The influence of fluvastatina for other medicinal products

Cyclosporin

With the simultaneous use of fluvastatin in a dose of 80 mg with cyclosporine, the bioavailability of the latter was not noted.

Colchicine

There are no data on the pharmacokinetic interaction of fluvastatin and colchicine. However, with the use of fluvastatin together with colchicine, in some cases, myopathy developed (muscle pain, muscle weakness and rhabdomyolysis).

Phenytoin

Changes in the pharmacokinetic parameters of phenytoin with simultaneous application of fluvastatin are relatively small and clinically insignificant, so when assigning such combinations it is sufficient to conduct a generally accepted control of the concentration of phenytoin in the blood plasma.

Warfarin and other coumarin derivatives

In healthy volunteers, a single dose of fluvastatin and warfarin was not observedadverse effects on the concentration of warfarin in the blood plasma and prothrombin time. However, there are very few reports of bleeding and / or an increase in prothrombin time observed in patients treated with fluvastatin, while concurrent administration of warfarin or other coumarin derivatives. Therefore, in patients who are on therapy with warfarin or other coumarin derivatives, it is recommended to monitor prothrombin time in the event of initiating or canceling fluvastatin therapy, as well as in case of a change in its dose.

Hypoglycemic agents for oral administration

In patients with type 2 diabetes, who are treated with sulfonylureas (glibenclamide, tolbutamide), the addition of fluvastatin to therapy does not lead to clinically significant changes in the glycemic profile.

In 32 patients with type 2 diabetes treated with glibenclamide, a simultaneous application of fluvastatin 40 mg twice daily for 14 days showed an increase in the mean values of the maximum concentration of the drug in the blood plasma (C_mOh), AUC and half-life (T_1/2) of glibenclamide by approximately 50%, 69%, and 121%, respectively. Wherein, glibenclamide in a dose of 5 mg to 20 mg caused an increase in the average values of C_mOh and AUC for fluvastatin by 44% and 51%, respectively. In this study, there was no change in the concentration of glucose, insulin and C-peptide. However, patients taking both fluvastatin and glibenclamide, appropriate monitoring is recommended when the fluvastatin dose is increased to 80 mg per day.

Clopidogrel

Fluvastatin has no effect on the antiplatelet activity of clopidrohydrol. Fluvastatin and clopidogrel can be used in combination without dose adjustment.

Special instructions:

Liver function

All patients are recommended to assess liver function before starting treatment with Lescola® Forte, 12 weeks after starting treatment or increasing the dose and periodically during treatment. If activity ACT or ALT is 3 times higher than the upper limit of the norm and is persistently maintained at this level, treatment should be discontinued. In very rare cases, hepatitis was detected, which may have been associated with taking the drug, and was resolved after discontinuation of treatment.

Skeletal musculature

When using Lescol® Forte described rare cases of myopathy, and there are some reports of the development of myositis and rhabdomyolysis. When patients complain of unexplained diffuse myalgia, muscle weakness or soreness, and / or detect a marked increase in CKK activity, one should suspect myopathy, myositis, or rhabdomyolysis. Patients should be advised immediately to report muscle pains of unknown etiology, tenderness or weakness of the muscles, especially if they are accompanied by general malaise or fever.

Measuring Activity creatine phosphokinase

At the moment there is no evidence of the need for mandatory control of the activity of CKK or other muscle enzymes in the blood plasma in the absence of the above symptoms. Do not measure the activity of CKK after intense physical exertion, as well as in the presence of any other factors that cause an increase in activity of CK.

Before the start of treatment, it is recommended to perform the determination of the activity of CK in the following cases:

- kidney failure;

- ghypothyroidism;

- nhereditary diseases muscle (own or family anamnesis);

- Pmuscular manifestations toxicity in the use of lipid-lowering drugs in history;

- зalcohol abuse;

- fromepsis;

- arterial hypotension;

- tequal;

- aboutbroad operational intervention;

- tsevere metabolic, enodoline or in oneelectrolyte disturbances;

- ncontrolled epilepsy;

- at elderly patients (over 65 years) should assess the need to determine the activity of CK in the presence of other factors predisposition to rhabdomyolysis.

In these cases, the relationship between the expected benefit of therapy and the risk of adverse events should be assessed and the patient carefully monitored. If there is a marked increase in CKK activity 5 times or more in comparison with the upper limit of the norm (VGN), it is necessary to re-measure after 5-7 days to confirm the result. With a persistent, marked increase in CPK activity (> 5 VGN), treatment should not begin.

In the course of treatment with Lescola® Forte, when muscle symptoms (pain, weakness, convulsions) occur, it is necessary to determine the activity of CKK.Treatment should be discontinued with a marked increase in CPK activity (> 5 VGN).

With severe muscular symptoms causing permanent discomfort, even if an increase in the activity of CK <5 VGN, consideration should be given to discontinuing therapy.

With the cessation of muscle pain, weakness, seizures and normalization of the activity of CKK, resumption of treatment with Lescola® Forte or any other inhibitor of HMG-CoA reductase should begin with a minimal dose and under close supervision.

There was an increased risk of myopathy with the co-administration of other HMG-CoA reductase inhibitors and preparations such as immunosuppressants (in particular, cyclosporin), fibrates, a nicotinic acid in lipid-lowering doses or erythromycin. However, in clinical trials with Lescola® Forte in combination with nicotinic acid in lipid-lowering doses (≥1 g / day), fibrates or cyclosporine, no cases of myopathy were noted. There are separate post-marketing reports on cases of myopathy with simultaneous application of Lescola® Forte with cyclosporine or colchicine.In patients receiving similar concomitant therapy, Lescola® Forte should be used with caution.

Effect on glucose metabolism

Patients taking HMG-CoA reductase inhibitors were observed increase in concentration glycosylated hemoglobin (HbAlC) and / or fasting plasma glucose concentration. There were also cases of newly emerged type 2 diabetes in patients with risk factors for diabetes mellitus.

Application of Lescol® Forte in children and adolescents under 18 years of age

The efficacy and safety of Lescola® Forte in children and adolescents under 18 years of age for a period exceeding 2 years has not been established.

The use of Lescola® Forte in children and adolescents older than 9 years with heterozygous familial hypercholesterolemia was studied.

Homozygous familial hypercholesterolemia

Currently, there is no data on the use of Lescola® Forte in patients with a rare disease such as homozygous familial hypercholesterolemia.

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

Data on the effect of Lescola® Forte on the ability to drive vehicles and work with mechanisms are not available.

Form release / dosage:Tablets of prolonged action, film-coated, 80 mg.

Packaging:

7 or 14 tablets in a foil aluminum foil.

For 4 blisters (7 tablets) or 1 or 2 blisters (14 tablets each), along with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013398 / 01

Date of registration:13.06.2011

The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland

Manufacturer: & nbsp

NOVARTIS FARMACEUTICA, S.A. Spain

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp26.09.2015

Illustrated instructions

Instructions

Lescola® Forte (Lescol® FORTE)