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

Active substanceMetoprolol + FelodipineMetoprolol + Felodipine

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Dosage form: & nbsptlong-acting aberrations coated with a film sheath

Composition:

1 tablet of prolonged action, film-coated, contains:

active substances: metoprolol succinate 47.5 mg corresponding to 39 mg of metoprolol or 50 mg metoprolol tartrate; felodipine 5 mg;

Excipients: hypromellose, sodium aluminosilicate, lactose anhydrous, giprolose, macrogol glyceryl hydroxy stearate, microcrystalline cellulose, sodium stearyl fumarate, propyl gallate, silicon dioxide, ethylcellulose;

in the form of a film tablet shell: (E171), iron dye oxide yellow (E172), iron dye red oxide (E172), iron oxide

Description:

Round, biconvex tablets, covered with a film membrane, light orange color; on one side engraving A FG.

Pharmacotherapeutic group:A combined hypotensive drug (beta-blocker + BCCC)

ATX: & nbsp

C.07.F.B.02 Metoprolol in combination with other antihypertensive agents

Pharmacodynamics:

Logimax® is a combined remedy that has antihypertensive and anti-anginal action.

Complementary mechanism of selective beta action₁(decrease in cardiac output) and vasoselective "slow" calcium channel blocker (BCCK) felodipine (decrease in total peripheral vascular resistance) leads to a more pronounced antihypertensive effect and better tolerability in comparison with indicators that can be obtained with monotherapy with metoprolol and felodipine. The hypotensive effect of the drug Logimax® persists for 24 hours.

Metoprolol

Metoprolol is a cardioselective beta antagonist₁-adrenoceptors, does not affect therapeutic doses on beta₂-adrenoceptors, localized mainly in peripheral vessels and bronchi. Has an insignificant membrane-stabilizing effect and does not possess internal sympathomimetic activity.

Beta-adrenoblockers have a negative inotropic and chronotropic effect. Metoprolol reduces the stimulating effect of catecholamines on the myocardium and contributes to a decrease in the heart rate (heart rate), a decrease in cardiac output and blood pressure (BP).In a state of stress with increased secretion of adrenaline does not interfere with normal physiological vasodilation.

In therapeutic doses metoprolol less influence on the musculature of the bronchi than non-selective beta-adrenoblockers.

To a lesser extent, than nonselective beta-blockers affect insulin secretion and carbohydrate metabolism, and in this connection it can be prescribed to patients with diabetes mellitus. Metoprolol has less effect on such cardiovascular reactions in hypoglycemia, such as tachycardia. With metoprolol therapy, the concentration of glucose in the blood plasma is restored to the normal value faster than with non-selective beta-blockers.

Metoprolol reduces elevated blood pressure in both the "standing" and "lying" positions, as well as during physical exertion. At the beginning of therapy, an increase in the total peripheral vascular resistance (OPSS) occurs. However, with prolonged treatment there is a decrease in blood pressure due to a decrease in OPSS with unchanged cardiac output. In patients with hypertension metoprolol reduces mortality from cardiovascular causes.Against the background of reception there were no changes in the indices of water-electrolyte balance of blood.

Felodipine

Felodipine is a dihydropyridine derivative, is a selective BCCI and is intended for the treatment of arterial hypertension and stable angina.

Felodipine is a racemic mixture.

Conductivity and contractility of the smooth muscles of blood vessels are suppressed by affecting the calcium channels of cell membranes.

Due to the high selectivity for smooth arteriolar musculature, felodipine in therapeutic doses does not have a negative inotropic effect on the contractility or conductivity of the myocardium.

Felodipine relaxes the smooth muscles of the respiratory tract and has a slight effect on the motility of the gastrointestinal tract.

With prolonged application has no clinically significant effect on the concentration of lipids in the blood.

In patients with type 2 diabetes mellitus, when felodipine was used for 6 months, there was no clinically significant effect on the concentration of glycosylated hemoglobin (HbA1c).

Felodipine can also be administered to patients with left ventricular dysfunction,who receive standard therapy, and patients with bronchial asthma, diabetes, gout or dyslipidemia.

Antihypertensive effect: a decrease in blood pressure when taking felodipine is due to a decrease in OPSS. Felodipine effectively reduces blood pressure in patients with arterial hypertension in both the "lying" and "sitting", "standing", at rest and under physical exertion. Because the felodipine does not affect the smooth musculature of the veins or adrenergic action, then there is no development of orthostatic hypotension. At the beginning of treatment, as a result of lowering blood pressure on the background of taking felodipine, there may be a temporary reflex increase in heart rate and cardiac output, which is leveled when combined with beta-blockers. The effect of felodipine on AD and OPSS is correlated with the plasma concentration of felodipine. After achieving a stable equilibrium concentration in the plasma of felodipine, the antihypertensive effect persists throughout the inter-dose interval for at least 24 hours.

Treatment with felodipine leads to regression of left ventricular hypertrophy.

Felodipine reduces vascular resistance in the kidneys,has a natriuretic and diuretic effect and does not have a potassium -uretic effect (due to a decrease in the rate of tubular reabsorption of sodium and water ions).

Felodipine does not affect the rate of glomerular filtration and albumin excretion.

Pharmacokinetics:

Metoprolol

After oral administration metoprolol completely absorbed in the intestine.

Systemic bioavailability of metoprolol in delayed-release tablets of Betaloc® ZOK is 30-40%. It is metabolized in the liver mainly by the action of the isoenzyme CYP2D6 with the formation of 3 major metabolites that do not have pharmacological activity and are not of clinical significance. Metoprolol is excreted through the kidneys. The half-life period averages 3.5 hours. About 5% of the accepted dose is excreted unchanged, the rest of the dose taken is in the form of metabolites. The connection with plasma proteins is low, about 5-10%.

Felodipine

The indicator of systemic bioavailability of felodipine is about 15% and does not depend on the intake of food. Food intake affects the rate of absorption of felodipine, leading to an increase in the rate of reaching maximum concentration (C_m_Oh) in the blood plasma by approximately 65%. FROM_m_Oh in blood plasma is achieved 3-5 hours after taking the drug inside. The connection with plasma proteins is approximately 99%. The volume of distribution in the equilibrium state is approximately 10 l / kg. The half-life (T_1/2) of felodipine in the final phase for about 25 hours, the equilibrium concentration is reached after 5 days. Do not cumulate. The total plasma clearance is an average of 1200 ml / min.

In patients with impaired liver function and elderly patients, the concentration of felodipine in the blood plasma increases. However, the age only partially explains the individual changes in the plasma concentration of felodipine.

Metabolized in the liver under the action of the isoenzyme CYP3A4, all metabolites are pharmacologically inactive. About 70% of the accepted dose is excreted as metabolites by the kidneys, the rest - through the intestine. Less than 0.5% is excreted by the kidneys unchanged. If the renal function is impaired, the plasma concentration of felodipine does not change, but cumulation of inactive metabolites is observed.

Felodipine is not excreted in hemodialysis.

Metoprolol + Felodipine

The administration of the drug Logimax® does not lead to a change in the bioavailability of the active components compared to the separate simultaneous administration of metoprolol and felodipine. Absorption rates do not depend on food intake.

Indications:

Arterial hypertension (can be used in cases when treatment with beta-adrenoblockers or BCCK dihydropyridine derivatives used in monotherapy does not have a clinically significant effect).

Contraindications:

- Hypersensitivity to metoprolol, felodipine or other components of the drug, as well as other derivatives of dihydropyridine or other beta-blockers;

- unstable angina;

- atrioventricular blockade of II and III degree;

- hemodynamically significant stenosis of the heart valves;

- dynamic stenosis of the outgoing tract of the heart;

acute myocardial infarction;

- Pregnancy;

- Chronic heart failure in the stage of decompensation (pulmonary edema, hypoperfusion or arterial hypotension, CHF III-IV functional class by classification NYHA) and continuous or intermittent inotropic therapy with beta-adrenoreceptor agonists;

- bradycardia or severe arterial hypotension with the presence of clinical symptoms;

- syndrome of weakness of the sinus node (except for patients with a constant rhythm driver);

- cardiogenic shock;

- marked violations of peripheral circulation (with the threat of gangrene development);

- Suspicion of an acute stage of myocardial infarction (heart rate less than 45 beats per minute, interval PQ more than 0.24 s or systolic blood pressure less than 100 mm Hg. item);

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

- pheochromocytoma (without simultaneous use of alpha-blockers);

- lactose intolerance, lactase deficiency and glucose-galactose malabsorption syndrome (the drug contains lactose).

Carefully:

(Comparing benefit / risk): severe renal failure (creatinine clearance less than 30 mL / min), aortic stenosis, impaired hepatic function, myocardial infarction, arterial hypotension, acute metabolic acidosis, chronic heart failureI-II functional class by classification NYHA), bronchial asthma, chronic obstructive pulmonary disease (COPD), stenocardia of Prinzmetal.

Pregnancy and lactation:

Pregnancy

Logimax® should not be administered during pregnancy.

Metoprolol can be used during pregnancy and lactation only in case of emergency, when the benefit to the mother exceeds the potential risk to the fetus and / or the child. Beta-adrenoblockers can cause bradycardia in the fetus, newborns and in infants who are breastfed. This should be considered when deciding whether to prescribe the drug during the last trimester of pregnancy and immediately before childbirth.

At present, there is insufficient data on the use of felodipine in pregnant women. Based on the data obtained on animals, the development of the fetus, felodipine should not be administered during pregnancy. BCCI can reduce uterine contractions in premature birth, however, there is insufficient data confirming the increase in the duration of physiological labor. There is a risk of fetal hypoxia in the presence of arterial hypotension in the mother and a decrease in perfusion in the uterus due to redistribution of blood flow and peripheral vasodilation.

Breast-feeding

Metoprolol and felodipine are excreted in breast milk.If you need to use the drug Logimaks® during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside, take in the morning, wash down with water. Do not divide the tablet, do not crush or chew. Tablets can be used on an empty stomach or with a small amount of food with a low content of fats and carbohydrates.

The dose of the drug Logimax® is selected individually. When choosing the initial dose, it is recommended to take into account the effect of previously taken doses of beta-blockers or BCCC.

Usually initial dose: 1 tablet of the drug Logimax® once a day. If necessary, the dose can be increased to 2 tablets in one dose 1 time per day.

Impaired renal function

Impaired renal function does not affect the concentration of the drug in the blood plasma. There is no need to adjust the dose of the drug for patients with impaired renal function, but caution should be exercised when administering the drug to patients with severe renal insufficiency (QC less than 30 ml / min) (see "Contraindications" and "Special instructions").

Impaired liver function

Usually, there is no need to adjust the dose of the drug for patients with cirrhosis, since metoprolol binds to blood proteins only to a small extent (5-10%). In the presence of symptoms of severe hepatic dysfunction (for example, patients undergoing portocaval shunt surgery), do not take more than 1 tablet of the drug Logimax® per day.

Elderly patients

Usually, one tablet of the drug Logimax® once a day is enough. If necessary, the dose can be increased to 2 tablets 1 time per day.

Children

The experience of using the drug in children under 18 years is absent.

Side effects:

The most common adverse reactions with taking Logimax® are: headache (11%), swelling of the ankles, redness of the facial skin, dizziness, nausea and fatigue. These side effects can be observed at the beginning of treatment or with increasing doses, usually pass on their own. Most of these effects are explained by vasodilating properties of felodipine.

The following are side effects noted during clinical trials and in the post-marketing application of metoprolol and felodipine alone.

The incidence of adverse reactions is indicated using the following symbols: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000),very rarely (<1/10000).

The following adverse events of metoprolol have been reported:

From the side of the blood and lymphatic system:

Very rarely - thrombocytopenia.

From the side of metabolism and nutrition:

Infrequent is an increase in body weight.

From the side of the psyche:

Infrequent - depression, decreased ability to concentrate, "nightmarish" dreams, sleep disturbance; rarely excitability, a sense of anxiety; very rarely - amnesia / memory impairment, confusion, hallucinations.

From the nervous system:

Often - dizziness, headache; infrequently paresthesia; very rarely - a violation of taste.

From the side of the organ of vision:

Rarely - visual impairment, dryness and / or eye irritation, conjunctivitis.

From the organ of hearing:

Very rarely - ringing in the ears.

From the heart:

Often - bradycardia, a feeling of palpitations; infrequently - reversible enhancement of symptoms of heart failure, AV blockade of I degree, chest pain; rarely - conduction disorders, arrhythmias.

From the side of the vessels:

Often - postural disorders (very rarely accompanied by syncope), cold extremities; very rarely - gangrene in patients with severe peripheral circulation disorders.

From the respiratory system:

Often - shortness of breath; infrequently bronchospasm in patients with bronchial asthma or bronchial obstructive syndrome; rarely rhinitis.

From the gastrointestinal tract:

Often - nausea, abdominal pain, diarrhea, constipation; infrequently - vomiting; rarely dryness of the oral mucosa.

From the liver and bile ducts:

Rarely - increased activity of "liver" transaminases; very rarely - hepatitis.

From the skin and subcutaneous tissues:

Infrequent - a rash (by the type of psoriasis-like urticaria), increased sweating; rarely - hair loss; very rarely - photosensitivity, exacerbation of psoriasis.

From the side of the musculoskeletal and connective tissue:

Infrequent - muscle spasm; very rarely - arthralgia.

From the genitals and the breast:

Rarely, impotence / sexual dysfunction.

General disorders:

Very often - increased fatigue; infrequent peripheral edema; rarely - reactions of hypersensitivity.

The following adverse events of felodipine have been reported:

From the nervous system:

Often - a headache; infrequently - dizziness, paresthesia.

From the heart:

Infrequent - tachycardia, a feeling of palpitations.

From the side of the vessels:

Often - redness of the skin of the face, accompanied by a feeling of heat, swelling of the ankles; infrequent - marked decrease in blood pressure, accompanied by tachycardia, which in predisposed patients can cause an exacerbation of the course of angina pectoris; rarely - faint; very rarely - extrasystole.

From the endocrine system:

Very rarely - hyperglycemia.

From the gastrointestinal tract:

Infrequent - nausea, pain in the abdomen; rarely vomiting; very rarely - hyperplasia of the mucous membrane of the tongue and gums, gingivitis.

From the liver and bile ducts:

Very rarely - increased activity of "liver" transaminases in the blood serum.

From the skin and subcutaneous tissues:

Infrequently - exanthema, itchy skin; rarely - hives; very rarely - photosensitization, leukocytoclastic vasculitis.

From the side of the musculoskeletal and connective tissue:

Rarely - arthralgia, myalgia.

From the side of the kidneys and urinary tract:

Very rarely - frequent urination.

From the genitals and the breast:

Rarely, impotence / sexual dysfunction.

General disorders:

Very often - peripheral edema; infrequently - increased fatigue; very rarely - reactions of increased sensitivity, for example, angioedema in the form of edema of the lips or tongue,fever.

There are some reports of sleep disturbances, but there is no connection with the use of felodipine.

Overdose:

Symptoms

In case of an overdose, there may be a marked decrease in blood pressure, an acute cardiac insufficiency, aetiology, bradyarrhythmia, intracardiac conduction disturbance, vascular tone disruption and bronchospasm.

Treatment

Treatment should be conducted in medical institution with equipment and facilities for maintenance of vital functions and monitoring of the patient's condition.

In view of the clinical situation, gastric lavage can be performed and / or assigned Activated carbon. With bradycardia and conduction disorders apply atropine and adrenomimetics, if necessary - establish a pacemaker.

At the expressed depression of arterial pressure, an acute cardiac insufficiency and shock should be given to therapy aimed at increasing the volume of circulating blood plasma; use glucagon in the form of injection (then, if necessary, enter glucagon in the form of intravenous infusion); intravenously administer adrenomimetics (such as dobutamine) together with α₁-adrenomimetics in the case of vasodilation. It is also possible intravenous administration of drugs containing calcium ions.

To stop bronchospasm, bronchodilators should be used.

Interaction:

Co-administration with agents interacting with the cytochrome P450 enzyme system can affect the concentration of metoprolol and felodipine in the blood plasma.

There is no evidence of an interaction between metoprolol and felodipine, since they are metabolized by various isoenzymes of the cytochrome P450 system.

Interaction with metoprolol

Metoprolol is a substrate for isoenzyme CYP2D6. Isozyme inhibitory drugs CYP2D6, such as quinidine, terbinafine, paroxetine, fluoxetine, sertraline, celecoxib, propafenone and diphenhydramine, can change the concentration of metoprolol in the blood plasma. It may be necessary to reduce the dose of the drug Logimax® when combined with these medicines.

Interaction with felodipine

Felodipine is a substrate for isoenzyme CYP3A4. Preparations that induce or inhibit the isoenzyme CYP3A4, have a significant effect on the concentration of felodipine in the blood plasma.

Drugs that induce the cytochrome P450 system: phenytoin, carbamazepine, phenobarbital and rifampicin, as well as preparations of St. John's wort increase the metabolism of felodipine due to the induction of the cytochrome P450 system. The combined use of phenytoin, carbamazepine, phenobarbital and rifampicin leads to a decrease in the area under the concentration-time curve (AUC) by 93% and C_m_Ohfelodipine by 82%. It is necessary to avoid the joint use with inductors of the isoenzyme CYP3A4.

Drugs that inhibit the cytochrome P450 system: antifungal agents of azole series (itraconazole, ketoconazole), macrolide antibiotics (for example, erythromycin) and HIV protease inhibitors are inhibitors of the isoenzyme CYP3A4.

When combined use of itraconazole C_m_OhFelodipine increases 8 times, AUC - 6 times.

With the joint use of erythromycin C_m_Ohand AUC Felodipine increases approximately 2.5 times. Combined use of felodipine and isozyme inhibitors should be avoided CYP3A4.

Grapefruit juice inhibits the enzyme system of isoenzyme CYP3A4. The use of felodipine with grapefruit juice increases C_m_Ohand AUC felodipine approximately 2 times. Joint use should be avoided.

Tacrolimus: felodipine can cause an increase in tacrolimus concentration in the blood plasma. When combined, it is recommended that the concentration of tacrolimus in the blood serum be monitored, and tacrolimus dosage adjustment may be required.

Cyclosporine: when combined with cyclosporine and felodipine C_m_OhFelodipine increases by 150%, AUC increases by 60%. However, the effect of felodipine on the pharmacokinetic parameters of cyclosporine is minimal.

Cimetidine: the combined use of cimetidine and felodipine leads to an increase in C_mOh and AUC felodipine by 55%.

The simultaneous use of the drug Logimax® should be avoided with the following:

Derivatives of barbituric acid: Barbiturates (the study was conducted with phenopharbital) slightly increases the metabolism of metoprolol, due to the induction of microsomal liver enzymes.

Propaphenon: when using propafenone by 4 patients treated with metoprolol, an increase in plasma concentration of metoprolol was observed in 2-5 times, while in 2 patients there were side effects typical of metoprolol.This interaction was confirmed during the study by 8 volunteers. Probably, the interaction is due to the inhibition of propafenone, like quinidine, metoprolol metabolism through the cytochrome system P4502D6. Taking into account the fact that propafenone has the properties of beta-adrenoblocker, the joint use of the drug Logimax® and propafenone is not advisable.

Verapamil: a combination of beta adrenoblockers (atenolol, propranolol and pindolol) and verapamil can cause bradycardia and lead to a decrease in blood pressure. Verapamil and beta-blockers have a complementary inhibitory effect on AV conductivity and sinus node function.

Correction of a dose of the drug Logimax® may be required with simultaneous use with the following medicines:

Class I antiarrhythmic drugs: antiarrhythmic drugs of the first class and beta-adrenoblockers with simultaneous application can lead to the summation of a negative inotropic effect, which leads to serious hemodynamic side effects in patients with left ventricular dysfunction.Also, this combination should be avoided in patients with sinus node weakness syndrome and impaired AV conductivity. The interaction is described by the example of disopyramide.

Diphenhydramine: diphenhydramine reduces the clearance of metoprolol to alpha-hydroxymethoprolol by a factor of 2.5. At the same time there is an increase in the effect of metoprolol.

Clonidine: an increase in blood pressure with a sharp abolition of clonidine may be more pronounced when taken together with beta-blockers. When combined, in the case of withdrawal of clonidine, discontinuation of beta-blockers should begin several days before the withdrawal of clonidine.

Diltiazem: diltiazem and beta-blockers mutually enhance the inhibitory effect on AV conductivity and sinus node function. In the combination of metoprolol with diltiazem, cases of severe bradycardia were noted.

Non-steroidal anti-inflammatory drugs (NSAIDs): NSAIDs weaken the antihypertensive effect of beta-blockers. This interaction is the most studied for indomethacin. This interaction was not noted for sulindac. In studies with diclofenac this reaction was not noted.

Phenylpropanolamine: phenylpropanolamine (norephedrine) in a single dose of 50 mg can cause an increase in diastolic blood pressure to pathological values in healthy volunteers. Propranolol mainly prevents the increase in blood pressure, caused by phenylpropanolamine. However, beta-adrenoblockers can cause reactions of paradoxical arterial hypertension in patients receiving high doses of phenylpropanolamine. Several cases of hypertensive crisis have been reported against phenylpropanolamine.

Epinephrine: reported 10 cases of severe arterial hypertension and bradycardia in patients taking non-selective beta-blockers (including pindolol and propranolol) and received epinephrine. Interaction is noted in the group of healthy volunteers. It is assumed that similar reactions may occur and the application of epinephrine with local anesthetic together with a random contact with the bloodstream. It is assumed that this risk is much lower with the use of cardioselective beta-blockers.

Quinidine: quinidine inhibits the metabolism of metoprolol in a particular group of patients with "fast" hydroxylation (in Sweden about 90% of the population), causing, mainly,a significant increase in plasma concentrations of metoprolol and an increase in beta-adrenoblockade. It is believed that this interaction is characteristic for other beta-blockers, in the metabolism of which cytochrome P4502D6 participates.

Amiodarone: the combined use of amiodarone and metoprolol can lead to severe sinus bradycardia. Taking into account the extremely long half-life of amiodarone (50 days), possible interaction should be considered after a long time after amiodarone withdrawal.

Rifampicin: rifampicin can enhance the metabolism of metoprolol, decreasing the plasma concentration of metoprolol.

Cardiac glycosides: in combination with beta-blockers may violate AV conductivity and cause bradycardia.

The concentration of metoprolol in the blood plasma can be increased when combined with cimetidine, hydralazine, selective serotonin reuptake inhibitors, such as paroxetine, fluoxetine and sertraline.

Patients simultaneously taking metoprolol and other beta-blockers (in the form of eye drops) or monoamine oxidase (MAO) inhibitors,should be under close supervision.

Against the background of taking beta-blockers, inhalational anesthetics increase cardiodepressive action.

Against the background of taking beta-blockers, patients receiving hypoglycemic agents for oral administration may need to adjust the dose of the latter.

Special instructions:

Caution should be exercised when combined with cardiac glycosides.

Logimax® may exacerbate the symptoms of impaired peripheral circulation, for example, "intermittent" lameness.

Special care is required in the following conditions: severe renal failure (QC less than 30 ml / min), aortic stenosis, impaired liver function, myocardial infarction complicated by acute heart failure, arterial hypotension, which in predisposed patients can cause myocardial ischemia, acute metabolic acidosis.

It is not recommended to start treatment with the drug Logimax® in patients who have not previously received antihypertensive therapy.

It is not recommended to prescribe the drug to patients with latent or identified heart failure with clinical manifestations without appropriate therapy.

The use of the drug Logimax® may have an effect on carbohydrate metabolism or mask hypoglycemia, but with the use of the drug Logimax®, the risk of exposure to carbohydrate metabolism is less than with the use of nonselective beta-blockers.

In some cases, the existing violations AVConductivity can be amplified, leading to AV blockade.

Patients taking Logimax® should not be injected intravenously with a type of verapamil BCCC.

In patients with Prinzmetal angina, the frequency and severity of angina attacks may increase due to spasm of coronary vessels caused by stimulation of alpha-adrenergic receptors. In this regard, it is not recommended to prescribe non-selective beta-blockers to this group of patients. Use with caution selective beta₁-adrenoceptor blockers.

In patients with bronchial asthma or chronic obstructive pulmonary disease, concomitant beta therapy₂-adrenomimetics. In the case where the patient begins to take Logimax®, an increase in the beta dose may be required₂-adrenomimetics.

Against the background of taking beta-blockers anaphylactic shock can take a more severe form.

The use of epinephrine (adrenaline) in a commonly used dose does not always lead to the expected therapeutic effect.

Patients with pheochromocytoma are recommended to prescribe alpha-blockers in parallel with the drug Logimax®.

The combined use of drugs inducing the isoenzyme CYP3A4 leads to a significant decrease in the concentration of felodipine in the blood plasma and the insufficient therapeutic effect of taking the drug (see "Interaction with other drugs and other interactions"). Joint use of such drugs should be avoided.

Joint use of isozyme inhibitory drugs CYP3A4, leads to a significant increase in the concentration of felodipine in the blood plasma.

It should avoid taking Logimax® with grapefruit juice due to a significant increase in the concentration of felodipine in the blood plasma.

It is necessary to avoid a sharp abolition of beta-blockers, especially in patients at high risk of cardiovascular complications because of the possible increase in symptoms of chronic heart failure and an increased risk of myocardial infarction and sudden death.If necessary, the abolition of the drug Logimax® should be carried out gradually by reducing the dose within 1-2 weeks.

It is not recommended to stop treatment with beta-blockers for patients who are undergoing surgery. In the case of surgical intervention, an anesthesiologist should be warned about the treatment with the drug Logimax®.

Reported cases of hyperplasia of the mucous membrane of the tongue and gums after taking felodipine in patients with severe gingivitis / paradontitis. This side effect can avoid or reduce the degree of its manifestation by observing the thorough oral hygiene.

Patients with pheochromocytoma are recommended to simultaneously prescribe alpha-blockers.

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

During the therapy with the drug Logimax®, care should be taken when driving vehicles and engaging in other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (dizziness and fatigue may occur).

Form release / dosage:Tablets of prolonged action, film-coated, 50 mg + 5 mg.

Packaging:

30 tablets in a plastic bottle.

One bottle in a cardboard box with instructions for use.

Storage conditions:

At temperatures not higher than 30 ° C, out of reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N016261 / 01

Date of registration:26.02.2010 / 13.12.2013

Expiration Date:Unlimited

The owner of the registration certificate:AstraZeneca ABAstraZeneca AB Sweden

Manufacturer: & nbsp

ASTRAZENECA, AB Sweden

Representation: & nbspAstraZeneca Pharmaceuticals Ltd.AstraZeneca Pharmaceuticals Ltd.

Information update date: & nbsp12.04.2018

Illustrated instructions

Instructions

Logimax® (Logimax®)