Nifecard HL pills po with controlled release 30mg №10×3

Name:
Nifecard HL tabl plen.ob. with control vysv. 30mg per blister. in pack. No. 10×3 Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Expiration date from date of manufacture3 years
Description:
of product Modified release tablets, film-coated from light brownish yellow to light brownish orange, round, biconvex, with “NDP 30” embossed on one side; yellow in cross section. Pharmacological action Selective blocker of slow calcium channels, a derivative of 1,4-dihydropyridine. It has antianginal and hypotensive effect. Reduces the current of extracellular calcium into cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses inhibits the release of calcium ions from intracellular depots. Reduces the number of functioning channels without affecting the time of their activation, inactivation and recovery. Dissociates the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, and in vascular smooth muscle, mediated by calmodulin. In therapeutic doses, it normalizes the transmembrane current of calcium ions, which is disturbed in a number of pathological conditions, primarily in arterial hypertension. Does not affect the tone of the veins. Enhances coronary blood flow, improves blood supply to ischemic areas of the myocardium without the development of the “steal” phenomenon, activates the functioning of collaterals. Improves myocardial function, reduces the strength of heart contractions and myocardial oxygen demand. By expanding the peripheral arteries, it lowers blood pressure and reduces OPSS and afterload on the heart. Almost no effect on the sinoatrial and AV nodes. Enhances renal blood flow, causes moderate natriuresis. It inhibits platelet aggregation, has anti-atherogenic properties (especially with prolonged use). Lowers pressure in the pulmonary artery, has a positive effect on the blood supply to the vessels of the brain. With prolonged use, the development of tolerance to nifedipine may occur. Pharmacokinetics Absorption and distribution After oral administration, nifedipine is rapidly and almost completely absorbed (92-98%). Due to the delayed release of the active substance, a gradual controlled increase in plasma concentrations of nifedipine is ensured. The plasma concentration of nifedipine reaches a plateau after about 6 hours and is maintained with slight fluctuations for 24 hours. Plasma protein binding is 90%. Penetrates through the BBB and the placental barrier, excreted in breast milk. There is no cumulative effect. Metabolism Metabolized in the liver. No active metabolites have been identified. The elimination T1 / 2 of nifedipine is approximately 2 hours. It is excreted as inactive metabolites mainly in the urine (80%) and bile (20%). Pharmacokinetics in special clinical situations Chronic renal failure, hemodialysis and peritoneal dialysis do not affect the pharmacokinetics of nifedipine. In case of impaired liver function, the clearance of nifedipine is reduced. In severe hepatic impairment, dose adjustment may be required. In elderly patients with intravenous administration, the clearance of nifedipine was reduced by 33% compared with young healthy volunteers. Indications for use Arterial hypertension; coronary artery disease: stable angina pectoris, angiospastic angina pectoris (Prinzmetal’s angina pectoris). Use during pregnancy and lactation Pregnancy No controlled studies on the use of nifedipine in pregnant women have been conducted. Animal studies have shown teratogenicity and embryo/fetotoxicity of nifedipine. The use of Nifecard® CL before the 20th week of pregnancy is contraindicated. The use of the drug Nifecard® CL after the 20th week of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus; the drug should be used only in a hospital with appropriate monitoring of the condition of the mother and fetus (control of maternal blood pressure; regular ultrasound monitoring of the development and viability of the fetus). If abnormalities occur, the drug should be discontinued. Breastfeeding period Nifedipine passes into breast milk, therefore, when used during lactation, it is necessary to resolve the issue of stopping breastfeeding. Fertility Calcium channel blockers such as nifedipine have been shown in some studies to produce reversible biochemical changes in the sperm head that can lead to dysfunction. In men who repeatedly experience problems conceiving a child through in vitro fertilization, the use of nifedipine should be considered as one of the possible causes, if no other explanation can be found. Special instructions It is recommended to stop treatment with Nifecard® HL gradually. It should be borne in mind that an attack of angina pectoris may occur at the beginning of treatment, especially after the recent abrupt withdrawal of beta-blockers (the latter should be canceled gradually). Simultaneous use of beta-blockers should be carried out under conditions of close medical supervision, as this may cause an excessive decrease in blood pressure, and in some cases, aggravation of symptoms of heart failure. With severe heart failure, the drug is dosed with great care. Rarely, in patients with severe coronary artery stenosis at the beginning of therapy or with an increase in the dose of nifedipine, the frequency and severity of anginal pain may increase, up to the development of myocardial infarction. Diagnostic criteria for the use of the drug in vasospastic angina pectoris are: the classic clinical picture, accompanied by an increase in the ST segment on the ECG, the occurrence of ergonovine-induced angina or spasm of the coronary arteries, the detection of coronary spasm during angiography or the detection of an angiospastic component without confirmation (for example, with a different threshold of tension or with unstable angina pectoris, when ECG data indicate transient angiospasm). For patients with severe hypertrophic obstructive cardiomyopathy, there is a risk of an increase in the frequency, severity of manifestation and duration of angina attacks after the use of nifedipine; in this case, it is necessary to cancel the drug. In patients with diabetes mellitus, when using the drug Nifecard® CL, it may be necessary to control the concentration of glucose in the blood plasma. In patients on hemodialysis, with high blood pressure and irreversible renal dysfunction, with reduced BCC, the drug should be used with caution, a sharp drop in blood pressure may occur. Patients with impaired liver function are closely monitored and, if necessary, reduce the dose of the drug and / or use other dosage forms of nifedipine. In patients with severe stenosis of any part of the gastrointestinal tract, intestinal obstruction may develop. In very rare cases, bezoars may develop, which may require surgery to remove. In isolated cases, symptoms of intestinal obstruction can be observed in patients who do not have gastrointestinal pathology. The risk of developing bezoars is increased in patients with reduced intestinal motility (constipation, gastroesophageal reflux, obesity, hypothyroidism, diabetes mellitus), intestinal tumors, diverticulitis, inflammatory bowel changes, vertical gastroplasty, gastric bypass, after resection of the small intestine, colostomy, as well as simultaneous use with H2-histamine receptor blockers, opiates, NSAIDs, anticholinergics, neuromuscular blockers (muscle relaxants), laxatives (laxatives). There are isolated reports of “sticking” of tablets to the intestinal wall with the formation of ulcers that required hospitalization and surgery. It should be borne in mind that when performing an X-ray examination of the intestine with barium, false-positive symptoms of a polyp (filling defect) can be detected. If during therapy the patient requires surgery under general anesthesia, it is necessary to inform the anesthesiologist about the nature of the therapy being carried out. Nifedipine, like other slow calcium channel blockers, inhibits platelet aggregation in vitro. A small number of reports confirm data on a statistically significant decrease in platelet aggregation and an increase in bleeding time. The clinical significance of this is unknown. During treatment, a positive result is possible during the direct Coombs test and an increase in the titer of antinuclear antibodies. There is no need for special precautions when destroying unused product. Influence on the ability to drive vehicles and control mechanisms During the period of treatment with Nifecard® HL, care must be taken when engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, and refrain from drinking alcohol. With caution (Precautions) With caution, the drug should be prescribed for stenosis of the aortic or mitral valve, hypertrophic obstructive cardiomyopathy, severe tachycardia, SSS, malignant arterial hypertension, myocardial infarction with left ventricular failure, cerebrovascular disorders, impaired liver and / or kidney function, hemodialysis (risk of arterial hypotension), diabetes mellitus, intestinal obstruction, pregnancy after the 20th week, simultaneous use of beta-blockers or cardiac glycosides, simultaneously with inducers or inhibitors of CYP3A4. Contraindications severe arterial hypotension (systolic blood pressure below 90 mm Hg); severe aortic valve stenosis with clinically significant hemodynamic disturbances; unstable angina pectoris; chronic heart failure in the stage of decompensation; cardiogenic shock (risk of myocardial infarction); acute period of myocardial infarction (in during the first 4 weeks); simultaneous use of rifampicin; rare hereditary forms of lactose intolerance, lactase deficiency or malabsorption of glucose / galactose (because the composition contains lactose); pregnancy up to 20 weeks; breastfeeding period; age up to 18 years (effectiveness and safety have not been established). Hypersensitivity to nifedipine, drug components and other derivatives of 1,4-dihydropyridine. Dosage and administration The drug is taken orally, at the same time of day. Tablets should be swallowed without chewing; tablets should not be crushed or divided. Do not take pills with grapefruit juice. The dosing regimen is set individually. The dose of Nifecard® HL is 1 tab. (30 mg or 60 mg) / day once. Dose selection begins with 30 mg / day, correction is carried out at intervals of 7-14 days. The maximum daily dose of Nifecard® HL is 90 mg. It is possible to slow down the excretion of nifedipine in elderly patients, therefore, smaller maintenance doses of the drug may be required compared with young patients. In patients with impaired liver function, the use of nifedipine should be carried out under close supervision, if necessary, a reduction in the dose of the drug may be required. In patients with impaired renal function, dose adjustment is not required. Patients with severe cerebrovascular disease should be treated with the drug at a low dose. If it is necessary to cancel the drug Nifecard® CL, the dose should be reduced gradually. OverdoseSymptoms: peripheral vasodilation with a pronounced and possibly prolonged decrease in blood pressure (headache, flushing of the skin of the face, inhibition of the activity of the sinus node, bradycardia and / or tachycardia, bradyarrhythmia), hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock with the development of pulmonary edema. In severe poisoning – loss of consciousness, coma. Treatment of an overdose consists in standard procedures for removing the drug from the body (administration of activated charcoal, gastric lavage), restoring stable hemodynamic parameters, and carefully monitoring the activity of the heart, lungs and excretory system. In cases of overdose of long-acting drugs, it is necessary to ensure the most complete removal of the drug from the body, if possible, washing the small intestine in order to prevent further absorption of the active substance. When using laxatives, it should be borne in mind that blockers of slow calcium channels can cause a decrease in the tone of the intestinal muscles up to intestinal atony. Hemodialysis is ineffective, plasmapheresis is recommended due to the high degree of protein binding and the relatively small volume of distribution. Treatment of bradyarrhythmias is symptomatic with atropine and/or beta-sympathomimetics; in the event of life-threatening bradyarrhythmias, a temporary pacemaker is required. With a persistent pronounced decrease in blood pressure as a result of cardiogenic shock and arterial vasodilation, calcium (1-2 g of calcium gluconate, i.v.), dopamine (up to 25 mcg/kg/min), dobutamine (up to 15 mcg/kg/min), epinephrine (adrenaline) or norepinephrine (norepinephrine). Doses of these drugs should be determined solely on the basis of the effect obtained. In view of the possible volume overload of the heart, infusion therapy is recommended to be carried out with caution under the control of hemodynamic parameters. The antidote is calcium supplements. Clearance of nifedipine is increased in patients with hepatic impairment. Side effectsAccording to WHO, adverse reactions are classified according to their frequency of development as follows: very often (?1/10), often (?1/100, <1/10), infrequently (?1/1000, <1/100) , rarely (?1/10,000, <1/1000) and very rarely (<1/10,000); the frequency is unknown - according to the available data, it was not possible to establish the frequency of occurrence. On the part of the blood and lymphatic system: the frequency is unknown - agranulocytosis, leukopenia, anemia, thrombocytopenia. From the immune system: infrequently - allergic reactions, allergic edema / angioedema; rarely - itching, skin rash, urticaria; frequency unknown - anaphylactic / anaphylactoid reaction, toxic epidermal necrolysis, exfoliative dermatitis, photodermatitis, autoimmune hepatitis, thrombocytopenic purpura. From the side of metabolism and nutrition: the frequency is unknown - hyperglycemia. From the nervous system: often - headache; infrequently - dizziness, migraine, fatigue, tremor, dysgeusia; rarely - paresthesia / dysesthesia of the extremities; the frequency is unknown - with prolonged use in high doses - depression, anxiety, extrapyramidal (parkinsonian) disorders (ataxia, mask-like face, "shuffling" gait, stiffness of the movements of the arms and legs, tremor of the hands and fingers, difficulty swallowing, hypesthesia, drowsiness) , irritability, sleep disturbance (including insomnia), nightmares, decreased libido. On the part of the organ of vision: infrequently - visual impairment (transient); frequency unknown - pain in the eye area. On the part of the organ of hearing and labyrinth disorders: infrequently - ringing in the ears. From the side of the cardiovascular system: often - peripheral edema, increased symptoms of vasodilation (asymptomatic decrease in blood pressure, flushing of blood to the skin of the face, flushing of the skin of the face, a feeling of heat); infrequently - tachycardia, palpitations, arrhythmia, excessive decrease in blood pressure (especially in patients on dialysis with malignant hypertension and reduced BCC), fainting, syncope; very rarely - in some patients, especially at the beginning of treatment, angina attacks may occur, which requires discontinuation of the drug. Isolated cases of myocardial infarction have been described; the frequency is unknown - retrosternal pain, aggravation of symptoms of the course of heart failure. From the respiratory system: infrequently - nosebleeds, nasal congestion, cough, sinusitis, difficulty breathing, upper respiratory tract infections; frequency unknown - dyspnea, bronchospasm, pulmonary edema. From the digestive system: often - constipation; infrequently - dryness of the oral mucosa, loss of appetite, dyspepsia (nausea, diarrhea), pain in the abdomen; rarely - gingival hyperplasia (bleeding, soreness, swelling); the frequency is unknown - dysphagia, erosive and ulcerative lesions of the intestinal mucosa, vomiting, insufficiency of the gastroesophageal sphincter, with prolonged use - impaired liver function (intrahepatic cholestasis, increased activity of hepatic transaminases, jaundice), bezoars. From the musculoskeletal system: infrequently - cramps of the upper and lower extremities, swelling of the joints, back pain, gout; frequency unknown - arthritis, arthralgia, myalgia. From the genitourinary system: infrequently - an increase / decrease in daily diuresis, erectile dysfunction; rarely - gynecomastia (in elderly patients, completely disappearing after discontinuation of the drug); frequency unknown - galactorrhea, deterioration of kidney function (in patients with renal insufficiency). From the skin and subcutaneous tissues: infrequently - alopecia, increased sweating, hemorrhagic rash. General disorders and disorders at the injection site: often - asthenia, weakness; infrequently - nonspecific pain, chills, swelling of the face, periorbital edema, fever, weight gain. Composition 1 tab. nifedipine 30 mg Excipients: povidone - 75 mg, sodium lauryl sulfate - 2.4 mg, hypromellose (hydroxypropyl methylcellulose) - 185.8 mg, Ludipress® (a mixture of lactose monohydrate, povidone, crospovidone in a ratio of 93: 3.5: 3.5) - 70 mg, talc (magnesium hydrosilicate) - 6 mg, magnesium stearate - 0.8 mg. Shell composition: hypromellose phthalate (hydroxypropyl methylcellulose phthalate) - 18.2 mg, triethyl citrate - 1.8 mg, hypromellose (hydroxypropyl methylcellulose 2910) - 3 mg, hyprolose (hydroxypropyl cellulose) - 3 mg, macrogol (polyethylene glycol) - 1 mg, talc (magnesium hydrosilicate) - 0.5 mg, titanium dioxide - 1.93 mg, iron dye yellow oxide - 0.57 mg. 10 pieces. - blisters (3) - packs of cardboard. Interaction with other drugs Nifedipine is metabolized mainly by the CYP3A4 isoenzyme, so drugs that inhibit or induce this enzyme may change the first pass metabolism or clearance of nifedipine. CYP3A4 isoenzyme inducers Rifampicin Rifampicin is a strong inducer of the CYP3A4 system. With simultaneous use with rifampicin, the bioavailability of nifedipine is significantly reduced and effective plasma concentrations cannot be achieved. Phenytoin, carbamazepine, phenobarbital Phenytoin induces the CYP3A4 isoenzyme. Able to reduce the bioavailability of nifedipine and reduce its effectiveness. With the simultaneous use of phenytoin and nifedipine, the clinical effect of the latter should be evaluated and, if necessary, its dose should be increased. If the dose of nifedipine has been increased during combination therapy, this should be taken into account when canceling phenytoin. Reliable studies of the interaction of nifedipine and carbamazepine and phenobarbital with simultaneous use have not been conducted. In other studies, carbamazepine and phenobarbital reduce the plasma concentration of another slow calcium channel blocker, nimodipine, so the possibility of a decrease in the plasma concentration of nifedipine when used simultaneously with carbamazepine and phenobarbital cannot be ruled out. CYP3A4 isoenzyme inhibitors The simultaneous use of nifedipine and drugs that have an inhibitory effect on the CYP3A4 isoenzyme causes an increase in the concentration of nifedipine in the blood plasma. Blood pressure should be monitored and, if necessary, the dose of nifedipine should be reduced. Macrolide antibiotics (eg, erythromycin) Some macrolide antibiotics are known to inhibit the CYP3A4-mediated metabolism of other drugs. Therefore, a potential increase in the plasma concentration of nifedipine when used together cannot be ruled out. Azithromycin, although structurally related to the macrolide class, does not inhibit the CYP3A4 isoenzyme. HIV protease inhibitors (eg, amprenavir, indinavir, nelfinavir, ritonavir, or saquinavir) There are no valid clinical drug interaction studies between nifedipine and HIV protease inhibitors. This class of drugs is known to inhibit the CYP3A4 isoenzyme. In addition, this class of drugs has been shown to inhibit the metabolism of nifedipine in an in vitro study. With the simultaneous use of nifedipine with HIV protease inhibitors, an increase in its plasma concentration cannot be excluded. Imidazole derivatives (eg, ketoconazole, itraconazole, or fluconazole) There are no reliable studies on the interaction of nifedipine with azole antifungals, but the latter are known to inhibit the CYP3A4 isoenzyme. With simultaneous use inside with nifedipine, an increase in its plasma concentration cannot be excluded. Fluoxetine Reliable studies on the interaction of nifedipine with fluoxetine have not been conducted. In an in vitro study, fluoxetine has been shown to inhibit the CYP3A4-mediated metabolism of nifedipine. Therefore, an increase in the plasma concentration of nifedipine when they are used together cannot be ruled out. Nefazodone Reliable studies on the interaction of nifedipine and nefadozone have not been conducted. In an in vitro study, nefadosone has been shown to inhibit the CYP3A4-mediated metabolism of nifedipine. Therefore, an increase in the plasma concentration of nifedipine when they are used together cannot be ruled out. Quinupristin / Dalfopristin The simultaneous use of quinupristin / dalfopristin and nifedipine can lead to an increase in plasma concentrations of the latter. Valproic acid Reliable studies of the interaction of nifedipine and valproic acid with simultaneous use have not been conducted. In other studies, valproic acid reduced the plasma concentration of another slow calcium channel blocker, nimodipine, so the possibility of a decrease in the plasma concentration of nifedipine when used simultaneously with valproic acid cannot be ruled out. Cimetidine Due to inhibition of the CYP3A4 isoenzyme, cimetidine increases plasma concentrations of nifedipine and may enhance the antihypertensive effect. Thus, when nifedipine is co-administered with cimetidine, quinupristine, dalfopristin, erythromycin, fluoxetine, nefazodone, valproic acid, HIV protease inhibitors (eg amprenavir, indinavir, nelfinavir, ritonavir or saquinavir) and azole derivatives (ketoconazole, itraconazole or fluconazole) blood pressure should be monitored, and if necessary, reduce the dose of the drug dose should be reduced. Other drugs that affect the metabolism of nifedipine Cisapride The simultaneous use of cisapride and nifedipine may lead to an increase in plasma concentrations of nifedipine. Diltiazem Diltiazem reduces the clearance of nifedipine and therefore increases the plasma concentration of nifedipine. Thus, caution should be exercised when using drugs in combination and, if necessary, reduce the dose of nifedipine. Cyclosporine Simultaneous use may lead to an increase in plasma concentrations of nifedipine. Effects of nifedipine on other drugs Antihypertensive drugs Nifedipine may enhance the antihypertensive effect of diuretics, beta-blockers, ACE inhibitors, angiotensin II receptor antagonists, other slow calcium channel blockers, alpha-blockers, PDE-5 inhibitors, alpha-methyldopa. When using nifedipine simultaneously with beta-blockers, careful monitoring of the patient's condition is necessary, since symptoms of heart failure may worsen (isolated cases are described). Digoxin The simultaneous use of nifedipine and digoxin can cause an increase in the plasma concentration of digoxin, therefore, the concentration of digoxin in the blood serum should be monitored and, if necessary, adjust the dose of digoxin. Quinidine With the simultaneous use of nifedipine and quinidine, there is a decrease in the plasma concentration of quinidine, and in some cases, with the abolition of nifedipine, an increase in its concentration in the blood plasma was noted. Therefore, if necessary, dose adjustment of quinidine is recommended. Some authors point to an increase in the plasma concentration of nifedipine with the simultaneous use of both drugs. Therefore, blood pressure should be closely monitored and, if necessary, the dose of nifedipine should be reduced. Tacrolimus Cyclosporine has been shown to be metabolized by the CYP3A4 isoenzyme. Published data indicate that it may be necessary to reduce the dose of tacrolimus when co-administered with nifedipine. Vincristine When used simultaneously with nifedipine, the excretion of vincristine decreases, and a dose reduction may be required. Magnesium sulfate It is necessary to carefully monitor blood pressure when in / in the introduction of magnesium sulfate in patients taking nifedipine, because possible marked decrease in blood pressure. Cephalosporins With simultaneous use with nifedipine, the plasma concentration of cephalosporins increases. Phenytoin Nifedipine may slow down the metabolism of phenytoin and increase its toxic effects. In patients taking phenytoin, at the beginning of treatment with nifedipine, it is recommended to control the plasma concentration of phenytoin. Nitrates It is necessary to take into account the synergistic effect with the simultaneous use of nifedipine and nitrates. Theophylline Nifedipine increases the concentration of theophylline in the blood plasma with simultaneous use. Fentanyl The simultaneous use of nifedipine and fentanyl can lead to severe arterial hypotension, so it is recommended to stop the use of nifedipine (if possible) at least 36 hours before anesthesia with fentanyl. Indirect anticoagulants There have been rare reports of an increase in prothrombin time with the simultaneous use of nifedipine with indirect anticoagulants (for example, warfarin). The relationship to nifedipine therapy has not been established, the clinical significance of this effect is unknown. Other forms of interaction In the spectrophotometric determination of vanillinmandelic acid in urine, nifedipine may cause a false positive result. Other measurements are recommended. Grapefruit juice Grapefruit juice inhibits the CYP3A4 isoenzyme. When taken simultaneously, grapefruit juice increases the concentration of nifedipine in the blood plasma due to a decrease in first-pass metabolism. Due to the increased bioavailability of nifedipine in patients with severe hypertension or stable angina, ischemic complications (heart attack, unstable angina) may develop. The use of grapefruit juice during treatment with nifedipine is not recommended. With the simultaneous use of nifedipine and acetylsalicylic acid, benazepril, candesartan, debrisoquin, doxazosin, irbesartan, omeprazole, orlistat, pantoprazole, ranitidine, rosiglitazone and triamterene / hydrochlorothiazide, there is no effect on the pharmacokinetics of nifedipine. Release form: Tablets with modified release, film-coated from light brownish yellow to light brownish orange, round, biconvex, with "NDP 30" embossed on one side; yellow in cross section. 1 tab. nifedipine 30 mg Excipients: povidone - 75 mg, sodium lauryl sulfate - 2.4 mg, hypromellose (hydroxypropyl methylcellulose) - 185.8 mg, Ludipress® (a mixture of lactose monohydrate, povidone, crospovidone in a ratio of 93: 3.5: 3.5) - 70 mg, talc (magnesium hydrosilicate) - 6 mg, magnesium stearate - 0.8 mg. Shell composition: hypromellose phthalate (hydroxypropyl methylcellulose phthalate) - 18.2 mg, triethyl citrate - 1.8 mg, hypromellose (hydroxypropyl methylcellulose 2910) - 3 mg, hyprolose (hydroxypropyl cellulose) - 3 mg, macrogol (polyethylene glycol) - 1 mg, talc (magnesium hydrosilicate) - 0.5 mg, titanium dioxide - 1.93 mg, iron dye yellow oxide - 0.57 mg. 10 pieces. - blisters (3) - packs of cardboard. 10 pieces. - blisters (6) - packs of cardboard. Light brownish-yellow to light brownish-orange, modified-release, round, biconvex, film-coated tablets, debossed with "NDP 60" on one side; yellow in cross section. 1 tab. nifedipine 60 mg Excipients: povidone - 150 mg, sodium lauryl sulfate - 4.8 mg, hypromellose (hydroxypropyl methylcellulose 2906) - 203.84 mg, hypromellose (hydroxypropyl methylcellulose 2208) - 123.36 mg, Ludipress® (a mixture of lactose monohydrate, povidone, crospovidone in a ratio of 93: 3.5 : 3.5) - 50 mg, talc (hydrous magnesium silicate) - 6 mg, magnesium stearate - 2 mg. Shell composition: hypromellose phthalate (hydroxypropyl methylcellulose phthalate) - 40 mg, triethyl citrate - 4 mg, hypromellose (hydroxypropyl methylcellulose) - 4.5 mg, hyprolose (hydroxypropyl cellulose) - 4.5 mg, macrogol (polyethylene glycol) - 1.5 mg, talc (magnesium hydrosilicate) - 0.75 mg , titanium dioxide - 2.9 mg, iron dye yellow oxide - 0.85 mg. 10 pieces. - blisters (3) - packs of cardboard. 10 pieces. - blisters (6) - packs of cardboard 10x3