Active substanceNifedipineNifedipine
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  • Dosage form: & nbspmodified release tablets coated with a film coating
    Composition:

    Each modified release tablet coated with a film coating contains: core: nifedipine 30.00 mg / 60.00 mg respectively; Povidone 75.00 / 150.00 mg sodium lauryl sulphate 2.40 / 4.80 mg, hypromellose (hydroxypropylmethylcellulose), 185.80 / (-) mg hypromellose (hydroxypropylmethylcellulose 2906) (-) / 203.84 mg Hypromellose (hydroxypropyl methylcellulose 2208) (-) / 123.36 mg, * Ludipress® 70.00 / 50.00 mg, magnesium hydrosilicate (talc) 6.00 / 6.00 mg, magnesium stearate 0.80 / 2.00 mg; shell: hypromellose phthalate (hydroxypropylmethylcellulose phthalate) 18.200 / 40.000 mg triethyl citrate 1.800 / 4.000 mg, hypromellose (hydroxypropylmethylcellulose 2910) 3.000 / 4.500 mg, giproloza (hydroxypropylcellulose) 3,000 / 4,500 mg, macrogol (polyethylene glycol) 1.0 / 1.5 mg, magnesium hydrosilicate (talc) 0.500 / 0.750 mg, titanium dioxide 1.930 / 2.900 mg, iron oxide dye yellow 0.570 / 0.850 mg.

    * Ludipress® is a mixture of lactose monohydrate, povidone, crospovidone in a ratio of 93: 3.5: 3.5.

    Description:

    Light brownish yellow to light brownish-orange color, round biconvex tablets,Covered with a film shell, with an embossed inscription "NDP 30 "or "NDP 60 "on one side, on the cross-section of yellow color.

    Pharmacotherapeutic group:blocker of "slow" calcium channels.
    ATX: & nbsp

    C.08.C.A.05   Nifedipine

    Pharmacodynamics:

    Nifedipine is a selective blocker of "slow" calcium channels, a 1,4-dihydropyridine derivative. Has antianginal and antihypertensive effect. Reduces the current of extracellular calcium inside cardiomyocytes and smooth muscle cells of the coronary and peripheral arteries; in high doses inhibits the release of calcium ions from intracellular stores. Reduces the number of functioning channels, without affecting the time of their activation, inactivation and recovery.

    Separates the processes of excitation and contraction in the myocardium, mediated by tropomyosin and troponin, in smooth muscle vessels, mediated by calmodulin. In therapeutic doses normalizes the transmembrane current of calcium ions, disturbed by a number of pathological conditions, first of all,with arterial hypertension. Does not affect the tone of the veins. Strengthens the coronary blood flow, improves the blood supply of the ischemic zones of the myocardium without the development of the phenomenon of "stealing", activates the functioning of collaterals.

    It improves the function of the myocardium, reduces the force of the heart and the need for myocardium in oxygen. Expanding the peripheral arteries, lowers blood pressure (BP) and reduces overall peripheral resistance and afterload on the heart. Almost no effect on the sinoatrial and atrioventricular nodes. It enhances kidney blood flow, causes a moderate natriuresis.

    Inhibits aggregation of platelets, has anti-atherogenic properties (especially with prolonged use). Lowers the pressure in the pulmonary artery, has a positive effect on the blood supply of cerebral vessels.

    Pharmacokinetics:

    Nifecard® CL, due to delayed release of the active substance, provides a gradual controlled increase in plasma concentrations of nifedipine. The plasma concentration of nifedipine leaves the plateau after about 6 hours and is maintained with slight fluctuations for 24 hours. Nifedipine quickly and almost completely absorbed after oral administration (92-98%). It is characterized by a high percentage of binding to blood plasma proteins (90%). The half-life is approximately 2 hours. It is metabolized in the liver. No active metabolites were detected. It is excreted as inactive metabolites in the main kidneys (80%) and bile (20%).

    Nifedipine penetrates through the blood-brain and placental barrier, excreted in breast milk.

    There is no cumulative effect.

    Chronic renal insufficiency, Hemodialysis and peritoneal dialysis do not affect pharmacokinetics.

    When a violation of liver function reduced the clearance of nifedipine. In severe violations of liver function, dose adjustment may be required.

    In elderly patients when administered intravenously, nifedipine clearance was reduced by 33% compared to young healthy volunteers.

    With prolonged use, development of tolerance to nifedipine may be observed.

    Indications:

    - arterial hypertension;

    - ischemic heart disease (CHD): stable angina tension, vasospastic angina (Prinzmetal angina).

    Contraindications:

    - hypersensitivity to nifedipine or drug components and other 1,4-dihydropyridine derivatives;

    - severe arterial hypotension (systolic blood pressure BP below 90 mmHg);

    - severe stenosis of the aortic valve with clinically significant hemodynamic disturbances;

    - unstable angina;

    - chronic heart failure in the stage of decompensation, cardiogenic shock (risk of myocardial infarction), acute myocardial infarction (within the first 4 weeks);

    - simultaneous application of rifampicin;

    - rare hereditary forms of lactose intolerance, lactase deficiency or impaired absorption of glucose / galactose (because the composition contains lactose);

    - pregnancy up to 20 weeks, the period of breastfeeding;

    - age to 18 years (efficacy and safety not established).

    Carefully:Stenosis of the mouth of the aorta or mitral valve; hypertrophic obstructive cardiomyopathy; severe tachycardia; syndrome of weakness of the sinus node; malignant hypertension; myocardial infarction with left ventricular failure; cerebrovascular diseases; function violationliver and / or kidney; hemodialysis (risk of arterial hypotension); diabetes; intestinal obstruction; pregnancy after 20 weeks; simultaneous use of beta-blockers or cardiac glycosides, with inducers or inhibitors of isoenzyme CYP3A4.
    Pregnancy and lactation:

    Fertility

    In some studies, blockers of "slow" calcium channels, such as nifedipine, led to reversible biochemical changes in the head of spermatozoa, which can lead to a disruption in their function. In men who repeatedly experience problems with conception of a child with in vitro fertilization, one of the possible causes should be considered the use of nifedipine, if no other explanation can be found.

    Pregnancy

    Controlled studies on the use of nifedipine in pregnant women have not been conducted. Studies in animals have shown teratogenicity and embryo / fetotokinicity of nifedipine. The use of Nifecard® CL up to week 20 is contraindicated. The use of the drug Nifecard ® CL after the 20th week of pregnancy is possible only in the event that,if the intended benefit to the mother exceeds the potential risk for the fetus and the drug should be used only in a hospital with adequate monitoring of the mother and fetus (monitoring the mother's blood pressure, regular ultrasound monitoring of fetal development and viability). If abnormalities occur, discontinue use of the drug.

    Breastfeeding period

    Nifedipine penetrates into breast milk, so when applied during lactation, it is necessary to resolve the issue of stopping breastfeeding.

    Dosing and Administration:

    Tablets should be taken at the same time of the day, without chewing, you can not split or divide them. The dosage regimen is set individually. You can not drink tablets with grapefruit juice.

    The dose of Nifecard® CL is 1 tablet of the drug 30 mg or 60 mg per day once. Selection of the dose begins with 30 mg / day, correction is carried out at intervals of 7-14 days.

    The maximum daily dose of Nifecard® XL is 90 mg.

    Possible slowing down of nifedipine the elderly patients, therefore, smaller maintenance doses may be required compared to younger patients.

    In patients with impaired liver function Nifedipine should be administered under close supervision and, 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 it is necessary to perform low-dose treatment.

    If you need to cancel the drug Nifecard ® CL, the dose should be reduced gradually.

    Side effects:

    According to the World Health Organization (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 / 10000, <1/1000) and very rarely (<1 / 10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    On the part of the blood and lymphatic system

    frequency is unknown: agranulocytosis, leukopenia, anemia, thrombocytopenia.

    From the immune system

    infrequently: allergic reactions, allergic edema / angioedema;

    rarely: skin itching, skin rash, hives;

    frequency is unknown: anaphylactic / anaphylactoid reaction, toxic epidermal necrolysis, exfoliative dermatitis, photodermatitis, autoimmune hepatitis, thrombocytopenic purpura.

    From the side of metabolism and nutrition:

    frequency is unknown: hyperglycemia.

    From the nervous system

    often: headache;

    infrequently: dizziness, migraine, increased fatigue, tremor;

    rarely: paresthesia / dysesthesia of the extremities;

    frequency is unknown: with prolonged use in high doses - depression, anxiety, extrapyramidal (parkinsonian) disorders (ataxia, "masky" face, "shuffling" gait, stiffness of movements of hands and feet, tremor of hands and fingers, difficulty swallowing, hyposthenia, drowsiness) increased excitability, sleep disturbance (including insomnia), night "nightmares", decreased libido.

    From the side of the organ of vision

    infrequently: visual impairment (transient);

    frequency is unknown: pain in the eye area.

    From the side of the hearing organ and labyrinthine disorders

    infrequently: "ringing" in the ears, dysgeusia (a violation of taste).

    From the side of the cardiovascular system

    often: peripheral edema, increased symptoms of vasodilation (asymptomatic decrease in blood pressure, "tides" of blood to the skin of the face, hyperemia of the skin of the face, a feeling of heat);

    infrequently: tachycardia, sensation palpitation, arrhythmia, excessive a decrease in blood pressure (especially in patients on dialysis with malignant hypertension and reduced volume of circulating blood), syncope, syncope;

    rarely: in some patients, especially at the beginning of treatment, there may be angina attacks, which requires withdrawal of the drug. Single cases of myocardial infarction are described;

    frequency is unknown: chest pains, aggravation of symptoms of the course of heart failure.

    From the respiratory system

    infrequently: nosebleeds, nasal congestion, cough, sinusitis, difficulty breathing, infections of the upper respiratory tract;

    frequency is unknown: dyspnoea, bronchospasm, pulmonary edema.

    From the digestive system

    often: constipation;

    infrequently: dryness of the oral mucosa, decreased appetite, indigestion (nausea, diarrhea), abdominal pain;

    rarely: gingival hyperplasia (bleeding, soreness, swelling);

    frequency unknown: dysphagia, erosive and ulcerative lesions of the intestinal mucosa, vomiting, gastroesophageal sphincter insufficiency, with prolonged use - a violation of liver function (intrahepatic cholestasis, increased activity of "liver" transaminases, jaundice), bezoars (lumps in the stomach from undigested food residues).

    From the musculoskeletal system and connective tissues

    infrequently: convulsions of the upper and lower extremities, swelling of the joints, back pain, gout;

    frequency is unknown: arthritis, arthralgia, myalgia.

    From the genitourinary system

    infrequently: increase / decrease in daily diuresis, erectile dysfunction

    rarely: gynecomastia (in elderly patients, completely disappearing after drug withdrawal);

    frequency is unknown: galactorrhea, impaired renal function (in patients with renal insufficiency).

    From the skin and subcutaneous tissues

    infrequently: alopecia, increased sweating, hemorrhagic rash.

    General disorders and disorders at the site of administration

    often: asthenia, weakness;

    infrequently: nonspecific pain, chills, face edema, periorbital edema, fever, weight gain.

    Overdose:

    Symptoms: peripheral vasodilation with marked and probably prolonged pronounced decrease in blood pressure (headache, facial flushing, suppression of sinus node activity, bradycardia and / or tachycardia, bradyarrhythmias), hyperglycemia, metabolic acidosis, hypoxia, cardiogenic shock with the development of pulmonary edema.In severe poisoning - loss of consciousness, coma.

    Treatment overdose consists in standard procedures for removing the drug from the body (the appointment of activated carbon, gastric lavage), the restoration of stable parameters of hemodynamics, careful monitoring of the heart, lungs and excretory system.

    In cases of overdose of prolonged-action drugs, it is necessary to ensure the most complete elimination of the drug from the body, if possible wash 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 musculature up to intestinal atony.

    Hemodialysis is not effective, plasmapheresis is recommended because of the high degree of binding to proteins and relatively small volume of distribution. Treatment of bradyarrhythmias symptomatic with the use of atropine and / or beta-sympathomimetics; In the case of life-threatening bradyarrhythmias, a temporary pacemaker is required.

    With a persistent, marked decrease in blood pressure as a result of cardiogenic shock and arterial vasodilation, calcium (1-2 g gluconate calcium, intravenously), dopamine (up to 25 μg / kg / min), dobutamine (up to 15 μg / kg / min), epinephrine (epinephrine) 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 should be performed with caution under the control of hemodynamic parameters.

    Antidote are calcium preparations. Nifedipine clearance is increased in patients with impaired hepatic function.

    Interaction:

    Nifedipine is metabolized mainly by isoenzyme CYP3A4, therefore, drugs that inhibit or induce this enzyme can alter the presystemic metabolism or clearance of nifedipine.

    Inductors of isoenzyme CYP3A4

    Rifampicin

    Rifampicin is a strong inducer of the system CYP3A4. With simultaneous use with rifampicin, the bioavailability of nifedipine is significantly reduced and an effective concentration in the blood plasma can not be achieved.

    Phenytoin, carbamazepine, phenobarbital

    Phenytoin induces isoenzyme CYP3A4. It is able to reduce the bioavailability of nifedipine and reduce its effectiveness. With the simultaneous use of phenytoin and nifedipine, the clinical effect of phenytoin and nifedipine should be evaluated and, if necessary, increased its dose.

    If the dose of nifedipine in combination therapy has been increased, this should be taken into account when phytoplasm is abolished.

    There were no reliable studies of the interaction of nifedipine with carbamazepine and phenobarbital with simultaneous application. In other studies carbamazepine and phenobarbital reduce the plasma concentration of another blocker of "slow" calcium channels -nimodipine, therefore, it is impossible to exclude the possibility of reducing and plasma concentrations of nifedipine when they are used simultaneously with carbamazepine and phenobarbital.

    Inhibitor inhibitors CYP3A4

    Simultaneous use of nifedipine and drugs that have an inhibitory effect on the isoenzyme CYP3A4, causes an increase in the concentration of nifedipine in blood plasma. You should monitor blood pressure and, if necessary, reduce the dose of nifedipine.

    Macrolide antibiotics (for example, erythromycin)

    Some macrolide antibiotics are known to inhibit SURCA4-mediated metabolism of other drugs. Therefore, the potential increase in plasma concentrations of nifedipine can not be ruled out when combined using them.

    Azithromycin, although structurally close to the class of macrolide antibiotics, does not inhibit the isoenzyme CYP3A4.

    Protease-HIV inhibitors (eg, amprenavir, indinavir, nelfinavir, ritonavir or saquinavir)

    There are no reliable clinical studies on the drug interaction between nifedipine and protease-HIV inhibitors. Drugs of this class are known to inhibit the isoenzyme CYP3A4. In addition, the study in vitro it was shown that drugs of this class inhibit the metabolism of nifedipine. With the simultaneous use of nifedipine with protease-HIV inhibitors, one can not exclude an increase in its plasma concentration.

    Imidazole derivatives (e.g., ketoconazole, itraconazole or fluconazole)

    There were no reliable studies on the interaction of nifedipine with azole antifungal drugs, but it is known that the latter inhibit the isoenzyme CYP3A4. At simultaneous application inside with nifedipine it is impossible to exclude an increase in its plasma concentration.

    Fluoxetine

    There were no reliable studies on the interaction of nifedipine with fluoxetine. In the study in vitro it was shown that fluoxetine inhibits SURCA4-mediated metabolism of nifedipine. Therefore, an increase in the plasma concentration of nifedipine when administered together can not be ruled out.

    Nefazodone

    There were no reliable studies on the interaction of nifedipine and nefadozone. In the study in vitro it was shown that nefadosone inhibits SURCA4-mediated nifedipine metabolism. Therefore, an increase in the plasma concentration of nifedipine when administered together can not be ruled out.

    Hinupristin / Dalfopristin

    The simultaneous use of quinupristin / dalfopristine and nifedipine may lead to an increase in the concentration in the blood plasma of the latter.

    Valproic acid

    There were no reliable studies of the interaction of nifedipine and valproic acid with simultaneous application. In other studies valproic acid reduced the plasma concentration of another blocker of "slow" calcium channels - nimodipine, therefore, it is impossible to exclude the possibility of reducing the plasma concentration of nifedipine when they are used simultaneously with valproic acid.

    Cimetidine

    Due to inhibition of the isoenzyme CYP3A4, Cimetidine increases plasma concentrations of nifedipine and may enhance the antihypertensive effect.

    Thus, with the simultaneous use of nifedipine with cimetidine, quinupristin, dalfopristin, erythromycin, fluoxetine, nefazodone, valproic acid, protease-HIV inhibitors (for example, amprenavir, indinavir, nelfinavir, ritonavir or saquinavir) andderivatives of azole (ketoconazole, itraconazole or fluconazole) should monitor BP, and if necessary, the 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, consequently, increases the plasma concentration of nifedipine.Therefore, care should be taken when using drugs in combination and, if necessary, reduce the dose of nifedipine.

    Cyclosporin

    Simultaneous application can lead to an increase in plasma concentrations of nifedipine.

    ENifedipine effects on other drugs

    Hypothetical drugs

    Nifedipine can enhance the antihypertensive effect of diuretics, beta adrenoblockers, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, other slow calcium channel blockers, alpha-blockers, phosphodiesterase-5 (PDE-5) inhibitors, alpha-methyldopa.

    When nifedipine is used concomitantly with beta-blockers, careful monitoring of the patient is necessary, since the symptoms of heart failure may worsen (single cases are described).

    Digoxin

    The simultaneous use of nifedipine and digoxin can cause an increase in plasma concentrations of digoxin, somonitor the concentration of digoxin in the blood serum, and if necessary, the dose of digoxin should be adjusted.

    Quinidine

    With the simultaneous use of nifedipine and quinidine, a decrease in the plasma concentration of quinidine occurs, and in some cases, when nifedipine was abolished, there was an increase in its concentration in the blood plasma. Therefore, if necessary, a correction of the dose of quinidine is recommended. Some authors indicate an increase in the plasma concentration of nifedipine with simultaneous application of both drugs. Therefore, blood pressure should be carefully monitored, and if necessary, the dose of nifedipine should be reduced.

    Tacrolimus

    It was shown that ciclosporin is metabolized by isoenzyme CYP3A4. The published data indicate that it may be necessary to reduce the dose of tacrolimus when used simultaneously with nifedipine.

    Vincristine

    With the simultaneous use of nifedipine, vincristine is reduced, it may be necessary to reduce its dose.

    Magnesium sulfate

    It is necessary to carefully monitor blood pressure when intravenous magnesium sulfate is administered to patients receiving nifedipine, t. possibly a marked decrease in blood pressure.

    Cephalosporins

    At simultaneous application with nifedipine plasma concentrationcephalosporins.

    Phenytoin

    Nifedipine can slow the metabolism of phenytoin and increase its toxic effect. In patients receiving phenytoin, at firsttreatment with nifedipine is recommended to monitor 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 blood plasma with simultaneous application.

    Fentanyl

    The simultaneous use of nifedipine and fentanyl can lead to severe arterial hypotension, therefore it is recommended to cancel the use of nifedipine (if possible) at least 36 hours before anesthesia with fentanyl.

    Anticoagulants of indirect action

    Rare reports of an increase in prothrombin time were recorded with simultaneous application of nifedipine with anticoagulants of indirect action (for example, warfarin). The relationship to therapy with nifedipine is not established, the clinical significance of this effect is unknown.

    Other forms of interaction

    When spectrophotometric determination of vanillylmandelic acid in the urine nifedipine may be the reason for receiving a false positive result. It is recommended to perform other measurements.

    Grapefruit juice

    Grapefruit juice inhibits isoenzyme CYP3A4. With the simultaneous intake of grapefruit juice increases the concentration of nifedipine in blood plasma due to a decrease in presystemic metabolism. In view of the increased bioavailability of nifedipine in patients with severe arterial hypertension or stable angina, it is possible to develop ischemic complications (heart attack, unstable angina). The use of grapefruit juice during treatment with nifedipine is not recommended.

    With the simultaneous use of nifedipine and acetylsalicylic acid, benazepril, candesartan, debrisokwin, doxazosin, irbesartan, omeprazole, orlistat, pantoprazole, ranitidine, rosiglitazone and triamterene / hydrochlorothiazide There is no effect on the pharmacokinetics of nifedipine.

    Special instructions:

    Discontinue treatment with Nifecard® HL is recommended gradually. It should be borne in mind that at the beginning of the treatment there may be an attack of angina pectoris, especially after the recent abrupt withdrawal of beta-blockers (the latter should be canceled gradually).

    Simultaneous use of beta-blockers should be carried out in conditions of careful medical control, as this can lead to excessive reduction of blood pressure, and in some cases - worsening of the symptoms of the course of heart failure.

    With severe heart failure, the drug is dosed with great care. Rarely in patients with severe stenosis of the coronary arteries 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 are: classical clinical picture, accompanied by a rise in the segment ST on the ECG, the emergence of ergon-induced angina pectoris or spasm of the coronary arteries, the detection of coronarospasm in angiography or the detection of an angiospastic component without confirmation (for example, with a different voltage threshold or unstable angina when the electrocardiogram data indicate a transient angiospasm).

    For patients with severe hypertrophic obstructive cardiomyopathy, there is a risk of increased frequency, severity, andduration of angina attacks after nifedipine; in this case, it is necessary to cancel the drug.

    In patients with diabetes mellitus, the use of Nifecard® CL may require monitoring of the concentration of glucose in the blood plasma.

    In patients on hemodialysis, with high blood pressure and irreversible renal dysfunction, with a reduced volume of circulating blood, the drug should be used with caution, a sudden drop in blood pressure may occur.

    Patients with impaired liver function are carefully monitored and, if necessary, reduce the dose of the drug and / or use other dosage forms of nifedipine.

    Patients with severe stenosis of any part of the gastrointestinal tract may develop intestinal obstruction. In very rare cases, bezoar can develop, for the removal of which may require surgical intervention. In isolated cases, the symptoms of intestinal obstruction can be observed in patients who have no pathology on the part of the gastrointestinal tract. The risk of developing bezoar is increased in patients with decreased intestinal peristalsis (constipation, gastroesophageal reflux, obesity, hypothyroidism,diabetes mellitus), intestinal tumors, diverticulitis, inflammatory bowel changes, vertical gastroplasty, gastric bypass, after resection of the small intestine, colostomy, and also with simultaneous use with H blockers2-gistaminovyh receptors, opiates, non-steroidal anti-inflammatory drugs, anticholinergic drugs, neuromuscular blockers (muscle relaxants), laxatives (laxatives).

    There are isolated reports of "sticking" of tablets to the intestinal wall with the formation of ulcers requiring hospitalization and surgical intervention.It should be borne in mind that during the X-ray study of the intestine with barium, false-positive symptoms of the polyp can be identified (defect of "filling").

    If during the therapy the patient is required to undergo surgery under general anesthesia, it is necessary to inform the anesthesia doctor about the nature of the therapy.

    Nifedipine, like other blockers of "slow" calcium channels, inhibits platelet aggregation in vitro. A small number of reports confirm data on a statistically significant decrease in platelet aggregation and an increasebleeding time. The clinical significance of this is not known.

    During treatment, a positive result is possible with a direct Coombs reaction and an increase in the titer of antinuclear antibodies.

    Effect on the ability to drive transp. cf. and fur:During the period of treatment with Nifecard ® CL, caution should be exercised when engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions, and refraining from the use of alcohol.
    Form release / dosage:

    Tablets with modified release, film-coated 30 mg, 60 mg.

    10 tablets in Al / Al blister. For 2, 3 or 6 blisters in a cardboard box together with instructions for use.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Special precautions when destroying an unused preparation

    There is no need for special precautions when destroying an unused preparation.

    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 N011996 / 01
    Date of registration:29.07.2011
    The owner of the registration certificate: Lek dd Lek dd Slovenia
    Manufacturer: & nbsp
    LEK d.d. Slovenia
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp29.10.2014
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