Novo-Passit tablets p / o No. 10×1

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Novo-Passit tab. p / o in bl. in pack. No. 10×1
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Oval-shaped, film-coated tablets, pale green in color with a separating line. The main active ingredient Hawthorn extract + elderberry extract + valerian extract + guaifenesin + St. John’s wort extract + lemon balm medicinal extract + passionflower extract + hops extract Release form Tablets Pharmacological properties text St. John’s wort also has an antidepressant effect. The mechanism of action is inhibition of serotonin reuptake and inhibition of monoamine oxidase (MAO). Valerian extract has a hypnotic and mild sedative effect. The mechanism of action is associated with the effect on GABA receptors and ion channels for chlorine, the opening of which is accompanied by a decrease in the excitability of neurons. The soothing effect of the plant extract is combined with the anxiolytic and muscle relaxant effects of guaifenesin. Pharmacokinetics Guaifenesin is rapidly absorbed from the gastrointestinal tract, metabolized in the liver by conjugation with glucuronic acid and excreted as inactive metabolites, mainly in the urine. Indications for use Mild forms of neurasthenic disorders, accompanied by anxiety, fear, irritability, decreased mood, increased fatigue; mild forms of insomnia. It can be used as part of the complex therapy of migraine, tension headache, functional vascular disorders in menopausal syndrome, functional diseases of the gastrointestinal tract (dyspeptic disorders, irritable bowel syndrome), “neurogenic” pruritic dermatoses (eczema, neurodermatitis). Dosage and administration Inside, adults: 1 tablet 3 times a day. If necessary, the daily dose can be increased to 2 tablets 3 times a day. In case of unwanted depression, it is necessary to reduce the morning and afternoon dose – 1/2 tablet per dose, and the evening dose of 1 tablet. The dose may be varied depending on the response of the patient. The interval between doses of the drug should be 4-6 hours. The maximum daily dose is 6 tablets. The drug should be taken with drinks (tea, juice, except for grapefruit juice). In case of nausea, the drug should be taken with meals. The drug in the usual recommended doses does not cause drowsiness and loss of attention, which allows it to be used in the daytime. Special categories of patients Patients over 65 years of age: dose adjustment is not required. Patients with impaired liver and kidney function: no data on the need for dose adjustment. Patients with impaired liver function are advised to use Novo-Passit with caution. Use during pregnancy and lactation Due to insufficient data on safety, it is not recommended to use the drug during pregnancy and lactation. Effects on driving and machine maintenance Due to the fact that Novo-Passit contains guaifenesin, treatment may be accompanied by lethargy. Therefore, during treatment with the drug, patients should not perform activities that require increased concentration of attention – driving vehicles, servicing machines and various mechanisms, working at height, etc. Precautions Caution should be exercised in acute diseases of the gastrointestinal tract. During pregnancy, especially during the 1st trimester and during lactation, you should consult your doctor. During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. The drug should be taken with caution in case of severe liver dysfunction, intoxication with CNS depressants. Avoid intense exposure to UV light (sunbathing, solar lamps, and solarium) while taking the drug, especially in people with pale skin. When taking indinavir or other antiretroviral drugs, it should be advised to avoid taking the drug due to the content of St. John’s wort and the risk of developing antiretroviral resistance, reducing the effectiveness of treatment. See section Interaction with other medicinal products. St. John’s wort should not be co-administered with SSRI antidepressants or triptans. See section Interaction with other medicinal products. The drug should be discontinued 48 hours before urine collection for the determination of vanillin-mandelic acid and 5-hydroxyindoleacetic acid using the 1-nitroso 2-naphthol reagent. The drug should not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. If you need to take Novo-Passit with other drugs – consult your doctor. Interaction with other drugs Guaifenesin enhances the effect of alcohol, sedative antihistamines, and other substances that cause depression of the central nervous system. St. John’s wort perforated St. John’s wort can cause induction of cytochrome P450 isoenzymes CYP3A4, CYP1A2 and 2C9, which can lead to a decrease in the effect of other drugs used simultaneously and metabolized by these isoenzymes. This action may also be due to the ability to induce the intestinal transport system of P-glycoprotein. This interaction was first observed in healthy volunteers while taking indinavir and St. John’s wort perforated. Similar interactions can also be expected with other retroviral protease inhibitors (aprenavir, nelfinavir, ritonavir, saquinavir), as well as non-nucleotide reverse transcriptase inhibitors (delaverdin, efavirenz, nevirapine) used in the treatment of HIV-1 positive patients. With the simultaneous use of antiretroviral drugs and perforated St. John’s wort, their action decreases with the possible emergence of resistance. Therefore, St. John’s wort should not be used simultaneously with these drugs. Significant clinical interactions with St. John’s wort have also been described with concomitant use of cyclosporine, digoxin, and warfarin. The interaction can lead to a decrease in the concentration of drugs in the blood plasma and, accordingly, to a decrease in the therapeutic effect. St. John’s wort should not be used with cyclosporine. If the patient is taking cyclosporine, then St. John’s wort should be discontinued and, based on the determination of the level of cyclosporine in the blood plasma, the dosage of cyclosporine should be adjusted. Any signs of tissue rejection in transplant patients should be carefully monitored. There is also the possibility of interaction of St. John’s wort with antiepileptic drugs. St. John’s wort interacts with many other drugs and substances that are biotransformed under the influence of the cytochrome P450 3A4 enzyme, including grapefruit juice. Patients receiving treatment with indinavir or other antiretroviral drugs should avoid the use of St. Co-administration of St. John’s wort with digoxin is not recommended. If it is necessary to prescribe St. John’s wort, the level of digoxin in the blood plasma should be monitored and its dose adjusted. With an increase in the dose of digoxin, the dose of St. John’s wort remains unchanged, the termination of therapy should be consulted with a doctor. The simultaneous use of St. John’s wort with warfarin is not recommended. If it is necessary to prescribe St. John’s wort during warfarin therapy, monitoring of prothrombin time (PT) should be carried out and the dose of warfarin should be adjusted. With an increase in the dose of warfarin, the dose of St. John’s wort remains unchanged, the termination of therapy should be consulted with a doctor. Co-administration of St. John’s wort and tacrolimus may result in sub-therapeutic levels of tacrolimus, which may lead to graft rejection. Patients should avoid concomitant use of St. John’s wort and tacrolimus. If St. John’s wort and tacrolimus are used concomitantly, St. John’s wort should be discontinued and plasma levels of tacrolimus should be monitored, as it may be necessary to reduce the dose of tacrolimus. Simultaneous use of perforated St. John’s wort with oral contraceptives can lead to abnormal uterine bleeding (menorrhagia, hypermenorrhagia, metrorrhagia). In rare cases, there may be a decrease in the contraceptive effect. It is recommended to use combined oral (hormonal) contraceptives in combination with other methods of contraception (barrier methods) while taking St. John’s wort. St. John’s wort can significantly reduce the effect of theophylline, so simultaneous use is not recommended. In the case when there is a need to take St. John’s wort, it is necessary to control the level of theophylline in blood plasma and, if necessary, adjust the dose of theophylline without changing the dose of St. Concomitant therapy with amitriptyline is not recommended. Simultaneous therapy with St. John’s wort and taking anticonvulsants (carbamazepine, phenobarbital, phenytoin) is not recommended. Perhaps a decrease in the level of the drug in the blood plasma and the occurrence of seizures. If it is necessary to prescribe St. John’s wort, the level of anticonvulsants in the blood plasma should be monitored to exclude a decrease in the effectiveness of the drug. In the event of discontinuation of therapy with St. Clinically significant pharmacodynamic interactions have been observed with the use of SSRI antidepressants and triptans. Due to the increased risk of adverse reactions associated with these interactions, St. John’s wort should not be used concomitantly with these drugs. St. John’s wort is not recommended for patients taking antibiotics, sulfonamides, antihypertensive calcium channel blockers, female sex hormones, hypocholesterolemic agents (statins). Passiflora When used simultaneously with drugs that depress the central nervous system, such as barbiturates, tranquilizers, the sedative and hypnotic effect of the drug is enhanced. Concomitant use with benzodiazepines is not recommended. Avoid concomitant use with disulfiram. Valerian Enhances the effect of alcohol, sedatives, hypnotics, hypotensive, anxiolytic and antispasmodic drugs. Hawthorn Enhances the effect of sedatives, hypnotics and antiarrhythmic drugs, cardiac glycosides. Melissa With simultaneous use, it is possible to enhance the effect of other sedatives and hypnotics. During treatment, you should not drink alcoholic beverages. Influence on the results of laboratory tests. The guaifenesin contained in the preparation can cause false-positive results of diagnostic tests in which 5-hydroxyindoleacetic acid is determined (photometric method using nitrosonaphthal as a reagent) and vanillylmandelic acid in the urine. In view of this, treatment with Novo-Passit must be stopped 48 hours before the planned urine collection for this analysis. ContraindicationsIncreased individual sensitivity to the components of the drug, especially to guaifenesin, myasthenia gravis, epilepsy. The drug is contraindicated in children under 18 years of age. Concomitant use of cyclosporine or tacrolimus; HIV-infected patients receiving protease inhibitors. Composition Each tablet contains: active substances: Novo-Passit dry extract (valerian officinalis, lemon balm, St. Passit dry extract is obtained by extraction of a mixture of plant materials (extractant – ethanol 30% v/v) followed by evaporation (4:1); Guaifenesin – 200.0 mg. excipients: anhydrous colloidal silicon dioxide, microcrystalline cellulose, glycerol tribehenate, magnesium stearate, lactose monohydrate; shell: opadri “AMB 80W31115” green (Polyvinyl alcohol partially hydrolyzed, titanium dioxide (E171), talc (E553b), quinoline yellow aluminum varnish (E104), iron oxide yellow (E 172), lecithin (E322), indigo carmine aluminum varnish ( E 132), xanthan gum (E 415)) – 24.0 mg. Overdose Overdose is initially manifested by a feeling of depression and drowsiness. Later, nausea, mild muscle weakness, joint pain, and a feeling of heaviness in the stomach may join these symptoms. After an overdose of guaifenesin, cases of urolithiasis have been recorded. Treatment is symptomatic. There is no specific antidote. Side effects When assessing side effects, the following categories of frequency of their occurrence are taken as a basis: Very often (? 1/10), often (? 1/100 to < 1/10), sometimes (? 1/1000 to < 1/100), rarely (? 1/10000 to < 1/1000), very rare (< 1/10000), not known (it is not possible to establish a frequency based on the available data). From the nervous system: Rarely: dizziness, drowsiness From the gastrointestinal tract: Rarely: nausea, vomiting, abdominal pain, heartburn, diarrhea, constipation From the skin and subcutaneous tissue: Rarely: rash, itching, From the musculoskeletal apparatus and connective tissue: Rare: muscle weakness General: Rare: fatigue. All of these side effects usually disappear quickly after discontinuation of the drug. Storage conditions At a temperature not exceeding 25 ° C, out of the reach of children. Shelf life 3 years. Do not use after the expiration date indicated on the package. 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