INSTRUCTION
for medical use of the medicinal product
Novo-Pasyt
(Novo-Passit®)
Storage:
active ingredients: dry Novo-Pasit extract, guaifenesin;
1 tablet contains: dry Novo-Pasit extract (elder flowers (Sambusi flos), leaves and flowers of hawthorn (Crataegi folium cum flore), St. John's wort (Hyperici herba), Melissae herba, Passionflower herb (Passiflorae herba), cones hops (Lupuli flos), valerian root (Valerianae radix)) 157.5 mg; guaifenesin 200 mg;
excipients:
core: colloidal anhydrous silicon dioxide, microcrystalline cellulose, glycerol tribehenate, magnesium stearate, lactose monohydrate;
shell: polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin, xanthan gum, quinoline yellow (E 104), iron oxide yellow (E 172), indigo carmine (E 132).
Medicinal form. Coated tablets.
The main physical and chemical properties: light green oval tablets, covered with a shell, with a fracture line on both sides.
Pharmacotherapeutic group. Sleeping pills and sedatives. ATX code N05C M.
Pharmacological properties.
Pharmacodynamics.
Pharmacologically active components of the drug are guaifenesin and an extract from medicinal plants, which have a predominantly sedative effect. St. John's wort also has an antidepressant effect. The mechanism of action consists in inhibition of reuptake of serotonin and inhibition of monoamine oxidase. Valerian extract (Valeriana medicinal) has a hypnotic and calming effect. The mechanism of action is related to the effect on GABA receptors and chloride channels, opening of chloride channels and inhibition of neuronal excitability.
The sedative effect of the extract is combined with the anxiolytic and myorelaxant effect of guaifenesin (relaxes smooth muscles).
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.
The biological half-life is approximately 1 hour.
Clinical characteristics.
Indication.
A mild form of neurasthenia, especially if it is accompanied by anxiety, fear, sadness, restlessness, irritability, reduced concentration or increased fatigue; a mild form of insomnia, exhaustion; neurotic memory disorders.
For supportive therapy in migraine, headache caused by nervous tension; vascular psychosomatic disorders with neurocirculatory asthenia, neurogenic tetany, pain in the face; with climacteric syndrome.
Functional diseases of the gastrointestinal tract, dyspeptic syndrome without organic damage, "irritable bowel" syndrome.
For adjunctive therapy in organic diseases of the gastrointestinal tract with a pronounced neurotic component.
Psychosomatic dermatoses accompanied by itching (urticaria, atopic eczema).
Contraindication.
Hypersensitivity to the active components or to any auxiliary substances of the medicinal product; myasthenia gravis; epilepsy; depression and other conditions accompanied by depression of the central nervous system; bradycardia; simultaneous use of cyclosporine or tacrolimus; application to children under 12 years of age; use in HIV-positive patients taking protease inhibitors.
Interaction with other medicinal products and other types of interactions.
Guaifenesin
Guaifenesin increases the analgesic effect of paracetamol and acetylsalicylic acid and increases the effect of alcohol, sedative antihistamines and other substances that depress the central nervous system. The central action of muscle relaxants may increase the unwanted effects of guaifenesin, especially muscle weakness.
St. John's wort is perforated
St. John's wort may cause induction of cytochrome P450 isoenzymes CYP3A4, CYP1A2, and CYP2C9, which may reduce the effect of other concomitantly administered drugs that are metabolized by these isoenzymes. St. John's wort also induces P-glycoprotein. This interaction was first discovered in healthy volunteers when indinavir and St. John's wort were taken simultaneously. It can also be expected that a similar interaction occurs with other retroviral protease inhibitors (amprenavir, nelfinavir, ritonavir, saquinavir), as well as non-nucleoside reverse transcriptase inhibitors (delavirdine, efavirenz, nevirapine) used in the treatment of HIV-positive patients. With the simultaneous use of antiretroviral drugs and St. John's wort, their effect decreases with the possible emergence of resistance. Therefore, St. John's wort should not be used simultaneously with these drugs.
Clinically significant interactions with St. John's wort have also been described with concomitant use of cyclosporine, tacrolimus, digoxin, and warfarin. This interaction can lead to a decrease in the concentration of these drugs in the blood plasma and, thus, to a decrease in their therapeutic effect.
St. John's wort has been clinically proven to interact with theophylline, amitriptyline, and oral contraceptives. There is also a possibility of animal interaction both with antiepileptic drugs. St. John's wort may interact with many other drugs that are biotransformed by cytochrome P450 isoenzyme 3A4, including grapefruit juice.
St. John's wort should not be used with cyclosporine. If the patient is using cyclosporine, it is necessary to cancel St. John's wort and adjust the dosage of cyclosporine based on the determination of the level of cyclosporine in the blood plasma. Post-transplant patients should be carefully monitored for any signs of tissue rejection.
Concomitant use of St. John's wort and tacrolimus may lead to subtherapeutic concentrations of tacrolimus, which may lead to transplant rejection. Patients should avoid simultaneous administration of St. John's wort and tacrolimus. In the case of simultaneous use of St. John's wort and tacrolimus by the patient, St. John's wort should be discontinued and tacrolimus plasma levels should be monitored, as there may be a need to adjust the dose of tacrolimus.
The simultaneous appointment 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 the dose adjusted accordingly. When the dose of digoxin is increased, the dose of St. John's wort remains unchanged, you should consult a doctor about stopping therapy.
Simultaneous use of St. John's wort with warfarin is not recommended. If it is necessary to prescribe St. John's wort, prothrombin time should be monitored during warfarin therapy and the dose adjusted accordingly. When the dose of warfarin is increased, the dose of St. John's wort remains unchanged, you should consult a doctor about stopping therapy.
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, the level of theophylline in the blood plasma should be monitored and, if necessary, the dose of theophylline should be adjusted without changing the dose of St. John's wort.
Simultaneous use with oral contraceptives can cause abnormal uterine bleeding (menorrhagia, hypermenorrhoea, metrorrhagia). A decrease in the contraceptive effect may be observed. It is recommended to use combined oral hormonal contraceptives in combination with other methods of contraception (barrier methods) during St. John's wort therapy.
Simultaneous therapy with amitriptyline is not recommended.
Simultaneous therapy with St. John's wort and antiepileptic drugs (carbamazepine, phenobarbital, phenytoin) is not recommended. A decrease in the level of the drug in the blood plasma and the occurrence of convulsions are possible. If it is necessary to prescribe St. John's wort, it is necessary to monitor the level of antiepileptic drugs in the blood plasma and the symptoms of a decrease in the effectiveness of the drug (for example, an increase in seizure activity). In the event of discontinuation of St. John's wort therapy, it may be necessary to reduce the dose of antiepileptic drugs, monitoring for symptoms of antiepileptic drug toxicity should be carried out.
Clinically significant interactions have been observed between St. John's wort and selective serotonin reuptake inhibitor (SSRI) antidepressants and triptans. Due to the increased risk of adverse reactions associated with these interactions, St. John's wort should not be used concurrently with these medications.
St. John's wort is not recommended for patients taking antibiotics, sulfonamides, hypotensive calcium channel blockers, female sex hormones, hypocholesterolemic agents (statins).
Passionflower
With simultaneous use with drugs that suppress the central nervous system, such as barbiturates, tranquilizers, the sedative and soporific effect of the drug increases. Simultaneous use with benzodiazepines is not recommended. Simultaneous use with disulfiram should be avoided. Alcoholic beverages should not be consumed during treatment with the drug.
Valerian
Enhances the effect of alcohol, sedatives, hypnotics, hypotensive, anxiolytic and antispasmodics.
Hawthorn
Enhances the effect of sedative, hypnotic and antiarrhythmic drugs, cardiac glycosides.
Melissa
With simultaneous use, it is possible to increase the effect of other sedatives and hypnotics.
Influence on the results of laboratory tests
Guaifenesin can cause false-positive results of diagnostic tests that determine 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as a reagent) and vanillin mandelic acid in urine. With this in mind, treatment with the drug must be stopped 48 hours before collecting urine for these tests.
Features of application.
The drug should be used with caution in severe liver and kidney diseases, intoxication with substances that suppress the action of the central nervous system.
During the period of use of the drug, patients, especially those with light skin, should avoid long-term intense exposure to ultraviolet rays (sunbaths, staying under the sun in the mountains, solarium).
St. John's wort should be avoided in patients receiving treatment with indinavir or other antiretroviral drugs as this can lead to the development of resistance to antiretroviral drugs and a decrease in the effectiveness of treatment.
Due to the possibility of interaction, it is recommended to stop using preparations containing St. John's wort in patients using SSRI antidepressants, triptans, theophylline, digoxin, anticonvulsants, warfarin, and oral contraceptives.
Use with caution in patients with severe organic diseases of the digestive tract.
In elderly patients, treatment should be started with the lowest dose.
During the use of the drug, you should refrain from drinking alcoholic beverages.
Specific sensitivity to the smell of valerian may occur.
Guaifenesin should be discontinued 48 hours before urine collection for the analysis of vanillin mandelic acid and 5-hydroxyindoleacetic acid in urine using nitrosonaphthol as a reagent (see the section "Interaction with other medicinal products and other types of interactions").
If the patient has an intolerance to some sugars, it is necessary to consult a doctor before taking this medicine. The drug should not be used by patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Use during pregnancy or breastfeeding.
Due to the lack of safety data, it is contraindicated to use the drug during pregnancy and breastfeeding.
The ability to influence the speed of reaction when driving vehicles or other mechanisms.
The use of the drug can lead to inhibition of the reaction, which is manifested individually in each patient (see the section "Side reactions"). Therefore, you should refrain from potentially dangerous activities that require increased attention, such as driving a motor vehicle or working with other mechanisms.
Method of application and dosage.
Adults and children (age 12 and over)
Use 1 tablet 3 times a day. If necessary, the daily dose can be increased to 2 tablets 3 times a day or reduced to ½ tablet in the morning and afternoon and
1 tablet in the evening. The dose can be changed according to the patient's condition. The interval between taking each individual dose should be from 4 to 6 hours.
The maximum daily dose is 6 tablets (dry Novo-Pasit extract 0.9 g/guaifenesin 1.2 g).
The recommended duration of use is 4-5 weeks. For longer use, you should consult a doctor.
Tablets should be swallowed whole, washed down with a sufficient amount of liquid (water, tea or fruit juice, except for grapefruit).
Children.
The drug should be used by children over 12 years of age.
Overdose.
Overdose is first manifested by depression of the central nervous system, drowsiness. Later, these symptoms may be accompanied by nausea, mild muscle weakness, joint pain, and a feeling of heaviness in the stomach.
The following symptoms may also be observed: a feeling of bitterness in the mouth, unpleasant sensations in the area of the liver; headache, dizziness, lethargy, general weakness, hand tremors, pupil dilation, chest tightness, abdominal pain, reduced hearing and vision, tachycardia; decrease in blood pressure, bradycardia; decreased concentration of attention.
Urolithiasis has been reported with guaifenesin overdose.
Treatment is exclusively symptomatic according to the general principles of overdose treatment. There is no specific antidote.
Adverse reactions.
From the side of the immune system: hypersensitivity reactions, vasculitis.
From the side of the nervous system: dizziness, drowsiness, suppression of emotional reactions, depression.
From the gastrointestinal tract: discomfort in the digestive tract, nausea, vomiting, spasms, heartburn, diarrhea or constipation.
From the side of the skin and subcutaneous tissue: exanthema, itching, rash, urticaria, photosensitivity (UV radiation should be avoided during treatment), hyperemia, skin edema.
From the musculoskeletal system and connective tissue: muscle weakness.
From the respiratory system: difficulty breathing.
From the cardiovascular system: increased blood pressure, tachycardia, bradycardia, ventricular tachycardia.
General disorders: increased fatigue, general weakness, decreased mental and physical performance.
Expiration date. 3 years.
Storage conditions.
Store at a temperature no higher than 25 °C in the original packaging and in a place inaccessible to children.
Packaging.
10 tablets in a blister, 1 or 3 blisters in a box.
Leave category. Without a prescription.
Producer. Teva Cheh Industries s.r.o.
The location of the manufacturer and the address of the place of its activity. St. Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic.
