Instructions Novo-Passit oral solution bottle 100 ml
Composition
active ingredients: guaifenesin, liquid extract for Novo-Passit;
1 ml of solution contains: extract for Novo-Passit liquid (Hyperici herba (St. John's wort herb), Passiflorae herba (passionflower herb), Valerianae radix (valerian root), Crataegi folium cum flore (hawthorn leaves and flowers), Lupuli flos (hop cones), Melissae herba (melissa herb), Sambusi flos (elderberry flowers)) (1:13, extractant - water) 0.0775 g, guaifenesin 0.04 g;
excipients: sodium cyclamate, xanthan gum, invert sugar, sodium saccharin, sodium benzoate (E 211), ethanol 96%, orange flavor, sodium citrate, maltodextrin, propylene glycol, purified water.
Dosage form
Oral solution.
Main physicochemical properties: clear or slightly cloudy solution from reddish-brown to dark brown in color with a characteristic aroma and taste. Turbidity that appears during storage or a fine sediment does not affect the effectiveness of the product.
Pharmacotherapeutic group
Hypnotics and sedatives. ATX code N05C M.
Pharmacological properties
Pharmacodynamics
The pharmacologically active components of the drug are guaifenesin and an extract from medicinal plants, which have a predominantly sedative effect. The sedative effect of the extract is combined with the muscle relaxant and anxiolytic 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 in the form of inactive metabolites, mainly in the urine.
The biological half-life is approximately 1 hour.
Indication
A mild form of neurasthenia, especially if accompanied by anxiety, fear, sadness, restlessness, irritability, decreased concentration, or fatigue; a mild form of insomnia, exhaustion, or neurotic memory disorders.
Supportive therapy for migraine, headache caused by nervous tension, vascular psychosomatic disorders with neurocirculatory asthenia, neurogenic tetany, facial pain, and climacteric syndrome.
Functional diseases of the gastrointestinal tract, dyspeptic syndrome without organic lesions, irritable bowel syndrome and adjunctive therapy for organic diseases of the gastrointestinal tract of neurotic origin.
Psychosomatic dermatoses accompanied by itching (urticaria, atopic eczema).
Contraindication
Hypersensitivity to the active ingredients or to any of the excipients of the drug; myasthenia gravis; simultaneous use of cyclosporine or tacrolimus; epilepsy; depression and other conditions accompanied by depression of the central nervous system; bradycardia.
Interaction with other medicinal products and other types of interactions
Guaifenesin
Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid and enhances the effects of alcohol, sedative antihistamines and other substances that depress the central nervous system. The central action of muscle relaxants may increase the undesirable effects of guaifenesin, especially muscle weakness.
Perforated St. John's wort
St. John's wort may induce cytochrome P450 isoenzymes CYP3A4, CYP1A2 and CYP2C9, which may lead to a decrease in the effect of other drugs used simultaneously and metabolized by these isoenzymes. This effect may also be due to the ability to induce the intestinal transport system P-glycoprotein. This interaction was first identified in healthy volunteers with the simultaneous administration of indinavir and St. John's wort. It can also be expected that a similar interaction occurs with other retroviral protease inhibitors (aprenavir, nelfinavir, ritonavir, saquinavir), as well as non-nucleotide reverse transcriptase inhibitors (delawaredine, efavirenz, nevirapine), used in the treatment of HIV-1 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.
Significant clinical interactions with St. John's wort have also been described with concomitant administration of cyclosporine, digoxin, and warfarin. The interaction may result in decreased plasma concentrations of the drugs and, consequently, reduced therapeutic effect.
St. John's wort should not be used with cyclosporine. If the patient is taking cyclosporine, St. John's wort should be discontinued and the cyclosporine dosage adjusted based on plasma cyclosporine levels. Patients should be closely monitored for any signs of tissue rejection after transplantation.
There is also a possibility of interaction of St. John's wort with antiepileptic drugs.
Patients receiving treatment with indinavir or other antiretroviral drugs should avoid the use of St. John's wort, as interaction with it may cause a decrease in their effect with the possible emergence of resistance.
Concomitant administration of St. John's wort with digoxin is not recommended. If necessary, the administration of St. John's wort should be monitored for digoxin plasma levels and the dose adjusted accordingly. When increasing the dose of digoxin, the dose of St. John's wort remains unchanged; a doctor should be consulted regarding discontinuation of therapy.
The 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; a doctor should be consulted regarding discontinuation of therapy.
Concomitant use of St. John's wort and tacrolimus may result in accumulation of subtherapeutic concentrations of tacrolimus, which may lead to graft rejection. Patients should avoid concomitant use of St. John's wort and tacrolimus. If a patient is taking St. John's wort and tacrolimus concomitantly, St. John's wort should be discontinued and tacrolimus plasma levels monitored as a reduction in the tacrolimus dose may be necessary.
Concomitant use with oral contraceptives may cause abnormal uterine bleeding (menorrhagia, hypermenorrhagia, metrorrhagia). In isolated cases, a decrease in the contraceptive effect may occur. It is recommended to use combined oral hormonal contraceptives in combination with other methods of contraception (barrier methods) during St. John's wort therapy.
St. John's wort perforated can significantly reduce the effect of theophylline, so simultaneous use is not recommended. In cases where it is necessary to take St. John's wort, it is necessary to monitor the level of theophylline in the blood plasma and, if necessary, adjust the dose of theophylline without changing the dose of St. John's wort.
Concomitant therapy with amitriptyline is not recommended.
Concomitant treatment with St. John's wort and anticonvulsants (carbamazepine, phenobarbital, phenytoin) is not recommended. A decrease in the drug's plasma level and the occurrence of seizures are possible. If it is necessary to prescribe St. John's wort, the level of anticonvulsants in the blood plasma (for example, increased seizure activity) and symptoms of a decrease in the drug's effectiveness should be monitored. In the event of discontinuation of St. John's wort therapy, the dose of anticonvulsants may not be reduced, but symptoms of anticonvulsant toxicity should be monitored.
Clinically significant pharmacodynamic interactions have been observed with 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.
The use of St. John's wort is not recommended for patients taking antibiotics, sulfonamides, antihypertensive calcium channel blockers, female sex hormones, and hypocholesterolemic agents (statins).
Passionflower
When used simultaneously with drugs that depress the central nervous system, such as barbiturates and tranquilizers, the sedative and hypnotic effect of the drug is enhanced.
Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.
During treatment with the drug, you should not drink alcoholic beverages.
Valerian
Enhances the effects 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, the effect of other sedatives and hypnotics may be enhanced.
Impact on laboratory test results.
Guaifenesin may cause false-positive results in diagnostic tests for 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as a reagent) and vanillylmandelic acid in urine. With this in mind, treatment with the drug should be discontinued 48 hours before collecting urine for this analysis.
Application features
The drug should be used with caution in severe liver and kidney diseases, intoxication with substances that depress the central nervous system.
While using the drugs, patients, especially those with fair skin, should avoid prolonged exposure to ultraviolet radiation (sunbathing, solarium, diathermy).
Patients receiving treatment with indinavir or other antiretroviral drugs should avoid the use of St. John's wort, as it may lead to the development of resistance to antiretroviral drugs and reduce the effectiveness of treatment.
St. John's wort should not be used simultaneously with SSRI antidepressants or triptans.
Use with caution in patients with severe organic diseases of the digestive tract.
In elderly patients, treatment should be started with the minimum dose.
While using the drug, you should refrain from drinking alcoholic beverages.
Guaifenesin should be discontinued 48 hours before urine collection for analysis for the determination of vanillylmandelic acid and 5-hydroxyindoleacetic acid in urine using nitrosonaphthol as a reagent.
The drug contains 12.19% (v/v) ethanol, one dose (5 ml) contains 0.481 g of ethanol, which should be taken into account when used during pregnancy, breastfeeding, children and risk groups (patients with liver disease, epilepsy, alcoholism).
One dose (5 ml) of the drug contains 1.99 g of a mixture of fructose and glucose. This should be taken into account when treating patients with diabetes mellitus. The drug should not be used in patients with hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Use during pregnancy or breastfeeding
Due to insufficient data on the safety of use during pregnancy or breastfeeding, the drug is contraindicated during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Due to the fact that the drug contains ethanol and guaifenesin, its use may lead to inhibition of reactions, which manifests itself individually in each patient (see "Adverse reactions from the nervous system"). Therefore, one should refrain from potentially dangerous activities that require increased attention, such as driving vehicles or working with other mechanisms.
Method of administration and doses
Usually, 5 ml (1 teaspoon) of the drug is prescribed 3 times a day. If necessary, the dose can be increased to 10 ml 3 times a day or reduced to 2.5 ml in the morning and afternoon and 5 ml 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 30 ml.
The drug can be mixed with drinks (juice, except grapefruit, tea).
Children.
The drug should be used in children over 12 years of age.
Overdose
Overdose initially manifests itself as central nervous system depression and 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 liver area; headache, dizziness, lethargy, general weakness, hand tremors, dilated pupils, a feeling of tightness in the chest, abdominal pain, decreased hearing and vision, tachycardia; decreased blood pressure, bradycardia; decreased concentration.
Urolithiasis has been reported with guaifenesin overdose.
Treatment is exclusively symptomatic and follows the general principles of treatment for overdose. There is no specific antidote.
Adverse reactions
Immune system disorders: hypersensitivity reactions, vasculitis.
From the nervous system: dizziness, drowsiness, inhibition of emotional reactions, depression.
Gastrointestinal: feeling of discomfort in the digestive tract, nausea, vomiting, cramps, heartburn, diarrhea or constipation.
Skin and subcutaneous tissue disorders: exanthema, itching, rash, urticaria, photosensitivity (UV radiation should be avoided during treatment), hyperemia, skin edema.
Musculoskeletal and connective tissue disorders: muscle weakness.
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
100 ml solution in a bottle – 4 years. After first opening – 28 days.
5 ml solution in a sachet – 2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging and out of the reach of children. Do not freeze.
Packaging
100 ml in a bottle; 1 bottle with a measuring cap in a box.
5 ml per sachet; 30 sachets per box.
Vacation category
Without a prescription.
Producer
Teva Czech Industries s.r.o.
Location of the manufacturer and its business address
Ostravska Street 29, 747 70 Opava-Komarov, Czech Republic.
