Novo-pasit

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOVO-PASSIT (Novo-Passit®)

Composition:

Active substances: Novo-Passit dry extract, guaifenesin;

One tablet contains: Novo-Passit dry extract (elder flowers (Sambuci flos), hawthorn leaves and flowers (Crataegi folium cum flore), St. John's wort herb (Hyperici herba), lemon balm herb (Melissae herba), passionflower herb (Passiflorae herba), hop cones (Lupuli flos), valerian root (Valerianae radix)) 157.5 mg; guaifenesin 200 mg;

Excipients:

Core: colloidal anhydrous silicon dioxide, microcrystalline cellulose, glyceryl tribehenate, magnesium stearate, lactose monohydrate;

Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, lecithin, xanthan gum, quinoline yellow (E 104), iron oxide yellow (E 172), indigo carmine (E 132).

Pharmaceutical form. Coated tablets.

Main physicochemical properties: light green, oval, coated tablets with a break line on both sides.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological Properties

Pharmacodynamics

The pharmacologically active components of the medicinal product are guaifenesin and herbal extracts exerting primarily calming effects. St. John's wort has additional antidepressant activity. Its mechanism of action involves inhibition of serotonin reuptake and inhibition of monoamine oxidase. Valerian root extract (Valeriana officinalis) has sedative and calming effects. Its mechanism of action is associated with effects on GABA receptors and chloride channels, opening of chloride channels, and inhibition of neuronal excitability.

The calming effect of the extract is combined with the anxiolytic and myorelaxant effects of guaifenesin (relaxing smooth muscles).

Pharmacokinetics

Guaifenesin is rapidly absorbed from the gastrointestinal tract, metabolized in the liver via conjugation with glucuronic acid, and excreted mainly in the form of inactive metabolites in the urine.

The biological half-life is approximately 1 hour.

Clinical characteristics.

Indications.

Mild form of neurasthenia, especially when accompanied by anxiety, fear, sadness, restlessness, irritability, decreased attention span, or increased fatigue; mild form of insomnia, exhaustion; neurotic memory disturbances.

For supportive therapy in migraine, headache due to nervous tension; psychosomatic vascular disorders with neurocirculatory asthenia, neurogenic tetany, facial pain; during climacteric syndrome.

Functional gastrointestinal disorders, dyspeptic syndrome without organic lesions, irritable bowel syndrome.

For adjunctive therapy in organic gastrointestinal diseases with a pronounced neurotic component.

Psychosomatic dermatoses accompanied by itching (urticaria, atopic eczema).

Contraindications.

Hypersensitivity to the active ingredients or to any of the excipients of the medicinal product; myasthenia gravis; epilepsy; depression and other conditions associated with central nervous system depression; bradycardia; concomitant use of cyclosporine or tacrolimus; use in children under 12 years of age; use in HIV-positive patients taking protease inhibitors.

Interaction with other medicinal products and other forms of interactions.

Guaifenesin

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid and potentiates the effects of alcohol, sedative antihistamines, and other substances that depress the central nervous system. The central action of muscle relaxants may enhance undesirable effects of guaifenesin, particularly muscle weakness.

Hypericum perforatum (St. John's wort)

Hypericum perforatum may induce CYP3A4, CYP1A2, and CYP2C9 isoenzymes of cytochrome P450, which may reduce the efficacy of other concurrently administered drugs that are metabolized by these isoenzymes. Hypericum also induces P-glycoprotein. This interaction was first observed in healthy volunteers receiving indinavir and Hypericum perforatum simultaneously. A similar interaction can also be expected with other antiretroviral 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. Concurrent use of antiretroviral drugs and Hypericum perforatum results in reduced efficacy of these drugs, possibly leading to resistance development. Therefore, Hypericum should not be used concomitantly with these drugs.

Clinically significant interactions with Hypericum have also been reported with concomitant use of cyclosporine, tacrolimus, digoxin, and warfarin. This interaction may lead to decreased plasma concentrations of these drugs and thus to reduced therapeutic efficacy.

Clinically proven drug interactions of Hypericum have been demonstrated with theophylline, amitriptyline, and oral contraceptives. Interaction with antiepileptic drugs is also possible. Potential interaction of Hypericum with many other drugs metabolized by cytochrome P450 isoenzyme 3A4, including grapefruit juice, cannot be excluded.

Hypericum must not be used concomitantly with cyclosporine. If a patient is taking cyclosporine, Hypericum should be discontinued and cyclosporine dosage adjusted based on plasma cyclosporine levels. Close monitoring for signs of tissue rejection is required in transplant patients.

Concomitant use of Hypericum and tacrolimus may result in subtherapeutic concentrations of tacrolimus, potentially leading to transplant rejection. Patients should avoid concomitant use of Hypericum perforatum and tacrolimus. In case of concomitant use, Hypericum should be discontinued and plasma levels of tacrolimus monitored, as dose adjustment may be necessary.

Concomitant administration of Hypericum with digoxin is not recommended. If Hypericum must be prescribed, digoxin plasma levels should be monitored and dosage adjusted accordingly. Digoxin dosage may need to be increased while Hypericum dosage remains unchanged; discontinuation of therapy should be discussed with a physician.

Concomitant use of Hypericum with warfarin is not recommended. If Hypericum must be prescribed, prothrombin time should be monitored during warfarin therapy and dosage adjusted accordingly. Warfarin dosage may need to be increased while Hypericum dosage remains unchanged; discontinuation of therapy should be discussed with a physician.

Hypericum perforatum may significantly reduce the efficacy of theophylline; therefore, concomitant use is not recommended. If Hypericum intake is necessary, plasma theophylline levels should be monitored and theophylline dosage adjusted as needed, without changing the Hypericum dose.

Concomitant use with oral contraceptives may lead to abnormal uterine bleeding (menorrhagia, hypermenorrhea, metrorrhagia). Reduced contraceptive efficacy may occur. It is recommended to use combined oral hormonal contraceptives together with other contraceptive methods (barrier methods) during Hypericum therapy.

Concomitant therapy with amitriptyline is not recommended.

Concomitant therapy with Hypericum and antiepileptic drugs (carbamazepine, phenobarbital, phenytoin) is not recommended. Possible reduction in plasma drug levels and occurrence of seizures may occur. If Hypericum must be prescribed, plasma levels of antiepileptic drugs and signs of reduced efficacy (e.g., increased seizure activity) should be monitored. Upon discontinuation of Hypericum therapy, a reduction in antiepileptic drug dosage may be necessary; symptoms of antiepileptic drug toxicity should be monitored.

Clinically significant interactions have been observed between Hypericum and antidepressants of the selective serotonin reuptake inhibitors (SSRIs) group and triptans. Due to the increased risk of adverse reactions associated with these interactions, Hypericum should not be used concomitantly with these drugs.

Use of Hypericum is not recommended in patients taking antibiotics, sulfonamides, calcium channel blockers, female sex hormones, or lipid-lowering agents (statins).

Passiflora

When used concomitantly with drugs that depress the central nervous system, such as barbiturates, tranquilizers, the sedative and hypnotic effects of the drug are enhanced. Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided. Consumption of alcoholic beverages should be avoided during treatment.

Valeriana

Enhances the effects of alcohol, sedatives, hypnotics, antihypertensives, anxiolytics, and spasmolytics.

Hawthorn

Enhances the effects of sedatives, hypnotics, antiarrhythmics, and cardiac glycosides.

Melissa

Concomitant use may enhance the effects of other sedatives and hypnotics.

Effect on laboratory test results

Guaifenesin may cause false-positive results in diagnostic tests for 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as reagent) and vanillylmandelic acid in urine. Therefore, treatment with the drug should be discontinued 48 hours before urine collection for these tests.

Special precautions for use.

The medicinal product should be used with caution in patients with severe liver or kidney diseases, and in cases of intoxication with substances that depress the function of the central nervous system.

During treatment, patients, especially those with fair skin, should avoid prolonged and intense exposure to ultraviolet radiation (sunbathing, staying in the sun at high altitudes, tanning beds).

Patients receiving indinavir or other antiretroviral drugs should avoid using Hypericum perforatum (St. John's wort), as it may lead to the development of resistance to antiretroviral drugs and reduced treatment efficacy.

Due to potential interactions, it is recommended to discontinue use of products containing St. John's wort in patients taking SSRIs, triptans, theophylline, digoxin, anticonvulsants, warfarin, or oral contraceptives.

Use with caution in patients with severe organic gastrointestinal disorders.

Elderly patients should start treatment with the minimum dose.

Alcoholic beverages should be avoided during treatment.

Specific sensitivity to the smell of valerian may occur.

Guaifenesin should be discontinued 48 hours prior to urine collection for testing vanillylmandelic acid and 5-hydroxyindoleacetic acid in urine when using nitrosonaphthol as the reagent (see section "Interaction with other medicinal products and other types of interactions").

If a patient has known sugar intolerances, consultation with a physician is necessary before taking this medicinal product. The product should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding.

Due to insufficient safety data, the use of this medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The use of this medicinal product may result in impaired reaction speed, with individual variations in each patient (see section "Side effects"). Therefore, patients should refrain from potentially hazardous activities requiring heightened attention, such as driving a vehicle or operating machinery.

Dosage and Administration

Adults and children (aged 12 years and older)

Take 1 tablet 3 times daily. If necessary, the daily dose may be increased to 2 tablets 3 times daily or reduced to ½ tablet in the morning and afternoon and 1 tablet in the evening. The dose may be adjusted according to the patient's condition. The interval between individual doses should be 4 to 6 hours.

Maximum daily dose – 6 tablets (dry extract of Nova-Passit 0.9 g/guaifenesin 1.2 g).

The recommended duration of treatment is 4–5 weeks. In case of longer-term use, consult a physician.

Tablets should be swallowed whole with sufficient amount of liquid (water, tea, or fruit juice, except grapefruit juice).

Children

The drug is indicated for children aged 12 years and older.

Overdose

Overdose initially manifests as depression of the central nervous system and drowsiness. Later, these symptoms may be accompanied by nausea, mild muscular weakness, joint pain, and a feeling of heaviness in the stomach.

Other possible symptoms include bitter taste in the mouth, discomfort in the liver area, headache, dizziness, lethargy, general weakness, hand tremors, dilated pupils, chest tightness, abdominal pain, decreased hearing and visual acuity, tachycardia, decreased blood pressure, bradycardia, and reduced concentration.

With guaifenesin overdose, cases of urolithiasis have been reported.

Treatment is exclusively symptomatic, following general principles of overdose management. There is no specific antidote.

Adverse reactions.

Immune system: hypersensitivity reactions, vasculitis.

Nervous system: dizziness, drowsiness, suppression of emotional responses, depression.

Gastrointestinal tract: discomfort in the gastrointestinal tract, nausea, vomiting, spasms, heartburn, diarrhea or constipation.

Skin and subcutaneous tissue: exanthema, pruritus, rash, urticaria, photosensitization (UV radiation should be avoided during treatment), hyperemia, skin swelling.

Musculoskeletal system and connective tissue: muscle weakness.

Respiratory system: dyspnea.

Cardiovascular system: increased blood pressure, tachycardia, bradycardia, ventricular tachycardia.

General disorders: increased fatigue, general weakness, decreased mental and physical performance.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging and in a place inaccessible to children.

Packaging.

10 tablets per blister, 1 or 3 blisters per box.

Supply category. Over-the-counter.

Manufacturer. Teva Czech Industries s.r.o.

Manufacturer's address and location of business operations: Ostrovska 305/29, Komarov, 747 70 Opava, Czech Republic.