Novo-passit

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOVO-PASSIT® (NOVO-PASIT)

Composition:

Active substances: guaifenesin, liquid extract for Novo-Passit;

1 ml of solution contains: liquid extract for Novo-Passit (Hyperici herba (St. John's wort herb), Passiflorae herba (passion flower herb), Valerianae radix (valerian root), Crataegi folium cum flore (hawthorn leaf with flowers), Lupuli flos (hop cones), Melissae herba (lemon balm herb), Sambuci flos (elderflower)) (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 flavoring, sodium citrate, maltodextrin, propylene glycol, purified water.

Pharmaceutical form. Oral solution.

Main physicochemical characteristics: clear or slightly cloudy solution ranging in color from reddish-brown to dark brown, with a characteristic odor. Cloudiness occurring during storage or a slight sediment does not affect the efficacy of the medicinal product.

Pharmacotherapeutic group. Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

The pharmacologically active components of the medicinal product are guaifenesin and herbal extract exerting predominantly sedative effects. The sedative effect of the extract is combined with the myorelaxant and anxiolytic action of guaifenesin (relaxes 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 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, reduced concentration or fatigue; mild form of insomnia, exhaustion or neurotic memory disorders.

For supportive therapy in migraine, headache due to nervous tension, psychosomatic vascular disorders with neurocirculatory dystonia, neurogenic tetany, facial pain, and 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 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 interaction.

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 increase undesirable effects of guaifenesin, especially muscle weakness.

Hypericum perforatum (St. John's wort)

Hypericum perforatum may induce CYP3A4, CYP1A2, and CYP2C9 isoenzymes of cytochrome P450, which may lead to reduced efficacy of other concurrently administered drugs 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 protease inhibitors (amprenavir, nelfinavir, ritonavir, saquinavir) and non-nucleoside reverse transcriptase inhibitors (delavirdine, efavirenz, nevirapine) used in the treatment of HIV-positive patients.

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 documented with theophylline, amitriptyline, and oral contraceptives. There is also a potential for interaction with antiepileptic drugs. Possible interactions may occur between Hypericum and many other drugs metabolized by cytochrome P450 3A4 isoenzyme, including grapefruit juice.

Patients receiving treatment with indinavir or other antiretroviral drugs should avoid using Hypericum perforatum, as the interaction may reduce their efficacy and lead to development of resistance.

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

Concomitant use of Hypericum and tacrolimus may lead to subtherapeutic concentrations of tacrolimus, potentially resulting in transplant rejection. Patients should avoid concomitant intake of Hypericum perforatum and tacrolimus. If concomitant use occurs, Hypericum should be discontinued and tacrolimus plasma levels 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. When increasing digoxin dose, Hypericum dose should remain unchanged; regarding discontinuation of therapy, consultation with a physician is advised.

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. When increasing warfarin dose, Hypericum dose should remain unchanged; regarding discontinuation of therapy, consultation with a physician is advised.

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

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

Concomitant therapy with amitriptyline is not recommended.

Concomitant therapy of Hypericum with antiepileptic drugs (carbamazepine, phenobarbital, phenytoin) is not recommended. Decreased plasma levels of the drug and occurrence of seizures are possible. If Hypericum must be prescribed, plasma levels of antiepileptic drugs and symptoms 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 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, hypolipidemic agents (statins).

Passiflora

When used concomitantly with central nervous system depressants such as barbiturates, tranquilizers, the sedative and hypnotic effect of the drug is enhanced. Concomitant intake with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided. Alcoholic beverages should not be consumed 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 measuring 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as reagent) and vanillylmandelic acid in urine. In view of this, 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 central nervous system.

During treatment, patients with fair skin should avoid prolonged and intense exposure to ultraviolet radiation (sunbathing, sun exposure in mountainous areas, solarium).

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

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

Use with caution in patients with severe organic gastrointestinal disorders.

In elderly patients, treatment should be initiated at the minimum dose.

Alcoholic beverages should be avoided during treatment.

Specific sensitivity to the smell of valerian may occur.

Guaifenesin intake should be discontinued 48 hours prior to urine collection for analysis of 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").

The medicinal product contains 13.2% ethanol by total volume; one dose (5 mL) contains 520 mg of ethanol. This should be taken into account when administering the product during pregnancy, breastfeeding, in children, and in patients at risk (patients with liver disease, epilepsy). Due to its ethanol content, the medicinal product is harmful for patients with alcoholism.

One dose (5 mL) of the product contains 1.99 g of a mixture of fructose and glucose. This should be considered when treating patients with diabetes mellitus. The medicinal product may be harmful to teeth. Patients with known intolerance to certain sugars should consult their physician before taking this medicinal product. The product must not be used in patients with hereditary fructose intolerance or glucose-galactose malabsorption.

Use during pregnancy or breastfeeding

Due to insufficient safety data, the product is contraindicated during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery

Since the product contains ethanol and guaifenesin, its use may result in impaired reaction time, with individual variations in each patient (see "Side effects"). Therefore, patients should refrain from potentially hazardous activities requiring high concentration, such as driving vehicles or operating machinery.

Method of Administration and Dosage.

Adults and Children (aged 12 years and older)

The usual dose is 5 mL (1 teaspoonful) of the medication three times daily. If necessary, the dose may be increased to 10 mL three times daily or reduced to 2.5 mL in the morning and at noon and 5 mL in the evening. The dose may be adjusted according to the patient's condition. The interval between doses should be 4 to 6 hours. The maximum daily dose is 30 mL.

Elderly Patients

Dosage is the same as for adult patients.

The individual dose can be measured using the provided dosing cap. The medication may be taken directly from the dosing cap or mixed with beverages (juice, except grapefruit juice, tea).

Children

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

Overdose.

Overdose initially manifests as central nervous system depression and drowsiness. Later, these symptoms may be accompanied by nausea, mild muscular weakness, joint pain, and a sensation 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 and based on general principles of overdose management. There is no specific antidote.

Adverse reactions.

Immune system: hypersensitivity reactions, vasculitis.

Nervous system: dizziness, somnolence, 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, photo-sensitization (during treatment, avoid UV radiation exposure), hyperemia, skin edema.

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.

100 ml solution in a bottle – 4 years. After first opening – 28 days.

5 ml solution in sachets – 2 years.

Storage conditions.

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

Packaging.

100 ml in a bottle; 1 bottle with a measuring cap in a box.

5 ml in sachets; 30 sachets in a box.

Availability category. Over-the-counter.

Manufacturer. Teva Czech Industries s.r.o.

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