Novo-Passit pills p / o No. 10×3

Novo-Passit Tablets: A Natural Solution for Anxiety, Stress, and Sleeplessness

Description:

Novo-Passit tablets are a natural remedy formulated with a blend of plant extracts known for their calming and relaxing effects. These oval-shaped, film-coated tablets are pale green in color and feature a separating line. Each tablet contains a combination of Hawthorn extract, elderberry extract, valerian extract, guaifenesin, St. John’s wort extract, lemon balm extract, passionflower extract, and hops extract.

Pharmacological Properties:

Novo-Passit works by targeting various mechanisms in the body to alleviate symptoms of anxiety, stress, and sleep disturbances.

• St. John’s Wort: This extract has antidepressant properties by inhibiting serotonin reuptake and monoamine oxidase (MAO).
• Valerian Extract: Known for its hypnotic and sedative effects, valerian works by influencing GABA receptors and chlorine ion channels, reducing neuronal excitability.
• Guaifenesin: This ingredient provides anxiolytic and muscle relaxant effects, further contributing to the soothing properties of the product.

Indications for Use:

Novo-Passit is recommended for:

• Mild Neurasthenic Disorders: Including anxiety, fear, irritability, low mood, and increased fatigue.
• Mild Insomnia: Difficulty falling asleep or staying asleep.
• Complementary Therapy: For migraine, tension headaches, menopausal syndrome, functional gastrointestinal disorders (dyspepsia, irritable bowel syndrome), and “neurogenic” pruritic dermatoses (eczema, neurodermatitis).

Dosage and Administration:

• Adults: Take 1 tablet 3 times daily. If needed, the dose can be increased to 2 tablets 3 times daily.
• Dose Adjustment: For mild depression, consider reducing the morning and afternoon dose to 1/2 tablet per dose and taking 1 tablet in the evening.
• Interval: Maintain a 4-6 hour interval between doses.
• Maximum Daily Dose: 6 tablets.
• Administration: Take with liquids (tea, juice, except for grapefruit juice). For nausea, take with meals.
• Drowsiness: Novo-Passit in standard doses does not cause drowsiness or loss of attention, allowing for daytime use.

Special Considerations:

• Patients over 65: Dose adjustment is generally not required.
• Patients with Impaired Liver/Kidney Function: No specific dose adjustment information is available. Use with caution if liver function is compromised.
• Pregnancy and Lactation: Due to insufficient safety data, Novo-Passit is not recommended during pregnancy or breastfeeding.
• Driving and Operating Machinery: Guaifenesin in Novo-Passit may induce lethargy. Avoid activities requiring high concentration, such as driving, operating machinery, or working at heights.
• Acute Gastrointestinal Diseases: Use with caution.
• Consult Your Doctor: Always consult a doctor before using Novo-Passit during pregnancy, especially in the first trimester, or while breastfeeding.

Precautions:

• Potential Hazards: Avoid potentially hazardous activities requiring heightened attention and fast psychomotor reactions while taking Novo-Passit.
• Liver Dysfunction: Use with caution in cases of severe liver dysfunction.
• CNS Depressants: Exercise caution when using Novo-Passit in conjunction with central nervous system depressants.
• UV Light: Avoid intense UV light exposure (sunbathing, solar lamps, and tanning beds) while taking Novo-Passit, particularly if you have pale skin.
• Indinavir/Antiretroviral Drugs: Avoid Novo-Passit when taking indinavir or other antiretroviral medications due to the potential for antiretroviral resistance and decreased treatment effectiveness.
• SSRI Antidepressants and Triptans: Do not take Novo-Passit simultaneously with SSRI antidepressants or triptans.
• Urine Collection: Discontinue Novo-Passit 48 hours before urine collection for vanillin-mandelic acid and 5-hydroxyindoleacetic acid tests using the 1-nitroso 2-naphthol reagent.
• Hereditary Conditions: Novo-Passit is not recommended for patients with rare hereditary conditions like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• Other Medications: Consult your doctor before taking Novo-Passit with other medications.

Drug Interactions:

• Guaifenesin: Enhances the effects of alcohol, sedative antihistamines, and other central nervous system depressants.
• St. John’s Wort: May induce cytochrome P450 isoenzymes (CYP3A4, CYP1A2, and 2C9), potentially reducing the effectiveness of other drugs metabolized by these isoenzymes. This interaction may also involve the intestinal transport system of P-glycoprotein. St. John’s Wort should not be used concurrently with:
  • Antiretroviral Drugs: (indinavir, other protease inhibitors, delaverdin, efavirenz, nevirapine).
  • Cyclosporine: Discontinue St. John’s Wort and adjust cyclosporine dosage based on blood plasma levels.
  • Digoxin: Monitor blood plasma levels and adjust digoxin dosage if necessary.
  • Warfarin: Monitor prothrombin time (PT) and adjust warfarin dosage.
  • Tacrolimus: Discontinue St. John’s Wort and monitor tacrolimus levels; dosage reduction may be necessary.
  • Oral Contraceptives: Consider additional contraception methods while taking St. John’s Wort.
  • Theophylline: Avoid concurrent use. Monitor theophylline blood plasma levels if necessary.
  • Amitriptyline: Avoid concurrent use.
  • Anticonvulsants: (carbamazepine, phenobarbital, phenytoin). Monitor blood plasma levels.
  • SSRIs and Triptans: Avoid concurrent use due to increased risk of adverse reactions.
  • Antibiotics, Sulfonamides, Antihypertensive Calcium Channel Blockers, Female Sex Hormones, Hypocholesterolemic Agents (Statins): Not recommended for patients taking these medications.
• Passiflora: Enhances the effects of central nervous system depressants (barbiturates, tranquilizers). Avoid concurrent use with benzodiazepines and disulfiram.
• Valerian: Enhances the effects of alcohol, sedatives, hypnotics, hypotensive, anxiolytic, and antispasmodic drugs.
• Hawthorn: Enhances the effects of sedatives, hypnotics, antiarrhythmic drugs, and cardiac glycosides.
• Melissa: May enhance the effects of other sedatives and hypnotics.
• Alcohol: Avoid alcohol consumption during treatment.

Influence on Laboratory Tests:

Guaifenesin in Novo-Passit may cause false-positive results in diagnostic tests measuring 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthal) and vanillylmandelic acid in urine. Discontinue Novo-Passit 48 hours before urine collection for these analyses.

Contraindications:

• Hypersensitivity: Increased individual sensitivity to the drug’s components, particularly guaifenesin.
• Myasthenia Gravis: Not recommended.
• Epilepsy: Not recommended.
• Children under 18 Years: Not recommended.
• Concurrent Use of Cyclosporine or Tacrolimus: Contraindicated.
• HIV-Infected Patients Receiving Protease Inhibitors: Contraindicated.

Composition:

Each tablet contains:

• Active Substances:
  • Novo-Passit Dry Extract (valerian officinalis, lemon balm, St. John’s wort, passionflower, hops, elderflower, and hawthorn)
  • 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:

• Initial Symptoms: Depression, drowsiness.
• Later Symptoms: Nausea, muscle weakness, joint pain, stomach heaviness.
• Guaifenesin Overdose: Cases of urolithiasis have been reported.
• Treatment: Symptomatic. No specific antidote available.

Side Effects:

Frequency Categories:

• 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 (cannot be established from available data)

Nervous System: Rarely – Dizziness, drowsiness.

Gastrointestinal Tract: Rarely – Nausea, vomiting, abdominal pain, heartburn, diarrhea, constipation.

Skin and Subcutaneous Tissue: Rarely – Rash, itching.

Musculoskeletal System: Rare – Muscle weakness.

General: Rare – Fatigue.

Storage Conditions:

• Store below 25°C.
• Keep out of reach of children.

Shelf Life:

• 3 years.
• Do not use after the expiration date indicated on the packaging.

Where to Buy:

Novo-Passit tablets are available for purchase online and at various pharmacies.

Please note: This information is for informational purposes only and should not be considered a substitute for professional medical advice. Always consult your doctor before starting any new medication or making any changes to your treatment plan.