Passnovel (Capsules) Instructions for Use

Marketing Authorization Holder

Artelar, LLC (Russia)

Manufactured By

Pharm-Pro, LLC (Russia)

Dosage Form

Passnovel

Capsules: 20 pcs.

Dosage Form, Packaging, and Product Composition

Capsules weighing 300 mg.

Auxiliary substances : gelatin capsule (gelatin, titanium dioxide (dye)), microcrystalline cellulose (carrier), maltodextrin (stabilizer), calcium stearate (anti-caking agent), aerosil (anti-caking agent).

10 pcs. – blisters (2) – carton packs.

Therapeutic Category

Dietary supplement with sedative action

Indications

• As a dietary supplement to the diet, a source of flavonoids and hydroxycinnamic acids, to help reduce mild nervous tension and promote relaxation.
• May be used to support emotional balance during periods of mild stress and anxiety.
• To support healthy sleep patterns and facilitate the onset of natural sleep.
• To provide mild calming effects without causing significant daytime drowsiness when taken at the recommended day-time dosage.

The combined action of the herbal extracts and L-tryptophan is intended to support the normal functioning of the nervous system and contribute to the maintenance of a positive mood.

Contraindications

• Hypersensitivity or individual intolerance to any component of the dietary supplement, including the active ingredients or excipients in the capsule shell.
• Pregnancy and breastfeeding (due to the presence of St. John’s wort extract and the lack of sufficient safety data for the combination of ingredients during these periods).
• Concomitant use with monoamine oxidase inhibitors (MAOIs) or within two weeks of their discontinuation.
• Patients with severe depression, especially with suicidal ideation; this product is not a substitute for appropriate antidepressant pharmacotherapy.
• Endogenous depression (St. John’s wort extract may precipitate manic episodes in individuals with bipolar disorder).
• Children and adolescents under 18 years of age, as safety and efficacy have not been established in this population.
• Patients with photosensitivity or a history of photosensitivity reactions, as St. John’s wort may increase sensitivity to sunlight.
• Patients undergoing organ transplantation or those taking cyclosporine or tacrolimus, due to the risk of reduced efficacy of these drugs from St. John’s wort induction of metabolizing enzymes.

Consult a healthcare professional before use if you have any pre-existing medical conditions, especially liver or kidney disease, or if you are taking any other medications.

Dosage Regimen

For adults and individuals over 18 years of age, take one capsule 2 to 3 times daily with meals, swallowed whole with a sufficient amount of water (approximately 150-200 ml).

The maximum recommended daily dosage is 3 capsules. Do not exceed this dose. The duration of continuous use should not exceed 4 weeks without consulting a healthcare provider. If symptoms of nervous tension or sleep disturbances persist, seek medical advice. For sleep support, the last capsule may be taken approximately 30-60 minutes before bedtime.

Adverse Reactions

Passnovel is generally well-tolerated when used at the recommended dosage. However, in rare cases or in susceptible individuals, the following adverse reactions may occur.

Gastrointestinal disorders: Nausea, abdominal discomfort, dry mouth, or changes in bowel habits (constipation or diarrhea) have been reported infrequently. Taking the capsules with food can help minimize these potential effects.

Nervous system disorders: Drowsiness, dizziness, fatigue, or confusion may occur, particularly at the beginning of therapy or when the dosage is increased. Patients should exercise caution when driving or operating machinery until their individual response to the supplement is known. St. John’s wort may rarely cause restlessness or anxiety in some individuals.

Allergic reactions: Skin rash, pruritus (itching), urticaria (hives), or other manifestations of hypersensitivity may occur in individuals with a predisposition. Discontinue use immediately if any signs of an allergic reaction appear.

Other effects: St. John’s wort can cause photosensitivity, increasing the skin’s reaction to sunlight and leading to sunburn more easily than usual. It is advisable to avoid excessive sun exposure, including tanning beds, and to use protective clothing and sunscreen (SPF 15 or higher) while using this product.

If any adverse reactions are severe or persistent, discontinue use and consult a physician.

Drug Interactions

Passnovel contains St. John’s wort extract, which is known to induce cytochrome P450 enzymes (particularly CYP3A4) and the P-glycoprotein (P-gp) transporter. This can lead to clinically significant reductions in the plasma concentrations and efficacy of a wide range of concomitant medications.

Contraindicated combinations: Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to the theoretical risk of serotonin syndrome, a potentially life-threatening condition.

Combinations requiring special caution and often considered inadvisable: The efficacy of the following drugs may be substantially decreased: cyclosporine, tacrolimus (risk of organ transplant rejection), warfarin and other coumarin anticoagulants (risk of reduced anticoagulant effect and thrombosis), digoxin (reduced plasma levels), theophylline, protease inhibitors for HIV (e.g., indinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine), oral contraceptives (risk of breakthrough bleeding and unintended pregnancy), some anticonvulsants (e.g., carbamazepine, phenobarbital), and many antidepressants (e.g., SSRIs, tricyclics).

Serotonergic drugs: Concomitant use with other serotonergic agents (e.g., SSRIs like fluoxetine, SNRIs, triptans, tramadol) may increase the risk of serotonin syndrome. Symptoms include agitation, confusion, tachycardia, hyperthermia, and muscle rigidity. Patients should be monitored closely if co-administration cannot be avoided.

Inform your doctor or pharmacist about all the products you are using, including prescription, over-the-counter medicines, and other herbal supplements, before starting Passnovel.

Overdose

Information on acute overdose with Passnovel is limited. In case of significant overdose, the effects of the individual components may be potentiated.

Symptoms of overdose may include severe gastrointestinal upset (nausea, vomiting, diarrhea), marked drowsiness, dizziness, confusion, and lethargy. Due to the St. John’s wort component, there is a potential risk of serotonin syndrome in cases of extreme overdose, particularly if taken with other serotonergic agents.

Management: There is no specific antidote. In case of suspected overdose, discontinue the supplement immediately. Treatment should be symptomatic and supportive. Gastric lavage or administration of activated charcoal may be considered if ingestion was recent. It is crucial to seek immediate medical attention or contact a poison control center, providing details of the ingested product and amount. Ensure adequate hydration and monitor vital signs and neurological status.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.