Flibanserin / Melatonin

(WellsYI-M) Capsules

Available Dosage Strengths:

75 mg / 1 mg  |  75 mg / 2 mg

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Disclaimer: Images are for reference only; actual products may vary.

Contraindications & Safety Information

Contraindications WellsYI, a compounded preparation, should not be used in patients with known hypersensitivity to any component of the formulation. Use is contraindicated in patients with hepatic impairment due to increased risk of adverse effects. Concomitant use with strong or moderate CYP3A4 inhibitors may significantly increase systemic exposure and risk of adverse reactions. Alcohol use may increase the risk of hypotension and syncope and should be avoided.

Warnings & Precautions Use caution in patients with a history of hypotension, cardiovascular conditions, or those taking medications that may lower blood pressure or cause CNS depression. Patients should be counseled on the potential for dizziness, somnolence, and impaired alertness, particularly when initiating therapy or adjusting dose.

Adverse Reactions Adverse effects that have been reported with pharmacologic therapies in this category may include dizziness, somnolence, fatigue, nausea, dry mouth, and hypotension. Syncope has been reported in rare cases. Most adverse effects are mild to moderate and may improve with continued use or dose adjustment under medical supervision.

Clinical Use This compounded preparation has not been evaluated or approved by the FDA for safety or effectiveness. Therapy should be prescribed only after appropriate patient evaluation and individualized risk-benefit assessment by a licensed healthcare provider.

Disclaimer: Melbourne Pharma operates as a 503A compounding pharmacy and prepares customized medications pursuant to a valid patient-specific prescription and provider direction. Compounded preparations are not reviewed, approved, or verified by the U.S. Food and Drug Administration (FDA).
 
Certain commercially manufactured products referenced or available through Melbourne Pharma are distributed separately from compounded preparations and are not compounded by our pharmacy. These products are supplied by their respective manufacturers and dispensed in accordance with applicable regulations.
 
Actual products available at the time of dispensing may vary due to supply chain availability. Any statements regarding commercially manufactured products are manufacturer-provided and have not been independently evaluated or verified by Melbourne Pharma. Please refer to product labeling for complete prescribing and safety information.
 
Patients should consult their healthcare provider regarding medical questions or potential side effects. Adverse events may be reported to the FDA at 1-800-FDA-1088.
 
For questions regarding compounded medications, a Melbourne Pharma pharmacist is available for consultation at 833-655-7500.
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