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Country or Region	Prescription Requirement	Regulation Notes
United States	Prescription required	FDA approved for ED and PAH
European Union	Prescription required	Varies by country
Australia	Prescription required	Classified as prescription medicine

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Standard	Details
Good Manufacturing Practice (GMP)	Must meet GMP standards for safety and efficacy
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Packaging	Tamper-proof, properly sealed, labeled accurately

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Side Effect	Frequency	Severity	Recommended Action
Headache	Common	Mild	Usually resolves; analgesics if needed
Flushing	Common	Mild	Cold compress, reassurance
Nasal Congestion	Moderate	Mild to Moderate	Decongestants with caution
Dizziness	Moderate	Mild to Moderate	Sit or lie down; avoid driving

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