Medication Safety Information

If you experience severe or life-threatening symptoms, call 911 or go to the nearest emergency room immediately.

At AmalfiDuo, your safety comes first. Prescription medications are provided only after a licensed healthcare provider reviews your health history, current medications, symptoms, and treatment goals.

Please read this information carefully before using any medication. The instructions on your prescription label and the guidance provided by your prescribing provider and dispensing pharmacy always take priority.

This safety information applies to AmalfiDuo products offered for men, women, or both, including products containing:
- Sildenafil
- Tadalafil
- Oxytocin
- Bremelanotide, also called PT-141
- Combinations of these ingredients

Prescription use only: Your medication was prescribed specifically for you. Do not share it with anyone, even if they have similar symptoms.

‍Provide complete health information: Tell your provider about all medical conditions, prescription medications, over-the-counter products, vitamins, supplements, and recreational substances you use.

‍Do not combine treatments on your own: Never take additional sexual-wellness medications, erectile-dysfunction treatments, or products containing the same active ingredients unless your prescribing provider specifically approves them.

‍Follow the prescribed dose: Do not take more medication, use it more frequently, or repeat a dose sooner than directed. Taking additional doses may increase the risk of low blood pressure, prolonged erection, nausea, cardiovascular effects, or other serious reactions.

‍Pregnancy and breastfeeding: Some AmalfiDuo medications may not be safe during pregnancy, while trying to become pregnant, or while breastfeeding. Tell your provider if any of these circumstances apply to you.

‍Alcohol and recreational substances: Alcohol may increase dizziness, fainting, and low blood pressure with certain medications. Never combine sildenafil- or tadalafil-containing products with recreational nitrites commonly known as “poppers.”

‍Sexually transmitted infections and pregnancy prevention: These medications do not prevent pregnancy or protect against sexually transmitted infections.

‍Allergic reactions: Stop using the medication and seek emergency care for swelling of the face, lips, tongue, or throat; difficulty breathing; widespread hives; severe dizziness; or fainting.

‍Emergencies: AmalfiDuo is not an emergency medical service. Call 911 or go to the nearest emergency room for severe or potentially life-threatening symptoms.

Compounded Medications

Some AmalfiDuo medications are custom-compounded by licensed pharmacies for an individual patient after a provider determines that treatment is medically appropriate.

Compounded medications are not FDA-approved. The FDA does not review or verify the safety, effectiveness, quality, strength, or consistency of a compounded medication before it is dispensed. A compounded sublingual film, gummy, nasal spray, or combination medication should not be considered equivalent to an FDA-approved product containing one of the same ingredients.

Always follow the exact instructions on your prescription label. The prescribed dose, frequency, administration method, and storage requirements may differ between formulations.

• Lorem

• Lorem

Sildenafil and Tadalafil

This section applies to products such as:
- Sildenafil / Tadalafil / Oxytocin sublingual film
- Tadalafil / Oxytocin / PT-141 combination medication
- Any other AmalfiDuo product containing sildenafil or tadalafil

Sildenafil and tadalafil belong to a class of medications called phosphodiesterase type 5 inhibitors, or PDE5 inhibitors. They can lower blood pressure and may interact dangerously with certain medications and recreational substances.

Do Not Use If You:
- Take nitrates in any form, including nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate
- Use recreational nitrites or “poppers,” including amyl nitrite or butyl nitrite
- Take riociguat, also known as Adempas
- Are allergic to sildenafil, tadalafil, or another ingredient in the formulation
- Have been told that sexual activity is unsafe because of a heart or cardiovascular condition
- Are already taking another medication containing sildenafil, tadalafil, vardenafil, avanafil, or another PDE5 inhibitor, unless your prescribing provider has expressly directed you to do so

Combining a PDE5 inhibitor with nitrates, poppers, or riociguat can cause a sudden and dangerous drop in blood pressure.

Tell Your Provider Before Use If You Have:
- Heart disease, chest pain, heart failure, an irregular heartbeat, or a history of heart attack
- A recent stroke or heart surgeryLow blood pressure or high blood pressure that is not controlledKidney or liver disease
- A history of fainting or severe dizzinessRetinitis pigmentosa, previous sudden vision loss, or a history of non-arteritic anterior ischemic optic neuropathyPrevious sudden hearing loss
- A bleeding disorder or active stomach ulcer
- Sickle cell disease, multiple myeloma, leukemia, Peyronie’s disease, or another condition that may increase the risk of prolonged erection
- An anatomical deformity of the penis

Also tell your provider if you take alpha-blockers, blood-pressure medications, certain antifungal medications, antibiotics, HIV medications, or other medicines that may affect sildenafil or tadalafil levels.

Possible Side Effects
Common side effects may include:
- Headache
- Facial flushingIndigestion or upset stomach
- Nasal congestion
- Dizziness or lightheadedness
- NauseaBack or muscle pain
- Temporary changes in vision, including blurred vision or a blue tint

Seek Immediate Medical Care For:
- Chest pain, severe dizziness, fainting, or nausea during sexual activity
- An erection lasting longer than four hours
- Sudden loss or significant reduction of vision
- Sudden hearing loss, sometimes accompanied by ringing in the ears or dizziness
- Symptoms of a severe allergic reaction

Sildenafil and tadalafil labeling warns about prolonged erection, sudden vision loss, sudden hearing loss, hypotension, and cardiovascular risk in susceptible patients.

Important Combination Warning
- The compounded Sildenafil / Tadalafil / Oxytocin film contains two PDE5 inhibitors in one provider-prescribed formulation. This is not an FDA-approved combination.

FDA-approved sildenafil labeling states that combining sildenafil with another PDE5 inhibitor has not been adequately studied and may further lower blood pressure. Use the compounded combination only as prescribed after an individualized provider review. Do not take any additional sildenafil, tadalafil, erectile-dysfunction medication, or pulmonary-hypertension medication containing a PDE5 inhibitor.

If you experience chest pain after taking a sildenafil- or tadalafil-containing product, do not take nitroglycerin or another nitrate yourself. Call 911 and tell emergency personnel what you took and when

Bremelanotide / PT-141

This section applies to products such as:
- PT-141 / Oxytocin gummy
- PT-141 sublingual film
- Tadalafil / Oxytocin / PT-141 combination medication
- Any other AmalfiDuo product containing bremelanotide or PT-141

Bremelanotide may temporarily increase blood pressure and decrease heart rate.

Do Not Use If You Have:
- Uncontrolled high blood pressure
- Known cardiovascular or heart disease
- An allergy to bremelanotide or another ingredient in the formulation

The FDA-approved injectable bremelanotide product is contraindicated in patients with uncontrolled hypertension or known cardiovascular disease.

Tell Your Provider Before Use If You Have:
- High blood pressure, even if treated
- A history of heart attack, stroke, chest pain, or irregular heartbeat
- Kidney or liver disease
- Frequent or severe nausea
- A history of significant skin pigmentation changes
- Any condition that makes temporary increases in blood pressure potentially unsafe

Possible Side Effects
Potential side effects may include:Nausea or vomiting
- Flushing
- Headache
- Dizziness
- Fatigue
- Temporary blood-pressure elevation
- Slower heart rate
- Darkening of the skin, gums, face, or other areas

Seek Prompt Medical Care For:
- Severe or persistent nausea or vomiting
- Chest pain
- Fainting or severe dizziness
- Severe headache accompanied by neurological symptoms
- Markedly elevated blood pressure
- Persistent or spreading skin darkening
- Symptoms of an allergic reaction

Drug Interactions
Bremelanotide may slow stomach emptying and affect the absorption of certain oral medications. Tell your provider about any medication for which rapid or reliable absorption is important.

Avoid using bremelanotide with oral naltrexone prescribed for alcohol- or opioid-use disorder unless your prescribing providers have specifically reviewed and approved the combination. FDA-approved bremelanotide labeling warns that it may substantially reduce exposure to oral naltrexone.

Pregnancy
People who can become pregnant should use effective contraception while using bremelanotide. Stop treatment and contact your provider if pregnancy is suspected. FDA-approved bremelanotide labeling advises discontinuation if pregnancy is suspected.

Important Formulation Notice
The FDA-approved bremelanotide product, Vyleesi®, is a subcutaneous injection approved for a limited indication in certain premenopausal women with acquired, generalized hypoactive sexual desire disorder.

AmalfiDuo compounded films, gummies, combination products, and any use of bremelanotide in men or other populations are not FDA-approved. Safety, absorption, onset, duration, and effectiveness may differ from the FDA-approved injection.

Oxytocin

This section applies to products such as:
- Oxytocin nasal sprayOxytocin sublingual film
- PT-141 / Oxytocin gummy
- Sildenafil / Tadalafil / Oxytocin sublingual film
- Tadalafil / Oxytocin / PT-141 combination medication
‍
‍Oxytocin nasal sprays, sublingual films, gummies, and sexual-wellness combination products are compounded formulations. They are not FDA-approved for sexual wellness, desire, arousal, intimacy, or relationship-related outcomes.

Do Not Use If You:
- Are pregnant or may be pregnant
- Are trying to become pregnant, unless your provider specifically approves use
- Are allergic to oxytocin or another ingredient in the formulation

Oxytocin can stimulate uterine contractions. FDA-approved oxytocin products are intended for specific obstetric uses under medical supervision, not for sexual wellness.

Tell Your Provider Before Use If You Have:
- Heart disease or an irregular heartbeat
- Kidney disease
- A history of low sodium or fluid-balance disorders
- A seizure disorderUnexplained abdominal or pelvic pain
- Abnormal uterine bleeding
- A history of significant reactions to oxytocin
- Possible Side Effects

Potential side effects may include:
- Headache
- Nausea
- Dizziness
- Facial flushing
- Fatigue
- Nasal irritation, dryness, or congestion with nasal spray
- Abdominal or uterine cramping
- Palpitations or changes in heart rate

Seek Immediate Medical Care For:
- Severe abdominal or pelvic pain
- Strong uterine contractions or vaginal bleeding
- Chest pain or an irregular heartbeat
- Severe headache, confusion, marked weakness, repeated vomiting, or seizure
- Symptoms of an allergic reaction
Severe neurological symptoms can be signs of dangerously low sodium. Serious water intoxication and hyponatremia have been reported with high-dose, prolonged systemic oxytocin administration. The likelihood with a compounded sexual-wellness formulation is not established, but concerning symptoms require immediate evaluation.

Combination Medications
Products containing more than one active ingredient may carry the risks and interactions of every ingredient in the formula. Side effects may overlap or become additive.

When using a combination medication:
- Use only the dose and frequency printed on your prescription label
- Do not add another product containing sildenafil, tadalafil, oxytocin, or PT-141
- Do not repeat a dose because the desired effect was not immediate
- Do not use another person’s medicationLimit alcohol and avoid recreational substances that can affect blood pressure
- Rise slowly from sitting or lying down if you experience dizziness
- Stop sexual activity and seek help for chest pain, fainting, severe dizziness, or shortness of breath

The safety and effectiveness of the exact compounded combinations have not been established through the FDA drug-approval process.

Storage and Handling
Storage requirements vary by formulation. Follow the pharmacy label rather than assuming that a medication should be refrigerated or stored at room temperature.
- Keep medication in its original labeled container
- Protect it from excessive heat, moisture, and direct sunlight
- Do not freeze unless the pharmacy specifically instructs you to do so
- Keep gummies, films, sprays, and all medications away from children and pets
- Do not share nasal-spray devices
- Do not use medication after its expiration date
- Contact the pharmacy if the medication changes color, texture, odor, or appearance, or if the packaging arrives damaged

Additional Information
This document summarizes important safety considerations but does not include every possible side effect, contraindication, or drug interaction.

Always review the information supplied by the dispensing pharmacy and follow the directions of your prescribing healthcare provider. Your exact formula may have additional risks based on its strength, dosage form, inactive ingredients, or your individual medical history.

Questions or Side Effects?
For unexpected or persistent side effects, stop using the medication and contact your prescribing provider through the patient portal.

For severe symptoms or a medical emergency, call 911 or go to the nearest emergency room.

For non-urgent administrative questions, contact AmalfiDuo Support through the patient portal or at support@amalfiduo.com

If you have questions regarding this Privacy Policy or our privacy practices, please contact us:

• Email: support@amalfiduo.com

• Address: 8911 N Capital of Texas Hwy suite 4200/1013, Austin, TX 78759