Bella Capsule Consent Form

WildBerryMD Informed Consent: Bella 1 Weight Loss Program (Bupropion, Naltrexone, Topiramate) via Telehealth.

1. Purpose of Treatment

I understand I am enrolling in the Bella 1 Weight Loss Program offered by WildBerryMD, which includes Bupropion, Naltrexone, and Topiramate prescribed off-label for weight management. I must be 18 years of age and be a resident of Arizona and be present in Arizona at the time of my appointment.These medications are not approved by the U.S. Food and Drug Administration (FDA) for weight loss. I am voluntarily choosing to proceed after being fully informed of potential benefits, risks, limitations, and uncertainties.

2. How It Works

Bupropion: May help reduce appetite and support mood.
Naltrexone: May help reduce food cravings and compulsive eating behaviors.
Topiramate: May help decrease appetite and promote feelings of fullness.

I understand these medications do not replace healthy lifestyle changes such as nutrition, exercise, and behavioral modifications, which are essential for long-term success.

3. Potential Benefits: Some individuals may experience:

Better control over emotional or binge eating
Improved appetite regulation
Enhanced mood or sense of well-being
Reduced cravings for unhealthy foods or substances
Greater motivation for healthy habits
Possible improvement in blood sugar, cholesterol, or blood pressure as a result of weight loss

4. Risks and Unknowns

I understand that:

Possible side effects include nausea, headache, dizziness, dry mouth, insomnia, mood changes, anxiety, agitation, suicidal thoughts, memory or concentration issues, increased blood pressure or heart rate, liver problems, opioid withdrawal, or seizures.
There may be unknown or unanticipated side effects, especially with long-term use, as this medication combination is prescribed off-label and lacks long-term safety and efficacy data.
Allergic reactions, though rare, may occur. Signs include rash, swelling, itching, difficulty breathing, or anaphylaxis. If these happen, I will stop the medication immediately and seek emergency care.

5. Medication Source and Delivery

I understand:

My medications come from a 503A state-licensed compounding pharmacy and are not FDA-approved for weight loss, safety, or effectiveness.
Delivery typically takes 7 to 12 business days. WildBerryMD and its pharmacy partners will do their best to ensure timely delivery, but delays may occur due to circumstances beyond their control.
I am responsible for reading all pharmacy inserts, medication guides, and safety information provided.

6. Who Should Not Use This Program

I should not use Bella 1 if I:

Have uncontrolled high blood pressure or serious heart disease
Have a history of seizures or eating disorders (bulimia, anorexia)
Am currently using opioid medications or receiving opioid dependence treatment
Have severe liver disease
Am pregnant, breastfeeding, or planning pregnancy
Have known allergies to Bupropion, Naltrexone, Topiramate, or related ingredients
Take medications that increase seizure risk or may dangerously interact, including:

Certain antidepressants (MAO inhibitors, high-dose SSRIs/SNRIs)
Antipsychotics
Other seizure-risk medications
Sedatives, benzodiazepines, sleep aids, or alcohol dependence treatments
Other weight loss medications or stimulants

Drink excessive alcohol or have a history of alcohol misuse, dependence, or withdrawal, as this may increase the risk of serious side effects

7. Alternatives

I understand alternatives include:

Lifestyle modifications (diet, exercise, behavior change), FDA-approved weight loss medications, Bariatric surgery or structured weight management programs

8. Telehealth and Limitations

I understand:

My care is provided through telehealth, meaning no in-person physical exams.
WildBerryMD is not my primary care provider, specialist, or any other medical or healthcare provider, and does not provide emergency care.
In an emergency or if I experience severe side effects, I will call 911 or go to the nearest emergency room (ER).
I will notify WildBerryMD if I have concerns or non-emergency side effects during treatment.

9. My Responsibilities as a Patient, Payment, Disclosures and Outcomes

I agree to:

Provide complete and accurate medical and medication history.
Follow all instructions for medication use, lifestyle changes, and follow-up care.
Inform my primary care provider (PCP) and all other healthcare providers or specialists that I am starting this weight loss program, to help avoid medication interactions or serious side effects.
Avoid or limit alcohol use and discuss any alcohol use with my provider, as combining alcohol with these medications may increase the risk of side effects such as dizziness, impaired judgment, mood changes, or seizures.
Avoid using sleep aids, sedatives, or other medications that affect the central nervous system unless approved by my provider.
Report any side effects or concerns to WildBerryMD promptly.
Not stop medications suddenly without consulting my provider, as this may cause serious health risks.
This is a self-pay program; WildBerryMD does not bill insurance, and no refunds or exchanges will be given for medications, consultations, or services — even if I stop the program early or am unsatisfied with the results.
Understand that no specific weight loss or health outcomes are guaranteed, and no express or implied promises of success are made.

11. Indemnity and Release of Liability

By signing below, I voluntarily assume all risks and agree to:

Release, defend, indemnify, and hold harmless WildBerryMD, its providers, employees, contractors, agents, and affiliated pharmacies from all claims, damages, losses, or legal actions (including attorney’s fees) related to:
My decision to participate in the Bella 1 Weight Loss Program
My failure to provide accurate medical or medication history
My failure to follow instructions or use medications as directed
Any side effects, complications, or outcomes, except those solely due to gross negligence or willful misconduct under applicable law

12. Consent to Treatment

I certify that:

I have read and understood this consent form.
I have had the opportunity to ask questions, and all were answered to my satisfaction.
I voluntarily consent to participate in the Bella 1 Weight Loss Program with Bupropion, Naltrexone, and Topiramate.
I accept the limitations of telehealth care and understand I may withdraw at any time but should consult my provider to avoid health risks.

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Consent Description

WildBerryMD Informed Consent: Bella 1 Weight Loss Program (Bupropion, Naltrexone, Topiramate) via Telehealth.

1. Purpose of Treatment
I understand I am enrolling in the Bella 1 Weight Loss Program offered by WildBerryMD, which includes Bupropion, Naltrexone, and Topiramate prescribed off-label for weight management. I must be 18 years of age and be a resident of Arizona and be present in Arizona at the time of my appointment.These medications are not approved by the U.S. Food and Drug Administration (FDA) for weight loss. I am voluntarily choosing to proceed after being fully informed of potential benefits, risks, limitations, and uncertainties.

2. How It Works
– Bupropion: May help reduce appetite and support mood.
– Naltrexone: May help reduce food cravings and compulsive eating behaviors.
– Topiramate: May help decrease appetite and promote feelings of fullness.

I understand these medications do not replace healthy lifestyle changes such as nutrition, exercise, and behavioral modifications, which are essential for long-term success.

3. Potential Benefits: Some individuals may experience:
– Better control over emotional or binge eating
– Improved appetite regulation
– Enhanced mood or sense of well-being
– Reduced cravings for unhealthy foods or substances
– Greater motivation for healthy habits
– Possible improvement in blood sugar, cholesterol, or blood pressure as a result of weight loss

4. Risks and Unknowns
I understand that:
– Possible side effects include nausea, headache, dizziness, dry mouth, insomnia, mood changes, anxiety, agitation, suicidal thoughts, memory or concentration issues, increased blood pressure or heart rate, liver problems, opioid withdrawal, or seizures.
– There may be unknown or unanticipated side effects, especially with long-term use, as this medication combination is prescribed off-label and lacks long-term safety and efficacy data.
– Allergic reactions, though rare, may occur. Signs include rash, swelling, itching, difficulty breathing, or anaphylaxis. If these happen, I will stop the medication immediately and seek emergency care.

5. Medication Source and Delivery
I understand:
– My medications come from a 503A state-licensed compounding pharmacy and are not FDA-approved for weight loss, safety, or effectiveness.
– Delivery typically takes 7 to 12 business days. WildBerryMD and its pharmacy partners will do their best to ensure timely delivery, but delays may occur due to circumstances beyond their control.
– I am responsible for reading all pharmacy inserts, medication guides, and safety information provided.

6. Who Should Not Use This Program
I should not use Bella 1 if I:
– Have uncontrolled high blood pressure or serious heart disease
– Have a history of seizures or eating disorders (bulimia, anorexia)
– Am currently using opioid medications or receiving opioid dependence treatment
– Have severe liver disease
– Am pregnant, breastfeeding, or planning pregnancy
– Have known allergies to Bupropion, Naltrexone, Topiramate, or related ingredients
– Take medications that increase seizure risk or may dangerously interact, including:
  – Certain antidepressants (MAO inhibitors, high-dose SSRIs/SNRIs)
  – Antipsychotics
  – Other seizure-risk medications
  – Sedatives, benzodiazepines, sleep aids, or alcohol dependence treatments
  – Other weight loss medications or stimulants
– Drink excessive alcohol or have a history of alcohol misuse, dependence, or withdrawal, as this may increase the risk of serious side effects

7. Alternatives
I understand alternatives include:
– Lifestyle modifications (diet, exercise, behavior change), FDA-approved weight loss medications, Bariatric surgery or structured weight management programs

8. Telehealth and Limitations
I understand:
– My care is provided through telehealth, meaning no in-person physical exams.
– WildBerryMD is not my primary care provider, specialist, or any other medical or healthcare provider, and does not provide emergency care.
– In an emergency or if I experience severe side effects, I will call 911 or go to the nearest emergency room (ER).
– I will notify WildBerryMD if I have concerns or non-emergency side effects during treatment.

9. My Responsibilities as a Patient, Payment, Disclosures and Outcomes
I agree to:
– Provide complete and accurate medical and medication history.
– Follow all instructions for medication use, lifestyle changes, and follow-up care.
– Inform my primary care provider (PCP) and all other healthcare providers or specialists that I am starting this weight loss program, to help avoid medication interactions or serious side effects.
– Avoid or limit alcohol use and discuss any alcohol use with my provider, as combining alcohol with these medications may increase the risk of side effects such as dizziness, impaired judgment, mood changes, or seizures.
– Avoid using sleep aids, sedatives, or other medications that affect the central nervous system unless approved by my provider.
– Report any side effects or concerns to WildBerryMD promptly.
– Not stop medications suddenly without consulting my provider, as this may cause serious health risks.
– This is a self-pay program; WildBerryMD does not bill insurance, and no refunds or exchanges will be given for medications, consultations, or services — even if I stop the program early or am unsatisfied with the results.
– Understand that no specific weight loss or health outcomes are guaranteed, and no express or implied promises of success are made.

11. Indemnity and Release of Liability
By signing below, I voluntarily assume all risks and agree to:
– Release, defend, indemnify, and hold harmless WildBerryMD, its providers, employees, contractors, agents, and affiliated pharmacies from all claims, damages, losses, or legal actions (including attorney’s fees) related to:
  – My decision to participate in the Bella 1 Weight Loss Program
  – My failure to provide accurate medical or medication history
  – My failure to follow instructions or use medications as directed
  – Any side effects, complications, or outcomes, except those solely due to gross negligence or willful misconduct under applicable law

12. Consent to Treatment
I certify that:
– I have read and understood this consent form.
– I have had the opportunity to ask questions, and all were answered to my satisfaction.
– I voluntarily consent to participate in the Bella 1 Weight Loss Program with Bupropion, Naltrexone, and Topiramate.
– I accept the limitations of telehealth care and understand I may withdraw at any time but should consult my provider to avoid health risks.

Patient Name*

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Date of Birth*

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Patient Signature*

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Bella1 Consent Form