Superpower Health

Informed Consent for Tadalafil Treatment

Last Updated and Effective:
5.15.2024

Introduction

THIS INFORMED CONSENT FOR TADALAFIL (THE "CONSENT") SETS FORTH THE TERMS AND POLICIES FOR THE CLINICAL SERVICES PROVIDED BY SUPERPOWER MEDICAL GROUP OF CA PC, A CALIFORNIA PROFESSIONAL MEDICAL CORPORATION, AND OTHER THIRD-PARTY MEDICAL GROUPS (THE "MEDICAL GROUPS") THROUGH THE ONLINE TECHNOLOGY PLATFORM ("PLATFORM" OR "SUPERPOWER PLATFORM"), WHICH IS OWNED AND OPERATED BY SUPERPOWER HEALTH, INC. ("SUPERPOWER").

This informed consent is for the use of tadalafil, a prescription medication, for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). The purpose of this consent is to provide you with information about the risks, benefits, and safety considerations associated with tadalafil treatment in order for you to make an informed decision as to whether or not to proceed with treatment, as well as to obtain your agreement to adhere to the treatment protocol as prescribed by your Medical Group healthcare provider (“Healthcare Provider”). Please read this form carefully and ask any questions you have before signing.

General Information

Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor that works by inhibiting the PDE5 enzyme, which is responsible for the breakdown of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum of the penis. By inhibiting PDE5, tadalafil allows for increased levels of cGMP, leading to smooth muscle relaxation and improved blood flow to the penis, facilitating the achievement and maintenance of an erection. Tadalafil is an FDA-approved medication for the treatment of erectile dysfunction.

Risks and Side Effects

While tadalafil can significantly improve erectile function and BPH symptoms, it may also cause side effects. Common side effects include, but are not limited to:

  • Headache
  • Dyspepsia, heartburn, indigestion, stomach discomfort
  • Body aches or pain 
  • Nasal congestion 
  • Flushing 

Series side effects are rare but may include: 

  • Priapism (prolonged erection lasting more than 4 hours or a painful erection for more than 6 hours). Seek immediate medical attention. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.
  • Sudden vision loss in one or both eyes (non-arteritic anterior ischemic optic neuropathy, NAION)
  • Sudden hearing decrease or loss, which may be accompanied by dizziness and ringing in the ears.
  • Angina pectoris 
  • Myocardial infarction 
  • Stroke
  • Hypotension 
  • Hypertension

If any of these serious side effects occur, seek immediate medical attention.

Do not drink excessive amounts of alcohol (eg, 5 or more glasses of wine or 5 or more shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Contraindications

Tadalafil is contraindicated in the following situations:

  • Known hypersensitivity to tadalafil or any of its components 
  • Concomitant use of nitrates (e.g., nitroglycerin, isosorbide mononitrate, isosorbide dinitrate)
  • Concomitant use of guanylate cyclase stimulators (e.g., riociguat) 
  • Severe hepatic impairment (Child-Pugh Class C)
  • Severe renal impairment (creatinine clearance < 30 mL/min)
  • Recent history (within 90 days) of myocardial infarction or stroke
  • Uncontrolled hypertension (> 170/100 mmHg) 
  • Unstable angina 
  • Known hereditary degenerative retinal disorders (e.g., retinitis pigmentosa)

If any of these contraindications apply to you, inform your Healthcare Provider before starting treatment. It is important to tell your Healthcare Provider about all medications and supplements you take and any heart problems you have now or may have had in the past. This medicine can interact with other medications and can cause serious side effects in patients with heart problems.

Treatment Protocol

Your Healthcare Provider will determine the appropriate dosage of tadalafil based on your individual needs and medical history. The recommended starting dose is generally 5mg or 10 mg orally once daily, taken at approximately the same time each day, with or without food. The dose may be increased to 10 mg or 20 mg (or decreased to 5 mg if you start at 10 mg) based on individual efficacy and tolerability. The maximum recommended dose is 20 mg once daily.

Use of Telehealth

You understand that all Clinical Services will be provided via telehealth. Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following:

  • Electronic transmission of client medical records, photo images, personal health information or other data between a patient and a provider; 
  • Interactions between a patient and provider via audio, video and/or data communications (such as messaging or email communications);
  • Use of output data from medical devices, sound and video files. 
  • Alternative methods of care may be available to you, such as in-person services, and you may choose an alternative at any time.

Electronic systems used will incorporate network and software security protocols to protect the confidentiality of customer identification and imaging data and will include measures to safeguard the data and to ensure its integrity against intentional or unintentional corruption.

Expected Benefits of Telehealth

  • Improved access to care by enabling a customer to remain at a remote site while consulting with  practitioners at distant/other sites. 
  • More efficient client evaluation and management.
  • Obtaining expertise of a distant specialist.

Possible Risks of Telehealth

  • There are potential risks associated with the use of telehealth. These risks include, but may not be limited to:
  • There is the potential that conditions that could be diagnosed with an in-person visit may go undetected in a remote encounter especially because a full physical exam cannot be performed
  • In rare cases, information transmitted may not be sufficient (e.g. poor resolution of images) to allow for appropriate decision making by the Healthcare Provider;
  • Delays in evaluation and treatment could occur due to deficiencies or failures of the equipment;
  • In very rare instances, security protocols could fail, causing a breach of privacy of personal health information;
  • In rare cases, a lack of access to complete health records may result in interactions or allergic reactions or other judgment errors.

Due to state licensure requirements for healthcare providers, you have to physically be in the state that your Healthcare Provider is licensed in during your telehealth visit. By agreeing to this Consent, you are confirming that you will only opt in to care when you are in your state of residence or in one of our locations. Furthermore, you are confirming that your state of residence is one in which the Medical Groups are licensed to treat.

PLEASE NOTE: THE MEDICAL GROUPS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, ARE CONSIDERING HARMING YOURSELF OR OTHERS, OR ARE OTHERWISE IN IMMINENT DANGER, YOU SHOULD DIAL 9-1-1 AND/OR GO TO THE NEAREST EMERGENCY ROOM.

You should seek emergency help or follow-up care when recommended by any healthcare provider or when otherwise needed. You should never discontinue medications or stop a course of treatment without first contacting your primary care provider or other medical professionals for advice. You should not delay treatment or advice from your primary care provider or other medical professionals based on information provided by the Healthcare Provider(s) via the Superpower Platform.

All laws and protections for in-person medical care also apply to telehealth care. This includes confidentiality of information, access to medical records, and sharing of information that could identify you personally. You may decide that you do not want to use the Clinical Services at any time, seek treatment elsewhere and/or with in-person offerings.   

Informed Consent & Adherence to Treatment Plan

Please sign below to acknowledge your understanding and agreement of the following terms in order to proceed with treatment with tadalafil therapy with a Medical Group Healthcare Provider via the Superpower Platform:

BY SIGNING THIS INFORMED CONSENT, YOU ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THE INFORMATION PROVIDED ABOUT TADALAFIL TREATMENT, INCLUDING THE RISKS, BENEFITS, AND SAFETY CONSIDERATIONS. YOU AGREE TO ADHERE TO THE TREATMENT PROTOCOL AS PRESCRIBED BY YOUR HEALTHCARE PROVIDER  AND TO REPORT ANY SEVERE SIDE EFFECTS OR CONCERNS TO YOUR HEALTHCARE PROVIDER PROMPTLY.

Take your medication exactly as directed and written on your prescription label. Use tadalafil exactly as directed by your Healthcare Provider. Do not use more of it, do not use it more often, and do not use it for a longer time than your Healthcare Provider ordered. By FDA law, this medication is not for resale nor can it be returned for refund. Do not let anyone else take your medication. This medication is intended for use solely by the person for whom it is prescribed and should not be shared with any other individuals. Please follow the directions of your prescribing Healthcare Provider and on your prescription label carefully. If you need further explanation or have questions, please ask your prescribing Healthcare Provider to explain any part you do not understand.

You understand that the Healthcare Provider prescribing tadalafil holds a professional license issued by the professional licensing board or agency in the state where they practice. You can report a complaint relating to the care provided by contacting the appropriate state professional licensing board.

No Guarantees:

You acknowledge that there are no guarantees or assurances made with respect to the results of taking the tadalafil prescribed for you, and there are no guarantees that there will not be side effects and complications. 

Complete Medical History:

You understand that Tadalafil may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your prescribing Healthcare Provider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your Medical Group prescribing Healthcare Provider updated as to any changes in your health conditions and history during treatment with tadalafil, and you agree there shall be no liability on the part of the Medical Groups, the Healthcare Providers or Superpower if you fail to do so.

CLICKING "I AGREE" OR OTHERWISE INDICATING YOUR ACCEPTANCE, YOU ARE PROVIDING YOUR INFORMED CONSENT TO RECEIVE TADALAFIL TREATMENT THROUGH THIS SERVICE. YOU CERTIFY THAT YOU ARE NOT CONSENTING ON BEHALF OF A MINOR CHILD, AS THIS SERVICE DOES NOT PROVIDE TREATMENT TO INDIVIDUALS UNDER THE AGE OF 18.

MEMBER NAME:___________________________

SIGNATURE:_____________________________

DATE:__________________________________