Legal Document

Important Safety Information

Please read this information carefully before using Vitäal Health services.

Last Updated: November 1, 2025
Vitäal Health LLC
1

Daily Tadalafil (Generic Cialis®)

Active Ingredient: Tadalafil

Available Doses: 5mg for daily use

FDA-Approved Use: Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

2

Critical Warnings - DO NOT TAKE TADALAFIL IF:

You take any medicines called nitrates

Often prescribed for chest pain (such as nitroglycerin), or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Taking tadalafil with nitrates can cause your blood pressure to drop to an unsafe level, which could lead to dizziness, fainting, heart attack, or stroke.

You use recreational drugs containing nitrates

Do not use with "poppers" such as amyl nitrate and/or butyl nitrate. These recreational drugs contain nitrates and can cause a dangerous drop in blood pressure when combined with tadalafil.

You take other ED medications

Do not take tadalafil together or in conjunction with any other PDE5 inhibitors, including but not limited to: Sildenafil citrate (branded as Viagra or Revatio), vardenafil (branded as Levitra or Staxyn), or avanafil (branded as Stendra). Do not take tadalafil more than once in a 24-hour period.

You are allergic to tadalafil or any of its ingredients

If you have had an allergic reaction to tadalafil or any PDE5 inhibitor, you may experience an allergic reaction including dizziness, rash, or in rare cases, loss of consciousness. If you experience signs of an allergic reaction, seek emergency medical help immediately.

3

Important Safety Warning - Cardiac Risk

Discuss your health with your healthcare provider to ensure that you are healthy enough for sexual activity. Erectile dysfunction medications should not be used by men for whom sexual activity is not advised because of their underlying cardiovascular status.

If you experience chest pain, dizziness, or nausea during sexual activity, seek immediate medical help.

4

Serious Side Effects

Tadalafil may cause serious side effects. Rare but serious side effects include:

  • An erection that will not go away (priapism): If you have an erection that lasts more than 4 hours, seek immediate emergency medical attention. If priapism is not treated right away, it can permanently damage your penis.
  • Sudden vision loss in one or both eyes: Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking tadalafil immediately and call your healthcare provider right away if you experience sudden vision loss in one or both eyes.
  • Sudden hearing decrease or hearing loss: Some people may also have ringing in their ears (tinnitus) or dizziness. If you experience these symptoms, stop taking tadalafil immediately and contact a healthcare provider right away.
  • Sudden drop in blood pressure: Tadalafil can cause small declines in your blood pressure that may cause dizziness, lightheadedness, or fainting, especially in people sensitive to blood pressure changes. Be sure you are well-hydrated and in a safe, controlled environment the first time you take tadalafil.

IF YOU ARE EXPERIENCING A MEDICAL EMERGENCY, CALL 911 OR SEEK IMMEDIATE MEDICAL ATTENTION.

5

Before You Take Tadalafil

Tell your healthcare provider if you have or have had:

Cardiovascular Conditions

  • Heart problems such as heart attack, irregular heartbeat, angina (chest pain), narrowing of the aortic valve, or heart failure
  • Heart surgery within the last 6 months
  • Stroke
  • Low blood pressure or high blood pressure that is not controlled
  • Cardiovascular risk that prevents you from partaking in sexual activity
  • Chest pain requiring nitroglycerin
  • Ventricular outflow obstruction (e.g., aortic stenosis)
  • Severely impaired autonomic control of blood pressure
  • Cardiac failure or coronary artery disease causing unstable angina

Blood and Vascular Conditions

  • Problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
  • Bleeding problems
  • Stomach ulcers

Eye Conditions

  • Retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • Severe vision loss, including an eye problem called NAION (non-arteritic anterior ischemic optic neuropathy)
  • "Crowded" optic disc

Other Medical Conditions

  • Pulmonary hypertension
  • Deformed penis shape
  • Erection that lasted for more than 4 hours (priapism or predisposition to priapism)
  • Benign prostatic hyperplasia (BPH) and are being treated with alpha-blockers
  • Liver problems or kidney problems, or are on dialysis
  • Any other medical conditions

CRITICAL: Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in serious harm, including, in some cases, death.

6

Drug Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tadalafil may affect the way other medicines work, and other medicines may affect the way tadalafil works, causing side effects.

Especially tell your healthcare provider if you take any of the following:

Nitrates (CRITICAL INTERACTION)

  • Medicines called nitrates (see warnings above)
  • Any form of nitrate medication for chest pain

Guanylate Cyclase Stimulators

  • Adempas (riociguat) for pulmonary arterial hypertension
  • Do not take tadalafil if you are taking Adempas

Alpha-Blockers

  • Hytrin (terazosin HCl)
  • Flomax (tamsulosin HCl)
  • Cardura (doxazosin mesylate)
  • Minipress (prazosin HCl)
  • Uroxatral (alfuzosin HCl)
  • Jalyn (dutasteride and tamsulosin HCl)
  • Rapaflo (silodosin)

Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of PDE5 inhibitor drugs (including tadalafil) with alpha-blockers can lower blood pressure significantly, leading to fainting.

HIV Protease Inhibitors (CYP3A4 Inhibitors)

  • Ritonavir (Norvir)
  • Indinavir sulfate (Crixivan)
  • Saquinavir (Fortovase or Invirase)
  • Atazanavir sulfate (Reyataz)

These medications increase tadalafil levels in the bloodstream, which can cause side effects.

Antifungal Medicines

  • Ketoconazole (Nizoral)
  • Itraconazole (Sporanox)

Antibiotics

  • Clarithromycin (Biaxin)
  • Telithromycin (Ketek)
  • Erythromycin

Other Medications

  • Other medicines that treat high blood pressure or antihypertensives
  • Other medicines or treatments for erectile dysfunction
  • Any other PDE5 inhibitors
7

Common Side Effects

The most common side effects of tadalafil include:

  • Headache
  • Flushing
  • Upset stomach
  • Heartburn
  • Abnormal vision (changes in color vision, blurred vision)
  • Stuffy or runny nose
  • Back pain
  • Muscle pain
  • Nausea
  • Dizziness
  • Rash
  • Pain in limb
  • Indigestion
  • Nasal congestion

These are not all of the side effects that may occur. If you have questions about side effects, call your healthcare provider.

8

Reporting Side Effects

You are encouraged to report negative side effects of prescription drugs to the FDA:

  • Call FDA at 1-800-FDA-1088
  • Visit www.fda.gov/medwatch
  • Call your healthcare provider for medical advice about side effects

This is not a complete list of all drugs or health problems that interact with tadalafil. Tell your healthcare provider and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tadalafil with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your healthcare provider.

9

How to Take Tadalafil

Daily Use (5mg)

  • Take once per day at approximately the same time each day
  • Can be taken with or without food
  • Take without regard to the timing of sexual activity

Important Dosing Guidelines

  • Do not take more than one dose in a 24-hour period
  • Do not take with other ED medications or PDE5 inhibitors
  • Take exactly as prescribed by your healthcare provider

Alcohol Consumption

Do not drink alcohol in excess (more than 3-5 drinks) when taking tadalafil. Drinking large amounts of alcohol with tadalafil can increase your chances of:

  • Getting a headache or dizziness
  • Increasing your heart rate
  • Lowering your blood pressure
  • Experiencing side effects

If You Take Too Much

If you take too much tadalafil or take it together with certain medicines, the chance for side effects will be higher. Seek medical attention if you experience severe side effects.

10

Important Reminders

Sexual Health

  • Tadalafil does NOT protect you or your partner from getting sexually transmitted diseases, including HIV (the virus that causes AIDS)
  • Use safe sex practices
  • Tadalafil does NOT serve as a contraceptive (birth control)

Medical Consultation Required

  • If your symptoms are not improving or you have questions about changing or stopping medication, reach out to your healthcare provider for guidance
  • You should take the medication exactly as prescribed

Effects on Other Activities

  • If you experience dizziness or vision changes, use caution when driving or operating machinery
11

Proper Storage and Disposal

Storage

  • Store tadalafil tablets at room temperature (between 59°F and 86°F / 15°C and 30°C)
  • Store in a dry, secure place
  • Keep out of the reach of children and pets
  • Protect from light and moisture

Disposal

  • Check with your pharmacist about how to properly dispose of unused medications
  • Do NOT flush unused medications down the toilet
  • Do NOT pour medications down a sink or drain
  • Follow FDA guidelines for safe medication disposal or use a drug take-back program
12

Additional Information

Prescription Required

Prescription products require an online consultation with a licensed medical provider who will determine if a prescription is appropriate based on your medical history and current health status.

Not For Everyone

Tadalafil may not be appropriate for everyone. Your healthcare provider will determine if tadalafil is safe and appropriate for you based on your individual medical history, current medications, and health conditions.

Full Prescribing Information

This information is not comprehensive. For complete safety information, please see the full Prescribing Information for tadalafil/Cialis at: https://pi.lilly.com/us/cialis-pi.pdf

13

Questions or Concerns

If you have questions about tadalafil, your prescription, or experience any side effects, please contact:

Mail

Vitäal Health LLC
26023 Jefferson Avenue
Suite D
Murrieta, CA 92562

For Medical Emergencies: Call 911 or go to the nearest emergency room

This Important Safety Information is intended to provide essential safety guidance for patients considering or using tadalafil for erectile dysfunction treatment. Always consult with your healthcare provider about your specific medical situation and treatment options.

* Prescription products require an online consultation with a medical provider who will determine if a prescription is appropriate.