Your health and safety come first. Please read the information below about your medication, possible side effects, and other important safety details. Take this medication only as prescribed by your healthcare provider.
Important Safety Information
Motivated Hard+™ Control is a compounded prescription product prescribed by medical providers that contains the generic versions of the brand name drugs Cialis® (Tadalafil) , Prozac® (Fluoxetine) and Zinc acetate.
Motivated Hard+™ Control is a compounded drug. The FDA does not approve or verify compounded drugs for safety, effectiveness, or quality.
BLACK BOX WARNING: SUICIDALITY AND FLUOXETINE (ANTIDEPRESSANTS)
Fluoxetine and other similar antidepressant medicines may increase suicidal thoughts or actions, especially in some people 24 years of age and younger within the first few months of treatment or when the dose is changed. You, your family, and your caregivers should Carefully monitor for any sudden or unusual changes in mood, behavior, thoughts, or feelings. Contact a healthcare provider immediately if you observe new or worsening symptoms, especially if they are severe. Extra caution is advised when starting Motivated Hard+ Control, which contains fluoxetine, or when modifying the dose.
STOP! You cannot take this medication if:
- You take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days
- You take medications containing nitrates, use “poppers” (amyl nitrate or butyl nitrate), or take a class of medications called guanylate cyclase stimulators (Riociguat, Adempas).
- You are allergic to tadalafil, Fluoxetine, Zinc or any inactive ingredients.
- You are younger than 18 years of age.
- You are female (this medication is only for men)
- You have severe or uncontrolled hypertension.
- You have certain cardiac arrhythmias.
- You have had a cerebrovascular event (e.g., stroke).
- You take tamoxifen.
- You take other medications that may cause a dangerous change in heartbeat, such as: azithromycin, clarithromycin, erythromycin, ketoconazole, amitriptyline, clomipramine, imipramine, doxepin, some antipsychotics such as haloperidol.
- You drink large amounts of alcohol, use recreational drugs, or abuse prescription medications- or suddenly stop substance abuse habits.
- You take other medications or treatments for erectile dysfunction.
- You take medications or treatments for pulmonary arterial hypertension.
- You take other antidepressants: SSRIs (sertraline/Zoloft, paroxetine/Paxil, escitalopram/Lexapro, citalopram/Celexa), SNRIs (duloxetine/Cymbalta, venlafaxine/Effexor, desvenlafaxine/Pristiq), or tricyclic antidepressants (amitriptyline, imipramine, nortriptyline, doxepin)
- You take certain medications called tricyclic antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine.
- You take pimozide or thioridazine (antipsychotic medications)
- You take certain medications called serotonin–norepinephrine reuptake inhibitors (SNRI) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine.
- You currently have or have ever had bipolar disorder (manic depression)
- You take tramadol (Conzip, Qdolo, Ultram, in Ultracet).
- You take nutritional supplements that contain St. John's wort or tryptophan.
- You currently have or ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death).
- You currently have or have ever had bipolar disorder.
- You currently or have ever had a seizure disorder.
- You currently or have ever had a history of an eye condition called closed-angle glaucoma.
- You have ever experienced severe side effects from either tadalafil or fluoxetine.
STOP taking this medication and seek immediate medical attention if:
- Thoughts of suicide or self-harm, or any worsening of mood or behavior
- You have an erection that is painful or lasts more than 4 hours.
- You have sudden loss of vision in one or both eyes (possible sign of non-arteritic anterior ischemic optic neuropathy [NAION]).
- You have sudden loss of hearing, ringing in your ears, or dizziness.
- You experience chest pain, shortness of breath, or severe heartburn.
- You develop an allergic reaction. Symptoms may include: swelling of the mouth/lips/tongue or throat, difficulty swallowing, chest pain, shortness of breath, rash, or hives.
- You develop gastrointestinal side effects such as severe nausea, vomiting, diarrhea, or pancreatitis.
- You develop significant sleep disturbance or anxiety symptoms.
- You experience severe dizziness or fainting.
- You have a seizure.
- You experience signs of a dangerous condition called serotonin syndrome, which may include agitation, fever, sweating, confusion, fast or irregular heartbeat, shivering, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea.
- You develop eye pain, changes in vision (such as seeing colored rings around lights), and swelling or redness in or around the eye.
You NEED to tell your doctor BEFORE taking this medication if:
- You have depression, anxiety, or another mood disorder; you have a history of suicidal thoughts or suicide attempts; or you have a family history of bipolar disorder or suicide.
- You are allergic to this drug or any part of this drug.
- You have pulmonary veno-occlusive disease (PVOD).
- You have retinitis pigmentosa.
- You have sickle cell disease.
- You use "poppers" that contain nitrites.
- You are taking any of these drugs: Cobicistat, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, riociguat, ritonavir, vericiguat, itraconazole, or ketoconazole.
- You are taking another drug that contains tadalafil, Fluoxetine or Zinc
- You are taking another drug for erectile dysfunction.
- You have been told you are not healthy enough for sex or have had a heart attack in the last 90 days, chest pain during sex, heart failure, abnormal heartbeat, blood pressure problems, or a stroke in the last 6 months.
- You are female or a child.
- You have a history of a misshapen penis (Peyronie’s disease).
- You have ever had an erection that was painful or lasted more than 4 hours.
- You have a history of: gastrointestinal ulcers, liver problems, kidney problems or dialysis, bleeding, anemia, blood cancers (e.g., leukemia, cytopenias, myeloma), vision loss or NAION, uncontrolled hypertension, stroke, cardiac arrhythmias, autoimmune disorders, Wilson disease, neurological or mood disorders, or other cancers.
- You have a substance use disorder or a history of alcohol abuse.
- You have diabetes.
- You have sensitivity to stimulants, sleep disorders, or anxiety disorders.
- You have any increased or unusual bruising or bleeding, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.
- You have a headache; weakness or feeling unsteady; confusion, problems concentrating, thinking, or remembering, as these may be the symptoms of low salt (sodium) levels in the blood (hyponatremia). Elderly people may be at greater risk for this.
Tell your healthcare provider If you are taking any of these drugs:
- MAOIs, nitrates, riociguat (Adempas), vericiguat, pimozide, thioridazine, tamoxifen
- Other SSRIs, SNRIs, or tricyclic antidepressants
- Tramadol, St. John's Wort, tryptophan
- Alpha-blockers (Hytrin/terazosin, Flomax/tamsulosin, Cardura/doxazosin, Minipress/prazosin, Uroxatral/alfuzosin, Jalyn/dutasteride+tamsulosin, Rapaflo/silodosin).
- Protease inhibitors for HIV (Norvir/ritonavir, Crixivan/indinavir, Fortovase/Invirase/saquinavir, Reyataz/atazanavir).
- Antifungals (Nizoral/ketoconazole, Sporanox/itraconazole).
- Antibiotics (clarithromycin, erythromycin, telithromycin).
- Any medications for blood pressure, erectile dysfunction, or pulmonary artery hypertension (e.g., Revatio).
- Tadalafil is also sold under the brand name Adcirca® for pulmonary arterial hypertension (PAH). Do not take this medication together with Adcirca®, Revatio® (sildenafil), or any other PDE5 inhibitors prescribed for PAH.
- Blood thinners (warfarin, aspirin, NSAIDs) - increased bleeding risk
- Medications that prolong QT interval (certain antibiotics, antipsychotics, heart medications)
- Lithium (mood stabilizer)
- Triptans for migraines
- Opioid pain medications
- Buspirone (anti-anxiety medication)
Other things you should know about this medication
- Talk with your doctor before you drink alcohol while taking this medication.
- This drug does not protect you against sexually transmitted diseases (including HIV).
- This medicine is not a cure for erectile dysfunction and does not increase libido.
- This medication also contains zinc acetate (30 mg). To avoid excessive zinc intake, check your other supplements for zinc content and avoid additional high-dose zinc unless recommended by a healthcare provider.
- Sexual dysfunction can sometimes be the sign of an underlying health condition such as cardiovascular disease or high cholesterol. Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sexual intercourse, seek immediate medical help.
- Do not stop Motivated Hard+ Control without first talking to your healthcare provider. Abruptly stopping can cause withdrawal symptoms including: vomiting, irritability, dizziness, headaches, sensation of tingling skin, or nightmares.
- Some people are at risk for visual problems such as eye pain, changes in vision, or swelling or redness around the eye. You may want to undergo an eye examination to see if you are at risk and get preventative treatment if you are.
- Fluoxetine can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how fluoxetine affects you.
- Fluoxetine may increase the effects of alcohol. Consuming more than 1-2 alcoholic drinks is not recommended while taking this medication, and you should never drive after any alcohol consumption while taking it.
Possible side effects when taking this medication:
- Rash; hives; itching; red, swollen, blistered, or peeling skin, flushing.
- Pressure or pain in the chest, chest tightness, wheezing, trouble breathing.
- Fast or abnormal heartbeat.
- High or low blood pressure.
- Headache, dizziness, Drowsiness, imbalance, or fainting.
- Vomiting, reflux, upset stomach, nausea.
- Stroke-like symptoms (weakness, trouble speaking or thinking, facial drooping).
- Change or loss of eyesight or blurriness.
- Swelling of throat/mouth/face/lips/tongue, hoarseness, difficulty swallowing, nasal congestion.
- Ringing in the ears, hearing loss.
- Swelling of extremities.
- Muscle aches or pains, fever.
- Bleeding, bruising.
- Painful erection or erection lasting longer than 4 hours.
- From zinc: nausea, metallic taste, abdominal cramping, or in high doses over time, copper deficiency or immune suppression.
- Changes in color vision.
- Diarrhea.
- Pain in the stomach, back, arms, or legs.
- Cough.
- Dry mouth.
- Nervousness or anxiety
- Difficulty falling asleep or staying asleep.
- Yawning.
- Weakness or fatigue
- Loss of appetite.
- Weight loss.
- Unusual dreams.
- Sexual problems including decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation.
- Excessive sweating.
If you experience signs or symptoms of an allergic reaction, stop taking Motivated Hard+™ Control Daily and seek medical attention immediately.
