Tadalafil (generic Cialis®) Tablets

About this medicine

Tadalafil is used to treat erectile dysfunction (ED). For full prescribing information, view the drug label information.

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Trade names

Cialis® (tadalafil) The list of names may not include all products that are available on the market.

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How to take this medicine

• Do not take tadalafil tablets more than one time each day.
• Do not change your dose or the way you take tadalafil without talking to your healthcare provider. Your healthcare provider may change your dose depending on how you respond to the medicine, and on your health condition.
• Tadalafil may be taken with or without meals.
• Some form of sexual stimulation is needed for an erection to happen with tadalafil.

For use as needed

• Take tadalafil exactly as your healthcare provider prescribes them. Your healthcare provider will prescribe the dose that is right for you.
• Take one tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking tadalafil and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take tadalafil before sexual activity.

For daily use

• Take tadalafil tablets exactly as your healthcare provider prescribes them. Your healthcare provider will prescribe the dose that is right for you.
• Take one tadalafil tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.

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What if I miss a dose?

For daily use, if you miss a dose, you may take it when you remember but do not take more than one dose per day.

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Who should not take this medicine?

Do not take tadalafil tablets if you:

• take any medicines called “nitrates”.
• use recreational drugs called “poppers” like amyl nitrite and butyl nitrite
• take any medicines called guanylate cyclase stimulators, such as riociguat.
• are allergic to tadalafil or ADCIRCA®, or any of the ingredients. Symptoms of an allergic reaction may include:
• rash
• hives
• swelling of the lips, tongue, or throat
• difficulty breathing or swallowing

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

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Side effects

Serious, but rare, side effects include:

• an erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.
• color vision changes. Color vision changes such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.
• sudden decrease or loss of vision. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including tadalafil tablets, and call a healthcare provider right away.
• sudden loss or decrease in hearing. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking tadalafil tablets and contact a healthcare provider right away.

The most common side effects with tadalafil tablets are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking tadalafil tablets. Back pain and muscle aches usually go away within 2 days. Contact your healthcare provider if you get any side effect that bothers you or one that does not go away. These are not all the possible side effects of tadalafil tablets. For more information, ask your healthcare provider or pharmacist.

Contact your doctor if you have additional questions about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Storage

• Keep out of the reach of children
• Store at 20° to 25°C (68° to 77°F)
• Throw away any unused medicine after the expiration date

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Other important information

Medicine may not work

As with almost all medicine, the recommended treatments do not work for every single person. There is a risk the medicine will not work and your ED continues. If after more than 4 weeks your symptoms have not improved, you should consider scheduling an in-person visit with a doctor.

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Avoid

• Do not use other ED medicines or ED treatments while taking tadalafil tablets.
• Do not drink too much alcohol when taking tadalafil tablets (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

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Inform your healthcare providers

Before taking tadalafil tablets, tell your healthcare provider about all your medical problems, including if you:

• have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take tadalafil tablets if your healthcare provider has told you not to have sexual activity because of your health problems.
• have pulmonary hypertension
• have low blood pressure or have high blood pressure that is not controlled
• have had a stroke
• have liver problems
• have kidney problems or require dialysis
• have retinitis pigmentosa, a rare genetic (runs in families) eye disease
• have ever had severe vision loss, including a condition called NAION
• have stomach ulcers
• have a bleeding problem
• have a deformed penis shape or Peyronie’s disease
• have had an erection that lasted more than 4 hours
• have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following:

• medicines called nitrates
• medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension
• medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If tadalafil tablets are taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
• other medicines to treat high blood pressure (hypertension)
• medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)
• some types of oral antifungals such as ketoconazole (Nizoral®), itraconazole (Sporanox®)
• some types of antibiotics such as clarithromycin (Biaxin®), telithromycin (Ketek®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).
• other medicines or treatments for ED.
• Tadalafil tablets are also marketed as ADCIRCA® for the treatment of pulmonary arterial hypertension. Do not take both tadalafil tablets and ADCIRCA®. Do not take sildenafil citrate (Revatio®) with tadalafil tablets.

Telemedicine does not replace your primary care physician. It is important to keep your primary care physician and pharmacist informed of all medications you are taking, including those in your Keeps treatment plan, as they can interact with other medicines you may be taking.