WARNINGS
What Is The Most Important Information I Should Know About CIALIS?
CIALIS can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. Never take CIALIS with any nitrate or guanylate cyclase stimulator medicines.
Do not take CIALIS if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm.
Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.
Do not take CIALIS if you take medicines called guanylate cyclase stimulators which include:
Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension.
Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.
(See “Who Should Not Take CIALIS?” below)
Tell all of your healthcare providers that you take CIALIS. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS.
After taking a single tablet, some of the active ingredient of CIALIS remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect CIALIS?”).
Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
See also the section SIDE EFFECTS below.
Who Should Not Take CIALIS?
Do not take CIALIS if you:
• take any medicines called “nitrates”.
• use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About CIALIS?”)
take any medicines called guanylate cyclase stimulators, such as riociguat.
are allergic to CIALIS or ADCIRCA®, or any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS. 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.
USES
CIALIS is a prescription medicine taken by mouth for the treatment of:
men with erectile dysfunction (ED)
men with symptoms of benign prostatic hyperplasia (BPH)
men with both ED and BPH
CIALIS for the Treatment of ED
ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. CIALIS helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.
Some form of sexual stimulation is needed for an erection to happen with CIALIS.
CIALIS does not:
cure ED
increase a man’s sexual desire
protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your
healthcare provider about ways to guard against sexually transmitted diseases.
serve as a male form of birth control
CIALIS is only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.
CIALIS for the Treatment of Symptoms of BPH
BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.
CIALIS for the Treatment of ED and Symptoms of BPH
ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take CIALIS for the treatment of both conditions.
CIALIS is not for women or children. CIALIS must be used only under a healthcare provider’s care.
HOW TO USE
How Should I Take CIALIS?
Take CIALIS exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you.
Some men can only take a low dose of CIALIS or may have to take it less often, because of medical conditions or medicines they take.
Do not change your dose or the way you take CIALIS without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to CIALIS and your health condition.
CIALIS may be taken with or without meals.
If you take too much CIALIS, call your healthcare provider or emergency room right away.
How Should I Take CIALIS for Symptoms of BPH?
For symptoms of BPH, CIALIS is taken once daily.
Do not take CIALIS more than one time each day.
Take one CIALIS tablet every day at about the same time of day.
If you miss a dose, you may take it when you remember but do not take more than one dose per day.
How Should I Take CIALIS for ED?
For ED, there are two ways to take CIALIS - either for use as needed OR for use once daily.
The most common side effects with CIALIS 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 CIALIS. Back pain and muscle aches usually go away within 2 days.
Call your healthcare provider if you get any side effect that bothers you or one that does not go away.
Uncommon 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, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS) reported a sudden decrease or loss of vision in one or both eyes. 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 CIALIS, and call a healthcare provider right away.
Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including CIALIS. 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 CIALIS and contact a healthcare provider right away.
These are not all the possible side effects of CIALIS. For more information, ask your healthcare
provider or pharmacist.
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use CIALIS for a condition for which it was not prescribed. Do not give CIALIS to other people, even if they have the same symptoms that you have. It may harm them.
What Are The Ingredients In CIALIS?
Active Ingredient: tadalafil
Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.
OVERDOSE
Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.
MISSED DOSE
If you miss a dose, you may take it when you remember but do not take more than one dose per day.
STORAGE
Store at 25-degrees C (77-degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F) [see USP Controlled Room Temperature].
Keep out of reach of children.
NOTES
Medication Guide: revision date 05/2017
Prescribing Information: revision date 04/2023
1. Potential for Pharmacodynamic Interactions with CIALIS
Nitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring.
Alpha-Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including CIALIS, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin.
Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo.
Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [see the sections WARNINGS and PRECAUTIONS above.)
2. Potential for Other Drugs to Affect CIALIS
[See the sections USE and WARNINGS and PRECAUTIONS above].
Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.
H2 Antagonists (e.g. Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. Cytochrome P450 Inhibitors — CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.
CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see the section USES above].
Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.
HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see the section USES above].
Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.
CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Although specific interactionshave not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. No dose adjustment is warranted. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown.
3. Potential for CIALIS to Affect Other Drugs
Aspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin.
Cytochrome P450 Substrates — CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
CYP1A2 (e.g. Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.
CYP2C9 (e.g. Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. CYP3A4 (e.g. Midazolam or Lovastatin) — Tadalafil had no significant effect on exposure (AUC) to midazolam or lovastatin. P-glycoprotein (e.g. Digoxin) — Coadministration of tadalafil (40 mg once per day) for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin (0.25 mg/day) in healthy subjects.
CIALIS is not right for everyone. Only your healthcare provider and you can decide if CIALIS is
right for you. Before taking CIALIS, 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 CIALIS 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
