FULL PRESCRIBING INFORMATION: CONTENTS*

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets.

12.3 Pharmacokinetics

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. 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. This is a summary of the most important information about CIALIS.

For more information you can also visit or call 1-877-CIALIS1 (1-877-242-5471).

• Mechanism of action: Inhibits phosphodiesterase type 5 (PDE5) in smooth muscle.
• PDE5 breaks down cyclic guanosine monophosphate (cGMP).
• Sexual stimulation releases nitric oxide (NO), which increases cGMP.
• cGMP causes smooth muscle relaxation in the corpus cavernosum of the penis.
• This relaxation allows increased blood flow and an erection.
• By inhibiting PDE5, tadalafil increases cGMP levels, enhancing the erectile response.
• In BPH/urinary tract, relaxation of prostate and bladder smooth muscle improves symptoms.
• In PAH, vasodilation occurs in the pulmonary vascular bed.
• It has minimal effect on PDE6 (retina) compared to sildenafil, possibly fewer visual effects.
• It has weak inhibition of PDE11 (function unknown); clinical significance unclear.
• The effect is dependent on sexual stimulation and intact neural pathways.

CIALIS® (tadalafil) is a registered trademark of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

7.2 Potential for Other Drugs to Affect CIALIS

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. There are two ways to take CIALIS: Do not take CIALIS more than one time each day.

Serious side effects

Take one CIALIS tablet before you expect to have sexual activity. Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition. Do not take CIALIS more than one time each day. Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any 25mg cialis time between doses. Prostate cancer (PC) detection has dramatically increased in Western countries with more patients being diagnosed at an earlier stage and at a younger age.

How Does Cialis 20 mg Tablet Work?

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. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates. Tell all of your healthcare providers that you take CIALIS.

Alternatives for ED and BPH

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. This has translated into an increased number of localized diseases receiving external beam radiotherapy with a curative intent. Successful treatment and longer life expectancy have been accompanied by a raising proportion of patients complaining of erectile dysfunction (ED) as an expression of post-radiation late toxicity.

A recent review reported ED rates reaching 24–84% in patients undergoing three-dimensional conformal radiation therapy (3DCRT) for PC [1].

• Patient counseling points: Take exactly as prescribed by your doctor.
• For on-demand (20mg), take at least 30 minutes before sexual activity.
• For daily use, take at approximately the same time each day, with or without food.
• Do not take more than one dose per day.
• Seek immediate medical help for an erection lasting more than 4 hours.
• Stop taking Cialis and seek medical help if you experience sudden vision or hearing loss.
• Be cautious when rising from a sitting/lying position to avoid dizziness.
• Report any new medications (prescription, OTC, herbal) to your doctor before taking Cialis.
• It does not protect against sexually transmitted infections (STIs) or pregnancy.
• Keep all appointments with your doctor for monitoring.
• Do not share your medication with others.

Before the advent of the phosphodiesterase 5 inhibitors (PDE5-I) era only scanty information on post-radiation therapy of ED were available.

• Summary of key advantages: Provides a long 36-hour window of opportunity for on-demand use.
• Allows for spontaneity within a multi-day period, reducing performance pressure.
• Daily dosing option provides constant readiness, eliminating timing concerns.
• Effective for two common conditions: ED and the symptoms of BPH.
• Can be taken with or without food, offering convenience.
• Generally well-tolerated with a predictable side effect profile.
• Has a strong body of clinical evidence supporting its efficacy and safety.
• Available in both brand and generic forms, improving accessibility.
• Can significantly improve quality of life and intimate relationships.
• Treatment should be part of a comprehensive approach to men's health.
• Always use under the guidance of a qualified healthcare professional.

Treatment of post-radiation ED with PDE5-I has gained little attention so far with only a few published phase II studies 2, 3. In one of these, sildenafil significantly improved the erectile function (EF) domain of the International Index of Erectile Function (IIEF) compared with placebo with up to 90% of patients being able to perform a successful intercourse using the maximal available dose (100 mg) [2].

Avoiding Interactions

See also “What Are The Possible Side Effects Of CIALIS?” CIALIS is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. 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. 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. protect a man or his partner from sexually transmitted diseases, including HIV.

Professional resources

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 who have ED, including men with diabetes or who have undergone prostatectomy CIALIS is not for women or children. CIALIS must be used only under a healthcare provider's care. use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About CIALIS?”) What Should I Tell My Healthcare Provider Before Taking CIALIS? Tadalafil (Cialis®, Eli Lilly and Company, Indianapolis, IN, USA), a relatively new selective PDE5-I 4, 5, proved effective in nearly 50% of patients treated with 20 mg on demand in the only trial on post-radiation ED patients currently available [6]. In view of its long half-life (17.5 hours) and steady-state plasma concentrations attained within 5 days of daily dosing [7], a once-a-day therapy formulation has been developed. A study compared 10-mg once-a-day with 20-mg on-demand dosing in an ED population of various etiologies, demonstrating that 72% of men preferred daily therapy [8], with a successful completion of sexual intercourse statistically higher for daily tadalafil than for on-demand dosing.

17.10 Recommended Administration

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. Store CIALIS at room temperature between 59° and 86°F (15° and 30°C). Keep CIALIS and all medicines out of the reach of children. A subsequent randomized trial demonstrated the 5-mg daily dose equally effective but better tolerated than the 10-mg dose [9]. In the current study, we aimed to compare the efficacy and safety of once-a-day dosing of tadalafil 5 mg with the 20-mg on-demand formulation in a series of patients who developed ED following curative radiotherapy for PC. Cialis is a brand (trade) name for tadalafil which may be used to treat erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Cialis (tadalafil) works by blocking the action of an enzyme known as cGMP-specific phosphodiesterase type-5 (PDE-5).

6.1 Clinical Studies Experience

If you miss a dose, you may take it when you remember but do not take more than one dose per day. What Should I Avoid While Taking CIALIS? Do not use other ED medicines or ED treatments while taking CIALIS. Do not drink too much alcohol when taking CIALIS (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.

Duration of action

What Are The Possible Side Effects Of CIALIS? See “What Is The Most Important Information I Should Know About CIALIS?” The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. 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. An erection that won't go away (priapism). This enzyme breaks down cGMP, a substance that induces smooth muscles to relax. Blocking PDE-5 means increased levels of cGMP within the smooth muscles which promotes muscle relaxation and vasodilation (a widening of blood vessels).

Tadalafil or Cialis: Are They Basically The Same?

Before taking CIALIS, tell your healthcare provider about all your medical problems, including if you: are allergic to CIALIS or ADCIRCA any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS. have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. You should not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. have low blood pressure or have high blood pressure that is not controlled have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, including a condition called NAION 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.

Are you currently using Tadalafil (Cialis, Adcirca, and others)?

Especially tell your healthcare provider if you take any of the following:* medicines called nitrates (see “What Is The Most Important Information I Should Know About CIALIS?”) These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl). other medicines to treat high blood pressure (hypertension) medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®) CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. 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.