13 NONCLINICAL TOXICOLOGY
are allergic to CIALIS or ADCIRCA®, or any of its ingredients.
- Cialis 5 mg has minimal food interactions, but heavy fatty meals may delay absorption.
- Use with alcohol may increase side effects like dizziness or headaches.
- Cialis 5 mg is generally well-tolerated when used as prescribed.
- Always notify your healthcare provider of existing health conditions before use.
See the end of this leaflet for a complete list of ingredients in CIALIS.
2.5 Use with Food
The efficacy results for patients with both ED and BPH, who received either CIALIS 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8. CIALIS 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. CIALIS 2.5 mg did not result in statistically significant improvement in the total IPSS. CIALIS for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8). In this study, the effect of CIALIS 5 mg once daily on Qmax was evaluated as a safety endpoint.
Comparison with actions of other PDE5 inhibitors
“See FDA-approved patient labeling (Patient Information)” Physicians should discuss with patients the contraindication of CIALIS with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of CIALIS with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention [see Contraindications (4.1) and Warnings and Precautions (5.1)]. Physicians should discuss with patients the contraindication of CIALIS with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of CIALIS with GC stimulators may cause blood pressure to drop to an unsafe level.
Can Cialis be used to treat ED after prostate surgery?
Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions (5.1)]. Physicians should discuss with patients the potential for CIALIS to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing CIALIS for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)]. Symptoms of an allergic reaction
- Cialis 5 mg is not intended for use in women.
- No studies have shown benefit in female sexual dysfunction.
- However, tadalafil is used off-label for some female conditions?
- Not recommended; potential harm during pregnancy.
- Do not expose fetuses to the drug.
- Nursing mothers should avoid use as tadalafil may pass into milk.
- Keep out of reach of women and children.
- Only male patients should take this medication.
may include:rashhivesswelling of the lips, tongue,
| Parameter | Value | Notes |
|---|---|---|
| Absorption Rate | Peak plasma levels in 2 hours | |
| Half-life | Approximately 17.5 hours | Duration of action |
| Metabolism | Liver via CYP3A4 enzymes | |
| Excretion | Mainly in feces; minor in urine |
or throatdifficulty breathing or swallowing
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 2.5mg | 270 + 10 Pills | 199.64€ 190.13€ | |
| Cialis Professional | 40mg | 20 Pills | 110.24€ 104.99€ | |
| Cialis Generic | 5mg | 180 + 10 Pills | 159.65€ 152.05€ | |
| Cialis Generic | 20mg | 120 + 8 Pills | 188.15€ 179.19€ | |
| Cialis Black | 80mg | 120 + 8 Pills | 264.77€ 252.16€ | |
| Cialis Professional | 20mg | 20 Pills | 78.33€ 74.60€ | |
| Cialis Generic | 40mg | 20 Pills | 59.47€ 56.64€ | |
| Cialis Black | 80mg | 10 Pills | 43.27€ 41.21€ | |
| Cialis Original | 20mg | 120 + 8 Pills | 497.29€ 473.61€ | |
| Cialis Original | 20mg | 92 + 4 Pills | 377.99€ 359.99€ | |
| Cialis Soft Tabs | 20mg | 60 + 4 Pills | 159.37€ 151.78€ | |
| Cialis Generic | 10mg | 30 + 4 Pills | 63.32€ 60.30€ |
swelling of the lips, tongue, or
2.1 CIALIS for Use as Needed for Erectile Dysfunction
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. throat Call your healthcare provider or get help right away if
Mechanism of action
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.
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See also “What Are The Possible Side Effects Of CIALIS?” CIALIS is a prescription medicine taken by mouth for the treatment of: men with symptoms of benign prostatic hyperplasia (BPH) 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. you have any of the symptoms of an allergic reaction listed above.
| Side Effect | Severity | Frequency | Notes |
|---|---|---|---|
| Headache | Mild | Common | Usually subsides in a few hours |
| Indigestion | Mild | Common | May occur if taken with fatty meals |
| Muscle Pain | Mild | Less common | Typically temporary |
| Flushing | Mild | Common | Facial redness |
| Nasal Congestion | Mild | Less common | Temporary |
What Should I Tell My Healthcare Provider Before Taking CIALIS?
- Common side effects include muscle aches and indigestion.
- Cialis 5 mg offers the convenience of a once-daily dose.
- Patients should avoid sudden standing movements due to possible dizziness.
- The medication is not a cure but helps achieve and maintain an erection.
Only your healthcare provider and you can
| Medication | Active Ingredient | Starting Dose | Typical Dose | Duration | Food Interaction |
|---|---|---|---|---|---|
| Cialis | Tadalafil | 5 mg | Up to 20 mg | 36 hours | Can be taken with or without food |
| Viagra | Sildenafil | 50 mg | 25-100 mg | 4-6 hours | Takes 30-60 min, limit high-fat meals |
| Levitra | Vardenafil | 10 mg | 5-20 mg | 4-5 hours | Best on an empty stomach |
decide if CIALIS is right for you. Before taking CIALIS, tell your healthcare provider
- Side effects less common: diarrhea, dizziness, rash.
- Serious side effects: abrupt vision loss (non-arteritic anterior ischemic optic neuropathy).
- Also hearing loss, tinnitus, or priapism.
- NAION risk is very rare but increased in patients with certain risk factors.
- Smokers and those with high cholesterol may be at higher risk.
- Stop tadalafil and seek medical help if sudden vision loss occurs.
- Do not resume use without ophthalmologist evaluation.
- Report any hearing changes to your doctor.
about all your medical problems, including if you:
Society and culture
This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about CIALIS when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist. What Is The Most Important Information I Should Know About CIALIS? CIALIS can cause your blood pressure to drop suddenly to an la cialis unsafe level if it is taken with certain other medicines.
Cialis and other medications
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.
What Are the Side Effects of Cialis and Tadalafil?
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 chronic-thromboembolic 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. Tell all of your healthcare providers that you take CIALIS. have heart problems such as angina, heart failure,
6.2 Postmarketing Experience
Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention. Physicians should advise patients to stop use of all PDE5 inhibitors, including CIALIS, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a "crowded" optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including CIALIS, for this uncommon condition [see Warnings and Precautions (5.4) and Adverse Reactions (6.2)].
Alternatives for benign prostatic hyperplasia (BPH)
Therefore, physicians should inform patients that 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 [see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered. Physicians should instruct patients on the appropriate administration of CIALIS to allow optimal use. For CIALIS for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.
Generic version
For CIALIS for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Cialis is effective at improving erectile function over the course of therapy. For CIALIS for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day. Read this important information before you start taking CIALIS and each time you get a refill. You may also find it helpful to share this information with your partner. irregular heartbeats, or have had a heart attack.
5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies
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. 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.
