Label: CIALIS- tadalafil tablet, film coated

If you have any questions, ask your doctor or pharmacist.

• The mechanism for treating BPH is separate from its effect on blood vessels.
• For BPH, it works by inhibiting PDE5 in the prostate, bladder, and urethra.
• This leads to smooth muscle relaxation in the lower urinary tract.
• Patients may experience improved urinary frequency, urgency, and flow.
• It is not a treatment for prostate cancer, though symptoms can overlap.
• A prostate-specific antigen (PSA) test is often done before and during treatment.
• Tadalafil can cause a slight decrease in measured PSA levels.
• Your doctor needs to be aware you are taking it when interpreting PSA results.
• It represents a non-surgical option for managing moderate BPH symptoms.
• Surgical options remain for cases where medication is not effective enough.

Take this medication by mouth, with or without food, as directed by your doctor.

• Cialis 10 mg is not suitable for everyone.
• Men with heart disease should discuss risk with a doctor.
• It’s essential to stay hydrated while taking Cialis.
• Avoid high-fat meals close to dosing time.
• Cialis may improve self-esteem and relationships.
• Overdose can cause significant health issues.
• Always adhere to the prescribed dosage.
• Cialis may be used in combination with psychotherapy.
• Effectiveness may improve with healthy lifestyle changes.
• Keep a medication diary to track effects.
• Report any persistent side effects immediately.

Do not take tadalafil more often than once daily.

• Cialis 10 mg dosage may be adjusted by doctors.
• It is effective in males with reduced libido.
• Cialis begins working within 30 minutes in most cases.
• It boosts confidence during intimate moments.
• The medication isn’t suitable for women.
• Keep track of your response to the medication.
• Cialis can be part of ED management strategies.
• Avoid taking multiple doses in a 24-hour period.
• The medication is approved by multiple health agencies.
• Consult a doctor if you experience dizziness.
• Cialis should be used responsibly with medical guidance.

The manufacturer directs to swallow this medication whole. However, many similar drugs (immediate-release tablets) can be split/crushed.

Follow your doctor's directions on how to take this medication.

5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

Your doctor may adjust your dose as needed.Children—Use is not recommended. Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose as needed. For treatment of erectile dysfunction (daily use):Adults—2.5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity. Adults—2.5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity.

Dosage adjustments

For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):Adults—5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity.Children—Use is not recommended. Adults—5 milligrams (mg) once a day, taken at the same time each day, without regard for the timing of sexual activity. For treatment of pulmonary arterial hypertension:Adults—40 milligrams (mg) (two 20 mg tablets) taken once a day. Adults—40 milligrams (mg) (two 20 mg tablets) taken once a day. Children—Use and dose must be determined by your doctor.

How long does Cialis stay in your system?

For treatment of benign prostatic hyperplasia (daily use): For oral dosage form (chewable tablet):For treatment of benign prostatic hyperplasia (daily use):Adults—5 milligrams (mg) once a day, taken at about the same time each day. Your doctor may adjust your dose as needed.Children—Use is not recommended.For treatment of erectile dysfunction (as needed):Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 30 minutes before you think sexual activity may occur. Your doctor may adjust your dose as needed.Children—Use is not recommended.For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):Adults—5 milligrams (mg) once a day, taken at about the same time each day, without regard for the timing of sexual activity.Children—Use is not recommended. For treatment of benign prostatic hyperplasia (daily use):Adults—5 milligrams (mg) once a day, taken at about the same time each day. Adults—5 milligrams (mg) once a day, taken at about the same time each day. The dosage is based on your medical condition, response to treatment, and other medications you may be taking.

Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To treat the symptoms of BPH, take this medication as directed by your doctor, usually once a day.

5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use

Using an effective barrier method (latex or polyurethane condom/dental dams) during sexual activity will help to decrease your risk of infection. This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Tadalafil is also available in another brand for high blood pressure in the lungs (pulmonary hypertension). Read the Patient Information Leaflet if available from your pharmacist before you start taking tadalafil and each time you get a refill. If you are also taking finasteride with this medication to treat symptoms of BPH, talk with your doctor about how long you should keep taking this medication.

To treat erectile dysfunction-ED, there are 2 ways that tadalafil may be prescribed.

12.3 Pharmacokinetics

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: faintness or lightheadedness when getting up suddenly from a lying or sitting position pain or discomfort in the arms, jaw, back, or neck Painful or prolonged erection of the penis blistering, peeling, or loosening of the skin fast, irregular, pounding, or racing heartbeat or pulse inability to move the arms, legs, or facial muscles numbness or tingling of the face, hands, or feet red skin lesions, often with a purple center sores, ulcers, or white spots in the mouth or on the lips swelling of the feet or lower legs Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Alternatives for benign prostatic hyperplasia (BPH)

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings burning feeling in the chest or stomach feeling of constant movement of self or surroundings feeling of warmth, redness of the face, neck, arms and occasionally, upper chest redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid swelling or puffiness of the eyes or face Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED).

5. Cialis can cause low blood pressure when taken with other medications

In combination with sexual stimulation, tadalafil works by increasing blood flow to the penis to help a man get and keep an erection. Tadalafil is also used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). It helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). Your doctor will determine which is the best way for you to take tadalafil.

• Cialis 10 mg can be effective for many men.
• Use caution when traveling with Cialis.
• Check with a healthcare provider about possible interactions.
• Certain foods can delay Cialis onset.
• Regular use can improve ED symptoms over time.
• Some men experience back pain as a side effect.
• Cialis is sometimes used off-label for lung hypertension.
• It is considered safe when used as directed.
• Discontinue use if adverse effects are severe.
• Cialis may be less effective with certain illnesses.
• Never share your medication with others.

Follow your doctor's directions exactly since your dosage depends on how you are taking it.

14.1 CIALIS for Use as Needed

For treatment of erectile dysfunction and benign prostatic hyperplasia (daily use):Adults—5 milligrams (mg) once a day, taken at about the same time each day, without regard for the timing of sexual activity.Children—Use is not recommended. Adults—5 milligrams (mg) once a day, taken at about the same time each day, without regard for the timing of sexual activity. For treatment of benign prostatic hyperplasia (daily use): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

2.2 Study design

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is important that you tell all of your doctors that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took tadalafil.

6. There are ways to manage Cialis side effects

If you will be taking this medicine for pulmonary arterial hypertension, it is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects. If you take tadalafil for pulmonary arterial hypertension, do not take Cialis® or other PDE5 inhibitors, including sildenafil (Revatio® or Viagra®) or vardenafil (Levitra®). If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher. The first way is to take it as needed, usually at least 30 minutes before sexual activity.

5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

If you experience a prolonged erection for more than 4 hours or a painful erection for more than 6 hours, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. It is important to tell your doctor about any heart problems you have now or may have had in the past.

What are the most common side effects of tadalafil?

This medicine can cause serious side effects in patients with heart problems. Do not use this medicine if you are also using riociguat (Adempas®) or a nitrate medicine, often used to treat angina (chest pain). Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If cialis help with premature ejaculation you need to use a nitrate medicine, take it at least 48 hours after your last dose of tadalafil. Do not drink excessive amounts of alcohol (eg, 5 or more glasses of wine or 5 or more shots of whiskey) when taking tadalafil.

Dosage for benign prostatic hyperplasia (BPH)

When taken in excess, alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure. If you experience sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.