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Cialis

GENERIC NAME(S): TADALAFIL

Uses

Tadalafil is used to treat male sexual function problems (impotence or erectile dysfunction -ED). 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 frequently or urgently (including during the middle of the night). Tadalafil is thought to work by relaxing the smooth muscle in the prostate and bladder .

OTHER USES: 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.

How to use Cialis

Read the Patient Information Leaflet provided by your pharmacist before you start taking tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth. with or without food, as directed by your doctor. Do not take tadalafil more often than once daily.

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. If you are also taking finasteride with this medication to treat symptoms of BPH, talk with your doctor about how long you should continue taking this medication.

To treat erectile dysfunction -ED, there are 2 ways that tadalafil may be prescribed. Your doctor will determine which is the best way for you to take tadalafil. Follow your doctor's directions exactly since your dosage depends on how you are taking it. The first way is to take it as needed, usually at least 30 minutes before sexual activity. Tadalafil's effect on sexual ability may last up to 36 hours.

The second way to treat ED is to take tadalafil regularly, once a day every day. If you take it this way, you may attempt sexual activity at any time between your doses.

If you are taking tadalafil to treat both ED and BPH, take it as directed by your doctor, usually once a day. You may attempt sexual activity at any time between your doses.

If you are taking tadalafil once daily for BPH, or for ED, or for both, take it regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Headache. stomach upset, back pain. muscle pain. stuffy nose, flushing, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Sexual activity may put extra strain on your heart. especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex. stop and get medical help right away: severe dizziness, fainting. chest/jaw/left arm pain, nausea .

Rarely, sudden decreased vision. including permanent blindness, in one or both eyes (NAION) may occur. If this serious problem occurs, stop taking tadalafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease. diabetes. high cholesterol. certain other eye problems ("crowded disk"), high blood pressure. if you are over 50, or if you smoke.

Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking tadalafil and get medical help right away if these effects occur.

In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction. including: rash, itching /swelling (especially of the face/tongue /throat), severe dizziness, trouble breathing .

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking tadalafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months, kidney disease, liver disease, high or low blood pressure, a severe loss of body water (dehydration), penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This brand of the drug is not usually used in women. During pregnancy, tadalafil should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: riociguat.

Tadalafil can cause a serious drop in your blood pressure when used with nitrates, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use tadalafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide), recreational drugs called "poppers" containing amyl or butyl nitrite.

If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may start treatment with a lower dose of tadalafil or adjust your alpha blocker medication to minimize your risk of low blood pressure.

Other medications can affect the removal of tadalafil from your body, which may affect how tadalafil works. Examples include azole antifungals (such as itraconazole, ketoconazole), macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as fosamprenavir, ritonavir), hepatitis C virus protease inhibitors (such as boceprevir, telaprevir), rifampin, among others.

Do not take this medication with any other product that contains tadalafil or other similar medications used to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil).

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you are taking this medication on a regular schedule and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

Images

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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See additional information.

Cialis

Cialis (tadalafil) relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body.

Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension. Do not take Cialis while also taking Adcirca, unless your doctor tells you to.

Important information

Some medicines can cause unwanted or dangerous effects when used with Cialis. Tell your doctor about all your current medicines, especially riociguat (Adempas).

Do not take Cialis if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking Cialis with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Stop using Cialis and get emergency medical help if you have sudden vision loss.

Before taking this medicine

You should not take Cialis if you are allergic to tadalafil, or:

if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).

Do not take Cialis if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Cialis with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure Cialis is safe for you, tell your doctor if you have any of these other conditions:

heart disease or heart rhythm problems, coronary artery disease;

a recent heart attack (within the past 90 days);

a recent history (in the past 6 months) of a stroke, or congestive heart failure;

angina (chest pain), high or low blood pressure;

liver or kidney disease (or if you are on dialysis);

a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

a bleeding disorder such as hemophilia;

a stomach ulcer;

retinitis pigmentosa (an inherited condition of the eye);

a physical deformity of the penis (such as Peyronie's disease); or

if you have been told you should not have sexual intercourse for health reasons.

Cialis can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Viagra or other drugs similar to tadalafil. Most of these people also had certain pre-existing eye problems or risk factors for blood vessel disorders (such as heart disease, diabetes, high blood pressure, high cholesterol, coronary artery disease, smoking, or being over 50 years old). It is not clear whether Cialis is the actual cause of vision loss.

tadalafil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether tadalafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Cialis?

Cialis is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Cialis can be taken with or without food.

Do not break or split a tablet. Swallow it whole.

For erectile dysfunction, take this medicine just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of Cialis.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

Cialis dosing information

Usual Adult Dose for Erectile Dysfunction:

Use as needed for ED:
-Initial dose: 10 mg orally once a day, as needed, prior to sexual activity
-Maintenance dose: 5 to 20 mg orally once a day, as needed, prior to sexual activity based on individual efficacy and tolerability

Comment: Consider that this drug has shown to improve erectile dysfunction up to 36 hours following dosing, when used as needed.

Once a day use for ED:
-Initial dose: 2.5 mg orally once a day at approximately the same time, without regard to timing of sexual activity
-Maintenance dose: 2.5 to 5 mg orally once a day based on individual efficacy and tolerability.

Once daily use for ED and Benign Prostatic Hyperplasia (BPH):
-5 mg orally once a day at approximately the same time, without regard to timing of sexual activity

Use: Treatment of erectile dysfunction (ED)

Usual Adult Dose for Benign Prostatic Hyperplasia:

Once daily use for BPH:
-5 mg orally once a day at approximately the same time

Concomitant administration with finasteride:
-5 mg orally once a day at approximately the same time, for up to 26 weeks

Comments: The incremental benefit of this drug decreases from 4 weeks until 26 weeks. The incremental benefit of this drug beyond 26 weeks is unknown.

Once daily use for ED and BPH:
-5 mg orally once a day at approximately the same time, without regard to timing of sexual activity

Use: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)

What happens if I miss a dose?

If Cialis is used as needed, you are not likely to be on a dosing schedule.

If you take Cialis every day and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Cialis?

Drinking alcohol with this medicine can cause side effects.

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.

Cialis side effects

Get emergency medical help if you have any signs of an allergic reaction to Cialis: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Cialis and get emergency medical help if you have:

erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis);

vision changes or sudden vision loss; or

heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Also call your doctor right away if you have:

ringing in your ears, or sudden hearing loss;

swelling in your hands, ankles, or feet;

shortness of breath;

Pedro Munoz Sanchez
2008 IALHA Board of Directors Region 2 (OR, WA, ID & AK)
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