Pronunciation:

tah-DA-la-fil

Brand Names:

• Cialis

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Erectile Dysfunction Agent

Pharmacologic—

Phosphodiesterase Type 5 Inhibitor

Uses of This Medicine:

Tadalafil is a medicine used to treat erectile dysfunction in men. Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis. This results in an erection. Tadalafil helps increase blood flow to the penis and may help men with erectile dysfunction 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 .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

No information is available on the relationship of age to the effects of tadalafil in the pediatric population. Safety and efficacy have not been established .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving tadalafil .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Erythrityl Tetranitrate
• Isosorbide Dinitrate
• Isosorbide Mononitrate
• Nitroglycerin
• Pentaerythritol Tetranitrate

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and this medicine should be used with caution in these patients .

• Age greater than 50 years or
• Coronary artery disease or
• Diabetes or
• Hyperlipidemia (excess of lipids in the blood) or
• Hypertension (high blood pressure) or
• Low cup to disc ratio ("crowded disc") or
• Smoking—These conditions may increase risk for a serious eye problem called NAION .

• Angina (reoccurring chest pain) or
• Arrhythmia (irregular heartbeat) or
• Heart attack (within the last 3 months) or
• Heart failure (within the last 6 months) or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Retinal disorders (rare hereditary eye problem) or
• Stroke (recent history of)—Tadalafil has not been studied in patients with these medical conditions and should not be used .

• Bleeding disorders or
• Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients .

• Heart disease, underlying—Chance of low blood pressure occurring is greater; tadalafil should be used carefully in these patients .

• Heart blood flow problems—These conditions may cause you to be more sensitive to tadalafil .

• Kidney disease (severe)—Tadalafil should be used with caution in these patients and a lower dose may be needed .

• Liver disease—Tadalafil should not be used in patients with serious liver disease; in patients with less serious liver disease, tadalafil should be used with caution and a lower dose may be needed .

• NAION (serious eye condition) in one or both eyes, previously—May increase your chance of getting NAION again .

• Sickle-cell anemia (blood disorder) or
• Bone marrow cancer or
• Leukemia (blood related cancer)—Tadalafil should be used with caution in these patients as problems with prolonged erection of the penis may occur .

Proper Use of This Medicine:

Special patient directions come with tadalafil. Read the directions carefully before you start using tadalafil and each time you get a refill of your medicine .

Use tadalafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased .

You may take this medicine with or without food .

The ability to have sexual activity may be improved for up to 36 hours after taking tadalafil .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • 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 change your dose if 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. Your doctor may increase your dose if needed .

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using This Medicine:

Tadalafil has not been studied with other medicines that are used for erectile dysfunction. Using them together is not recommended .

It is important that you tell all of your healthcare providers that you take tadalafil. If you need emergency medical care for a heart problem, it is important that your healthcare provider knows when you last took tadalafil .

If you experience a prolonged or painful erection for 4 hours or more, 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. 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 may have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems .

Do not drink alcohol to excess (for example, 5 glasses of wine or 5 shots of whiskey) when taking tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure .

If you experience sudden loss of vision in one or both eyes, stop using tadalafil and contact your doctor immediately .

Also, stop using this medicine and check with your doctor right away if you have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

Side Effects of This Medicine:

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:

Less common

Arm, back, or jaw pain

blurred vision

chest pain or discomfort

chest tightness or heaviness

chills

cold sweats

confusion

dizziness

fainting

faintness or lightheadedness when getting up from a lying or sitting position suddenly

fast or irregular heartbeat

headache

hearing loss

nausea

nervousness

pain or discomfort in the arms, jaw, back, or neck

pounding in the ears

shortness of breath

slow or fast heartbeat

sweating

unusual tiredness or weakness

vomiting

Rare

Painful or prolonged erection of the penis

Incidence not known

Abdominal or stomach pain

blindness

blistering, peeling, or loosening of the skin

cough

cracks in the skin

decrease or change in vision

diarrhea

difficulty with speaking

double vision

fast, irregular, pounding, or racing heartbeat or pulse

headache, severe and throbbing

hives or welts

inability to move arms, legs, or facial muscles

inability to speak

itching

joint or muscle pain

loss of heat from the body

numbness or tingling of the face, hands, or feet

red irritated eyes

red skin lesions, often with a purple center

red, swollen skin

redness of the skin

redness or soreness of the eyes

scaly skin

skin rash

slow speech

sores, ulcers, or white spots in the mouth or on the lips

sudden cardiac death

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. 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:

More common

Acid or sour stomach

belching

heartburn

indigestion

stomach discomfort, upset, or pain

Less common

Bloody nose

body aches or pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

burning feeling in the chest or stomach

congestion

difficulty with moving

difficulty with swallowing

dry mouth

dryness or soreness of the throat

excessive eye discharge

eye pain

feeling of constant movement of self or surroundings

feeling of warmth, redness of the face, neck, arms and occasionally, upper chest

fever

hoarseness

increased erection

lack or loss of strength

loose stools

muscle aching or cramping

muscle stiffness

nasal congestion

neck pain

pain

pain in the arms and/or legs

pain or burning in the throat

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

reduced sensitivity to touch

runny nose

sensation of spinning

sleepiness or unusual drowsiness

sleeplessness

spontaneous penile erection

stomach upset

swelling of the eyelids

swelling or puffiness of the eyes or face

swollen joints

tearing

tender, swollen glands in the neck

tenderness in the stomach area

trouble sleeping

unable to sleep

upper abdominal pain

voice changes

watering of the eyes

Rare

Changes in color vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.