Commonly used brand name(s)
In the U.S
Available Dosage Forms:
Therapeutic Class: Erectile Dysfunction Agent
Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor
Uses For 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 in 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 healthcare 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.
Pediatric: Tadalafil is not for use in children.
Geriatric: This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.
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 with this medication or change some of the other medicines you take.
Tetranitrate , isosorbide Dinitrate, lsosorbide Mononitrate , Nitroglycerin, Pentaerythritol Tetranitrate
Interactions with Food/Tobacco/Alcohol: 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all- inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of 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:
• 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
• Hypotension (low blood pressure) or
• Hypetension (high blood pressure) or
• Stroke (recent history of) or
• Heart attack (within the last 3 months) or.
• Heart failure (within the last 6 months) or
• Retinal disorders (rare hereditary eye problem) Tadalafil has not been studied in patients with these medical conditions and should not be used.
• 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.
• 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
• 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.
• 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.
• NAION (serious eye condition) in one or both eyes, previously- May increase your chance of getting NAION again
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.
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:
• Adults 1 0 mg as a single dose no more than once a day, taken before you think sexual activity may occur. The ability to have sexual activity may be improved up to 36 hours after taking tadalafil when compared to placebo (sugar pill). If needed, your doctor may change your dose.
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
Tadalifil has not been studied with other medicines used for treatment of 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,
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:
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; nausea; nervousness; pain or discomfort in arms, jaw, back or neck; pounding in the ears; shortness of breath; slow or fast heartbeat; sweating; unusual tiredness or weakness; vomiting
Painful or prolonged erection of the penis
Incidence not known
Abdominal or stomach pain; blistering, peeling, loosening of skin; cracks i n the skin; decrease or change in vision; difficulty in speaking; double vision; hives or welts; inability to move arms, legs, or facial muscles; inability to speak; loss of heat from the body; numbness or, tingling of face, hands or feet; red irritated eyes; red skin lesions, often with a purple center; red, swollen skin; redness or soreness of eyes; redness of skin, scaly skin; slow speech; sore throat; sores in mouth; swelling of 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 healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them
Acid or sour stomach; belching; heartburn; indigestion; stomach discomfort, upset, or pain
Bloody nose; burning, crawling, itching, numbness, prickling, "pins and needles', or tingling feelings; burning feeling in chest or stomach; burning, dry or itching eyes, body aches or pain; congestion; cough; diarrhea; difficulty in moving; difficulty swallowing; dry mouth; dryness or soreness of throat; eye pain; excessive eye discharge; fever; feeling of constant movement of self or surroundings; feeling of warmth redness of the face, neck, arms and occasionally, upper chest; hoarseness; increased erection; itching skin; joint pain; lack or loss of strength; loose stools, muscle aching or cramping; muscle pains or stiffness; nasal congestion; neck pain; pain; pain in arms and/or legs; pain or burning in throat; rash; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; reduced sensitivity to touch; runny nose; sensation of spinning; sleepiness or unusual drowsiness; sleeplessness; sores, ulcers, or white spots on lips or tongue or inside the mouth; spontaneous penile erection; stomach upset; swelling of eyelids; swelling or puffiness of eye or face; swollen joints; tearing; tender, swollen glande in neck; tenderness in stomach area: trouble sleeping; unable to sleep; upper abdominal pain, voice changes; watering of eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, cheek with your healthcare professional.