Tadalafil Safety Information

Brand Names in Canada

1. Cialis
2. Adcirca

Descriptions

Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

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 to produce an erection. By controlling the enzyme, tadalafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, tadalafil will not work to cause an erection.

Tadalafil is also used to treat men who have signs and symptoms of benign prostatic hyperplasia (BPH). BPH is caused by an enlarged prostate. Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Tadalafil will make these symptoms less severe and reduce the chance that prostate surgery will be needed. This medicine is also used to treat erectile dysfunction and signs and symptoms of BPH.

Tadalafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension to improve your ability to exercise. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadalafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

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

This product is available in the following dosage forms:

• Tablet

Before Using

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 clinician will make. For this medicine, the following should be considered:

Allergies

Tell your clinician 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.

Pediatric

Use of Cialis® tablet is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Adcirca® and Alyq™ tablet in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

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.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your clinician may decide not to treat you with this medication or change some of the other medicines you take.

• Amyl Nitrite
• Boceprevir
• Erythrityl Tetranitrate
• Isosorbide Dinitrate
• Isosorbide Mononitrate
• Nitroglycerin
• Pentaerythritol Tetranitrate
• Propatyl Nitrate
• Riociguat
• Telaprevir

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Alfuzosin
• Atazanavir
• Bunazosin
• Clarithromycin
• Cobicistat
• Darunavir
• Erythromycin
• Fosamprenavir
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Moxisylyte
• Nefazodone
• Phenoxybenzamine
• Phentolamine
• Prazosin
• Ritonavir
• Saquinavir
• Simeprevir
• Simvastatin
• Tamsulosin
• Telithromycin
• Terazosin
• Tipranavir
• Trimazosin
• Urapidil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Doxazosin
• Rifampin
• Silodosin

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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 clinician may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Abnormal penis, including curved penis and birth defects of the penis (eg, angulation, cavernosal fibrosis, or Peyronie's disease) or

• Leukemia (blood related cancer) or

• Multiple myeloma (blood related cancer) or

• Sickle-cell anemia (blood disorder)—Use with caution. May increase risk of unwanted side effects (eg, prolonged erection of the penis).

• Age greater than 50 years or

• Coronary artery disease or

• Diabetes or

• Hyperlipidemia (high lipids or fats in the blood) or

• Hypertension (high blood pressure) or

• Low cup to disc ratio (eye condition also called "crowded disc") or

• Smoking—Use with caution. May increase risk for non–arteritic anterior ischemic optic neuropathy (NAION).

• Angina (severe chest pain) or

• Arrhythmia (irregular heartbeat), uncontrolled or

• Heart attack (within the last 3 months) or

• Heart failure (within the last 6 months) or

• Hypertension (high blood pressure), uncontrolled or

• Hypotension (low blood pressure) or

• Retinal disorders (eye problem) or

• Retinitis pigmentosa (an inherited eye disorder) or

• Stroke, recent history of—Should not be used in patients with these conditions.

• Bleeding disorders or

• Stomach ulcers—Use must be determined by your clinician. May increase your risk of bleeding.

• Heart or blood vessel disease or

• Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—Use with caution. May make this condition worse.

• Kidney disease, mild or moderate or

• Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Non–arteritic anterior ischemic optic neuropathy (NAION, serious eye condition) in one or both eyes, history of—Use with caution. May increase your risk of getting NAION again.

Proper Use

Use tadalafil exactly as directed by your clinician. Do not use more of it, do not use it more often, and do not use it for a longer time than your clinician ordered. Also, do not stop taking this medicine without checking first with your clinician.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your clinician if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole. Do not split, break, chew, or crush it.

When using this medicine for erectile dysfunction, the ability to have sexual activity may be improved for up to 36 hours after taking the tablet.

Use only the brand of this medicine that your clinician prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your clinician'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 clinician 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 benign prostatic hyperplasia (daily use):
    • Adults—5 milligrams (mg) as a single dose, no more than once a day, taken at the same time each day.
    • 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 clinician may adjust your dose as needed.
    • Children—Use is not recommended.
  • 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 clinician 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 the same time each day, without regard for the timing of sexual activity.
    • Children—Use is not recommended.
  • For treatment of pulmonary arterial hypertension:
    • Adults—40 milligrams (mg) (two 20 mg tablets) taken once a day. Take both tablets at the same time each day. Do not divide the 40 mg dose. Your clinician may adjust your dose as needed.
    • Children—Use and dose must be determined by your clinician.

Missed Dose

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. Do not double doses.

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

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

If you will be taking this medicine for pulmonary arterial hypertension, it is very important that your clinician check your progress at regular visits. This will allow your clinician 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, such as sildenafil (Revatio® or Viagra®) or vardenafil (Levitra®). Cialis® also contains tadalafil. If you take too much tadalafil or take it together with these medicines, the chance for side effects will be higher.

If you experience a prolonged erection for more than 4 hours or a painful erection for more than 6 hours, contact your clinician 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 clinician if you have any questions about this.

It is important to tell your clinician about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.

Do not use this medicine if you are also using riociguat or a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates. If 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. 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 clinician immediately.

Check with your clinician 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 eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Do not take other medicines unless they have been discussed with your clinician. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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 clinician immediately if any of the following side effects occur:

Less common

• Arm, back, or jaw pain
• blurred vision
• chest pain, discomfort, tightness, or heaviness
• chills
• cold sweats
• confusion
• dizziness
• fainting
• faintness or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• headache
• hearing loss
• increased erection
• nausea
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• slow or fast heartbeat
• spontaneous penile erection
• sweating
• unusual tiredness or weakness
• vomiting

Rare

• Painful or prolonged erection of the penis

Incidence not known

• 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, itching, skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• joint or muscle pain
• loss of heat from the body
• numbness or tingling of the face, hands, or feet
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• redness of the skin
• redness or soreness of the eyes
• scaly skin
• slow speech
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• 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

• 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
• lack or loss of strength
• loose stools
• muscle aching, cramping, or stiffness
• neck pain
• pain in the arms 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 or stuffy nose
• sensation of spinning
• sleepiness or unusual drowsiness
• 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 with sleeping
• upper stomach 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.

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

Original article: https://www.mayoclinic.org/drugs-supplements/tadalafil-oral-route/description/drg-20067204?p=1