Consumer Information for: APO-TADALAFIL

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-TADALAFIL is used for treatment of

  • erectile dysfunction (ED) in men (when a man cannot get, or keep a hard, erect penis suitable for sexual activity).

  • the signs and symptoms of benign prostatic hyperplasia (BPH). These symptoms include a frequent need to urinate, a sensation of not emptying the bladder completely, or painful urination.

  • both ED and the signs and symptoms of BPH.
What it does

APO-TADALAFIL belongs to a group of medicines called phosphodiesterase type 5 inhibitors.

Treatment of ED: Following sexual stimulation APO-TADALAFIL works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. This results in improved erectile function.

It is important to note that APO-TADALAFIL works only with sexual stimulation. APOTADALAFIL alone does not increase sexual desire.

Treatment of BPH and ED/BPH: APOTADALAFIL works by relaxing muscles in the prostate and bladder, which may reduce BPH symptoms.

When it should not be used
  • If you are taking any medicines that contain nitrates in any form (oral, sublingual [under the tongue], skin-patch, or by inhalation). Similarly, nitrates must never be used by men who take APO-TADALAFIL. Nitrates are found in many prescription medicines used in the treatment of angina pectoris (chest pain due to heart disease), such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate. If nitrates have previously been prescribed to you, even though you may not have used them, or are unsure, tell your doctor.

    If you take APO-TADALAFIL with any nitrate-containing medicines or any other nitrates (e.g., amyl nitrite “poppers”), your blood pressure could suddenly drop to a life-threatening level. You could get dizzy, faint, or even have a heart attack or stroke.

  • Do not take APO-TADALAFIL if you have had an allergic reaction in the past to tadalafil or any of the other ingredients in APOTADALAFIL listed below.

  • If you have had a previous episode of an eye condition called NAION which causes a sudden decrease or loss of vision in one or both eyes.

  • If you are taking riociguat (ADEMPAS®).
What the medicinal ingredient is

Tadalafil

What the non-medicinal ingredients are

The other ingredients are:
croscarmellose sodium, ferric oxide red (2.5 mg strength only), ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide.

What dosage form it comes in

APO-TADALAFIL is supplied as almond shaped film-coated tablets:

2.5 mg (for Once-a-Day use): Light Yellow, almond shaped, biconvex, film-coated tablets. Engraved “APO” on one side, “T2.5” on the other side.

5 mg (for Once-a-Day use): Yellow, almond shaped, biconvex, film-coated tablets. Engraved “APO” on one side, “T5” on the other side.

10 mg (for On-Demand dosing): Yellow, almond shaped, biconvex, film-coated tablets. Engraved “APO” on one side, “T10” on the other side.

20 mg (for On-Demand dosing): Yellow, almond shaped, biconvex, film-coated tablets. Engraved “APO” on one side, “T20” on the other side.

Warnings and precautions

Before taking APO-TADALAFIL talk to your doctor if you:

have or had any of the following conditions:

  • Heart disease or previously had a heart attack: Sexual activity carries a possible risk to patients with heart disease because it puts extra strain on your heart. Before you start any treatment for erectile dysfunction, ask your doctor if your heart is healthy enough to handle the extra strain of having sex. If you have chest pains, dizziness or nausea during sex, stop exerting yourself and tell your doctor you have had this problem.
  • Stroke.
  • Low blood pressure or uncontrolled high blood pressure.
  • Liver or kidney problem.
  • Sickle cell anemia (an abnormality of red blood cells), multiple myeloma (cancer of the bone marrow), or leukemia (cancer of the blood cells).
  • Peptic ulcer or other bleeding disorders.
  • Deformation of the penis.
  • Ever had severe loss of vision, including a condition called Non-Arteritic Ischemic Optic Neuropathy (NAION). The specific type of vision decrease or loss known as NAION has been reported rarely after the intake of APO-TADALAFIL or other PDE5 inhibitors. Vision decrease or loss may be partial or complete, in one or very occasionally in both eyes. While in some cases the condition may improve over time, it can also be irreversible. If you are taking APO-TADALAFIL and experience temporary or permanent loss or change in vision, stop taking APO-TADALAFIL and call your doctor.
  • Hearing problems: Sudden decrease or loss of hearing has been reported with the use of PDE5 inhibitors, including APO-TADALAFIL, although it is not known if it is due to drug or other factors.
  • Lactose or milk sugar intolerance. APO-TADALAFIL contains a small amount of lactose.
  • APO-TADALAFIL is not recommended to be used in combination with alpha blockers if you have symptoms of BPH.
  • APO-TADALAFIL does not protect against sexually transmitted diseases including HIV/ AIDS.
  • Long-term studies have shown that APO-TADALAFIL therapy may decrease sperm concentration in some men. The effect on fertility in men is unknown.
  • APO-TADALAFIL is not intended for use by women or by children under 18 years of age.

When APO-TADALAFIL is used for the treatment of erectile dysfunction, diarrhea was reported more frequently in patients 65 years of age and older (2.5% of patients).

Only your doctor can decide if APO-TADALAFIL is right for you. If you have ED, you will need to have a physical examination to diagnose your erectile dysfunction and to find out if you can take APO-TADALAFIL alone or with your other medicines. If you have urinary problems, you will need to have a physical examination to diagnose your BPH and not a more serious condition such as prostate cancer.

Interactions with this medication

Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including medicines you can buy without prescription and natural health products.

Drugs that may interact with APO-TADALAFIL PAH include:

  • nitrates (see previous section)

  • rifampin (an antibacterial product used against tuberculosis)

  • ketoconazole or itraconazole (used against fungal infections)

  • erythromycin (an antibacterial product)

  • protease inhibitors such as ritonavir and saquinavir (HIV treatments)

You should not use APO-TADALAFIL together with any other treatments for erectile dysfunction or PDE5 inhibitors for treatment of pulmonary arterial hypertension (PAH), such as ADCIRCA® (tadalafil) or REVATIO® (sildenafil).

Tell your doctor if you are taking:

  • medicines to treat high blood pressure

  • alpha-blockers (such as doxazosin) for the treatment of prostate problems.

The combination of these medicines with APO-TADALAFIL may add to the blood-pressure-lowering effect of these drugs.

Proper use of this medication

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

How To Take APO-TADALAFIL PAH:

Always take APO-TADALAFIL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not take a higher dose than the one which your doctor prescribed for you.

APO-TADALAFIL tablets are for oral use. Swallow the tablet whole, with some water.

You may take APO-TADALAFIL with or without food.

Alcohol consumption may decrease the ability to attain an erection and may also temporarily decrease blood pressure.

There are two different ways of taking APO-TADALAFIL tablets to treat ED: a 20 mg On-Demand dose taken as needed, or a lower 5 mg daily dose. It may take up to up 5 days for APO-TADALAFIL Once-a-Day to reach steady blood levels.

For patients with ED:

  • Try sex at different times to find out what works best for you and your partner.

  • APO-TADALAFIL works only if you are sexually stimulated.

  • If you don't get the results you expect - talk to your doctor or pharmacist.

APO-TADALAFIL for “On-Demand” Dosing: The recommended dose is one tablet (20 mg) before sexual activity, as needed. You should NOT take more than the prescribed dose of one APO-TADALAFIL 10 mg or 20 mg tablet per day. The 10 mg and 20 mg doses are not recommended for continuous daily use.

You can engage in sexual activity within 30 minutes of taking the tablet and up to 36 hours later. The amount of time APO-TADALAFIL takes to work varies from person to person.

APO-TADALAFIL for Once-a-Day Use:

Treatment of ED: Your doctor may recommend that you take one tablet of APO-TADALAFIL (5 mg or 2.5 mg) Once-a-Day every day, at approximately the same time each day, regardless of when you are planning to have sex.

Treatment of BPH and ED/BPH: Your doctor may recommend that you take one tablet of APO-TADALAFIL 5 mg Once-a-Day every day, at approximately the same time each day.

Overdose

If you think you have taken too much APO-TADALAFIL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them

Like all medicines, APO-TADALAFIL PAH can have some side-effects. These effects are usually mild to moderate in nature.

The most common side effects are headache, indigestion, back pain, muscle aches, nasal congestion, facial flushing, dizziness and high blood pressure.

Uncommon side-effects: swelling of the eyelids, eye pain, conjunctival hyperemia (red eyes) and allergic reactions (including skin rashes).

Rarely, a prolonged and possibly painful erection may occur after taking APO-TADALAFIL. If you have such an erection which lasts continuously for more than 4 hours, you should contact a doctor immediately. If this is not treated immediately, permanent penile tissue damage and erectile dysfunction may result.

Sudden decrease or loss of vision has occurred rarely after the use of oral erectile dysfunction medications, including APO-TADALAFIL. It has not been established whether the loss of vision is related directly to the use of PDE5 inhibitors or other factors. People who have previously experienced a type of vision loss called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) may be at an increased risk of reoccurrence of NAION. If you experience reduction or loss of vision in one or both eyes, stop taking APO-TADALAFIL and call your doctor.

If you take APO-TADALAFIL and have chest pain during or after sexual activity, DO NOT use nitrates, and seek immediate medical assistance.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Common
headache ✔    
indigestion ✔    
back pain ✔    
muscle aches ✔    
nasal congestion ✔    
facial flushing ✔    
Uncommon
Swelling of eyelids ✔    
eye pain ✔    
red eyes ✔    
dizziness ✔    
allergic reaction   ✔  
Rare
prolonged erection     ✔
chest pain     ✔
vision loss     ✔
hearing loss     ✔
transient amnesia     ✔

This is not a complete list of side effects. For any unexpected effects while taking APO-TADALAFIL, contact your doctor or pharmacist.

How to store

STORING APO-TADALAFIL TABLETS

Keep out of the reach and sight of children.

Store your tablets at room temperature 15°C -30°C.

Store in the original package.

Do not use after the expiry date stated on the carton and blister.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 1908C
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet, plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex’s Drug Information Service at:

1-800-667-4708

This leaflet can also be found at: http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto Ontario, M9L 1T9.

Last revised: March 20, 2017

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