Details for: TADALAFIL
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02455358 | TADALAFIL | TADALAFIL | 5 MG | TABLET | ORAL |
| 02455366 | TADALAFIL | TADALAFIL | 10 MG | TABLET | ORAL |
| 02455374 | TADALAFIL | TADALAFIL | 20 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
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
TADALAFIL belongs to a group of medicines
called phosphodiesterase type 5 inhibitors.
Treatment of ED: Following sexual stimulation
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 TADALAFIL works only
with sexual stimulation. TADALAFIL alone does
not increase sexual desire.
Treatment of BPH and ED/BPH: TADALAFIL
works by relaxing muscles in the prostate and
bladder, which may reduce BPH symptoms.
When it should not be used
Do not take TADALAFIL:
- 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 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 TADALAFIL with any nitratecontaining medicines or any other nitrates (e.g., amyl nitrite “poppers”), your blood pressure could suddenly drop to a lifethreatening level. You could get dizzy, faint, or even have a heart attack or stroke. - Do not take TADALAFIL if you have had an allergic reaction in the past to tadalafil or any of the other ingredients in TADALAFIL 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.
What the medicinal ingredient is
Tadalafil
What the non-medicinal ingredients are
The other ingredients are:
croscarmellose sodium, 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
TADALAFIL is supplied as almond shaped filmcoated
tablets:
5 mg (for Once-a-Day use): Yellow, almond
shaped, biconvex, film-coated tablets. Engraved
“T5” on one side, plain on the other side.
10 mg (for On-Demand dosing): Yellow, almond
shaped, biconvex, film-coated tablets. Engraved
“T10” on one side, plain on the other side.
20 mg (for On-Demand dosing): Yellow, almond
shaped, biconvex, film-coated tablets. Engraved
“T20” on one side, plain on the other side.
Warnings and precautions
Before taking 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 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 TADALAFIL and experience temporary or permanent loss or change in vision, stop taking TADALAFIL and immediately call your doctor.
- Hearing problems: Sudden decrease or loss of hearing has been reported with the use of PDE5 inhibitors, including TADALAFIL, although it is not known if it is due to drug or other factors.
- Lactose or milk sugar intolerance. TADALAFIL contains a small amount of lactose.
- TADALAFIL is not recommended to be used in combination with alpha blockers if you have symptoms of BPH.
- TADALAFIL does not protect against sexually transmitted diseases including HIV/ AIDS.
- Long-term studies have shown that TADALAFIL therapy may decrease sperm concentration in some men. The effect on fertility in men is unknown.
- TADALAFIL is not intended for use by women or by children under 18 years of age.
When 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 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 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
the medicine you can buy without prescription and
natural health products.
Drugs that may interact with TADALAFIL 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 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 TADALAFIL may add to the blood-pressurelowering 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 TADALAFIL
Always take 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.
TADALAFIL tablets are for oral use. Swallow
the tablet whole, with some water.
You may take 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
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
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.
- TADALAFIL works only if you are sexually stimulated.
- If you don't get the results you expect - talk to your doctor or pharmacist.
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
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 TADALAFIL takes to
work varies from person to person.
TADALAFIL for Once-a-Day Use:
Treatment of ED: Your doctor may recommend
that you take one tablet of TADALAFIL (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
TADALAFIL 5 mg Once-a-Day every day, at
approximately the same time each day.
Overdose
Side effects and what to do about them
Like all medicines, TADALAFIL 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 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 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 TADALAFIL and call your doctor.
If you take 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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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 TADALAFIL, contact your doctor or pharmacist.
How to store
STORING 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 Pro Doc Ltée at 1-800-361-8559,
www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée, Laval, Québec, H7L 3W9
Last revised: December 22, 2017