Details for: TADALAFIL
Company: SANIS HEALTH INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02457016 | TADALAFIL | TADALAFIL | 5 MG | TABLET | ORAL |
02457024 | TADALAFIL | TADALAFIL | 10 MG | TABLET | ORAL |
02457032 | 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], skinpatch, 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 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 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.
- If you are taking riociguat (ADEMPAS®)
What the medicinal ingredient is
Tadalafil
What the non-medicinal ingredients are
Acetone (trace amount), croscarmellose sodium, dimethyl sulphoxide (trace amount), hypromellose, iron oxide yellow, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, silica colloidal anhydrous, sodium laurilsulfate, titanium dioxide, and triacetin. TADALAFIL 5 mg also contains talc, TADALAFIL 10 mg and 20 mg contain iron oxide black.
What dosage form it comes in
TADALAFIL comes as yellow or yellow-orange film-coated tablets. They are almond shaped, biconvex and have an “M” on one side and “TL6”(5mg tablets), “TL7”(10mg tablets), or “TL8”(20mg tablets) on the other side. The active substance is tadalafil. Each tablet of TADALAFIL contains 5 mg, 10 mg or 20 mg of tadalafil.
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-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 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
In case of drug overdose, contact a health care practitioner, 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, 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. People who have previously experienced a type of
vision loss called Non-Arteritic Anterior Ischemic Optic
Neuropathy (NAION) are 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 immediately
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 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 TADALAFIL, please contact your doctor or pharmacist.
How to store
Store TADALAFIL between 15°C and 30°C.
Reporting side effects
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for
Canadians by reporting serious and unexpected side effects to
Health Canada. Your report may help to identify new side effects
and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
-
Mail to: Canada Vigilance Program Health Canada, Postal Locator 1908C Ottawa, ON K1A 0K9
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
The full Product Monograph prepared for health professionals can
be obtained by contacting the sponsor, Sanis Health Inc., at: 1-
866-236-4076.
This leaflet was prepared by Sanis Health Inc., 1 President's
Choice Circle, Brampton, Ontario, L6Y 5S5.
Revised on: April 10, 2017