Details for: LEVITRA
Company: BAYER INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02250470 | LEVITRA | VARDENAFIL (VARDENAFIL HYDROCHLORIDE) | 10 MG | TABLET | ORAL |
| 02250489 | LEVITRA | VARDENAFIL (VARDENAFIL HYDROCHLORIDE) | 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
LEVITRA is used in the treatment of erectile dysfunction. This is when a man cannot get or keep a hard, erect penis suitable for sexual activity.
What it does
LEVITRA belongs to a class of agents known as
phosphodiesterase type 5 (PDE5) inhibitors. Following sexual
stimulation, LEVITRA works by helping the blood vessels in
your penis relax, allowing blood to flow into your penis. This
results in improved erectile function.
LEVITRA will not increase your sex drive. LEVITRA will
only help you get an erection if you are sexually stimulated.
When it should not be used
What the medicinal ingredient is
Vardenafil (as vardenafil hydrochloride)
What the non-medicinal ingredients are
The tablets contain the following non-medicinal ingredients: microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.
What dosage form it comes in
LEVITRA is available as orange, round tablets marked with the BAYER cross on one side, and "5", "10" or "20" on the other. LEVITRA is available in 3 dosage strengths: 5 mg, 10 mg, and 20 mg, containing 5 mg, 10 mg, or 20 mg of the active ingredient vardenafil.
Warnings and precautions
BEFORE you use LEVITRA talk to your doctor or pharmacist if you have or had any of the following conditions:
Sudden decrease or loss of hearing has been reported in a few post-marketing and clinical trial cases with the use of PDE5 inhibitors, including LEVITRA. It has not been established whether these are related directly to the use of these medications or to other factors. If you experience these symptoms, stop taking LEVITRA and call your doctor.
Interactions with this medication
Drugs that may interact with LEVITRA include:
Levitra might increase the amount of some medicines in your blood (sensitive P-gp substrates). Dabigatran (used to prevent blood clots from forming) is an example of these medicines.
Do not consume grapefruit juice while taking LEVITRA.
LEVITRA should not be used together with other treatments of erectile dysfunction.
Proper use of this medication
Usual dose:
Overdose:
If you have taken more LEVITRA than you should, contact your doctor or a Poison Control Centre immediately
Side effects and what to do about them
As with most drugs, LEVITRA can cause some side-effects.
These effects are usually mild to moderate in nature and do not
last for a long time.
The most common side-effects are headache and flushing (a
burning/warm sensation, usually in the face). Less commonly
reported side-effects are indigestion, stuffy nose, sudden
decrease or loss of hearing, and transient global amnesia
(temporary memory loss). A small percentage of patients could
experience abnormal vision (eg, decreased and blurred vision,
increased perception to light, changes in blue/green colour
discrimination) after taking LEVITRA. If this happens to you,
do not operate a motor vehicle or any heavy machinery until the
adverse effects disappear. If you have any of these adverse
effects and they are severe or do not disappear, talk to your
doctor or pharmacist.
Sudden decrease or loss of vision has occurred rarely after the use of oral erectile dysfunction medications, including LEVITRA. 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 LEVITRA and call your doctor.
| 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 |
|---|---|---|---|
| Rare (<0.1%) | |||
| Priapism/erection lasting longer than 4 hours | ✔ | ||
| Symptoms of a heart attack upon starting sexual activity/chest pain, irregular heartbeat, shortness of breath | ✔ | ||
| Allergic reaction/rash, itching, swollen face, lips, throat, shortness or breath | ✔ | ||
How to store
LEVITRA should be stored between 15-30°C in the original
package. Do not freeze.
Keep out of the reach of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
For more information, please contact your health professional
or pharmacist first, or Bayer Medical Information at 1-800-265-
7382
This document plus the full product monograph, prepared for
health professionals can be found at: http://www.bayer.ca or by
contacting the manufacturer at the above-mentioned phone
number and e-mail address.
This leaflet was prepared by:
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
Canada
Last revised: February 25, 2020
© 2020, Bayer Inc.
® TM see www.bayer.ca/tm-mc