Patient Medication Information: uses, side effects, how to take - Jamp-Vardenafil ODT

What the medication is used for:

JAMP-VARDENAFIL ODT 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:

JAMP-VARDENAFIL ODT belongs to a class of agents known as phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, JAMP- VARDENAFIL ODT works by helping the blood vessels in your penis relax, allowing blood to flow into your penis. This results in improved erectile function.

JAMP-VARDENAFIL ODT will not increase your sex drive. JAMP-VARDENAFIL ODT will only help you get an erection if you are sexually stimulated.

When it should not be used:

If you are taking any medicines containing nitrates in any form. Similarly, nitrates must never be used by men who take JAMP- VARDENAFIL ODT. Nitrates are found in many prescription medicines used to treat angina (chest pain due to heart disease) such as nitroglycerin, isosorbide mononitrate and isorbide dinitrates. If you do not understand what nitrates are, or are unsure about whether a medication you are on is a "nitrate", ask your doctor or pharmacist.
If you take JAMP-VARDENAFIL ODT with nitrate-containing medicines or any other nitrates (eg, 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.
- If you are taking cobicistat, indinavir, ritonavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, or clarithromycin. Cobicistat, indinavir, ritonavir, saquinavir, and atazanavir are used to treat HIV infections. Ketoconazole and itraconazole are used against fungal infections. Erythromycin and clarithromycin are antibiotics.
- If you have ever had an allergic reaction to any of the ingredients in JAMP-VARDENAFIL ODT. (See What the medicinal ingredient is and What the nonmedicinal ingredients are.)
- If you have had an episode of vision loss in one or both eyes from a disease called non-arteritic anterior ischaemic optic neuropathy (NAION).
- Do not take JAMP-VARDENAFIL ODT with guanylate cyclase stimulators, such as riociguat.

What the medicinal ingredient is:

Vardenafil (as vardenafil hydrochloride trihydrate)

What the nonmedicinal ingredients are:

JAMP-VARDENAFIL ODT orally disintegrating tablets contain the following nonmedicinal ingredients: Microcrystalline Cellulose, Lactose Anhydrous, Crospovidone, Colloidal Silicon Dioxide, Sodium Chloride, natural flavours, maize maltodextrin, modified corn starch, pulegone, aspartame, Sodium Stearyl Fumarate.

What dosage forms it comes in:

JAMP-VARDENAFIL ODT is available as white to off-white, round, biconvex uncoated tablets debossed with “VD10” on one side and plain on the other side. JAMP-VARDENAFIL ODT is available in one dosage strength: 10 mg, containing 10 mg of the active ingredient vardenafil.

BEFORE you use JAMP-VARDENAFIL ODT talk to your doctor or pharmacist if you have or had any of the following conditions:

Heart problems (irregular heartbeats, angina, chest pain, or had a previous heart attack or stroke, QT/QTc prolongation, or a family history of QT/QTc prolongation). If you have heart problems, ask your doctor if your heart is healthy enough to handle the extra strain of having sex.
An erection that lasted more than 4 hours.
Low blood pressure.
Uncontrolled high blood pressure.
Kidney dialysis.
Severe liver problems.

IMPORTANT: PLEASE READ

ABOUT THIS MEDICATION

WARNINGS AND PRECAUTIONS

Blood problems, including sickle cell anemia or leukemia.
Stomach ulcers or any type of bleeding problem.
Deformation of the penis or Peyronie's disease.
Eye disease, or severe loss of vision due to damage to the optic nerve from insufficient blood supply, a condition called Non-arteritic Anterior Ischemic Optic Neuropathy (NAION). If you are taking JAMP-VARDENAFIL ODT and experience temporary or permanent loss or change in vision, stop taking JAMP- VARDENAFIL ODT and call your doctor.
Hearing problems or hearing loss. Sudden decrease or loss of hearing has been reported with the use of this class of drug (PDE5 inhibitors), including JAMP-VARDENAFIL ODT. If you experience these symptoms, stop taking JAMP- VARDENAFIL ODT and contact your doctor.
Phenylketonuria. JAMP-VARDENAFIL ODT contains Aspartame, a source of phenylalanine, and may be harmful for people with phenylketonuria.

JAMP-VARDENAFIL ODT offers no protection against sexually transmitted diseases including Human Immunodeficiency Virus (HIV).

JAMP-VARDENAFIL ODT is not recommended for patients less than 18 years old.

Drugs that may interact with JAMP-VARDENAFIL ODT include:

nitrate-containing medicines or nitrates (eg, amyl nitrate “poppers”),
cobicistat, indinavir, ritonavir, saquinavir, or atazanavir (used to treat HIV infections),
ketoconazole, or itraconazole (used to treat fungal infections),
gatifloxacin (used to treat infections),
antiarrhythmic medications (for irregular heartbeat, eg, amiodarone, sotalol, quinidine, procainamide),
alpha-blockers (used to treat prostate problems or high blood pressure).
riociguat (medicine used to treat high blood pressure in the arteries carrying blood from the heart to the lungs). Taking this medicine with JAMP-VARDENAFIL ODT could seriously affect your blood pressure (see “When it should not be used”).

JAMP- VARDENAFIL ODT 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 JAMP- VARDENAFIL ODT.

Do not use JAMP-VARDENAFIL ODT together with other treatments of erectile dysfunction. If you see a different doctor for any reason, be sure to inform

him/her that you are taking JAMP-VARDENAFIL ODT.

You must take this medicine exactly as prescribed by your doctor.

Usual dose:

Take one tablet (10 mg) of your JAMP- VARDENAFIL ODT 45-90 minutes before sexual activity. However, sexual activity can be initiated for up to 8 hours after taking JAMP- VARDENAFIL ODT.
Do not take more than 10 mg of JAMP- VARDENAFIL ODT per day.
Place JAMP-VARDENAFIL ODT tablet on the
tongue, where it will dissolve in seconds, then swallow with saliva. JAMP-VARDENAFIL ODT tablets should be taken without any liquid.
Do not remove the orally disintegrating tablet
from the blister until you are going to take it. With dry hands, pull the blister edge from the blister holder and press gently on top to release the tablet on your hand. Do not crush the tablet.
JAMP-VARDENAFIL ODT can be taken before or after food.
JAMP-VARDENAFIL ODT is not affected by moderate amounts of alcohol (approximately 2
drinks of alcohol, wine, or beer in a 70 kg person). However, large amounts of alcohol can impair the ability to get an erection; therefore do not consume large amounts of alcohol prior to sexual activity.
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.

Overdose:

As with most drugs, JAMP-VARDENAFIL ODT can cause some side-effects.

The most common side-effects are headache and flushing (a burning/warm sensation, usually in the face).

The common side-effects are indigestion, stuffy nose, dizziness, and back pain.

IMPORTANT: PLEASE READ

INTERACTIONS WITH THIS MEDICATION

PROPER USE OF THIS MEDICATION

If you think have taken too much JAMP- VARDENAFIL ODT 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

Less common side effects are 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). 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.

If you have an erection which lasts longer than 4 hours, you should contact a doctor immediately. If this is not treated immediately, permanent penile tissue damage and erectile dysfunction may result.
If you have a heart condition and you experience any symptoms of a heart attack upon starting
sexual activity (such as chest pains, irregular heartbeat, or shortness of breath), you should stop this activity and consult a doctor.
If an allergic reaction occurs after taking JAMP- VARDENAFIL ODT, such as a rash, itching,
swollen face, lips, throat, or shortness of breath, contact a doctor immediately.

Sudden decrease or loss of vision has occurred rarely after the use of oral erectile dysfunction medications, including JAMP-VARDENAFIL ODT. It has not been established whether the loss of vision is related directly to the use of PDE5 inhibitors or other factors. If you experience reduction or loss of vision in one or both eyes, stop taking JAMP-VARDENAFIL ODT and call your doctor.

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

JAMP-VARDENAFIL ODT should be stored between 15°C to 30°C in the original package. Do not freeze.

Keep out of the reach and sight of children.

If you want more information about JAMP- VARDENAFIL ODT:

Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website; (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling the sponsor, JAMP Pharma Corporation at: 1-866-399-9091

J4B 5H3, Canada

Last Revised: March 9, 2021

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom/ Effect	Talk with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
Symptom/ Effect	Only if severe	In all cases
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