Patient Medication Information: uses, side effects, how to take - AG-Vardenafil
ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
IMPORTANT: PLEASE READ
PART III: CONSUMER INFORMATION
Pr AG-Vardenafil
(Vardenafil tablets)
This leaflet is part III of a three-part "Product Monograph" published when AG-Vardenafil was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about AG-Vardenafil. Contact your doctor or pharmacist if you have any questions about the drug.
Please read this information carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist.
What the medication is used for:
AG-Vardenafil 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:
AG-Vardenafil belongs toa class of agents known as phosphodiesterase type 5 (PDE5) inhibitors. Following sexual
stimulation, AG-Vardenafil works by helping the blood vessels in your penis relax, allowing blood to flow into your penis. This results in improved erectile function.
AG-Vardenafil will not increase your sex drive. AG-Vardenafil 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 AG-Vardenafil. 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 AG-Vardenafil with nitrate-containing medicines or any other nitrates (eg, amylnitrite "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, or itraconazole. Cobicistat, Indinavir, ritonavir, saquinavir, and atazanavir are used to treat HIV infections. Ketoconazole and itraconazole are used against fungal infections.
If you have ever had an allergic reaction to any of the ingredients in AG-Vardenafil (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 AG-Vardenafil with guanylate cyclase stimulators, such as riociguat.
What the medicinal ingredient is:
Vardenafil (as vardenafil hydrochloride)
What the nonmedicinal ingredients are:
The tablets contain the following non-medicinal ingredients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, yellow iron oxide, and red iron oxide.
What dosage forms it comes in:
AG-Vardenafil is available as orange, filmcoated round tablets debossed with 'VD5', ‘VD10’, ‘VD20’ on one side and plain surface on the other for 5 mg, 10 mg and 20 mg respectively. AG-Vardenafil 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.
BEFORE you use AG-Vardenafil 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). If you have heart problems, ask your doctor if your heart is healthy enough to handle the extra strain of having sex.
- Low blood pressure.
- Uncontrolled high blood pressure.
- Kidney dialysis.
- Severe liver problems.
- Blood problems, including sickle cell anemia or leukemia.
- Stomach ulcers or any type of bleeding problem.
- Deformation of the penis, Peyronie's disease or an erection that lasted more than 4 hours.
If you are taking AG-Vardenafil and experience temporary or permanent loss or change in
vision, stop taking AG-Vardenafil and call your doctor.
- 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 AG-Vardenafil and experience temporary or permanent loss or change in vision, stop taking AG-Vardenafil and call your doctor.
- A rare, inherited eye disease called retinosa pigmentosa.
AG-Vardenafil offers no protection against sexually transmitted diseases including Human Immunodeficiency Virus (HIV).
AG-Vardenafil is not recommended for patients less than 18 years old.
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
IMPORTANT: PLEASE READ
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 AG-Vardenafil. 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 AG-Vardenafil and call your doctor.
Drugs that may interact with AG-Vardenafil include:
- nitrate-containing medicines or nitrates (eg, amylnitrate “poppers”),
- cobicistat, indinavir or ritonavir, saquinavir, or atazanavir (used to treat HIV infections),
- ketoconazole, or itraconazole (used to treat fungal infections),
- erythromycin, clarithromycin, or 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 AG-Vardenafil could seriously affect your blood pressure(see “When it should not be used”).
AG-Vardenafil 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 AG-Vardenafil.
AG-Vardenafil should not be used together with other treatments of erectile dysfunction.
Usual dose:
- You must take this medicine exactly as prescribed by your doctor.
Take your AG-Vardenafil 25-60 minutes before
sexual activity. However, sexual activity can be initiated as soon as 15 minutes and as longas 8-10 hours after taking AG-Vardenafil.
- AG-Vardenafil will only help you get an erection if you are sexually stimulated.
AG-Vardenafil tablets should be swallowed whole with some water. It does not matter if you take AG-Vardenafil with or without food.
AG-Vardenafil 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.
- You should not take more than one dose of AG-Vardenafil per day.
- Never change the dose unless your doctor tells you to.
- If you have to see a different doctor for any reason, be sure to inform him/her that you are taking AG-Vardenafil 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:
| If you have taken more AG-Vardenafil than you should, contact your doctor or a Poison Control Centre immediately. |
As with most drugs, AG-Vardenafil 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 AG-Vardenafil. 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 AG-Vardenafil, such as a rash, itching, swollen face, lips, throat, or shortness of breath, stop use and contact a doctor.
Sudden decrease or loss of vision has occurred rarely after the use of oral erectile dysfunction medications, including AG-Vardenafil. 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 AG-Vardenafil and call your doctor.
MORE INFORMATION
HOW TO STORE IT
IMPORTANT: PLEASE READ
This is not a complete list of side effects. For any unexpected effects while taking AG-Vardenafil, contact your doctor or pharmacist.
AG-Vardenafil should be stored between 15-30°C in the original package. Do not freeze.
Keep out of the reach and sight of children.
| 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 | |
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 | |||
If you want more information about AG-Vardenafil
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the (https://health- products.canada.ca/dpd- bdpp/index-eng.jsp); the manufacturer’s website (www.angitapharma.ca), or by calling Angita Pharma 450-449-9272.
1310 rue Nobel Boucherville Quebec
J4B 5H3, Canada