Details for: SILDENAFIL
Company: PHARMASCIENCE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02317559 | SILDENAFIL | SILDENAFIL (SILDENAFIL CITRATE) | 25 MG | TABLET | ORAL |
| 02317575 | SILDENAFIL | SILDENAFIL (SILDENAFIL CITRATE) | 50 MG | TABLET | ORAL |
| 02317583 | SILDENAFIL | SILDENAFIL (SILDENAFIL CITRATE) | 100 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
SILDENAFIL (sildenafil citrate) is a treatment for
erectile dysfunction in male adults. This is when a man
cannot achieve or maintain a hard, erected penis for
satisfactory sexual activity.
It is important to note that SILDENAFIL works only
with sexual stimulation. SILDENAFIL alone does not
increase your sex drive.
What it does
SILDENAFIL belongs to a class of medicine called phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, SILDENAFIL works by helping to relax the blood vessels in your penis by allowing blood to flow into your penis. This results in improved erectile function.
When it should not be used
- If you are taking any medicines containing nitrates in any form (oral, sublingual [under the tongue], skin patch, or by inhalation [spray]). Although SILDENAFIL is used occasionally, nitrates must never be used. Nitrates are found in many prescription medicines that are used in the treatment of angina pectoris (chest pain due to heart disease), such as nitroglycerin, isosorbide mononitrate, or isosorbide dinitrate. If you do not understand what nitrates are, or are unsure about whether a medication you are taking is a “nitrate”, ask your doctor or pharmacist.
- If you have loss of vision in one or both eyes from an eye disease called Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION).
- If you have ever had an allergic reaction to sildenafil citrate or the non-medicinal ingredients in SILDENAFIL.
- SILDENAFIL is not to be used in men for whom sexual activity is inadvisable.
- Do not take SILDENAFIL with guanylate cyclase stimulators, such as riociguat.
If you take SILDENAFIL with 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.
What the medicinal ingredient is
sildenafil citrate.
What the non-medicinal ingredients are
Colloidal silicon dioxide, corn starch, FD&C blue #2/indigo carmine aluminum lake, hypromellose, lactose, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulphate, sodium starch glycolate, and titanium dioxide.
What dosage form it comes in
Tablets: 25 mg, 50 mg, and 100 mg
Warnings and precautions
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.
BEFORE you use SILDENAFIL talk to your
doctor or pharmacist if you:
- have heart problems (irregular heart beats, angina, chest pain, or had a heart attack). If you have heart problems, ask your doctor if your heart is healthy enough to handle the extra strain of having sex. If you have chest pain, dizziness or nausea during sex, stop exerting yourself. You should not use nitrates but you should seek immediate medical assistance.
- are 65 years of age or over
- have had a stroke
- have low blood pressure or uncontrolled high blood pressure
- have liver or kidney problems
- have sickle cell anemia (abnormality of the red blood cells), multiple myeloma (cancer of the bone marrow) or leukaemia (cancer of the white blood cells)
- are allergic to sildenafil or any of the other ingredients of SILDENAFIL tablets
- have a deformed penis or Peyronie’s disease
- have ever had an erection that lasted more than 4 hours
- have stomach ulcers or other bleeding problems.
- have a rare inherited eye disease called retinitis pigmentosa
- have had temporary, decrease, or permanent loss of vision in one or both eyes, including a condition called Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). The specific type of vision decrease or loss, called Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION), seems to occur rarely when blood flow to the optic nerve is reduced or blocked. Vision decrease or loss may be partial or complete, in one or very occasionally both eyes. While in some cases the condition may improve over time, it can also be irreversible.
- rare but serious skin reactions of Stevens-Johnson’s Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported during the post-marketing period.
SILDENAFIL does not protect against sexually transmitted diseases (STD), including Human Immunodeficiency Virus (HIV).
Alcohol consumption may decrease the ability to get an erection. Patients should know how to react to the drug before operating a motor vehicle or any machinery.
If you are taking SILDENAFIL and experience temporary, decrease, or permanent loss of vision, stop taking SILDENAFIL and call your doctor.
In case of chest pain occurring during or after sexual activity you should not use nitrates but you should seek immediate medical assistance.
Sudden decrease or loss of hearing has been reported in a few number of post-marketing and clinical trial cases with the use of PDE5 inhibitors, including SILDENAFIL. 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 SILDENAFIL and call your doctor.
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to SILDENAFIL. Dizziness or altered vision can occur while using SILDENAFIL.
Interactions with this medication
You should tell your doctor or pharmacist about any
other medications that you are taking. SILDENAFIL
may interfere with some drugs. Only take
SILDENAFIL with other drugs if recommended
by your doctor.
Drugs that may interact with SILDENAFIL
include:
- any drugs that contain nitrates in any form (oral, sublingual [under the tongue], skin patch or by inhalation [spray]). Nitrates are found in many prescriptions that are used to treat angina pectoris (chest pain due to heart disease). You should not take SILDENAFIL if you are taking these drugs.
- alpha-blockers (drugs used to treat prostate problems or high blood pressure)
- ketoconazole or itraconazole (drugs used to treat fungal infections)
- erythromycin (a drug used to treat bacterial infections)
- ritonavir, saquinavir or other drugs for the treatment of HIV
- cimetidine (a drug generally used to treat duodenal or gastric problems)
- bosentan (a drug used in the treatment of high blood pressure in the blood vessels between the heart and the lungs)
- drugs used to treat erectile dysfunction
- other drugs that contain sildenafil. They are used in the treatment of high blood pressure in the blood vessels between the heart and the lungs.
Proper use of this medication
Usual dose
Your doctor can determine the dose that
works best for you. Always take
SILDENAFIL as prescribed by your doctor.
You should speak with your doctor or
pharmacist if you are unsure. A dose above
100 mg per day is not recommended.
Swallow the tablet whole, with some water.
You should not take more than one dose of
SILDENAFIL per day.
If you have serious liver or kidney problems or
you are 65 years of age or over, your doctor may
start you at the lowest dose (25 mg) of
SILDENAFIL.
How to optimize your use of SILDENAFIL:
You should take SILDENAFIL approximately 30 to 60
minutes before sexual activity. You can engage in
sexual activity within 30 minutes of taking the tablet
and for up to 4 hours. The amount of time it takes to
have an effect varies slightly from person to person.
Remember, sexual stimulation is required for
SILDENAFIL to work.
You should avoid excessive drinking of alcohol, since
alcohol can temporarily impair the ability to get an
erection.
SILDENAFIL can be taken with or without food.
However, you may find that it takes longer for
SILDENAFIL to work if you take it with a high-fat
meal.
SILDENAFIL may not work the first time or every time.
If SILDENAFIL did not work for you on one occasion,
try again on another day. You will learn how well
SILDENAFIL works for you through your personal
experience. The first few times may be charged with
emotion or anxiety. If after a few separate attempts,
you do not get the results you expect, talk to your
doctor.
Overdose
Side effects and what to do about them
As with most drugs, SILDENAFIL can cause some side effects. These effects are usually mild to moderate in nature and do not last for a long time. Side effects may include:
- headache, facial flushing
- nausea, vomiting, indigestion, abdominal pain,
- dizziness
- dry, stuffy, or swollen nose
- throat tightness, dry mouth, decreased sensitivity of the mouth
- pain in arms and legs, myalgia (muscle pain)
- somnolence
- erection increased
| 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 |
|---|---|---|---|
| Less common | |||
| Effect on hearing: sudden decrease or loss of hearing | ✔ | ||
| Effects on vision: colour tinge, increased brightness of light, blurred vision | ✔ | ||
| Impaired or sudden loss of vision: decreased eyesight or unable to see with one or both eyes | ✔ | ||
| Detached retina: a decrease in, or sudden loss of vision in one or both eyes | ✔ | ||
| Rare | |||
| Serious skin reactions: rash, blisters, peeling skin and pains | ✔ | ||
| Very rare | |||
| Priapism: erection lasting more than 4 hours | ✔ | ||
| Unknown | |||
| Cough | ✔ | ||
| Allergic reactions: rash, hives, itch, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Nosebleed | ✔ | ||
| Noted in patients taking sildenafil citrate for pulmonary hypertension: Fever | ✔ | ||
| Shortness of breath | ✔ | ||
| Seizure, seizure recurrence | ✔ | ||
| Transient global amnesia: temporary memory loss | ✔ | ||
| Heart attack (myocardial infarction): chest pain, shortness of breath | ✔ | ||
| Chest pain (unstable angina) | ✔ | ||
| Arrhythmia/tachy cardia, palpitations: fast or irregular heartbeat, heart rate increased | ✔ | ||
| Hypotension (low blood pressure): dizziness, fainting, lightheadedness | ✔ | ||
| Stroke (cerebrovascular hemorrhage): bleeding in the brain, vision changes, difficulty speaking, weakness on one side of the body, dizziness, lack of coordination or poor balance | ✔ | ||
| Transient ischaemic attack: temporary loss of vision, difficulty speaking, weakness on one side of the body, numbness or tingling usually on one side of the body, dizziness, lack of coordination or poor balance | ✔ | ||
| Pulmonary Hemorrhage (acute bleeding from the lung): oozing of bloody fluid from the nose and respiratory tract, accompanied by rapid worsening of patient respiration, turning blue and in severe cases, shock) | ✔ | ||
+ An allergic reaction can be a rash, itching, a swollen face, swollen lips or shortness of breath. If this ever happens to you, discontinue SILDENAFIL and notify your doctor or pharmacist
This is not a complete list of side effects. For any unexpected effects while taking SILDENAFIL, contact your doctor or pharmacist.
How to store
- Store between 15°C and 30°C, in the original package. Do not freeze.
- Do not take SILDENAFIL after the expiry date shown on the package.
- Always keep SILDENAFIL out of reach and sight 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 (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/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
This document plus the full product monograph, prepared
for health professionals, can be obtained by contacting the
sponsor, Pharmascience Inc. at, 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montreal Quebec
H4P 2T4
www.pharmascience.com
Last revised: November 07, 2018