Consumer Information for: APO-SILDENAFIL R

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-SILDENAFIL R (sildenafil citrate) is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels between the heart and the lungs) in adults (18 years of age or older).

APO-SILDENAFIL R improves the ability to exercise. If you are already on a stable dose of epoprostenol (FLOLAN®) it may also slow down the worsening of your physical condition and symptoms of pulmonary hypertension.

With pulmonary arterial hypertension, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.

APO-SILDENAFIL R is not indicated for use in children less than 18 years of age.

What it does

APO-SILDENAFIL R belongs to a group of medicines called phosphodiesterase type 5 inhibitors. APO-SILDENAFIL R brings down pulmonary (lung) blood pressure by widening these vessels.

When it should not be used

Do not use APO-SILDENAFIL R if you:

  • have ever had an allergic reaction to APO-SILDENAFIL R or any medicines containing sildenz`afil citrate, or any of the ingredients of the drug (see “What are the ingredients in APO-SILDENAFIL R?”). An allergic reaction can be a rash, itching, a swollen face, swollen lips or shortness of breath. Please notify your doctor if this ever happens to you.
  • are taking any medicines that contain nitrates in any form (oral, sublingual [under the tongue], skin patch or by inhalation. Nitrates are found in many prescriptions that are used to treat angina (chest pain due to heart disease) such as:
    • nitroglycerin (sprays, ointments, skin patches or pastes, and tablets that are swallowed or dissolved in the mouth)
    • isosorbide mononitrate and isosorbide dinitrate (tablets that are swallowed, chewed, or dissolved in the mouth) If you are not sure if any of your medicines contain nitrates, or if you do not understand what nitrates are, ask your doctor or pharmacist. If you take APO-SILDENAFIL R with any nitrate-containing medicine or any nitrate, your blood pressure could suddenly drop to a life-threatening level. You could get dizzy, faint, or even have a heart attack or stroke.
  • have loss of vision in one or both eyes from an eye disease called non-arteritic anterior ischaemic optic neuropathy (NAION)
  • take drugs like ketoconazole (Nizoral®), itraconazole (Sporanox®), ritonavir (Kaletra®)
  • have pulmonary hypertension secondary to sickle cell anaemia (abnormality of the red blood cells)
  • have severe liver disease
  • have a recent history of stroke or heart attack or lifethreatening arrhythmia (a heart rhythm disorder)
  • have a coronary artery disease (heart vessels disease) causing unstable angina (chest pain)
  • have severe hypotension (low blood pressure) when you start taking APO-SILDENAFIL R
  • take guanylate cyclase stimulators, such as riociguat (Adempas®)

What the medicinal ingredient is

Sildenafil citrate

What the non-medicinal ingredients are

Tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose.

Film coat: hydroxyl propyl methyl cellulose, hydroxyl propyl cellulose, polyethylene glycol and titanium dioxide.

What dosage form it comes in

APO-SILDENAFIL R film-coated tablets contain 20 mg sildenafil (as sildenafil citrate) and are white to off white and round biconvex in shape. The tablets are marked with “APO” on one side and “SIL over 20” on the other. The tablets are provided in blister packs containing 90 tablets (15 tablets per blister strip) and in bottles of 100 tablets.

Warnings and precautions

Serious Warnings and Precautions

Before taking APO-SILDENAFIL R, talk to your doctor or pharmacist if you:

  • have high blood pressure in your lung arteries (pulmonary veno-occlussive disease)
  • 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).

BEFORE you use APO-SILDENAFIL R talk to your doctor or pharmacist if you:

  • have heart problems (irregular heartbeats, angina, chest pain, or had a heart attack or stroke)
  • have high or low blood pressure
  • have kidney problems
  • have liver problems
  • have blood problems, including sickle cell anemia or leukemia
  • have a deformed penis (Peyronie’s disease, abnormal curvature of the penis), or ever had an erection that lasted more than 4 hours
  • have stomach ulcers or any types of bleeding problems
  • have an eye disease called retinitis pigmentosa
  • are taking an alpha blocker (a drug used to treat high blood pressure or prostate problems)
  • are pregnant or breastfeeding
  • are taking bosentan therapy for pulmonary arterial hypertension.
  • are taking products such as Viagra (sildenafil), Cialis, Levitra, Adcirca and Staxyn.
  • are taking any other medicines

Driving and using machines:
A small percentage of patients experience dizziness or altered vision. You should be aware of how you might be affected by APO-SILDENAFIL R before driving or operating machinery.

Interactions with this medication

Serious drug interaction

  • Use of organic nitrates in any form is absolutely contraindicated (see Do not use APO-SILDENAFIL R if:)
  • Use of products such as Viagra (sildenafil), Cialis, Levitra, Adcirca and Staxyn, and
  • Use of other vasodilators, a class of drugs that open (dilate) the blood vessels (see WARNINGS AND PRECAUTIONS)

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Drugs that may interact with APO-SILDENAFIL R include:

  • Alpha-Blockers (e.g. doxazosin), drugs used to treat high blood pressure or prostate problems
  • Beta-Blockers and amlodipine, drugs used to treat high blood pressure
  • Bosentan therapy for pulmonary arterial hypertension.
  • Calcium channel blockers (e.g. amlodipine, verapamil) drugs used to treat high blood pressure, angina and abnormal heart rhythms
  • Ketoconazole or itraconazole to treat fungal infections.
  • Nitrates in any form (oral, sublingual [under the tongue], skin patch or by inhalation). Nitrates are found in many prescriptions that are used to treat angina (chest pain due to heart disease) (also see Section “When it should not be used”).
  • Ritonavir and saquinavir or other drugs used for the treatment of HIV.
  • Cimetidine (a drug generally used to treat duodenal or gastric problems)
  • Erythromycin, clarithromycin and telithromycin (drugs used to treat bacterial infections)
  • Nefazodone (a drug used to treat depression)

Grapefruit juice may affect APO-SILDENAFIL R blood levels. You should avoid taking APO-SILDENAFIL R with grapefruit juice.

Alcohol can react with APO-SILDENAFIL R. It may increase the heart rate, decrease standing blood pressure, or cause dizziness, and headache. You should avoid consuming alcohol while taking APO-SILDENAFIL R.

St-Johns’s Wort may affect APO-SILDENAFIL R blood levels. You should advise your doctor if you are taking StJohns’s wort.

If you are unsure about the medications you are taking, ask your doctor or pharmacist.

Proper use of this medication

Usual Dose

Always take APO-SILDENAFIL R exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The recommended oral dose is 20 mg three times a day (taken 6 to 8 hours apart) swallowed with or without food.

If you have the impression that the effect of APOSILDENAFIL R is too strong or too weak, talk to your doctor or pharmacist.

APO-SILDENAFIL R is not indicated for use in children less than 18 years of age.

Overdose

You should not take more tablets than your doctor tells you. If you take more tablets than you have been told to take contact your doctor.

If you think you have taken too much of APO-SILDENAFIL R, contact your health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you missed a dose of APO-SILDENAFIL R, take it as soon as you remember, then continue with your next scheduled dose. Do not take two doses at the same time.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking APO-SILDENAFIL R. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

As with most drugs, APO-SILDENAFIL R can cause some side effects.

The most common side effects are headache, facial flushing, indigestion, back pain, diarrhoea, nausea and pain in extremity.

Other side effects you might notice: flu-like symptoms, difficulty sleeping, muscle aches.

If any of these side effects is severe, talk with your doctor or pharmacist.

If you notice any side effects not mentioned in this leaflet, or any of the above-mentioned effects persist or become bothersome, please inform your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, 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)   ✔  
Blurred vision   ✔  
Impaired vision (decreased eyesight or loss of vision in one or both eyes)     ✔
Unknown
Cough   ✔  
Nosebleed   ✔  
Fever   ✔  
Shortness of breath   ✔  
Seizure, seizure recurrence     ✔
Transient global amnesia (temporary memory loss).   ✔  
Serious skin reactions characterized by rash, blisters, peeling skin and pains.     ✔
Erection lasting more than 4 hours (Priapism)     ✔
Noted in patients taking sildenafil citrate for erectile dysfunction: Heart problems symptoms like heart attack (Myocardial infarction), chest pain (unstable angina), irregular heart beat (ventricular arrhythmia), bleeding in the brain (cerebrovascular haemorrhage)     ✔
Noted in patients taking sildenafil citrate for erectile dysfunction: Transient ischaemic attack symptoms like 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.     ✔
Noted in patients taking sildenafil citrate for erectile dysfunction: Pulmonary Haemorrhage (acute bleeding from the lung) symptoms like oozing of bloody fluid from the nose and respiratory tract, accompanied by rapid worsening of patient respiration, cyanosis and in severe cases, shock)     ✔

Loss of Vision
APO-SILDENAFIL R belongs to a group of medicine called phosphodiesterase type 5 inhibitors. In rare cases men using such medicines for erectile dysfunction have reported a sudden decrease or loss of vision in one or both eyes. If you experience sudden decrease or loss of vision, you should stop taking APO-SILDENAFIL R and call your doctor immediately for advice.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store at 25°C; excursions permitted from 15°C to 30°C. Keep out of reach and sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about APO-SILDENAFIL R:

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: February 11, 2019

Report a problem or mistake on this page
Please select all that apply:
Date modified: