Consumer Information for: AURO-SILDENAFIL

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

AURO-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 AURO-SILDENAFIL works only with sexual stimulation. AUROSILDENAFIL alone does not increase your sex drive.

What it does

AURO-SILDENAFIL belongs to a class of medicine called phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, AUROSILDENAFIL 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 AURO-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 take AURO-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.

  • 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 nonmedicinal ingredients in AURO-SILDENAFIL.
  • AURO-SILDENAFIL is not to be used in men for whom sexual activity is inadvisable.
  • Do not take AURO-SILDENAFIL with guanylate cyclase stimulators, such as riociguat.
What the medicinal ingredient is

sildenafil citrate.

What the non-medicinal ingredients are

anhydrous calcium hydrogen phosphate, croscarmellose Sodium,magnesium Stearate, microcrystalline cellulose and silica colloidal anhydrous
Coating Ingredients:
Opadry II blue 31K80956: It contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, FD & C Blue #2/Indigo Carmine Aluminium lake

What dosage form it comes in

25mg Tablets - Blue coloured, biconvex, film coated, diamond shaped tablets debossed with ‘T’ on oneside & ‘28’ on the other side. Available in blister pack sizes of 1X4’s, 2 x 2’s and HDPE pack of 30’s, 100’s & 1000’s count.
50mg Tablets - Blue coloured, biconvex, film coated, diamond shaped tablets debossed with ‘T’ on oneside & ‘29’ on the other side. Available in blister pack sizes of 1X4’s, 2 x 2’s & 4 x 2’s and HDPE pack of 30’s, 100’s & 1000’s count.
100mg Tablets - Blue coloured, biconvex, film coated, diamond shaped tablets debossed with ‘T’ on oneside & ‘30’ on the other side. Available in blister pack sizes of 1X4’s, 2 x 2’s & 4 x 2’s and HDPE pack of 30’s, 100’s & 500’s count.

Warnings and precautions

Serious 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 AURO-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 AURO-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 ischemic 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 StevensJohnson’s Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported during the post-marketing period.

AURO-SILDENAFIL is not recommended for use in children under 18 years of age and in women. AURO-SILDENAFIL does not protect against sexually transmitted diseases (STD), including Human Immunodeficiency Virus (HIV).

Alcohol consumption may decrease the ability to get an erection.

If you are taking AURO-SILDENAFIL and experience temporary, decrease, or permanent loss of vision, stop taking AURO-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 postmarketing and clinical trial cases with the use of PDE5 inhibitors, including AURO-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 AURO-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 AUROSILDENAFIL. Dizziness or altered vision can occur while using AURO-SILDENAFIL.

Interactions with this medication

You should tell your doctor or pharmacist about any other medications that you are taking. AUROSILDENAFIL may interfere with some drugs. Only take AURO-SILDENAFIL with other drugs if recommended by your doctor.

Drugs that may interact with AUROSILDENAFIL 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 AURO-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 to treat erectile dysfunction. These drugs are Cialis, Levitra, Adcirca and Staxyn.
  • other drugs that contain sildenafil. They can be called Revatio. They are used in the treatment of high blood pressure in the blood vessels between the heart and the lungs.

Grapefruit juice may increase the levels of AUROSILDENAFIL in your blood.

Proper use of this medication

Usual dose: Your doctor can determine the dose that works best for you. Always take AUROSILDENAFIL 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 AUROSILDENAFIL 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 AURO-SILDENAFIL.

How to optimize your use of AUROSILDENAFIL:

You should take AURO-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 AURO-SILDENAFIL to work.

You should avoid excessive drinking of alcohol, since alcohol can temporarily impair the ability to get an erection.

AURO-SILDENAFIL can be taken with or without food. However, you may find that it takes longer for AURO-SILDENAFIL to work if you take it with a high-fat meal.

AURO-SILDENAFIL may not work the first time or every time. If AURO-SILDENAFIL did not work for you on one occasion, try again on another day. You will learn how well AURO-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.

Usual Dose

Overdose

You should not take more than one dose of AUROSILDENAFIL per day.

If you think you have taken too much AUROSILDENAFIL contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Side effects and what to do about them

As with most drugs, AURO-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

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

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your healthcare Professional only if severe Talk with your healthcare Professional in all cases Stop taking drug and get immediate medical help
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/tach ycardia, palpitations: fast or irregular heart beat, 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)     ✔

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

How to store
  • Store at room temperature (15°C to 30°C).
  • Do not take AURO-SILDENAFIL after the expiry date shown on the package.
  • Always keep AURO-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:

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 leaflet is part III of a three-part "Product Monograph" published when AUROSILDENAFIL was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about AURO-SILDENAFIL. Contact your doctor or pharmacist if you have any questions about the drug.

This leaflet was prepared by

Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.

Date of Revision: June 10, 2019.

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