Sildenafil (Actavis Pharma): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 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.

• 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 SILDENAFIL.

• SILDENAFIL is not to be used in men for whom sexual

  activity is inadvisable.

What the medicinal ingredient is:

sildenafil citrate.

What the nonmedicinal ingredients are:

Calcium hydrogen phosphate, croscarmellose sodium, FD&C Blue #2/Indigo carmine aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake, magnesium stearate, microcrystalline cellulose, polyetheylene glycol, polyvinyl alcohol, titanium dioxide and talc,

What dosage forms it comes in:

SILDENAFIL film-coated tablets are available in 3 tablet strengths: 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 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 Stevens-Johnson’s

  Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported during the post-marketing period.

SILDENAFIL is not recommended for use in children under 18 years of age and in women.

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 postmarketing and clinical trial cases with the use of PDE5 inhibitors, including sildenafil citrate. 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.

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)

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

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:

You should not take more than one dose of SILDENAFIL per day. If you have taken more SILDENAFIL than you should, contact your doctor or a poison control centre immediately.

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.

The most common side effects are headache and facial flushing. Less commonly reported side effects are indigestion, dizziness, stuffy nose, effects on vision (including colour tinge, increased brightness of light and blurred vision), seizure, seizure recurrence, sudden decrease or loss of hearing and transient global amnesia (temporary memory loss).

In extremely rare instances, a man may have an erection that lasts many hours. You should call a doctor immediately if you ever have an erection that lasts more than 4 hours.

Reports of sudden loss of vision have occurred rarely with the use of oral erectile dysfunction medications (PDE5 inhibitors). Patients who have already experienced a condition called Non-

Arteritic Anterior Ischaemic Optic Neuropathy (NAION) should not use of PDE5 inhibitors. Rare cases of central serous chorioretinopathy (serous detachment of the macula layers of the retina) have been reported. You should stop taking ACTSILDENAFIL, and consult your doctor immediately if you experience a decrease in, or sudden loss of, vision in one or both eyes.

Reports of serious skin reactions characterized by rash, blisters, peeling skin and pain, which require immediate medical attention, have also occurred rarely. You should stop taking SILDENAFIL and consult your doctor if you experience such reactions.

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.

* including colour tinge, increased brightness of light and blurred vision. + 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 IT

• Store between 15°C and 30°C.

• Do not take SILDENAFIL after the expiry date shown on the

  package.

  • Always keep SILDENAFIL out of reach and sight of children.

REPORTING SUSPECTED 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 3 ways:

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• 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 MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company, at: 1-866-254-6111.

Actavis Pharma Company

6733 Mississauga Road, Suite 400

L5N 6J5

Date of Preparation: November 3, 2014