Details for: AG-SILDENAFIL
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02480417 | AG-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
AG-SILDENAFIL tablets are 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 AG-SILDENAFIL tablets work only with sexual stimulation. AG-SILDENAFIL tablets alone do not increase your sex drive.
What it does
AG-SILDENAFIL belongs to a class of medicine called phosphodiesterase type 5 (PDE5) inhibitors. Following sexual stimulation, AG-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, orby inhalation [spray]). Although AG-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, isosorbidemononitrate, orisosorbidedinitrate. If you do not understand what nitratesare, or are unsure about whether a medication you are taking is a “nitrate”, ask your doctor or pharmacist.
If you take AG-SILDENAFIL tablets with nitrate-containing medicines or any other nitrates (e.g., 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 have loss of vision in one or both eyes from an eye disease called non-arteritic anterior ischaemic opticneuropathy (NAION)
- If you have ever had an allergic reaction to sildenafil citrateor the non medicinal ingredients in AG-SILDENAFILtablets.
- AG-SILDENAFIL tablets are not to be used in men forwhom sexual activity is inadvisable.
- Do not take sildenafil citrate with guanylatecyclasestimulators,such as riociguat.
What the medicinal ingredient is
Sildenafil citrate.
What the non-medicinal ingredients are
croscarmellose sodium, calcium hydrogen phosphate anhydrous, cellulose microcrystalline, magnesium stearate, lactose
monohydrate, hypromellose, titanium dioxide, triacetin, FD&C Blue #2.
What dosage form it comes in
AG-SILDENAFIL- 25 mg tablets (sildenafil citrate equivalent to 25 mg of sildenafil per tablet) are blue coloured, rounded diamond shaped, film coated tablets, plain on one side and debossed with ‘25’ on the other side.
AG-SILDENAFIL- 50 mg tablets (sildenafil citrate equivalent to 50 mg of sildenafil per tablet) are blue coloured, rounded diamond shaped, film coated tablets, plain on one side and debossed with ‘50’ on the other side.
AG-SILDENAFIL- 100 mg tablets (sildenafil citrate equivalent to 100 mg of sildenafil per tablet) are blue coloured, rounded diamond shaped, film coated tablets, plain on one side and debossed with ‘100’ on the other side.
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 AG-SILDENAFIL talk to your doctor or pharmacist if you:
- have heart problems (irregular heart beats, angina, chestpain, or had a heart attack). If you have heart problems, ask your doctor if your heart is healthy enoughto 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 bloodcells),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 AG-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 calledNon-Arteritic Anterior Ischemic Optic Neuropathy(NAION). The specific type of vision decrease or loss, called non-arteritic anterior ischemic opticneuropathy (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, inone or very occasionally both eyes. While in some casesthe condition may improve over time, it can also be irreversible.
AG-SILDENAFIL tablets are not recommended for use in children under 18 years of age and in women.
AG-SILDENAFIL tablets do 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 AG-SILDENAFIL tablets and experience temporary,decrease, or permanent loss of vision, stop taking AG-SILDENAFIL tablets 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 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 AG-SILDENAFIL tablets and call your doctor.
Interactions with this medication
You should tell your doctor or pharmacist about any other medications that you are taking. AG-SILDENAFIL tablets may interfere with some drugs. Only take AG-SILDENAFIL tablets with other drugs if recommended by your doctor.
Drugs that may interact with AG-SILDENAFIL tablets 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 areused to treat angina pectoris (chest pain due to heartdisease). You should not take AG-SILDENAFIL if you aretaking 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 orgastric 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.
- other drugs that contain sildenafil. They are used in thetreatment of high blood pressure in the blood vessels between the heart and the lungs.
Grapefruit juice may increase the levels of sildenafil citrate in your blood.
Proper use of this medication
Usual Dose
Your doctor can determine the dose that works best for you. Always take AG-SILDENAFIL tablets 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 AG-SILDENAFIL tablets 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 AG-SILDENAFIL tablets.
How to optimize your use of AG-SILDENAFIL tablets
You should take AG-SILDENAFIL tablets 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 AG-SILDENAFIL tablets to work.
You should avoid excessive drinking of alcohol, since alcohol can temporarily impair the ability to get an erection.
AG-SILDENAFIL tablets can be taken with or without food. However, you may find that it takes longer for AG-SILDENAFIL tablets to work if you take it with a high-fat meal.
AG-SILDENAFIL tablets may not work the first time or every time. If AG-SILDENAFIL tablets did not work for you on one occasion, try again on another day. You will learn how well AG-SILDENAFIL tablets 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 AG-SILDENAFIL tablets per day. If you have taken more AG-SILDENAFIL tablets than you should, contact your doctor or a poison control centre immediately.
Side effects and what to do about them
As with most drugs, AG-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 ofthe 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.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drugand call your doctor or pharmacist |
|---|---|---|---|
| Less common | |||
| Effect on hearing:sudden decrease or loss ofhearing | ✔ | ||
| Effects on vision: colourtinge, increased brightness of light, blurred vision | ✔ | ||
| Impaired or sudden loss of vision:decreased eye sight 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/tachycardia, palpitations: fast or irregular heartbeat, heart rate increased | ✔ | ||
| Hypotension (low blood pressure): dizziness, fainting, light headedness | ✔ | ||
| 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 AG-SILDENAFIL, contact your doctor or pharmacist.
How to store
Store at controlled room temperature between 15°C and 30°C.
Do not take AG-SILDENAFIL tablets after the expiry date shown on the package.
Always keep AG-SILDENAFIL tablets 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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 distributor, Angita Pharma Inc.at 1 866-399-9091.
This leaflet was prepared byAngita Pharma Inc..
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Quebec
J4B 5H3
Date of Revision: August 28, 2018