Patient Medication Information: uses, side effects, how to take - Teva-Sildenafil R
ABOUT THIS MEDICATION
What the medication is used for:
TEVA-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).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.
TEVA-SILDENAFIL R is not indicated for use in children less than 18 years of age.
What it does:
TEVA-SILDENAFIL R belongs to a group of medicines called phosphodiesterase type 5 inhibitors. TEVA-SILDENAFIL R brings down pulmonary (lung) blood pressure by widening these vessels.
When it should not be used:
Do not use TEVA-SILDENAFIL R if you:
- have ever had an allergic reaction to TEVA-SILDENAFIL R or any medicines containing sildenafil citrate, or any of the ingredients of the drug (see “What the non-medicinal ingredients are”). 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 TEVA-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 life-threatening 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 TEVA-SILDENAFIL R
- take guanylate cyclase stimulators, such as riociguat (Adempas®)
What the medicinal ingredient is:
Sildenafil as sildenafil citrate
What the non-medicinal ingredients are:
Tablet core: calcium hydrogen phosphate, crosscarmellose sodium, magnesium stearate, microcrystalline cellulose,
Film coat: hydroxy propyl methylcellulose, polyethylene glycol, talcum, titanium dioxide
What dosage forms it comes in:
TEVA-SILDENAFIL R is supplied as 20 mg,
White to off white, biconvex circular film-coated tablets debossed with "20" on one side and plain on the other side..
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Before taking TEVA-SILDENAFIL R, talk to your doctor or pharmacist if you:
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BEFORE you use TEVA-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 lasting 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 TEVA-SILDENAFIL R before driving or operating machinery.
INTERACTIONS WITH THIS MEDICATION
Serious Drug Interactions
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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 TEVA-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,
- 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 TEVA-SILDENAFIL R blood levels. You should avoid taking TEVA-SILDENAFIL R with grapefruit juice.
Alcohol can react with TEVA-SILDENAFIL R. It may increase the heart rate, decrease standing blood pressure, or cause dizziness, and headache. You should avoid consuming alcohol while taking TEVA-SILDENAFIL R.
St-Johns’s Wort may affect TEVA-SILDENAFIL R blood levels. You should advise your doctor if you are taking St-Johns’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 TEVA-SILDENAFIL R exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The recommended 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 TEVA-SILDENAFIL R is too strong or too weak, talk to your doctor or pharmacist.
TEVA-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 TEVA-SILDENAFIL R, contact your health care practitioner, hospital emergency |
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| department or regional Poison Control Centre immediately, even if there are no symptoms. |
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Missed Dose:
If you missed a dose of TEVA-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 TEVA-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, TEVA-SILDENAFIL R can cause some side effects.
The most common side effects are headache, facial flushing, indigestion, back pain, diarrhea, 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 | ||||
| Frequency | Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | |||
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 | ✓ | |||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Frequency | Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| Only if severe | In all cases | ||
| 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 | ✓ | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Frequency | Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| Only if severe | In all cases | ||
| by rapid worsening of patient respiration, cyanosis and in severe cases, shock) | |||
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 IT
Store at controlled room temperature (15- 30°C), in the original package. Do not take TEVA-SILDENAFIL R after the expiry date shown on the package. Keep 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
If you want more information about < TEVA-SILDENAFIL R >:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
Last revised: APR 15, 2024
Loss of Vision
TEVA-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 TEVA-SILDENAFIL R and call your doctor immediately for advice.