Revatio (Sildenafil)

Usual dose:

Always take REVATIO 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. REVATIO solution for injection is for the continuous treatment of patients with pulmonary arterial hypertension who are currently prescribed REVATIO tablets and who are temporarily unable to take oral medication.

For those patients, the recommended intravenous dose is 10 mg (corresponding to 12.5 mL) three times a day administered as an intravenous bolus injection administered by your doctor who will tell you when to resume to the tablets. Each dose requires a new vial.

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

REVATIO is not indicated for use in children less than 18 years of age.

Overdose:

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

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.

Missed dose:

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

These are not all the possible side effects you may feel when taking REVATIO. If you experience any side effects not listed here, contact your healthcare professional.

As with most drugs, REVATIO 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.

Loss of Vision:

REVATIO 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 REVATIO 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.

Serious Warnings and Precautions

Before taking REVATIO, 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 REVATIO talk to your doctor or pharmacist if you:

• have heart problems (irregular heart beats, 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 REVATIO before driving or operating machinery.

Serious Drug Interactions

• Use of organic nitrates in any form is absolutely contraindicated
• 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

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 REVATIO 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)
• 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 REVATIO blood levels. You should avoid taking REVATIO with grapefruit juice.

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

St-John’s wort may affect REVATIO blood levels. You should advise your doctor if you are taking St-John’s wort.

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