Country: Canada
Language: English
Source: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
PB PHARMA INC
G04BE03
SILDENAFIL
100.0MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 100.0MG
ORAL
100
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261003; AHFS:
CANCELLED PRE MARKET
2019-06-07
_PB -SILDENAFIL _ _Page 1 of 44_ _ _ PRODUCT MONOGRAPH PR PB -SILDENAFIL Sildenafil (as sildenafil citrate) tablets 25 mg, 50 mg and 100 mg cGMP-Specific Phosphodiesterase Type 5 Inhibitor Treatment of Erectile Dysfunction PB PHARMA 400-3871 Belanger Street, Montréal, DATE OF PREPARATION: Québec, Canada. November 01, 2013 H1X 3M7 SUBMISSION CONTROL NO: 168869 _PB -SILDENAFIL _ _Page 2 of 44_ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................3 SUMMARY PRODUCT INFORMATION .........................................................................3 INDICATIONS AND CLINICAL USE................................................................................3 CONTRAINDICATIONS .....................................................................................................3 WARNINGS AND PRECAUTIONS....................................................................................4 ADVERSE REACTIONS......................................................................................................7 DRUG INTERACTIONS ....................................................................................................10 DOSAGE AND ADMINISTRATION................................................................................13 OVERDOSAGE ..................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ..............................................................15 STORAGE AND STABILITY............................................................................................18 SPECIAL HANDLING INSTRUCTIONS .........................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................18 PART II: SCIENTIFIC INFORMATION ......................................................................19 PHARMACEUTICAL INFORMATION............................................................................1 Read the complete document