RAN-TADALAFIL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-07-2017
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Active ingredient:
TADALAFIL
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
G04BE08
INN (International Name):
TADALAFIL
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
TADALAFIL 2.5MG
Administration route:
ORAL
Units in package:
4/28/30/56/100/500
Prescription type:
Prescription
Therapeutic area:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0149485003; AHFS:
Authorization status:
APPROVED
Authorization date:
2016-07-12
Summary of Product characteristics
Page 1 of 48
PRODUCT MONOGRAPH
PR
RAN™-TADALAFIL
(tadalafil tablets, USP)
2.5 mg, 5 mg tablets (for _Once-a-Day_ use)
10 mg, 20 mg tablets (for _“On-Demand”_ dosing)
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
TREATMENT OF ERECTILE DYSFUNCTION (ED)
Ranbaxy Pharmaceuticals Canada Inc.
DATE OF REVISION:
126 East Drive
July 17, 2017
Brampton, Ontario
L6T 1C1
Control# 207323
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Page 2 of 48
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
.........................................................................................................................
8
DRUG
INTERACTIONS........................................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................................
14
OVERDOSAGE
......................................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
16
STORAGE AND STABILITY
...............................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 21
PAR
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