TARO-DOMPERIDONE

2 Breast-feeding TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................

4 1. 1 Pediatrics ......................................................................................................................... 2 Geriatrics .........................................................................................................................

4 2. 4 3. 5 4. 1 Dosing Considerations ..................................................................................................... 2 Recommended Dose and Dosage Adjustment................................................................

4 Administration ................................................................................................................. 5 Missed Dose ....................................................................................................................

6 5. 6 6. 7 7. 1 Special Populations.......................................................................................................... 1 Pregnant Women.............................................................................................................

2 Breast-feeding ................................................................................................................. 3 Pediatrics .........................................................................................................................

4 Geriatrics.......................................................................................................................... 9 8. 1 Adverse Reaction Overview ............................................................................................

2 Clinical Trial Adverse Reactions ....................................................................................... 3 Less Common Clinical Trial Adverse Reactions ............................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ..........................................................................................................

5 Post-Market Adverse Reactions .................................................................................... 10 9. DRUG INTERACTIONS.................................................................................................................

1 Serious Drug Interactions .............................................................................................. 2 Drug Interactions Overview...........................................................................................

4 Drug-Drug Interactions). Domperidone should be used at the lowest possible dose for the shortest duration necessary. One 10 mg tablet three times per day with a maximum dose of 30 mg per day is recommended for all indications as the risk of serious cardiac events may be increased in association with daily doses > 30 mg.

4 Drug-Drug Interactions). Patients at a higher risk of QT interval prolongation and/or cardiac arrhythmia should be considered for cardiac assessment including Electrogastrographic EGG before initiation of domperidone therapy and during the treatment.

PrTARO-DOMPERIDONE (Domperidone Tablets) Page 6 of 32 For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764- 7669).

2 Recommended Dose and Dosage Adjustment One 10 mg tablet three times per day with a maximum dose of 30 mg per day is recommended for all indications as the risk of serious cardiac events may be increased in association with daily doses > 30 mg.

(See 2 CONTRAINDICATIONS and