HEMANGIOL

2 Drug Interactions Overview 10/2019 4 DOSAGE AND ADMINISTRATION. 3 Administration 10/2019 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES............................................................................................

2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................

4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................

2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................

4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .......................................................................................

2 Recommended Dose and Dosage Adjustment..................................................... 3 Administration................................................................................................. 4 Missed Dose ....................................................................................................

12 5 OVERDOSAGE ........................................................................................................... 12

4 Post-Market Adverse Reactions 10/2019

4 Geriatrics 06/2021

5 kg Product Monograph HEMANGIOL (propranolol hydrochloride) Page 5 of 48  Breastfed infants, if the mother is treated with medicines contraindicated with propranolol (see section 9 DRUG INTERACTIONS)  Asthma or history of bronchospasm  Second- or third-degree heart blocks  Disease of the sinus node (including sinoatrial block)  Bradycardia: the following limits were used in the HEMANGIOL clinical trials: Age 0-3 months 3-6 months 6-12 months Heart rate (beats/min) 100 90 80  Low blood pressure below the following limits: Age 0-3 months 3-6 months 6-12 months Blood pressure (systolic/diastolic, mmHg) 65/45 70/50 80/55  Cardiogenic shock  Heart failure not controlled by treatment  Prinzmetal’s angina  Severe peripheral arterial circulatory disturbances (Raynaud’s phenomenon)  Patients prone to hypoglycemia  Pheochromocytoma HEMANGIOL is contraindicated in patients who are hypersensitive to propranolol or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.