ZOMIG RAPIMELT

1 Dosing Considerations The following general statements apply to all dosage formulations of ZOMIG. • ZOMIG should only be used where a clear diagnosis of migraine has been established. • ZOMIG is not indicated for prophylaxis of migraine.

• Lactose is a non-medicinal ingredient in ZOMIG tablets. Patients with hereditary problems of galactose intolerance should use another ZOMIG formulation (orally disintegrating tablets, nasal spray) (see

1 Adverse Reaction Overview The adverse experience profile seen with ZOMIG NASAL SPRAY is similar to that seen with ZOMIG conventional tablets and ZOMIG RAPIMELT tablets, except for localized adverse events related to intranasal dosing.

ZOMIG is generally well tolerated. Across all doses, most adverse reactions were mild to moderate in severity as well as transient and self-limiting. The incidence of adverse events in controlled clinical trials was not affected by gender, weight, or age of patients; use of prophylactic medications; or presence of aura.

There were insufficient data to assess the impact of race on the incidence of adverse events. Serious cardiac events, including some that have been fatal, have occurred following the use of 5-HT1 agonists. These events are very rare and most have been reported in patients with risk factors predictive of coronary artery disease.

Events reported have included coronary artery vasospasm, transient myocardial ischemia, angina pectoris, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. (see 2 CONTRAINDICATIONS; 3 SERIOUS WARNINGS AND PRECAUTIONS BOX; 7 WARNINGS AND PRECAUTIONS - Cardiovascular).

As with other 5HT1 agonists, transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.

Isolated reports of chest pain, pulmonary edema, coronary vasospasm, transient cerebral ischemia, angina and subarachnoid hemorrhage have been received (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). As with other 5-HT1 agonists, ZOMIG has been associated with sensations of heaviness, pressure, tightness or pain which may be intense.

These may occur in any part of the body including the chest, throat, neck, jaw and upper limb. There have been rare reports of hypersensitivity reactions including urticaria and angioedema (see 7 WARNINGS AND PRECAUTIONS - Immune). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.

3 Pediatrics 04/2024 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 ......................................................................

5 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 8 5 OVERDOSAGE..............................................................................................................

8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS .................................................................................. 15 8 ADVERSE REACTIONS ................................................................................................

23 9 DRUG INTERACTIONS ................................................................................................ 27 10 CLINICAL PHARMACOLOGY .......................................................................................

28 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 32 12 SPECIAL HANDLING INSTRUCTIONS […]

). Safety and efficacy have not been established for cluster headache, which is present in an older, predominantly male population. 3 Pediatrics). 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS ZOMIG (zolmitriptan) is contraindicated: • in patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes, valvular heart disease or cardiac arrhythmias (especially tachycardias).

, atherosclerotic disease, congenital heart disease) should not receive ZOMIG. , stable angina of effort and vasospastic forms of angina such as the Prinzmetal’s variant), all forms of myocardial infarction, and silent myocardial ischemia.

Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks (TIAs). Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, or Raynaud’s syndrome (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular).

• in patients with uncontrolled or severe hypertension, as ZOMIG can give rise to increases in blood pressure (see 7 WARNINGS AND PRECAUTIONS - Cardiovascular). 4 Drug-Drug InteractionsError! ). ZOMIG (zolmitriptan) Product Monograph Page 6 of 56 • in patients with hemiplegic, basilar or ophthalmoplegic migraine.

4 Drug-Drug Interactions). • in patients who are hypersensitive to this drug 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.