HALOETTE

1 Dosing Considerations • Pregnant women: HALOETTE should not be used in women who are pregnant. 4 Drug-Drug Interactions section. • Discontinue medication: Please see 7 WARNINGS AND PRECAUTIONS section. 2 Recommended Dose and Dosage Adjustment To achieve maximum contraceptive effectiveness, HALOETTE must be used as directed (see When to Start HALOETTE below).

One HALOETTE is inserted in the vagina by the woman herself. As HALOETTE is designed to be a once-a-month contraceptive regimen the ring is to remain in place continuously for HALOETTE (etonogestrel/ethinyl / estradiol vaginal ring) Page 6 of 64 three weeks.

It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted no more than one week after removal of the last ring. Advise women to regularly check for the presence of HALOETTE in the vagina (for example, before and after intercourse).

3 Drug-Behavioural Interactions, Expulsion). Health Canada has not authorized an indication for pediatric and geriatric use. 4 Administration The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down.

The ring is to be compressed and inserted into the vagina until it feels comfortable. The exact position of HALOETTE inside the vagina is not critical for the contraceptive effect of the ring. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks.

This means that the ring is removed three weeks later on the same day of the week as it was inserted and at about the same time. HALOETTE can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out.

The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet). The withdrawal bleeding usually starts 2-3 days after removal of the ring and may not have finished before the next ring is inserted.

In order to maintain contraceptive effectiveness, the new ring must be inserted one week after the previous one was removed even if menstrual bleeding has not finished. For example, if HALOETTE is inserted on Wednesday at 22:00 h the ring should be removed again on the Wednesday 3 weeks later at about 22:00 h.

The following Wednesday a new ring should be inserted.

When to Start HALOETTE IMPORTANT:

The possibility of ovulation and conception prior to the first use of HALOETTE should be considered. , Day 1-5 of her menstrual bleeding). During the first seven days of HALOETTE use in the first cycle, an additional barrier method, such as male condoms or spermicide, is recommended.

, retinal thrombosis (See 7 WARNINGS AND PRECAUTIONS) • Myocardial infarction • Cerebral thrombosis • Cerebral hemorrhage • Hypertension (See 7 WARNINGS AND PRECAUTIONS; 2 CONTRAINDICATIONS) • Benign and malignant hepatic tumors • Gallbladder disease • Congenital anomalies The following adverse reactions also have been reported in patients receiving CHCs: Nausea and vomiting constitute the most common adverse reactions and occur in approximately 10% of patients during the first cycle.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The most common treatment-related adverse events seen in the two pivotal clinical studies were headache, vaginitis, and leukorrhea (Table 2).

These adverse events as well as the incidence of acne, breast tenderness, and nausea which are typical of contraceptives were low. 6 *Total n=2,322 subjects Cervical cytology was assessed in 2,039 women during treatment with etonogestrel / ethinyl estradiol slow release vaginal rings.

For the majority of subjects, the cervical Pap smear result was Pap I at screening and at last assessment. 3%). Clinically relevant shifts of particular note occurred for 7 subjects with a Pap result of I at screening to a Pap result of IIIb/IV (high-grade SIL) at last assessment.

In summary, changes to abnormal cervical cytology occurred in a low percentage of the subjects. 0%, respectively). 6%, respectively), partly due to the adverse events device-related events and vaginal discomfort, which were only reported in the etonogestrel / ethinyl estradiol slow release vaginal ring group.

, Hepatic/Biliary/Pancreatic, Immune 03/2025 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 .....................................................................

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

1 Dosing Considerations 03/2025 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Immune 03/2025 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