LOLO

1 Dosing Considerations To achieve maximum contraceptive effectiveness, LOLO should be taken exactly as directed and at intervals not exceeding 24 hours. • LOLO tablets may be administered without regard to meals. • LOLO provides a regimen consisting of 24 blue estrogen-progestin tablets, 2 white estrogen-only tablets, and 2 lilac placebo tablets.

2 Recommended Dose and Dosage Adjustment During the first cycle of use: • The possibility of ovulation and conception prior to initiation of medication should be considered. The patient is instructed to begin taking LOLO on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start).

If menstruation begins on a Sunday, the first tablet (blue) is taken that day. One blue tablet should be taken daily for 24 consecutive days followed by one white tablet for 2 consecutive days, followed by one lilac tablet daily for 2 consecutive days.

During the first cycle with a Sunday Start, contraceptive reliance should not be placed on LOLO until a blue tablet has been taken daily for 7 consecutive days and a non-hormonal back-up method of birth control (such as latex or polyurethane condoms or spermicide) should be used during those 7 days.

LOLO is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle. • The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week on which she began her first course, following the same schedule: 24 days on blue tablets – 2 days on white tablets - 2 days on lilac tablets.

If in any cycle the patient starts tablets later than the proper day, she should protect herself against pregnancy by using a non-hormonal back-up method of birth control until she has taken a blue tablet daily for 7 consecutive days.

Health Canada has not authorized an indication for pediatric use. See 1 INDICATIONS. 4 Administration Switching from another hormonal method of contraception: When the patient is switching to LOLO after completing a 21-day regimen of oral contraceptive tablets, transdermal patches, or a vaginal ring, she should wait 7 days after her last tablet, patch, or ring before she starts LOLO.

She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching to LOLO after completing a 28-day regimen of oral contraceptive tablets, she should start her first pack of LOLO on the day after her last tablet.

, retinal thrombosis) • pulmonary embolism • thrombophlebitis The following adverse reactions also have been reported in patients receiving oral contraceptives: Nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle.

The following other reactions, as a general rule, are seen less frequently or only occasionally: Blood and lymphatic system disorders: hemolytic uremic syndrome Ear and labyrinth disorders: auditory disturbances, otosclerosis-related hearing loss1 Eye disorders: cataracts, change in corneal curvature (steepening), intolerance to contact lenses, retinal thrombosis Gastrointestinal disorders: abdominal pain, Crohn’s disease1, diarrhea, gastrointestinal symptoms (such as abdominal cramps and bloating), pancreatitis, ulcerative colitis1 General disorders and administration site conditions: edema LOLO (ethinyl estradiol / norethindrone acetate and ethinyl estradiol) Page 17 of 52 Hepatobiliary disorders: cholestatic jaundice, gallstone formation1, liver function disturbances1 Immune system disorders: hypersensitivity Infections and infestations: rhinitis, vaginal candidiasis, vaginitis Investigations: change in weight (increase or decrease), reduced tolerance to carbohydrates Metabolism and nutrition disorders: changes in appetite, hypertriglyceridemia (increased risk of pancreatitis when using COCs)1, porphyria Musculoskeletal and connective tissue disorders: systemic lupus erythematosus1 Neoplasms benign, malignant and unspecified (including cysts and polyps): increase in size of uterine leiomyomata Nervous system disorders: chorea, dizziness, headache, migraine, optic neuritis, Sydenham’s chorea1 Psychiatric disorders: changes in libido, mental depression, nervousness Renal and urinary disorders: cystitis-like syndrome, impaired renal function Reproductive system and breast disorders: amenorrhea during and after treatment, breakthrough bleeding, breast changes including tenderness, enlargement, and secretion, change in menstrual flow, dysmenorrhea, endocervical hyperplasia, possible diminution in lactation when given immediately post- partum, premenstrual-like syndrome, spotting, temporary infertility after discontinuance of treatment, vaginal discharge Skin and subcutaneous tissue disorders: chloasma or melasma which may persist, loss of scalp hair, hirsutism, erythema multiforme, erythema nodosum, hemorrhagic eruption, herpes gestationis1, pruritis related to cholestasis1, rash (allergic), urticaria Vascular disorders: hypertension1, Raynaud's phenomenon 1.

• LOLO is contraindicated 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, COMPOSITION AND PACKAGING.

, due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) - severe dyslipoproteinemia - over age 35 and smoke - diabetes mellitus with vascular involvement - major surgery associated with an increased risk of postoperative thromboembolism - prolonged immobilization 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Cigarette smoking increases the risk of serious cardiovascular events associated with the use of hormonal contraceptives.

This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, LOLO should not be used by women who are over 35 years of age and smoke. See Cardiovascular. • Patients should be counselled that birth control pills DO NOT PROTECT against sexually transmitted infections (STIs) including HIV/AIDS.

For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH birth control pills. 1 Dosing Considerations To achieve maximum contraceptive effectiveness, LOLO should be taken exactly as directed and at intervals not exceeding 24 hours.

• LOLO tablets may be administered without regard to meals. • LOLO provides a regimen consisting of 24 blue estrogen-progestin tablets, 2 white estrogen-only tablets, and 2 lilac placebo tablets. 2 Recommended Dose and Dosage Adjustment During the first cycle of use: • The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient is instructed to begin taking LOLO on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start). If menstruation begins on a Sunday, the first tablet (blue) is taken that day.

• Use with the hepatitis C virus (HCV) combination drug regimen ombitasvir, paritaprevir, ritonavir with or without dasabuvir. See 7 WARNINGS AND PRECAUTIONS. • LOLO is contraindicated 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, COMPOSITION AND PACKAGING. , due to MTHFR C677T, A1298 mutations), prothrombin mutation G20210A, and antiphospholipid- antibodies (anticardiolipin antibodies, lupus anticoagulant) - severe dyslipoproteinemia - over age 35 and smoke - diabetes mellitus with vascular involvement - major surgery associated with an increased risk of postoperative thromboembolism - prolonged immobilization