Ethinyl Estradiol / Norethindrone Acetate (Lolo)

1. Health Canada Product Monograph — Ethinyl Estradiol / Norethindrone Acetate

• Lolo is used for the prevention of pregnancy.
• Lolo does not protect against sexually transmitted infections, including HIV, so condoms should be used for that purpose.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• Lolo is contraindicated in women who are or may be pregnant.
• If pregnancy occurs while taking Lolo, the tablets should be stopped immediately.
• There is no conclusive evidence that accidental use of Lolo in early pregnancy harms the developing baby.

• Lolo is not recommended while breastfeeding, since hormonal contraceptives are excreted in breast milk and may reduce milk quantity and quality.
• If a nursing mother chooses to use hormonal contraception, a non-hormonal method is generally preferred until breastfeeding is fully established or weaning is complete.

• Lolo is not indicated for use in postmenopausal women.

• Lolo has not been studied in women under 18 years of age, and its use is not indicated before the first menstrual period.

• Lolo is taken as one blue active tablet daily for 24 consecutive days, followed by one white active tablet daily for 2 days, then one lilac placebo tablet daily for 2 days, repeating every 28-day cycle.
• The first pack can be started using a Day 1 Start (the first day of the menstrual period) or a Sunday Start (the first Sunday after the period begins).
• With a Sunday Start, a non-hormonal back-up method of birth control should be used for the first 7 days of the first cycle.
• When switching from another hormonal contraceptive, the timing of the first Lolo tablet depends on the method being switched from, so a healthcare provider's instructions should be followed closely.
• Lolo should not be started earlier than 28 days after childbirth in women who are not breastfeeding, due to an increased risk of blood clots in the postpartum period.
• Lolo may be started immediately after a first-trimester miscarriage or abortion without needing back-up contraception.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Serious harm has not been reported following accidental ingestion of large numbers of oral contraceptive tablets by young children.
• Overdose may cause nausea, vomiting, and withdrawal bleeding in women.
• There is no specific antidote; treatment of overdose is symptomatic.

• Headache may occur.
• Nausea may occur.
• Irregular or breakthrough bleeding (metrorrhagia) may occur, especially in the first few months of use.
• Breast tenderness may occur.
• Painful periods (dysmenorrhea) may occur.
• Weight changes may occur.
• Acne may occur.
• Mood swings may occur.
• Some women may not have a period each month (amenorrhea) while using Lolo.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Lolo can increase the risk of blood clots in the veins, such as deep vein thrombosis and pulmonary embolism.
• Lolo can increase the risk of blood clots in the arteries, such as heart attack and stroke.
• Lolo may increase the risk of being diagnosed with breast cancer.
• Lolo may increase the risk of benign or malignant liver tumours.
• Lolo may increase the risk of gallbladder disease.
• Lolo may increase blood pressure.
• Lolo may cause or worsen migraine headaches.
• Vision problems from blood vessel changes in the eye, including retinal blood clots, have been reported.
• Severe allergic reactions, including hypersensitivity, have been reported.
• Severe stomach pain, liver enlargement, or signs of internal bleeding may indicate a rare liver tumour and require urgent evaluation.
• Seek urgent medical attention for chest pain, sudden shortness of breath, leg swelling or pain, sudden severe headache, vision changes, or slurred speech or weakness on one side of the body.

• Use with caution in women who smoke, especially those over 35 years of age, due to a significantly increased cardiovascular risk.
• Use with caution in women with diabetes, high blood pressure, high cholesterol, or obesity, which increase cardiovascular risk with combined hormonal contraceptives.
• Use with caution in women with a personal or family history of blood clots, since this may indicate an inherited clotting tendency.
• Use with caution in women with a history of depression, since hormonal contraceptives may worsen mood symptoms.
• Use with caution in women with uterine fibroids, which may enlarge with estrogen use.
• Use with caution in women with a history of jaundice during pregnancy or with cholestatic liver disease.
• Use with caution in women scheduled for major surgery; stopping Lolo at least 4 weeks beforehand is generally advised due to clot risk.
• Use with caution in women prone to chloasma (skin darkening), since sun exposure can worsen this while on Lolo.

• Contraindicated in women hypersensitive to this drug or to any ingredient in the formulation.
• Contraindicated in women taking the hepatitis C combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir.
• Contraindicated in women with a history of blood clots in the veins, such as deep vein thrombosis or pulmonary embolism.
• Contraindicated in women with a history of stroke or other cerebrovascular disease.
• Contraindicated in women with a history of heart attack or coronary artery disease.
• Contraindicated in women with complicated valvular heart disease.
• Contraindicated in women with active liver disease or a history of liver tumours.
• Contraindicated in women with known or suspected breast cancer.
• Contraindicated in women with cancer of the uterine lining or other estrogen-sensitive cancers.
• Contraindicated in women with undiagnosed abnormal vaginal bleeding.
• Contraindicated in women with a history of jaundice related to hormone use or pregnancy.
• Contraindicated in women with eye blood vessel disease causing vision loss or visual field defects.
• Contraindicated in women who are or may be pregnant.
• Contraindicated in women with current or past migraine with aura.
• Contraindicated in women with severe or multiple risk factors for blood clots, such as uncontrolled high blood pressure or a known clotting disorder.

• Rifampin and rifabutin can increase the metabolism of Lolo's hormones and reduce contraceptive effectiveness; an alternative method of contraception is recommended.
• Certain anticonvulsants, including carbamazepine, phenytoin, phenobarbital, topiramate, and oxcarbazepine, can reduce Lolo's effectiveness.
• The antifungal griseofulvin can reduce contraceptive effectiveness.
• Certain HIV medications, including ritonavir, and the non-nucleoside reverse transcriptase inhibitor nevirapine, can alter hormone levels and affect Lolo's safety and effectiveness.
• St. John's Wort can reduce Lolo's effectiveness and increase the risk of breakthrough bleeding.
• Lolo may reduce the effectiveness of anticoagulant medications and lamotrigine.
• Lolo may increase the effects of theophylline, corticosteroids, cyclosporine, and certain benzodiazepines, requiring dose adjustment or monitoring.
• Antacids may reduce absorption of the progestin component if taken at the same time.

• Lolo can be taken with or without food; food does not meaningfully affect its contraceptive effectiveness.

• Lolo is taken once daily at approximately the same time each day, with or without regard to meals, to maintain consistent hormone levels and contraceptive effectiveness.

• Store Lolo at controlled room temperature, between 20°C and 25°C, in its original blister package.

• Lolo is a combined birth control pill taken daily in a specific 28-day pattern of active and placebo tablets.
• Taking Lolo at the same time every day and not missing tablets is important for reliable pregnancy prevention.
• Smoking while taking Lolo, especially after age 35, significantly increases the risk of serious blood clot and heart problems.
• Lolo does not protect against sexually transmitted infections.