Levonorgestrel / Ethinyl Estradiol (Min-Ovral)

1. Health Canada Product Monograph — Levonorgestrel / Ethinyl Estradiol

• Levonorgestrel and ethinyl estradiol is used for conception control (birth control) in women of reproductive age.
• It is not indicated for use before a woman's first menstrual period (menarche) or in postmenopausal women.

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

• This medicine is contraindicated when pregnancy is suspected or confirmed, and it should be stopped immediately if pregnancy occurs during use.
• There is no conclusive evidence that accidental exposure to the hormones in this medicine early in pregnancy harms the developing baby.

• Both hormones in this medicine pass into breast milk in small amounts and may reduce the quantity and quality of breast milk.
• Jaundice and breast enlargement have been reported in breastfed infants of mothers using this type of medicine.
• Breastfeeding mothers should use a different method of contraception until they have completely weaned their child.

• This medicine is not indicated for use in postmenopausal women.

• Safety and effectiveness have been established in women of reproductive age; use before a woman's first menstrual period (menarche) is not indicated.

• For the 21-tablet regimen, one tablet is taken daily for 21 consecutive days, followed by a 7-day break with no tablets, then the cycle repeats.
• For the 28-tablet regimen, one active tablet is taken daily for 21 consecutive days, followed by one inert (placebo) tablet daily for 7 days, with no break between packs.
• The first pack is usually started on day 1 of the menstrual cycle, on day 5, or on the first Sunday after the period begins; a backup method of birth control should be used for the first 7 days if starting on any day other than day 1.
• If vomiting or diarrhea occurs within 4 hours of taking a tablet, the dose may not be fully absorbed and should be managed the same way as a missed dose.
• This medicine does not require dose adjustment based on kidney or liver function, but it is not recommended in patients with significant liver impairment.

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

• Symptoms of overdose can include nausea, vomiting, breast tenderness, dizziness, stomach pain, and drowsiness or fatigue.
• Withdrawal bleeding may occur in women who take an overdose.
• There is no specific antidote for overdose; treatment is directed at the symptoms that occur.

• Spotting or breakthrough bleeding between periods may occur, especially in the first few cycles.
• Headache, including migraine, may occur.
• Nausea may occur.
• Breast tenderness, enlargement, or discomfort may occur.
• Painful periods (dysmenorrhea) may occur.
• Acne may occur.
• Weight or appetite changes may occur.
• Mood changes, including depression, may occur.
• Vaginal discharge or yeast infection may occur.
• Digestive symptoms, such as bloating or stomach cramps, may occur.

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

• This medicine increases the risk of blood clots in the veins (deep vein thrombosis, pulmonary embolism) and arteries (heart attack, stroke), especially in smokers over 35 and women with other risk factors.
• Liver problems, including benign and, rarely, malignant liver tumours, jaundice, and hepatitis, have been reported.
• An increased risk of breast cancer diagnosis has been associated with current and recent use of combined oral contraceptives, though this risk gradually declines after stopping.
• An increased risk of cervical cancer has been associated with long-term use in women with persistent human papillomavirus (HPV) infection.
• Gallbladder disease, including gallstones, may develop or worsen.
• High blood pressure may develop or worsen.
• Vision problems, including sudden vision loss from retinal blood vessel clots, may occur.
• Severe abdominal pain, a lump, or a mass may indicate a rare but serious liver tumour that can bleed internally.
• Severe or worsening headache, including migraine with aura, may signal an increased stroke risk and requires the medicine to be stopped.
• Seek urgent medical attention for sudden chest pain or shortness of breath, sudden severe headache, sudden vision changes, leg pain or swelling, or signs of a stroke.

• Use with caution, or avoid, in women who smoke, especially those over 35 years of age, because of a significantly increased risk of serious heart and blood vessel problems.
• Use with caution in women with diabetes, high cholesterol, obesity, or a family history of blood clots or heart disease.
• Use with caution in women with well-controlled high blood pressure, and only under close medical supervision.
• Use with caution in women with a history of depression, since mood changes can occur or worsen.
• Use with caution in women with gallbladder disease, since this medicine may worsen it.
• Use with caution in women who wear contact lenses, since this medicine can cause changes in vision or contact lens tolerance.
• Use with caution before major surgery or during long periods of immobility, since the risk of blood clots is increased; stopping this medicine one month before elective surgery is generally recommended.

• Contraindicated in patients with a known hypersensitivity to this medicine or any of its ingredients.
• Contraindicated in patients with a current or past history of blood clots (thrombophlebitis, deep vein thrombosis, or thromboembolic disorders).
• Contraindicated in patients with a current or past history of stroke, heart attack, or coronary artery disease.
• Contraindicated in patients with migraine with aura (focal neurological symptoms).
• Contraindicated in patients with active liver disease, abnormal liver function, or a history of liver tumours.
• Contraindicated in patients with known or suspected breast cancer or other estrogen-sensitive cancers.
• Contraindicated in patients with undiagnosed abnormal vaginal bleeding.
• Contraindicated in patients with uncontrolled high blood pressure or diabetes with blood vessel involvement.
• Contraindicated when pregnancy is suspected or confirmed.
• Contraindicated in patients taking certain hepatitis C antiviral combinations (ombitasvir, paritaprevir, ritonavir, with or without dasabuvir).

• Antibiotics such as rifampin and rifabutin can significantly reduce the effectiveness of this medicine by increasing hormone breakdown; another method of birth control should be used.
• Anticonvulsants such as carbamazepine, phenytoin, phenobarbital, and topiramate can reduce the effectiveness of this medicine.
• St. John's Wort can reduce the effectiveness of this medicine and increase breakthrough bleeding.
• Certain HIV medicines, including ritonavir and some protease inhibitors, can alter hormone levels and reduce contraceptive effectiveness.
• Griseofulvin, an antifungal medicine, can reduce the effectiveness of this medicine.
• This medicine can increase blood levels of other drugs, such as cyclosporine and theophylline, which may require dose adjustment.
• This medicine can decrease blood levels of lamotrigine, an anti-seizure medicine, which can lead to breakthrough seizures.
• Combining with the hepatitis C antiviral regimen ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, is contraindicated because of an increased risk of liver enzyme elevations.
• This medicine may increase the sedative effect of benzodiazepines and other sedatives.

• Levonorgestrel and ethinyl estradiol can be taken with or without food.

• This medicine is usually taken at the same time every day, preferably in the evening or at bedtime, to help maintain steady hormone levels and support a consistent daily habit.
• Taking it with food or before bed may help reduce nausea, particularly when first starting therapy.

• Store at room temperature (15°C to 30°C).
• Keep tablets in their original packaging and protect them from light once opened.
• Keep out of reach of children and pets.

• This medicine does not protect against sexually transmitted infections; use condoms in addition to this medicine if you need that protection.
• If you smoke and are over 35, talk to your healthcare professional about your increased risk of serious heart and blood vessel problems with this medicine.
• Seek urgent medical attention for sudden chest pain, shortness of breath, severe headache, vision changes, or leg swelling and pain.
• If you miss pills or have vomiting or diarrhea, use a backup method of birth control, since this medicine may not work as well.
• Tell your healthcare professional right away if you think you might be pregnant.