This combination is indicated for use by females of reproductive potential to prevent pregnancy.

Drospirenone and Estetrol tablets is an oral contraceptive.

• 24 pink active tablets: Each tablet contains Drospirenone USP 3 mg and Estetrol Monohydrate INN equivalent to Estetrol 14.2 mg. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen.

• 4 white inert tablets.

The recommended dosage is one tablet daily for 28 consecutive days: one pink active tablet daily at the same time during the first 24 days followed by one white inactive tablet daily during the 4 following days.

Instruction for missed doses

If one pink active tablet is missed: Take the missed tablet as soon as possible and take the next tablet at the scheduled time, even if two active tablets are taken in one day. Continue taking one tablet a day until the pack is finished.

If two or more pink active tablets are missed in Week 1 or Week 2: Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the other missed tablets. Continue taking one tablet a day until the pack is finished. Use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.

If two pink active tablets are missed in Week 3: Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the other missed tablets. Finish the active tablets and discard the inactive tablets in the pack. Start a new pack of tablets the next day. Use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.

If one or more white inert tablets are missed: Skip the missed pill days and continue taking one tablet a day until the pack is finished.

Administration recommendations after vomiting or acute diarrhea: If vomiting or acute diarrhea occurs within 3 to 4 hours after taking an active tablet, take the new active tablet (scheduled for the next day) as soon as possible. Take the new tablet within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, follow the advice concerning missed tablets, including using back-up non-hormonal contraception.

CYP3A Inducers: May cause contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use an alternative or backup contraceptive method during co-administration and for up to 28 days after discontinuation of the CYP3A inducer.

This is contraindicated in females who develop or have known presence of the following conditions:

• High risk of arterial or venous thrombotic diseases
• Current or history of a hormonally-sensitive malignancy (e.g., breast cancer)
• Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or decompensated cirrhosis
• Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
• Abnormal uterine bleeding of undiagnosed etiology
• Renal impairment
• Adrenal insufficiency

Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and decreased libido.

Discontinue this product if pregnancy occurs, as there is no need to use hormonal contraceptives during pregnancy. Contraceptive hormones and/or their metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well established. When possible, advise nursing women to use other methods of contraception until they discontinue breastfeeding.

Thromboembolic Disorders and Other Vascular Problems: Stop LIANA if a thrombotic or thromboembolic event occurs. Do not start earlier than 4 weeks after delivery. Assess all cardiovascular risk factors before initiating therapy in any female, especially if multiple risk factors are present.

Hyperkalemia: Check serum potassium concentration during the first treatment cycle of LIANA in females on long-term therapy with medications that may increase serum potassium.

Hypertension: Monitor blood pressure periodically and discontinue use if blood pressure rises significantly.

Migraine: Discontinue LIANA if new, recurrent, persistent, or severe migraines develop.

Hormonally Sensitive Malignancy: Discontinue LIANA if a hormonally sensitive malignancy is diagnosed.

Liver Disease: Withhold or permanently discontinue LIANA for persistent or significant elevation of liver enzymes.

Glucose Tolerance and Hypertriglyceridemia: Monitor blood glucose in females with prediabetes or diabetes. Consider an alternative contraceptive method for females with hypertriglyceridemia.

Gallbladder Disease and Cholestasis: Consider discontinuing LIANA in females with symptomatic gallbladder disease or cholestasis.

Bleeding Irregularities and Amenorrhea: LIANA may cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

Pediatric Use: The safety and efficacy of LIANA have been established in females of reproductive potential. Use of LIANA before menarche is not indicated.

Geriatric Use: LIANA has not been studied in postmenopausal females and is not indicated in this population.

Overdosage of combined hormonal contraceptives (CHCs) may cause nausea, vomiting, and severe headaches. Individual reports of thromboembolic complications and vaginal bleeding have occurred from overdosage. Pediatric patients with unintended CHC ingestion have reported nausea and vomiting; some developed irritability and drowsiness; rare reports described vaginal bleeding. Overdose Management Recommendations Consider short-term prophylactic anticoagulation therapy for patients at high risk of venous thromboembolism (VTE). Monitor serum potassium and sodium levels, and watch for evidence of metabolic acidosis.

Oral Contraceptive Preparations

Store at 20°C to 25°C in a frost-free place. Keep away from light. Excursions permitted between 15°C and 30°C. Keep out of reach of children.