Indications

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

Composition

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 synthetie progestin and estetrol is a synthetic estrogen.
4 white inert tablets.

Dosage & Administration

The recommended dosage of 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

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 diseard the other missed tablets.
Finish the active tablets and diseard 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. It more than two tablets are missed, follow the advice conceming missed tablets, including using backup non
hormonal contraception.

Interaction

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

Contraindications

This is contraindicated in females who develop or are known to have the following conditions:
. A high risk of arterial or venous thrombotic diseases
Current or history of a hormonally-sensitive malignancy (e.g., breast cancer]
Hepatie 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 that has an undiagnosed atiology
Renal impairment
. Adrenal insutficiency

Side Effects

Most common adverse reactions (22%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased.

Pregnancy & Lactation

Discontinue this if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy. Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk
production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. When possible, advise the nursing woman to use other methods of
contraception until she discontinues breast-feoding.

Precautions & Warnings

Thromboembolie Disorders and Other Vaseular Problems: Stop LIANA it a thrombotic or thromboembolic event ocours. Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before
initiating in any female, particularty in the presence of multiple risk factors.

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

Hypertension: Monitor blood pressure periodically and stop use it blood pressure rises significantly.

Migraine: Discontinue it new, recurrent, persistent, or severe migraines occur.

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

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

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

Gallbladder Disease and Cholestasis: Consider discontinuing LIANA in females with symptomatie gallbladder or cholestatie disease.

Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes it symptoms porsist.

Use in Special Populations

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

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

Overdose Effects

Overdosage of CHCs may cause nausea, vomiting, and severe headaches. Individual reports of thromboembolic complications and vaginal bleeding have occurred from overdosage. Pediatrie patients with
unintended CHC ingestion have reported nausea and vomiting and some developed irrtability and drowsiness; rare reports described vaginal bleeding. Overdosage Management Recommendations Consider
short-term prophylactie anticoagulation therapy for patients with high risk of VTE. Monitor serum potassium and sodium levels, and for evidence of metabolic acidosis.

Therapeutic Class

Oral Contraceptive preparations

Storage Conditions

Store at 20C to 25"C & frost-free place. Keep away from light. Excursions permitted to 15C to 30"C. Keep out of the reach of children.