Drospirenone + Ethinyl Estradiol (0.03 mg)

Drospirenone + Ethinyl Estradiol (0.03 mg) is a combined oral contraceptive containing synthetic progestin (drospirenone) and synthetic estrogen (ethinyl estradiol). It prevents pregnancy by inhibiting ovulation, thickening cervical mucus, and making the endometrium unsuitable for implantation. Drospirenone has antimineralocorticoid and antiandrogenic activity. The pack contains 21 active tablets (3 mg drospirenone/0.03 mg EE) and 7 inactive tablets. Take one tablet daily at the same time for 21 days, then have a 7-day tablet-free break. Contraindicated in pregnancy, thrombosis, severe hepatic/renal disease, and hormone-sensitive malignancies.

• Oral contraception

Drospirenone + Ethinyl Estradiol is a combined oral contraceptive containing synthetic progestin (drospirenone) and synthetic estrogen (ethinyl estradiol). Drospirenone has antimineralocorticoid and antiandrogenic activity. Its contraceptive effect is based on inhibition of ovulation and changes in cervical secretion.

Drospirenone + Ethinyl Estradiol prevents ovulation, thickens cervical mucus to block sperm penetration, and makes the endometrium unsuitable for implantation.

Adult Dose: 1 active tablet (3 mg drospirenone/0.03 mg EE) PO daily for 21 days, THEN 1 inert tablet PO daily for 7 days.

Hepatic Dose: Contraindicated in severe liver disease.

Renal Dose: Contraindicated in severe renal disease.

Oral tablet. Take in the dose and duration as advised by your doctor. Swallow whole. Do not chew, crush or break. Take at the same time every day. Take with water if necessary.

If less than 12 hours late: Take as soon as remembered and next tablets at usual time. If more than 12 hours late: Contraceptive efficacy may be reduced.

1 tablet missed in Week 1: Take missed tablet as soon as remembered (even if 2 tablets at once), use extra contraception for next 7 days.

1 tablet missed in Week 2: Take missed tablet as soon as remembered, no extra precautions needed.

1 tablet missed in Week 3: Take missed tablet as soon as remembered and start next pack immediately, or have tablet-free break of 7 days.

Common Side Effects:

• Nausea
• Abdominal pain
• Vomiting
• Diarrhea
• Weight increased
• Fluid retention
• Headache
• Migraine
• Depressed mood
• Breast pain and tenderness
• Libido decreased
• Breast hypertrophy
• Rash, urticaria
• Venous and arterial thromboembolic disorders (rare)

• Thromboembolic Disorders: Increased risk of myocardial infarction, deep venous thrombosis, pulmonary embolism and cerebrovascular accidents.
• Cervical Cancer: May be associated with COC use.
• Hypertriglyceridemia: Triglyceride levels may increase.
• Blood Pressure: Monitor regularly.
• Jaundice: Discontinue if jaundice occurs.
• Liver and Kidney Disturbances: Caution required.
• Diabetes: Do not use if vascular involvement.

• Thrombosis (venous or arterial) present or history (DVT, PE, MI, CVA)
• Presence or history of prodromi of thrombosis (TIA, angina pectoris)
• Migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• Disturbed lipometabolism
• Severe or multiple risk factors for venous/arterial thrombosis
• Pancreatitis with severe hypertriglyceridemia
• Severe hepatic disease (until liver function normal)
• Severe renal insufficiency or acute renal failure
• Liver tumors (benign or malignant)
• Genital or breast malignancies (sex steroid-influenced)
• Undiagnosed vaginal bleeding
• Pregnancy (known or suspected)

Additive CNS effects with CNS depressants (alcohol, hypnotic sedatives, tranquilizers). Some medicines may reduce contraceptive efficacy: epilepsy drugs (primidone, phenytoin, barbiturates), tuberculosis drugs (rifampicin), antibiotics (ampicillin, tetracyclines, griseofulvin).

Caution is advised when consuming alcohol with Drospirenone + Ethinyl Estradiol (0.03 mg). Please consult your doctor.

Do not use during pregnancy. Discontinue immediately if pregnancy occurs.

Generally not recommended during breastfeeding. Seek doctor's advice if use during breastfeeding is desired.

Safety and efficacy in children not established.

No dose adjustment needed for elderly patients.

Renal impairment: Severe renal insufficiency or acute renal failure: Contraindicated.

Hepatic impairment: Severe hepatic disease (until liver function normal): Contraindicated.

Overdose may cause nausea, vomiting or vaginal bleeding. No serious harmful effects reported.

Store below 30°C. Keep out of reach of children.

Drospirenone + Ethinyl Estradiol (0.03 mg)