Drospinetta 4 mg 28 tablets

Drospinetta 28 film-coated tablets

Composition:

Each active film-coated tablet contains:

Drospirenone micronized 4 mg

Placebo tablet:

Microcrystalline Cellulose 102

Spray Dried Lactose

Quinoline Yellow Color

Magnesium Stearate

Description:

Drospinetta is an oral progestin-only contraceptive intended for use by females of reproductive potential to prevent pregnancy. It contains drospirenone, which provides contraceptive efficacy with anti-mineralocorticoid and anti-androgenic properties. It is presented as 24 active (white) tablets and 4 inert (yellow) placebo tablets to be taken in a 28-day cycle.

Indications for Use:

Drospinetta is indicated for the prevention of pregnancy in women of reproductive age.

Dosage and Method of Administration:

Take one white active tablet daily at the same time for 24 consecutive days, followed by one yellow inert tablet daily for 4 days.

Start on Day 1 of menstrual bleeding if not switching from another contraceptive.

If switching from another method (COC, patch, ring, injection, IUD, or implant), start Drospinetta on the corresponding day of transition.

Missed Dose:

One missed white tablet: Take as soon as possible, continue remaining tablets as scheduled.

Two or more missed white tablets: Take the last missed tablet as soon as possible, use backup contraception for 7 days.

Missed yellow tablet(s): Skip and continue the pack as normal.

In case of vomiting/diarrhea within 3–4 hours of taking a tablet: take next day’s tablet early (within 12 hours).

Contraindications:

Renal impairment

Adrenal insufficiency

Hepatic impairment or liver tumors

Known or suspected progestin-sensitive cancers (e.g., cervical cancer)

Undiagnosed abnormal uterine bleeding

Precautions:

Hyperkalemia: Monitor potassium levels in high-risk patients.

Thromboembolic disorders: Increased risk in postpartum period or history of clotting disorders.

Bone loss: Potential for decreased estradiol levels.

Liver disease: Discontinue if liver dysfunction occurs.

Ectopic pregnancy: Be alert if abdominal pain or pregnancy symptoms develop.

Diabetes: May reduce insulin sensitivity.

Bleeding irregularities: Common in initial months; assess persistent irregular bleeding.

Depression: Monitor and discontinue if depression worsens.

Lactose intolerance: Not recommended for patients with rare galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Side Effects:

Adverse effects occurring in ≥1% of users:

Acne

Headache

Nausea

Breast pain or tenderness

Weight gain

Dysmenorrhea

Metrorrhagia or vaginal hemorrhage

Decreased libido

Menstrual irregularity

Pregnancy and Breastfeeding:

Not for use during pregnancy; discontinue if pregnancy occurs.

Safe for use during lactation; negligible transfer into breast milk and no effect on milk production.

Storage Conditions:

Store in a dry place at a temperature not exceeding 30°C.

Packaging:

Carton contains 1 strip of 24 active tablets + 4 placebo tablets and an insert leaflet.