YASMIN FC TAB 21/FC TAB

Indications

Approved Uses

Prevention of pregnancy (oral contraception).

Dosage & Administration

Dosing by Condition

Contraception: 1 tablet orally once daily for 21 days, then 7 days tablet‑free; repeat cycles starting the next pack on day 8.

Initial Dose

Take 1 tablet daily for 21 days starting on Day 1 of menses or Sunday after.

Maintenance Dose

One tablet daily for 21 days followed by 7 tablet-free days

Maximum Dose

1 tablet orally once daily (drospirenone 3 mg/ethinyl estradiol 0.03 mg) for 21 consecutive days per cycle (per 21-tablet pack).

Children's Dosage

Safety and efficacy established in females of reproductive age, including post-pubertal adolescents. Use before menarche is not indicated.

Dose Adjustment Notes

No dose titration is required; contraindicated in severe renal impairment and in hepatic disease/severe hepatic impairment; consider serum potassium monitoring in at‑risk patients during the first cycle.

How to Take

Take 1 film‑coated tablet orally once daily at the same time each day, following the order on the blister, for 21 consecutive days, then have a 7‑day tablet‑free interval and start the next pack on day 8; may be taken with or without food and swallowed with water.

Side Effects

Common Side Effects

Headache/migraine, nausea (± vomiting), breast pain/tenderness, irregular uterine bleeding/spotting, mood changes, bloating, and weight changes.

Side Effect Frequency

Common/very common adverse effects include: headache/migraine, nausea (± vomiting), breast pain/tenderness, mood changes, and unscheduled bleeding/spotting; other common effects can include abdominal pain and weight change. Serious but rare: venous thromboembolism/arterial thrombosis; possible hyperkalemia risk with drospirenone in susceptible patients.

Safety & Warnings

Contraindications

Contraindicated in: current/history of VTE (DVT/PE) or arterial thromboembolism (stroke/MI); known thrombophilias or high-risk for thrombosis; migraine with aura; breast cancer or other estrogen/progestin-sensitive malignancy; undiagnosed abnormal uterine bleeding; pregnancy; severe hepatic disease or liver tumors; renal impairment; adrenal insufficiency; uncontrolled hypertension; diabetes with vascular disease; smokers >35 years; and coadministration with ombitasvir/paritaprevir/ritonavir ± dasabuvir (HCV regimen) due to ALT elevations.

Warnings & Precautions

Major warnings/precautions: increased VTE/ATE risk (higher with smoking, age >35, postpartum, surgery/immobilization-stop 4 weeks pre-op); monitor blood pressure; drospirenone may cause hyperkalemia-check serum potassium during the first cycle in patients on potassium-elevating drugs or with risk factors; discontinue if jaundice/hepatic dysfunction occurs; does not protect against HIV/STIs.

Age Restriction

Not indicated for use before menarche; intended for females of reproductive potential.

Drug Interactions

Drug Interactions

Key interactions: CYP3A/UGT enzyme inducers (e.g., rifampin/rifabutin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate, St. John’s wort) reduce contraceptive efficacy; certain antiretrovirals can alter hormone levels; lamotrigine levels may decrease; drugs that raise potassium (ACEIs/ARBs, potassium-sparing diuretics, potassium supplements, some NSAIDs, heparin/aldosterone antagonists) increase hyperkalemia risk with drospirenone; ombitasvir/paritaprevir/ritonavir ± dasabuvir increases ALT risk.

Interaction Severity

MAJOR: Strong enzyme inducers (e.g., rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital/primidone, some antiretrovirals, St. John’s wort) reduce efficacy; ombitasvir/paritaprevir/ritonavir ± dasabuvir regimens are contraindicated due to ALT elevations. MODERATE: Potassium‑raising drugs (ACEIs/ARBs, potassium‑sparing diuretics incl. spironolactone, potassium supplements, some NSAIDs) increase hyperkalemia risk; lamotrigine levels may decrease (loss of seizure control).

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Children

Safety and efficacy established in females of reproductive age, including post-pubertal adolescents. Use before menarche is not indicated.

Elderly

Not applicable - indicated for women of reproductive age only; not used post-menopause

Kidney Impairment

Contraindicated in renal impairment (particularly moderate-to-severe) due to hyperkalemia risk; no dose adjustment-avoid use.

Liver Impairment

Contraindicated in hepatic disease/severe hepatic impairment and in liver tumors; no dose adjustment applicable-do not use until liver function normalizes.

Storage & Patient Advice

Missed Dose

If <12 hours late: take the missed tablet ASAP and continue as usual. If ≥12 hours late (or ≥1 pill missed): take the most recent missed tablet ASAP, continue daily, and use backup contraception for 7 days; if misses occur in week 3, omit the tablet‑free interval and start the next pack immediately.

Stopping the Medicine

Can be stopped at any time; discontinue at least 4 weeks before major surgery or prolonged immobilization with increased VTE risk.

Overdose

Likely symptoms: nausea, vomiting, and withdrawal/vaginal bleeding; treat with supportive care-no specific antidote; consider checking electrolytes (including potassium) if clinically indicated.

Patient Counseling

Take 1 tablet orally once daily at the same time for 21 days, then have a 7‑day tablet-free interval; start the next pack after exactly 7 days even if bleeding continues. If starting not on Day 1, use backup for 7 days. Missed pill guidance: if <24 hours late, take ASAP and continue; if ≥24 hours late (or ≥2 pills missed), take the most recent missed pill ASAP, continue daily, and use condoms for 7 days (consider emergency contraception if misses occurred in week 1 with unprotected sex). No STI protection. Avoid smoking (especially age >35). Seek urgent care for VTE/arterial event symptoms (leg swelling/pain, chest pain/SOB, severe headache, vision/speech changes). Check for drug interactions (enzyme inducers e.g., rifampin, certain antiepileptics, St John’s wort) and monitor blood pressure; drospirenone can increase potassium-caution with ACEi/ARB, K-sparing diuretics, NSAIDs in at-risk patients.

Monitoring Requirements

Check blood pressure before initiation and periodically thereafter; check serum potassium during the first cycle in patients at increased hyperkalemia risk (e.g., renal impairment or concomitant potassium‑raising drugs).

Pharmacology

Mechanism of Action

Suppresses ovulation by inhibiting gonadotropins (FSH/LH); progestin thickens cervical mucus and alters endometrium, while estrogen stabilizes endometrium and contributes to ovulation suppression.

Onset of Action

If started on Day 1 of menstrual bleeding: contraceptive protection is immediate. If started at any other time (and reasonably certain not pregnant): use additional contraception for 7 consecutive days.

Duration of Effect

Contraceptive effect persists with correct daily use; each tablet is taken once daily and efficacy is maintained across the 21-day course provided no doses are missed and the tablet-free interval does not exceed 7 days.

Metabolism

Drospirenone: extensively metabolized mainly by non-CYP pathways (e.g., reduction/opening of the lactone ring); CYP3A4 is a minor pathway. Ethinylestradiol: presystemic conjugation (sulfation/glucuronidation) and oxidative metabolism primarily via CYP3A4, with enterohepatic recirculation.

Excretion

Drospirenone: metabolites excreted via urine and feces in roughly similar proportions. Ethinylestradiol: metabolites excreted in urine and bile/feces with enterohepatic recycling.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: 3mg drospirenone and 0.03mg ethinylestradiol.

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Hormone Type

Combined

Method

Oral

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