YAZ PLUS FC TAB 28/FC TAB

Indications

Approved Uses

Oral contraception; and to raise folate levels to reduce the risk of neural tube defects in a pregnancy conceived during use or shortly after discontinuation.

Off-Label Uses

Acne and PMDD are approved indications for women who choose oral contraception.

Dosage & Administration

Dosing by Condition

For contraception with folate supplementation: 1 tablet daily for 28 days (24 active hormone tablets then 4 levomefolate tablets) taken in order; start next pack immediately after finishing the 28 tablets.

Initial Dose

Take one tablet daily by mouth at the same time every day in the order directed on the blister pack. For Day 1 start: first day of menstrual period. For Sunday start: first Sunday after period begins. Use backup contraception for first 7 days if not starting on Day 1.

Maintenance Dose

One tablet daily continuously (28-day cycle with no pill-free interval)

Maximum Dose

1 tablet orally once daily (one tablet per 24 hours).

Children's Dosage

Not approved for use before menarche; not applicable in prepubertal females

Dose Adjustment Notes

No routine dose adjustment; do not use in severe renal impairment or hepatic disease, and use caution/monitor potassium in patients at risk of hyperkalemia (e.g., renal impairment or concomitant potassium-elevating drugs).

How to Take

Take 1 tablet by mouth once daily at the same time each day, with or without food, following the order on the blister: 24 active hormone tablets followed by 4 levomefolate (non-hormonal) tablets; take all 28 tablets continuously and start the next pack the day after the last tablet (no pill-free interval).

Side Effects

Common Side Effects

Nausea, headache, breast tenderness/pain, irregular uterine bleeding/spotting, mood changes, and weight change/fluid retention; vomiting can occur.

Side Effect Frequency

Very common (≥10%): headache/migraine, nausea, breast pain/tenderness, irregular uterine bleeding/spotting. Common (1-10%): mood changes (including depressed mood), abdominal pain, acne, weight increase, dysmenorrhea, vaginal discharge. Uncommon/rare: venous thromboembolism and hypertension (rare but clinically important).

Safety & Warnings

Contraindications

Contraindicated in: current/history of venous thromboembolism or arterial thrombotic disease (DVT/PE/MI/stroke); thrombogenic valvular disease or rhythm disorders; migraine with aura; uncontrolled hypertension; diabetes with vascular disease; known/suspected breast cancer or other estrogen/progestin-sensitive malignancy; liver tumors or severe hepatic disease; renal impairment/insufficiency; adrenal insufficiency; undiagnosed abnormal uterine bleeding; pregnancy; hypersensitivity; and concomitant hepatitis C regimen ombitasvir/paritaprevir/ritonavir (± dasabuvir). Also contraindicated in women >35 years who smoke.

Warnings & Precautions

Warnings/precautions: increased VTE/ATE risk (higher with smoking, age >35, obesity, immobilization/surgery); advise no smoking and stop before major surgery/immobilization when appropriate; monitor blood pressure; consider potassium monitoring in patients on K+-raising drugs or with risk factors; watch for depression/mood changes; reduced efficacy with enzyme inducers; does not protect against HIV/STIs; may affect lab tests (coagulation, lipids, glucose, binding proteins).

Age Restriction

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

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: enzyme inducers (e.g., rifampin/rifabutin, carbamazepine, phenytoin, phenobarbital, primidone, topiramate, oxcarbazepine, griseofulvin, St. John’s wort) reduce efficacy; some antiretrovirals can alter hormone levels; drospirenone with potassium-elevating drugs (ACEIs/ARBs, potassium-sparing diuretics incl. spironolactone, NSAIDs, potassium supplements, heparin, etc.) increases hyperkalemia risk; ombitasvir/paritaprevir/ritonavir (± dasabuvir) increases ALT; COCs can lower lamotrigine levels.

Interaction Severity

MAJOR: Strong enzyme inducers (e.g., rifampicin/rifabutin, carbamazepine, phenytoin, phenobarbital, some antiretrovirals, St John’s wort) can reduce contraceptive efficacy-use alternative/backup contraception; ombitasvir/paritaprevir/ritonavir (± dasabuvir) regimens are contraindicated due to ALT elevations. MODERATE: Potassium-elevating drugs (ACE inhibitors/ARBs, potassium-sparing diuretics incl. spironolactone, NSAIDs, potassium supplements, heparin) may increase hyperkalemia risk-consider potassium monitoring in at-risk patients.

Food Interaction

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

Alcohol Interaction

Safe

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Caution

Children

Not approved for use before menarche; not applicable in prepubertal females

Elderly

Not indicated post-menopause; no relevant data in elderly women

Kidney Impairment

Contraindicated in renal impairment/renal insufficiency (including severe renal insufficiency or acute renal failure) due to hyperkalemia risk from drospirenone.

Liver Impairment

No dose adjustment recommended; contraindicated in severe hepatic impairment/active liver disease and in hepatic tumors-discontinue if clinically significant liver dysfunction develops.

Storage & Patient Advice

Storage Conditions

Do not store above 30°C. Store in original packaging to protect from moisture and light.

Missed Dose

If 1 active (hormone) tablet is missed: take it as soon as remembered (even if this means 2 in one day) and continue; backup is generally needed if ≥2 active tablets are missed or if the delay is ≥48 hours-use condoms for 7 days and follow week-specific instructions (if misses occur late in the cycle, omit the 4 folate tablets and start a new pack). Missed levomefolate (non-hormonal) tablets: discard missed tablet(s) and continue; no backup needed.

Stopping the Medicine

Can be stopped at any time; fertility typically returns quickly (often within the first cycle), but stop immediately and seek care if symptoms/signs of thromboembolism, severe headache/neurologic or visual symptoms, jaundice, or marked BP elevation occur.

Overdose

Overdose may cause nausea, vomiting, and withdrawal/vaginal bleeding; serious toxicity is unlikely-manage with symptomatic/supportive care and seek medical attention for large ingestions.

Patient Counseling

Take 1 tablet daily at the same time in blister order (24 active then 4 folate) with no break between packs; if vomiting/severe diarrhea occurs within ~3-4 hours of an active tablet, take another active tablet and manage as a missed pill if needed; use backup for 7 days when starting off-cycle, after significant missed active pills, or with enzyme-inducing drugs; does not protect against STIs; avoid smoking (especially age >35) and seek urgent care for VTE/stroke symptoms (leg swelling/pain, chest pain/SOB, severe headache, vision changes); the folate component helps reduce neural tube defect risk if pregnancy occurs soon after stopping.

Monitoring Requirements

Check blood pressure before initiation and periodically; consider serum potassium during the first cycle in patients at increased hyperkalemia risk (e.g., on long-term potassium-elevating medications or with renal impairment).

Pharmacology

Mechanism of Action

Drospirenone/ethinylestradiol suppress gonadotropins (FSH/LH) to inhibit ovulation, thicken cervical mucus, and alter the endometrium; levomefolate calcium provides active folate to increase folate status and reduce neural tube defect risk if pregnancy occurs during use or soon after stopping.

Onset of Action

If started on Day 1 of menses: immediate contraceptive protection; if started at any other time (e.g., Day 2-5 or “quick start”): use backup contraception for 7 consecutive days of active tablets.

Duration of Effect

Approximately 24 hours per tablet; contraceptive protection is maintained with correct daily use without gaps between packs.

Half-Life

Drospirenone: ~30 hours (range ~25-33 h). Ethinylestradiol: ~24 hours (range ~12-26 h). Levomefolate/5‑MTHF: ~4-5 hours.

Metabolism

Drospirenone: extensively metabolized primarily by non‑CYP pathways (e.g., reduction/opening of the lactone ring); CYP3A4 contributes only a minor fraction. Ethinylestradiol: extensive hepatic first-pass metabolism (including CYP3A4-mediated oxidation and conjugation) with enterohepatic recirculation. Levomefolate calcium: dissociates to L‑5‑methyltetrahydrofolate and enters the endogenous folate pool (no clinically meaningful CYP metabolism).

Excretion

Drospirenone: metabolites excreted via urine and feces in approximately equal proportions. Ethinylestradiol: metabolites excreted in urine and bile/feces with enterohepatic recirculation. Levomefolate (5‑MTHF): eliminated mainly via renal excretion and incorporation into body folate pools (with some fecal loss).

Protein Binding

Drospirenone: ~95-97% bound mainly to albumin (not to SHBG/CBG). Ethinylestradiol: ~98% bound to albumin (and increases SHBG but is not primarily SHBG-bound). Levomefolate/5‑MTHF: moderately protein bound (~50-60%).

Product Information

Available Dosage Forms

Film-coated tablet (28-tablet blister: 24 active pink tablets + 4 inactive light orange tablets)

Composition per Dose

Each active film-coated tablet (24 tablets): Drospirenone 3mg + Ethinylestradiol 0.02mg + Levomefolate calcium 0.451mg. Each inactive film-coated tablet (4 tablets): Levomefolate calcium 0.451mg only

Generic Availability

Yes

OTC Alternatives

No OTC alternative for hormonal contraception.

Hormone Type

Combined

Method

Oral

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