REGULON FC TAB 21/FC TAB

Indications

Approved Uses

Oral contraception (prevention of pregnancy).

Off-Label Uses

Cycle regulation and treatment of dysmenorrhea; endometriosis-related pain; acne/hirsutism and menstrual control in PCOS; PMS/PMDD symptom management (evidence varies).

Dosage & Administration

Dosing by Condition

Contraception: 1 tablet orally once daily for 21 days, then 7 days tablet‑free; repeat with the next pack.

Maintenance Dose

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

Maximum Dose

1 film-coated tablet orally once daily (desogestrel 150 µg/ethinyl estradiol 30 µg) every 24 hours.

Side Effects

Common Side Effects

Nausea (± vomiting), headache, breast tenderness/pain, breakthrough bleeding/spotting, mood changes, and melasma; acne and weight change can occur.

Side Effect Frequency

Very common (≥10%): headache, nausea, breast pain/tenderness, irregular bleeding/spotting. Common (1-10%): mood changes (including depressed mood), abdominal pain, weight change, acne, decreased libido, vomiting. Uncommon (0.1-1%): rash/urticaria, migraine, fluid retention. Rare (<0.1%): venous/arterial thromboembolism, hypertension, hepatic disorders (e.g., cholestasis), hypersensitivity.

Special Populations

Pregnancy

Contraindicated

Elderly

Not applicable - this product is indicated for women of reproductive age only

Pharmacology

Mechanism of Action

Suppresses ovulation by inhibiting gonadotropins (FSH/LH), thickens cervical mucus, and induces endometrial changes that reduce the likelihood of fertilization/implantation.

Duration of Effect

Approximately 24 hours per tablet; when taken correctly, contraceptive protection is maintained during the 7‑day tablet‑free interval.

Half-Life

Etonogestrel (active metabolite): ~30 hours (range ~28-38 h). Ethinylestradiol: ~24 hours (range ~20-30 h).

Product Information

Available Dosage Forms

Film‑coated tablet.

Composition per Dose

Each film-coated tablet: Desogestrel 150µg + Ethinylestradiol 30µg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Hormone Type

Combined

Method

Oral

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.