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diane 35 ethinylestradiol and cyproterone acetate sugar coated tablet 21tablets per box

Description

 Indication & Scope

Diane-35® is a prescription anti-androgen combined hormonal contraceptive indicated for the treatment of moderate to severe androgen-sensitive acne (with or without seborrhea), hirsutism, and hyperandrogenic manifestations associated with polycystic ovary syndrome (PCOS) in women of reproductive age.For acne, it should be used only after topical therapy or systemic antibiotic treatment has failed.

  • Mechanism: Cyproterone acetate blocks androgen receptors and reduces androgen production, while ethinylestradiol suppresses ovulation, increases sex hormone-binding globulin (SHBG), and lowers circulating free androgens.
  • Drug Class: Combined anti-androgen oral hormonal contraceptive.
  • Clinical Use: Treatment of androgen-related acne, hirsutism, hyperandrogenism associated with PCOS, and oral contraception.
Specification
Generic Name Ethinylestradiol and Cyproterone Acetate Tablets
Brand Name Diane-35®
Ingredient Cyproterone Acetate + Ethinylestradiol
Dosage Form Sugar-coated Tablet
Package 21 tablets/carton
Conditions Treated Androgen-sensitive acne, hirsutism, hyperandrogenism associated with PCOS, oral contraception
Taboos Pregnancy, breastfeeding, thromboembolic disorders, severe liver disease, hormone-dependent malignancy, hypersensitivity
Place of origin Germany
Prescription type Prescription Only (Rx)
Storage Conditions Store at room temperature in a dry place, protected from moisture and light.
Manufacturer Bayer Weimar GmbH und Co. KG
Registration Authority National Medical Products Administration (NMPA), China
Approval Number HJ20170209
Approval Date January 04, 2023
Shelf Life 24 months

How to use ?

Recommended Dose: Take one tablet orally once daily at the same time each day for 21 consecutive days, followed by a 7-day tablet-free interval. Start the next pack on the 8th day, regardless of whether withdrawal bleeding has ended.

 

Time: It is recommended to start on the first day of menstruation. Withdrawal bleeding usually occurs 2–3 days after the last tablet.

 

Instructions for use: Swallow the tablet with water and follow the order indicated on the blister pack. If a tablet is missed by 12 hours or less, take it immediately. If more than 12 hours have elapsed, contraceptive protection may be reduced and additional barrier contraception should be used for 7 days. Treatment for acne or hirsutism generally requires 3–6 months before clinical improvement can be assessed.

 

Interaction: Enzyme-inducing medicines (e.g., rifampicin, carbamazepine, oxcarbazepine, topiramate, and St. John’s wort) may reduce contraceptive and anti-androgen efficacy. Do not use concurrently with other hormonal contraceptives.

 

Side effects: Common adverse reactions include breakthrough bleeding, breast tenderness, headache, nausea, mood changes, weight changes, and decreased libido. Rare but serious reactions include venous or arterial thromboembolism, myocardial infarction, stroke, severe liver disorders, and hypersensitivity reactions.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What is Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets) used for?

Diane-35® is used to treat androgen-sensitive acne, hirsutism, and hyperandrogenic symptoms associated with PCOS, while also providing oral contraception.

Can Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets) be used only for contraception?

No. Diane-35® is primarily indicated for women requiring treatment of androgen-related conditions. Although it provides effective contraception, it should not be used solely as a routine contraceptive unless clinically appropriate.

When should I start taking Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets)?

It is recommended to start on the first day of your menstrual period, take one tablet daily for 21 days, followed by a 7-day break, then begin the next pack.

How long does Diane-35® (Ethinylestradiol and Cyproterone Acetate Tablets) take to improve acne?

Clinical improvement is generally observed after 3–6 months of continuous treatment.

Diane-35® | Ethinylestradiol and Cyproterone Acetate | Contraception | DengYueRX

INN: Ethinylestradiol and Cyproterone Acetate
Indications: Moderate to Severe Acne, Hirsutism & Oral Contraception
Dosage Form: Sugar-coated Tablet
Strength: Cyproterone Acetate 2 mg + Ethinylestradiol 0.035 mg/Tablet

Original price was: $14.62.Current price is: $12.43.

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