Dienogest / Ethinylestradiol

What it is and how it works

A monophasic combined oral contraceptive containing dienogest 2 mg, a progestogen with antiandrogenic activity, and ethinylestradiol 30 micrograms. It inhibits ovulation and alters cervical mucus and the endometrium; the antiandrogenic effect can improve acne.

Indications

Oral contraception; in some markets also treatment of moderate acne in women who wish to use oral contraception, after failure of topical treatment.

Dosage and administration (summary)

One tablet daily at about the same time for 21 days, followed by a 7-day tablet-free interval.

Contraindications

Current or past venous or arterial thromboembolism, thrombophilia, migraine with aura, severe or multiple cardiovascular risk factors (including smoking over 35 years), severe hepatic disease or liver tumours, sex-steroid-dependent malignancy and undiagnosed vaginal bleeding.

Warnings and precautions

Carries the venous and arterial thromboembolic risks of combined hormonal contraceptives, with a venous risk somewhat higher than levonorgestrel-containing pills. Blood pressure should be checked before and during use. Efficacy may be reduced by vomiting, diarrhoea and enzyme-inducing drugs.

Pregnancy

Not indicated in pregnancy; discontinue if pregnancy occurs.

Storage and supply

Store below 25 °C in the original package.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.