Finished product reference

Contraceptive Hd

Tablet · Oral · 0.25 mg/50 µg

List code
356
Pharmacologic class
Combined oral contraceptive (high-dose, monophasic)

What it is and how it works

A high-dose monophasic combined oral contraceptive containing ethinylestradiol 50 micrograms with a progestogen of the norgestrel/levonorgestrel type. It inhibits ovulation through suppression of gonadotrophins and also alters cervical mucus and the endometrium.

Indications

Oral contraception, generally reserved for situations requiring a higher oestrogen dose (for example concurrent enzyme-inducing drugs); also used in some protocols for cycle control.

Dosage and administration (summary)

One tablet daily for 21 days followed by a 7-day tablet-free interval, unless otherwise directed by the prescriber.

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

Thromboembolic risk is dose-related to the oestrogen content and is greater with 50-microgram preparations than with low-dose pills, which are preferred for routine contraception. Blood pressure, migraine and liver function should be monitored. Efficacy may be reduced by vomiting, diarrhoea and interacting 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.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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