GNH USA

Europe — EMA

Oedien (Dienogest, Ethinylestradiol | Lactose Monohydrate)

GNH USA supplies Oedien (Dienogest/Ethinylestradiol), a combined estrogen‑progestogen oral contraceptive for prevention of pregnancy and menstrual cycle

Request sourcing

1
Pack/s

What is Dienogest, Ethinylestradiol | Lactose Monohydrate?

Dienogest, the active ingredient in Oedien, is a combined estrogen‑progestogen oral contraceptive presented as a tablet for oral use. It works to prevent pregnancy and may be used to regulate the menstrual cycle in women of reproductive age. The formulation also contains ethinylestradiol, a synthetic estrogen, which together with dienogest provides reliable hormonal contraception.

GNH USA supplies Oedien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides batch‑tested products for global distribution.

What is Dienogest, Ethinylestradiol | Lactose Monohydrate used for?

Oedien, a combined estrogen‑progestogen oral contraceptive, is indicated for hormonal management of reproductive health.

- Prevention of pregnancy: provides reliable contraceptive protection for women of childbearing potential. - Regulation of menstrual cycle: helps achieve more predictable bleeding patterns and reduces menstrual flow. - Management of ovulatory disorders: assists in establishing regular ovulation cycles in women with irregular periods.

What are the side effects of Dienogest, Ethinylestradiol | Lactose Monohydrate?

Adverse reactions may occur with any hormonal contraceptive. The following lists reported events.

Common Side Effects: - Nausea: mild to moderate stomach upset. - Breast tenderness: discomfort or swelling of the breasts. - Headache: occasional tension‑type or migraine‑like pain. - Weight change: slight increase or decrease in body weight. - Mood changes: irritability or mood swings. - Breakthrough bleeding: unscheduled spotting between periods.

Serious or Rare Side Effects: - Venous thromboembolism: blood clots in deep veins or lungs. - Arterial thrombosis: clot formation in arteries, potentially causing stroke or myocardial infarction. - Hypertension: new‑onset or worsening high blood pressure. - Liver dysfunction: abnormal liver enzymes or cholestasis. - Severe allergic reaction: rash, swelling, or anaphylaxis. - Visual disturbances: sudden loss of vision or eye pain.

What precautions apply to Dienogest, Ethinylestradiol | Lactose Monohydrate?

Before prescribing Oedien, clinicians should consider several safety factors.

- Contraindicated in pregnancy: product is Category X and must not be used. - Avoid in women with a history of thromboembolic disorders: increased risk of clot formation. - Screen for hypertension: monitor blood pressure prior to initiation and during use. - Assess liver function: hepatic disease may alter drug metabolism. - Do not use in smokers over 35 years: smoking adds cardiovascular risk. - Store at room temperature: keep in the original pack, protect from moisture and heat.

What does Dienogest, Ethinylestradiol | Lactose Monohydrate interact with?

Oedien may interact with other medicines, altering its effectiveness or safety.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine): may markedly reduce contraceptive efficacy. - Anticoagulants (e.g., warfarin): hormonal components can enhance anticoagulant effect and increase INR.

Moderate Interactions (Monitor Closely): - Antibiotics such as tetracycline or fluoroquinolones: may slightly decrease absorption of estrogen. - Herbal supplements like St. John's wort: can lower plasma levels of ethinylestradiol. - Anticonvulsants (e.g., phenobarbital): may reduce hormonal concentrations, requiring additional contraceptive measures.

Frequently asked questions

What is Oedien used for?+
Oedien is a combined estrogen‑progestogen oral tablet indicated for the prevention of pregnancy and for regulation of the menstrual cycle in women of reproductive age. It provides reliable hormonal contraception and can help achieve more predictable bleeding patterns.
How does Dienogest work in Oedien?+
Dienogest, together with ethinylestradiol, suppresses the hypothalamic‑pituitary‑ovarian axis, preventing the luteinizing hormone surge that triggers ovulation. The progestogenic component also thickens cervical mucus and alters the endometrium, creating an environment that is unfavorable for fertilisation and implantation.
What is the usual dose of Oedien?+
The dosing regimen for Oedien is determined by the prescribing healthcare professional. Typically, combined oral contraceptives are taken once daily for a defined cycle, but the exact schedule and tablet strength should be confirmed by the prescriber.
Is Oedien safe to use during pregnancy or breastfeeding?+
Oedien is classified as Pregnancy Category X, meaning it must not be used during pregnancy because it can cause fetal harm. Use while breastfeeding is generally not recommended without medical advice, as hormonal contraceptives can affect milk production and infant exposure.
How do I order Oedien from GNH USA?+
To order Oedien, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.
How does Oedien compare with other combined oral contraceptives?+
Oedien contains dienogest and ethinylestradiol, a combination that offers a low‑dose progestin with a favorable bleeding profile. Compared with older formulations that use higher‑dose progestins, Oedien may be associated with fewer androgenic side effects while maintaining contraceptive efficacy.
What are the storage requirements for Oedien?+
Oedien tablets should be stored at room temperature, below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.
How is Oedien administered?+
Oedien is taken orally, usually once daily at the same time each day. The tablets are swallowed with water and should be started according to the prescriber’s instructions, often on the first day of the menstrual period.
What are the most serious risks associated with Oedien?+
The most serious risks include venous and arterial thromboembolic events, such as deep‑vein thrombosis, pulmonary embolism, stroke, and myocardial infarction. Additional serious concerns are hypertension, severe liver disease, and rare allergic reactions that may require immediate medical attention.
Who should not use Oedien?+
Oedien should not be used by women who are pregnant, have a known or suspected thromboembolic disorder, have uncontrolled hypertension, have a history of estrogen‑dependent tumors, or are smokers over the age of 35. It is also contraindicated in individuals with severe liver disease or known hypersensitivity to any component of the tablet.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Dienogest, Ethinylestradiol | Lactose Monohydrate
Route
Oral Use
Manufacturer
Laboratoires Bailleul S.A.
Origin
EU

Related products