GNH USA

Europe — EMA

Novadien (Dienogest, Ethinylestradiol | Lactose Monohydrate)

GNH USA supplies Novadien (Dienogest/Ethinylestradiol), a combined oral contraceptive for prevention of pregnancy. Request a quote for global supply.

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What is Dienogest, Ethinylestradiol | Lactose Monohydrate?

Dienogest, the active ingredient in Novadien, is a combined oral contraceptive presented as an oral tablet for oral use. Together with ethinylestradiol, it provides hormonal contraception for women of reproductive age, suppressing ovulation and creating cervical mucus conditions that reduce the chance of fertilisation. The formulation is designed for daily intake and is regulated under EU pharmaceutical standards.

GNH USA supplies Novadien as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company follows stringent quality and regulatory protocols to ensure product integrity across global markets.

What is Dienogest, Ethinylestradiol | Lactose Monohydrate used for?

Novadien, a combined oral contraceptive, is indicated for hormonal contraception.

Contraception (prevention of pregnancy): provides reliable, reversible birth control for women of child‑bearing age when taken as directed. Menstrual cycle regulation: helps establish regular monthly bleeding, reduces the length and volume of periods, and can lessen menstrual‑associated symptoms. Management of dysmenorrhea: alleviates painful menstrual cramps and improves quality of life for women experiencing moderate to severe dysmenorrhea.

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

Novadien may be associated with a range of adverse reactions, which vary in frequency and severity.

Common Side Effects: - Nausea - Headache - Breast tenderness - Irregular vaginal bleeding

Serious or Rare Side Effects: - Deep vein thrombosis - Pulmonary embolism - Severe allergic reaction (anaphylaxis)

What precautions apply to Dienogest, Ethinylestradiol | Lactose Monohydrate?

Before prescribing Novadien, clinicians should consider several precautionary measures to ensure patient safety.

- Contraindications: avoid use in women with known thromboembolic disorders, active liver disease, or hormone‑sensitive cancers. - Smoking: advise against use in women over 35 who smoke, due to increased cardiovascular risk. - Cardiovascular risk: assess history of hypertension, diabetes, or hyperlipidaemia before initiating therapy. - Interactions: review concomitant medications that may affect clotting or hormone metabolism. - Pregnancy and lactation: discontinue if pregnancy is confirmed; avoid initiating during breastfeeding unless benefits outweigh risks. - Store at ambient temperature: keep tablets in original packaging, protect from moisture and direct sunlight.

What does Dienogest, Ethinylestradiol | Lactose Monohydrate interact with?

Novadien can interact with other medicines, altering its effectiveness or safety profile.

Major Interactions (Avoid): - Combined hormonal contraceptives with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine) may reduce efficacy, increasing risk of pregnancy. - Anticoagulants (warfarin) may have altered plasma levels, requiring monitoring. - Selective serotonin reuptake inhibitors (e.g., fluoxetine) may increase risk of bleeding.

Moderate Interactions (Monitor Closely): - Antiepileptic drugs (e.g., phenytoin) may modestly reduce contraceptive effect. - Antibiotics such as tetracycline may have a slight impact on hormone levels. - Herbal supplements containing St. John’s wort may decrease contraceptive reliability.

Frequently asked questions

What is Novadien used for?+
Novadien is a combined oral contraceptive indicated for the prevention of pregnancy in women of reproductive age. It is also used to help regulate menstrual cycles and to alleviate symptoms of dysmenorrhea when prescribed by a healthcare professional.
How does dienogest/ethinylestradiol work?+
The formulation contains dienogest, a progestogen that suppresses the mid‑cycle surge of luteinising and follicle‑stimulating hormones, thereby preventing ovulation. Ethinylestradiol provides estrogenic activity that stabilises the endometrium, modifies cervical mucus, and supports the overall contraceptive effect.
What is the usual dose of Novadien?+
The specific dosing regimen for Novadien is determined by the prescribing clinician. Typically, the medication is taken as one oral tablet daily at the same time each day, but the exact schedule and duration are individualized based on the patient’s medical history and needs.
Is Novadien safe to use during pregnancy or while breastfeeding?+
Novadien is not intended for use during pregnancy and should be discontinued if pregnancy is confirmed. While limited data exist for breastfeeding, the decision to use the product during lactation should be made by a healthcare professional, weighing potential benefits against any risks to the infant.
How do I order Novadien from GNH USA?+
To order Novadien, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams across international markets. The sales team will verify trade or institutional credentials and then provide pricing, availability, shipping details and any necessary import documentation.
How does Novadien compare with other combined oral contraceptives?+
Novadien contains the progestogen dienogest, which offers a slightly different hormonal profile compared with other COCs that use levonorgestrel or desogestrel. Efficacy in preventing pregnancy is comparable, but the side‑effect and bleeding‑pattern profile may differ, allowing clinicians to tailor therapy to individual patient preferences.
How should Novadien be stored and handled?+
Novadien tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, excessive heat and direct sunlight. Keep the product out of reach of children and do not use after the expiry date printed on the label.
How is Novadien administered?+
Novadien is taken orally as a tablet, usually once daily at the same time each day. The tablet should be swallowed whole with water and not chewed or broken. Consistent daily intake maximises contraceptive effectiveness.
What are the most serious risks to watch for while using Novadien?+
Serious risks include thromboembolic events such as deep‑vein thrombosis and pulmonary embolism, as well as arterial events like stroke or myocardial infarction. Rare but severe allergic reactions (anaphylaxis) and significant liver dysfunction may also occur. Prompt medical attention is required if any of these symptoms arise.
Who should not use Novadien?+
Novadien is contraindicated in women with a history of thromboembolic disorders, active liver disease, hormone‑sensitive cancers, or known hypersensitivity to any component. It should also be avoided by smokers over 35 years of age, pregnant or breastfeeding women, and those with uncontrolled hypertension or severe diabetes.
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
Farmitalia S.R.L.
Origin
EU

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