GNH USA

Europe — EMA

Novofem (Estradiol | Norethisterone Acetate, Estradiol)

GNH USA supplies Novofem (Estradiol/Norethisterone), a hormone therapy for menopausal symptom relief and contraception. Request a quote for global supply.

Request sourcing

1
Pack/s

What is Estradiol | Norethisterone Acetate, Estradiol?

Estradiol, the active ingredient in Novofem, is a hormone presented as an oral tablet for systemic use. It works together with norethisterone acetate to address estrogen deficiency and provide progestogenic activity, commonly used in hormone replacement therapy and combined oral contraception for women. GNH USA supplies Novofem as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Estradiol | Norethisterone Acetate, Estradiol used for?

Novofem combines estradiol and norethisterone acetate to act on hormonal pathways involved in estrogen and progesterone balance. It is indicated for: - Menopausal symptom relief: reduction of hot flashes, night sweats and vaginal dryness. - Hormone replacement therapy: prevention of bone loss and treatment of estrogen deficiency in post‑menopausal women. - Contraception: prevention of ovulation as part of a combined oral contraceptive regimen.

What are the side effects of Estradiol | Norethisterone Acetate, Estradiol?

Novofem may cause a range of adverse reactions.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Breast tenderness: discomfort or swelling of breast tissue. - Headache: transient cranial pain. - Weight gain: fluid retention or increased appetite. - Mood changes: irritability or mild depression. - Irregular bleeding: spotting or breakthrough bleeding.

Serious or Rare Side Effects: - Thromboembolic events: deep vein thrombosis or pulmonary embolism. - Stroke or transient ischemic attack. - Myocardial infarction: heart attack risk, especially in smokers. - Hepatic adenoma: benign liver tumor. - Severe allergic reaction: anaphylaxis, angioedema. - Visual disturbances: sudden loss of vision or eye pain.

What precautions apply to Estradiol | Norethisterone Acetate, Estradiol?

Novofem should be used with awareness of several safety considerations. - Assess cardiovascular risk: evaluate history of clotting disorders before prescribing. - Review smoking status: avoid use in women over 35 who smoke. - Monitor liver function: caution in patients with hepatic impairment. - Consider bone health: assess osteoporosis risk in long‑term users. - Evaluate hormone‑sensitive conditions: avoid in active breast or endometrial cancer. - Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture and direct sunlight.

What does Estradiol | Norethisterone Acetate, Estradiol interact with?

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

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce hormonal levels and contraceptive efficacy. - Anticoagulants (e.g., warfarin): increased risk of bleeding. - Selective serotonin reuptake inhibitors (e.g., fluoxetine): may elevate plasma estrogen levels.

Moderate Interactions (Monitor Closely): - Antibiotics (e.g., tetracycline): may slightly decrease contraceptive reliability. - Antifungals (e.g., ketoconazole): can increase hormone concentrations. - Antiepileptics (e.g., phenytoin): may lower hormone effectiveness. - Herbal supplements (e.g., St. John’s wort): potential reduction in drug exposure.

Frequently asked questions

What is Novofem used for?+
Novofem is a combined oral formulation of estradiol and norethisterone acetate. It is used to relieve menopausal symptoms, provide hormone replacement therapy for estrogen deficiency, and serve as a combined oral contraceptive to prevent pregnancy.
How does estradiol work in Novofem?+
Estradiol in Novofem binds to estrogen receptors throughout the body, activating gene transcription that restores estrogen‑dependent functions such as bone maintenance, thermoregulation, and vaginal health. This action helps alleviate hot flashes, night sweats, and other menopausal complaints.
What is the usual dose of Novofem?+
The specific dose and dosing schedule of Novofem are determined by the prescribing clinician based on the individual’s medical condition, age, and treatment goals. Patients should follow the prescriber’s instructions and not alter the regimen without medical advice.
Is Novofem safe during pregnancy or breastfeeding?+
Novofem contains estrogen and a progestogen, which are generally contraindicated during pregnancy because they can affect fetal development. Breastfeeding mothers should consult their healthcare provider, as hormonal therapy may influence milk production and infant exposure.
How do I order Novofem from GNH USA?+
To order Novofem, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.
How does Novofem compare with other hormone therapies?+
Novofem combines estradiol with norethisterone acetate, offering both estrogenic and progestogenic effects in a single tablet. Compared with estrogen‑only products, it provides endometrial protection and can be used for contraception, while differing from other combined pills that may use ethinyl estradiol, which has a higher hepatic impact.
What are the storage requirements for Novofem?+
Novofem tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the medication out of reach of children and do not use if the packaging is damaged.
How is Novofem administered?+
Novofem is taken orally, usually once daily at the same time each day, with or without food, as directed by the prescriber. Consistent daily intake helps maintain stable hormone levels and maximizes therapeutic benefit.
What are the most serious risks associated with Novofem?+
Serious risks include thromboembolic events such as deep vein thrombosis or pulmonary embolism, stroke, myocardial infarction, and rare hepatic tumors. Patients should promptly report symptoms like sudden leg pain, shortness of breath, chest pain, or visual changes to a healthcare professional.
Who should not use Novofem?+
Novofem is contraindicated in women with a history of thromboembolic disorders, active breast or endometrial cancer, uncontrolled hypertension, severe liver disease, or known hypersensitivity to any component of the product. It should also be avoided in smokers over 35 years of age.
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
Estradiol | Norethisterone Acetate, Estradiol
Route
Oral Use
Manufacturer
Novo Nordisk Pharma Gmbh
Origin
EU

Related products