Leaflet NOVOFEM 1mg / 1mg film-coated tablets

Indicated for: menopausal symptoms

Route of administration: oral

Substance: estradiol + norethisterone (estrogen + progestogen)

ATC: G03FB05 (Genito urinary system and sex hormones | Progestogens and estrogens in combination | Progestogens and estrogens, sequential preparations)

Precautions:
Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Estradiol and norethisterone are used together in hormone replacement therapy (HRT) for postmenopausal women. This combination helps alleviate menopausal symptoms and prevent osteoporosis in women at high risk.

Estradiol, an estrogen, replaces natural hormones that decline during menopause, reducing symptoms such as hot flashes, night sweats, vaginal dryness, and irritability. Norethisterone, a synthetic progestin, protects the uterine lining from excessive estrogen effects, preventing endometrial hyperplasia and reducing the risk of endometrial cancer.

This combination is also effective for women with severe menopausal symptoms, providing a more stable hormonal balance. Norethisterone may also help reduce irregular bleeding that can occur during hormonal therapy.

Side effects may include headaches, nausea, breast tenderness, mood changes, or water retention. In rare cases, more serious reactions such as blood clots, high blood pressure, or liver problems may occur, making regular medical monitoring essential.

Patients should strictly follow their doctor’s recommendations, and long-term use should be periodically evaluated to minimize risks and maximize treatment benefits.

General data about NOVOFEM 1mg / 1mg

  • Substance: estradiol + norethisterone
  • Date of latest medicines list: 01-07-2013
  • Product code: W12758001
  • Concentration: 1mg / 1mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Concentrations available for estradiol + norethisterone

  • 0.5mg/0.1mg
  • 1mg/0.5mg
  • 1mg/1mg