Novofem

Novofem is a sequential combined hormone replacement therapy used to relieve menopausal symptoms and to prevent postmenopausal osteoporosis in women at high risk of fractures.

Each pack contains two types of tablet: white tablets containing estradiol alone and red tablets containing estradiol combined with norethisterone acetate.

This sequential design provides continuous oestrogen with cyclical progestogen, mimicking a more natural hormonal pattern.

The oestrogen component replaces the declining ovarian production of estradiol, relieving vasomotor symptoms such as hot flushes and night sweats, as well as urogenital symptoms.

The progestogen, given for the last twelve days of each 28-day cycle, protects the endometrium from the stimulatory effect of unopposed oestrogen, reducing the risk of endometrial hyperplasia.

Novofem is suitable for perimenopausal and early postmenopausal women who still have an intact uterus.

A regular withdrawal bleed is expected towards the end of, or shortly after, the progestogen phase of each cycle.

Take one tablet daily by mouth, at roughly the same time each day, with or without food.

Start with the white estradiol-only tablets and take one each day for sixteen days, then switch to the red combined tablets for twelve days.

Begin the next pack immediately after finishing the previous one, without a break. A withdrawal bleed typically occurs during or shortly after the red-tablet phase.

If you miss a tablet, take it within twelve hours if possible. If more than twelve hours have passed, discard the missed tablet and take the next one at the usual time. Do not double the dose.

Each cycle consists of 16 white tablets (1 mg estradiol) followed by 12 red tablets (1 mg estradiol plus 1 mg norethisterone acetate), taken one daily without interruption.

The pack is designed to be taken in order and should not be altered.

Dose adjustments are not applicable for Novofem; if the strength is unsuitable, your prescriber will recommend a different HRT preparation.

Common side effects (up to 1 in 10 women) include headache, breast tenderness, nausea, abdominal pain, and withdrawal bleeding.

Uncommon effects include bloating, mood changes, fluid retention, and weight fluctuation. Spotting between expected bleeds may occur, particularly in the first few cycles, and usually settles.

Rare serious risks include venous thromboembolism, stroke, and a small increase in breast cancer risk with prolonged use.

Seek immediate medical attention for sudden chest pain, leg swelling, or visual disturbances.

Before starting Novofem, discuss your full medical history with your prescriber, including any history of blood clots, breast lumps, fibroids, endometriosis, migraine, epilepsy, or liver disease.

Attend routine mammographic screening. Treatment should be reviewed at least annually.

Stop the medication and seek urgent medical advice if you experience symptoms suggestive of deep vein thrombosis, pulmonary embolism, or stroke.

Novofem is not a contraceptive and should not be relied upon to prevent pregnancy.

Novofem is contraindicated in women with known or suspected breast cancer, oestrogen-dependent malignancy, undiagnosed vaginal bleeding, untreated endometrial hyperplasia, active or recent thromboembolic disease, known thrombophilic disorders, active hepatic disease, porphyria, or hypersensitivity to estradiol, norethisterone, or any excipient.

It must not be used during pregnancy or breastfeeding.