Novofem

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Novofem on Prescriptsy

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Novofem is a sequential combined hormone replacement therapy (HRT) used to relieve menopausal symptoms and prevent postmenopausal osteoporosis.

Each 28-day cycle comprises 16 white tablets containing estradiol 1 mg and 12 red tablets containing estradiol 1 mg plus norethisterone acetate 1 mg.

The sequential design provides continuous oestrogen supplementation throughout the cycle, with cyclical progestogen added for 12 days to protect the womb lining.

Novofem is a prescription-only medicine (POM) in the United Kingdom, manufactured by Novo Nordisk.

The menopause marks the permanent cessation of menstruation due to the loss of ovarian follicular activity.

In the UK, the average age of natural menopause is 51, although it can occur from the mid-40s onwards.

The perimenopause, the transitional phase leading up to the final period, may begin several years earlier and is characterised by fluctuating hormone levels, irregular periods, and the onset of symptoms such as hot flushes, night sweats, sleep disturbance, mood changes, and vaginal dryness.

Approximately 80% of women experience vasomotor symptoms during the menopausal transition, and for many, these symptoms significantly affect quality of life, relationships, and work productivity.

This page provides a detailed clinical guide to Novofem, including how it works, dosage instructions, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Novofem

Before reading further, please note these essential safety points.

• Novofem is a prescription-only medicine and should be used at the lowest effective dose for the shortest duration necessary.
• Combined HRT is associated with a small increased risk of breast cancer, venous thromboembolism, and stroke. Your prescriber will assess your individual risk before starting treatment.
• Report any unscheduled vaginal bleeding to your prescriber, particularly if it occurs after the first 6 months of treatment or after previously regular withdrawal bleeds.
• HRT is not a contraceptive. Use a separate method of contraception if you are perimenopausal and could still become pregnant.
• Attend routine NHS breast screening and report any breast changes to your GP promptly.

Understanding the menopause and HRT

The menopause occurs when the ovaries stop producing oestrogen and progesterone.

This decline in hormone levels is responsible for the symptoms that many women experience during the menopausal transition.

Oestrogen has widespread effects throughout the body, influencing not only the reproductive system but also the cardiovascular system, bones, brain, skin, and urogenital tract.

The fall in oestrogen levels contributes to vasomotor instability (hot flushes, night sweats), urogenital atrophy (vaginal dryness, urinary symptoms), bone loss (increasing the risk of osteoporosis and fractures), and changes in mood and cognition.

Hormone replacement therapy works by restoring oestrogen to alleviate these symptoms.

For women with an intact uterus, a progestogen must be added to oppose the proliferative effect of oestrogen on the endometrium.

Without progestogen, unopposed oestrogen significantly increases the risk of endometrial hyperplasia and endometrial cancer.

The progestogen can be given either cyclically (sequential combined HRT, producing a monthly withdrawal bleed) or continuously (continuous combined HRT, which aims to be bleed-free).

Sequential HRT is typically recommended for perimenopausal women or those within 12 months of their last period, while continuous combined HRT is usually prescribed for women who are at least 12 months past their last period.

What Novofem contains and how it works

Novofem contains two active ingredients. Estradiol (also written as oestradiol) is a naturally occurring oestrogen that is bio-identical to the hormone produced by the ovaries.

When taken orally, estradiol is absorbed from the gastrointestinal tract and undergoes first-pass hepatic metabolism, during which it is partly converted to estrone and estrone sulphate.

Despite this metabolism, sufficient estradiol reaches the systemic circulation to relieve menopausal symptoms and maintain bone density.

Norethisterone acetate (NETA) is a synthetic progestogen derived from testosterone. It is rapidly converted to norethisterone after absorption.

Norethisterone has strong progestogenic activity and transforms the oestrogen-primed endometrium from a proliferative to a secretory state, preventing hyperplasia.

It also has mild androgenic properties, which may influence lipid profiles and, in some women, cause acne or unwanted hair growth, although these effects are generally mild at the dose used in Novofem.

The sequential design of Novofem mimics the natural menstrual cycle to some extent: continuous oestrogen provides symptom relief throughout the month, while the 12-day progestogen phase triggers an orderly shedding of the endometrium, resulting in a predictable withdrawal bleed.

This pattern reassures both the woman and her prescriber that the endometrium is being adequately protected.

Clinical evidence and UK prescribing guidance

HRT is the most effective treatment for menopausal vasomotor symptoms.

NICE guideline NG23 (Menopause: diagnosis and management, updated 2019) recommends offering HRT to women with menopausal symptoms after discussing the benefits and risks.

The guideline states that for most women who start HRT under the age of 60 or within 10 years of menopause, the benefits of HRT outweigh the risks.

This applies to symptom relief, quality of life, and bone protection.

Sequential combined HRT products such as Novofem have been shown in clinical trials to significantly reduce the frequency and severity of hot flushes, typically by 80% to 90% within 4 to 8 weeks of starting treatment.

They also improve vaginal dryness, sleep quality, and mood. The progestogen phase effectively prevents endometrial hyperplasia when used at the recommended dose and duration within each cycle.

The British Menopause Society (BMS) position statement supports individualised prescribing of HRT and emphasises that the lowest effective dose should be used.

Novofem, with its 1 mg estradiol dose, provides a mid-range oestrogen level suitable for many women.

Women who require a higher dose for adequate symptom control may be prescribed alternative preparations.

Novofem compared with other sequential HRT options

Several sequential combined HRT products are available in the UK. Elleste Duet 1 mg contains estradiol 1 mg with norethisterone 1 mg in a similar sequential regimen.

Femoston 1/10 contains estradiol 1 mg with dydrogesterone 10 mg; dydrogesterone is a progestogen with a different side-effect profile that some women tolerate better than norethisterone.

Femoston 2/10 contains a higher estradiol dose (2 mg) for women with more severe symptoms. Clinorette contains estradiol valerate with norgestrel.

The choice between these products depends on symptom severity, tolerability, side-effect profile, and individual preference.

Transdermal HRT (patches or gel) avoids first-pass hepatic metabolism and is associated with a lower risk of VTE compared with oral preparations.

NICE NG23 recommends considering transdermal HRT for women with a higher baseline risk of VTE. Oestrogel (estradiol gel) is one such transdermal option.

For women who prefer or require oral treatment and have no elevated VTE risk, oral sequential HRT such as Novofem remains a well-established and effective choice.

Dosage and administration

Take one tablet daily at approximately the same time each day, swallowed whole with water, with or without food.

The blister strip is clearly marked with numbered tablets: start with tablet 1 (a white estradiol-only tablet) and follow the sequence through to tablet 28 (the last red combined tablet).

Begin the next strip immediately the day after finishing the previous one. There is no break between packs.

If you forget a dose, take it as soon as you remember if it is less than 12 hours late, then continue as normal.

If it is more than 12 hours late, discard the missed tablet and take the next one at the usual time. Do not double up.

Missing tablets increases the chance of breakthrough bleeding or spotting.

Your prescriber should review your HRT annually.

At each review, your prescriber will reassess your symptoms, check your blood pressure, ask about any vaginal bleeding, and discuss whether continued treatment is appropriate.

NICE NG23 recommends that there is no arbitrary limit on HRT duration; the decision to continue should be individualised.

Side effects of Novofem

Common side effects

Breast tenderness or swelling is one of the most frequently reported side effects and often improves within the first 3 months.

Headache, nausea, abdominal bloating, and mood changes (including low mood and irritability) are common during early treatment.

Breakthrough bleeding or spotting may occur, especially during the first 3 to 6 months.

A regular withdrawal bleed during or after the progestogen phase (red tablets) is expected and is not a side effect.

Venous thromboembolism

Oral HRT is associated with an increased risk of VTE. The absolute risk depends on age and baseline risk factors.

For women aged 50 to 59, the background incidence of VTE is approximately 2 to 3 per 1,000 over 5 years.

Oral HRT increases this to approximately 4 to 7 per 1,000 over 5 years.

Transdermal HRT does not appear to increase VTE risk and may be preferred for women with elevated baseline risk.

Symptoms of DVT include sudden swelling, pain, warmth, or redness in one leg. Symptoms of PE include sudden breathlessness, chest pain, and coughing up blood.

Call 999 immediately if these occur.

Breast cancer

Combined HRT is associated with a small increased risk of breast cancer that rises with duration of use.

The MHRA estimates that for women aged 50 to 59, using combined HRT for 5 years results in approximately 8 additional breast cancer cases per 1,000 women.

The risk declines after stopping treatment and returns to baseline within approximately 5 years. Oestrogen-only HRT carries a smaller increase in risk.

Attend all routine NHS breast screening appointments and report any breast changes to your GP promptly.

Other risks

There is a small increased risk of ischaemic stroke with oral HRT, though the absolute risk is low in women under 60.

The risk of endometrial cancer is not increased with correctly used combined HRT because the progestogen opposes oestrogen stimulation of the endometrium.

Ovarian cancer risk may be very slightly increased with long-term HRT use (more than 5 years). Gallbladder disease risk is mildly elevated with oral HRT.

When to seek medical advice

Stop Novofem and contact your prescriber urgently if you develop sudden leg swelling or pain, chest pain, breathlessness, sudden severe headache, visual disturbance, signs of jaundice (yellowing of the skin or eyes), or a significant rise in blood pressure.

Call 999 if symptoms suggest a DVT, PE, or stroke. Contact your GP or call NHS 111 for persistent or unusual vaginal bleeding, breast lumps, or worsening mood.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Novofem must not be used in women with known or suspected breast cancer or other oestrogen-dependent malignancies, current or previous VTE (unless on anticoagulant therapy), active or recent arterial thromboembolic disease, untreated endometrial hyperplasia, undiagnosed vaginal bleeding, active liver disease or liver tumours, known thrombophilic disorders, porphyria, or hypersensitivity to any ingredient.

Pre-treatment assessment

Before prescribing Novofem, your prescriber should take a thorough medical history, including family history of breast cancer, VTE, and cardiovascular disease. Blood pressure should be measured.

Breast examination and mammography should be performed where appropriate. NICE NG23 advises a thorough individualised risk-benefit discussion before starting HRT.

Monitoring during treatment

Annual reviews should include blood pressure measurement, assessment of ongoing symptom control, discussion of any new risk factors, and enquiry about vaginal bleeding patterns.

Unscheduled bleeding after the first 6 months of treatment, or a change in bleeding pattern after previously regular withdrawal bleeds, should be investigated with endometrial assessment.

Drug interactions

Enzyme-inducing medicines (rifampicin, carbamazepine, phenytoin, phenobarbital, St John's wort) accelerate the metabolism of estradiol and may reduce the effectiveness of HRT, potentially leading to breakthrough bleeding and reduced symptom control. Discuss all current medicines with your prescriber.

Lifestyle advice during the menopause

HRT is one component of a broader approach to managing the menopause. Regular weight-bearing and resistance exercise supports bone health, cardiovascular fitness, and mood.

A balanced diet rich in calcium and vitamin D supports bone density.

Limiting alcohol intake to 14 units or fewer per week, maintaining a healthy weight, and not smoking all reduce the risks associated with HRT and improve overall health outcomes.

Cognitive behavioural therapy (CBT) has been shown to help with vasomotor symptoms, sleep disturbance, and low mood during the menopause.

Peer support groups and reliable information sources, such as the NHS and the British Menopause Society, can provide valuable reassurance and guidance.

How to get Novofem in the UK

Novofem is available on NHS prescription from your GP, a menopause clinic, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Prepayment certificates are available for those who need multiple prescription items.

Sources

• Novofem, Summary of Product Characteristics (EMC)
• Norethisterone, British National Formulary (BNF)
• NICE NG23: Menopause, diagnosis and management
• Hormone replacement therapy (HRT), NHS
• British Menopause Society
• MHRA Yellow Card Scheme