Femodene

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Femodene on Prescriptsy

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Femodene is a combined oral contraceptive pill (commonly known as "the pill") used to prevent pregnancy.

Each tablet contains two active hormones: gestodene 75 micrograms (a progestogen) and ethinylestradiol 30 micrograms (an oestrogen).

Femodene is manufactured by Bayer and is one of several combined oral contraceptives available on the NHS.

It is taken daily for 21 days followed by a 7-day pill-free break, during which a withdrawal bleed occurs.

This page provides a detailed clinical overview of Femodene, including how it works, how to take it, who it is suitable for, potential side effects, important safety warnings, and how to obtain it in the United Kingdom.

Contraception is a fundamental aspect of reproductive healthcare. In the UK, approximately 3.1 million women use a combined oral contraceptive pill as their primary method of birth control.

The combined pill remains one of the most widely chosen reversible contraceptive methods because of its high effectiveness, ease of use, and additional non-contraceptive benefits including lighter, more regular periods, reduced period pain (dysmenorrhoea), and lower long-term risk of ovarian and endometrial cancer.

Choosing the right contraceptive requires a careful discussion between a woman and her healthcare provider, taking into account medical history, lifestyle, preferences, and risk factors.

Femodene is one option within a broad range of available methods.

Important safety information about Femodene

Before reading further, note these essential safety points about Femodene and combined hormonal contraceptives.

• Femodene is a prescription-only medicine (POM) and requires a clinical assessment before use.
• Combined pills carry a small but real increased risk of blood clots (venous thromboembolism), heart attack, and stroke. The risk is higher in women who smoke, are overweight, have high blood pressure, or have a personal or family history of blood clots.
• Do not use Femodene if you have migraine with aura.
• Women aged 35 and over who smoke must not use combined hormonal contraception.
• Know the signs of blood clots (leg swelling, sudden chest pain, breathlessness, sudden severe headache, visual disturbance, limb weakness) and seek emergency help immediately.

Understanding combined hormonal contraception

Combined oral contraceptives contain two types of hormone: an oestrogen (usually ethinylestradiol) and a progestogen (there are several types, each with slightly different properties).

The combination of these hormones prevents pregnancy by suppressing ovulation (the release of an egg from the ovary), thickening the cervical mucus to block sperm from reaching the egg, and thinning the endometrium (womb lining) to reduce the likelihood of implantation.

Combined pills are categorised by the generation of progestogen they contain. Second-generation pills contain levonorgestrel or norethisterone. Third-generation pills contain gestodene or desogestrel.

The choice of progestogen affects the side effect profile and, to a small extent, the risk of venous thromboembolism.

NICE guideline NG37 and the Faculty of Sexual and Reproductive Healthcare (FSRH) clinical guideline on combined hormonal contraception provide detailed recommendations on choosing the most appropriate pill for each woman based on her individual risk factors and preferences.

The FSRH recommends that prescribers discuss the risks and benefits of different pill types with each woman, ensuring she can make an informed choice.

For women without additional VTE risk factors who prefer a pill containing gestodene, Femodene is a suitable option.

How Femodene works: mechanism of action

Femodene works through the combined actions of its two hormonal components. Ethinylestradiol (the oestrogen) suppresses follicle-stimulating hormone (FSH) secretion from the anterior pituitary gland, preventing follicular development.

Gestodene (the progestogen) primarily inhibits the luteinising hormone (LH) surge required to trigger ovulation. Together, they reliably prevent the release of a mature egg.

In addition to suppressing ovulation, the progestogenic component causes the cervical mucus to become thicker and more viscous, creating a physical barrier to sperm penetration. The endometrial lining also becomes thinner and less receptive, providing a further safeguard against pregnancy.

Gestodene is one of the most potent progestogens in clinical use, meaning it achieves its contraceptive effect at a lower dose than older progestogens.

It has relatively low androgenic activity, which may contribute to a favourable effect on skin and hair in some women.

The 30 micrograms of ethinylestradiol in Femodene provides reliable cycle control with a low incidence of breakthrough bleeding.

Clinical evidence and UK prescribing context

Combined oral contraceptives have been in clinical use for over 60 years and are among the most extensively studied medicines in the world.

When taken perfectly (no missed pills, no drug interactions), combined pills achieve a failure rate of approximately 0.3% per year.

With typical use, the failure rate rises to approximately 9% per year, largely due to missed pills.

Femodene has been available in the UK for more than 30 years. It is listed in the BNF and is available on NHS prescription.

NICE and the FSRH provide comprehensive guidance on the prescribing of combined hormonal contraceptives.

The key considerations in selecting a specific pill include the woman's VTE risk profile, her experience with previous contraceptives, cycle control preferences, and any non-contraceptive benefits she may wish to achieve.

The prescriber should perform a baseline assessment including blood pressure measurement, body mass index, smoking status, personal and family history of VTE and arterial disease, migraine history, and current medications.

These factors determine the UK Medical Eligibility Criteria (UKMEC) category for combined hormonal contraception, guiding whether it is safe to prescribe.

Femodene compared with other combined pills

Femodene contains ethinylestradiol 30 micrograms with gestodene 75 micrograms. Its sister product, Femodette, contains a lower oestrogen dose of 20 micrograms with the same progestogen.

The lower oestrogen dose in Femodette may result in fewer oestrogen-related side effects (such as breast tenderness, nausea, and bloating) but may also lead to slightly less reliable cycle control and a higher incidence of breakthrough bleeding in some women.

Compared with second-generation pills (such as Microgynon, which contains levonorgestrel and ethinylestradiol 30 micrograms), Femodene carries a slightly higher risk of VTE.

The MHRA and FSRH recommend that prescribers discuss this difference with women, noting that the absolute risk of VTE remains low with all combined pills and that individual risk factors (obesity, smoking, immobility, family history) contribute more substantially to overall risk than the choice of progestogen.

For women who experience androgenic side effects (such as acne or hirsutism) on second-generation pills, a switch to a third-generation progestogen like gestodene or desogestrel, or to a pill containing cyproterone acetate (Dianette), may be beneficial.

Conversely, for women with no specific preference and no additional VTE risk factors, a second-generation pill is often recommended as a first-line choice due to its slightly lower VTE risk.

Non-contraceptive benefits of Femodene

Combined oral contraceptives, including Femodene, offer several non-contraceptive health benefits.

These include lighter, more predictable menstrual bleeding, which can be particularly helpful for women with heavy periods (menorrhagia) or iron deficiency anaemia. Period pain (dysmenorrhoea) is typically reduced.

The combined pill is associated with a reduced risk of ovarian cysts, benign breast disease, pelvic inflammatory disease, ectopic pregnancy, ovarian cancer (risk reduced by approximately 40 to 50% with 5 or more years of use), and endometrial cancer (risk reduced by approximately 50% with 5 or more years of use).

These protective effects persist for many years after stopping the pill.

Dosage and administration

Take one Femodene tablet at the same time each day for 21 consecutive days, then take a 7-day break.

During the break, a withdrawal bleed (similar to a period) will usually occur within 2 to 3 days.

Start the next 21-day strip after the 7-day break, even if bleeding has not fully stopped.

Consistent timing helps maintain reliable contraceptive protection and makes it easier to remember your daily pill.

If starting Femodene for the first time without prior hormonal contraception, begin on day 1 of your menstrual cycle. No additional contraception is needed. If you start on day 2 to 5, use condoms for the first 7 days.

If switching from another combined pill, start Femodene the day after your last active pill. If switching from a progestogen-only method, consult the patient information leaflet or your prescriber for specific guidance, as timing varies by method.

Missed pill guidance

Missing pills reduces contraceptive efficacy. The risk of pregnancy depends on how many pills are missed and when in the cycle they are missed.

Follow the standard missed pill rules endorsed by the FSRH: one missed pill (up to 24 hours late) requires no additional precautions; two or more missed pills (48 hours or more late) require barrier contraception for 7 days, and if the missed pills fall in the last 7 days of the strip, the pill-free interval should be omitted.

If unsure about what to do after missed pills, contact your pharmacist, GP, or NHS 111 for advice.

Side effects of Femodene

Common side effects

The most frequently reported side effects include headache, nausea, breast tenderness or swelling, mood changes (including low mood or irritability), changes in menstrual bleeding patterns (spotting or breakthrough bleeding, particularly in the first 3 months), weight change, and fluid retention.

These effects are usually mild and often improve with continued use.

Uncommon and rare side effects

Uncommon effects include migraine, decreased libido, abdominal pain, vomiting, skin rash, and urticaria. Rare but serious effects include venous thromboembolism (DVT and PE), arterial thromboembolism (heart attack and stroke), liver tumours (benign and, very rarely, malignant), and hypertension.

Venous and arterial thromboembolism

The most important rare risk associated with combined hormonal contraception is blood clots.

Combined pills containing gestodene carry an estimated VTE risk of 9 to 12 per 10,000 women per year, compared with approximately 2 per 10,000 in non-users.

Arterial events (heart attack and stroke) are extremely rare in young, healthy, non-smoking women without additional risk factors.

Smoking, obesity, immobility, and age over 35 substantially increase these risks.

Cancer risk

Long-term use of combined pills is associated with a small increase in the risk of breast cancer and cervical cancer, which gradually returns to baseline after stopping.

However, combined pills significantly reduce the risk of ovarian and endometrial cancer. Overall, the balance of cancer risk is generally considered favourable for most women.

When to seek urgent medical advice

Call 999 or attend A&E if you experience sudden severe chest pain, breathlessness or coughing up blood (possible PE), sudden swelling, warmth, or pain in one leg (possible DVT), sudden severe headache unlike any experienced before, visual disturbance, weakness or numbness on one side of the body (possible stroke), or crushing chest pain with sweating and nausea (possible heart attack).

Contact your GP or NHS 111 for persistent headache, mood changes, breast lumps, or any new concerning symptoms. Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Who should not take Femodene

Femodene is contraindicated in women with current or previous VTE or arterial thromboembolism, known thrombophilic conditions, migraine with aura, uncontrolled hypertension, diabetes with vascular complications, active or history of severe liver disease, known or suspected breast cancer or other hormone-sensitive cancers, undiagnosed vaginal bleeding, pancreatitis associated with severe hypertriglyceridaemia, or hypersensitivity to any ingredient.

Risk factors for blood clots

Risk factors that may increase VTE or arterial risk include smoking (especially aged 35 and over), obesity (BMI 30 or above), immobility (long-haul travel, surgery, bed rest), family history of VTE or arterial disease in a first-degree relative under 45, migraine, hypertension, and age.

Women should be reassessed at each prescription review for changes in risk factors.

Drug interactions

Enzyme-inducing medicines (including carbamazepine, phenytoin, phenobarbital, rifampicin, rifabutin, efavirenz, nevirapine, and St John's wort) can reduce the effectiveness of combined pills.

Additional contraceptive measures or an alternative method should be used. Lamotrigine levels may be reduced by combined hormonal contraceptives; this interaction requires careful management if both are prescribed.

Surgery and immobilisation

If you are having major surgery that will involve prolonged immobilisation, your surgeon may advise stopping Femodene 4 to 6 weeks before the procedure to reduce VTE risk.

Alternative contraception should be arranged during this time. Restart the pill only after full mobilisation, on the advice of your surgical team.

How to get Femodene in the UK

Femodene is a prescription-only medicine available free of charge on the NHS.

You can obtain a prescription from your GP, a sexual health or family planning clinic, or an authorised online prescriber following a clinical assessment.

Contraception prescriptions are exempt from the standard NHS prescription charge; you do not need to pay even in England.

Regular reviews (at least annually) are recommended to reassess risk factors and suitability.

Sources

• Femodene Tablets, Summary of Product Characteristics (EMC)
• Ethinylestradiol with gestodene, British National Formulary (BNF)
• FSRH Clinical Guideline: Combined Hormonal Contraception
• NICE NG37: Contraception
• Combined pill, NHS
• MHRA Yellow Card Scheme