Femodette

What is Femodette?

Femodette is a combined hormonal birth control pill containing ethinylestradiol and gestodene. The contraceptive pill is one of the most reliable and reversible methods of contraception and can also help in regulating the menstrual cycle, making it lighter and less painful. Femodette also alleviates pre-menstrual symptoms.

It is available as white sugar-coated tablets in a box pack containing 21 pills each. When taken correctly, the combined pill, like Femodette, is more than 99% effective at preventing pregnancy when taken correctly. However, with typical use, such as being sick, having severe diarrhoea, or missing a pill, it’s closer to being 91% effective.

How Does Femodette Work?

Each tablet of Femodette contains 75 micrograms of gestodene, a progestogen, and 20 micrograms of ethinylestradiol, an oestrogen.

The hormones work in three distinct ways to protect you from unwanted pregnancy:

• It alters hormone levels and prevents the release of an egg from the ovaries each month (ovulation).
• Femodette thickens cervical mucus, making it difficult for sperm to reach the egg in the womb (uterus).
• It thins the uterus lining, making it less suitable for the implantation and growth of a fertilised egg.

Together, these mechanisms greatly reduce the chances of becoming pregnant.

How Do I Take Femodette?

Femodette comes in a 21-pill strip marked with the names of weekdays. Mark the first pill with the name of the day you started, and continue to take it regularly for the next 21 days. Follow the direction of the arrows on the strip and take the pill at the same time every day.

After completing the 21 pills, there is a pill-free week when you take no tablets for 7 days. If you have taken all the pills regularly, you will be protected against pregnancy this week. During this pill-free break, you should experience a withdrawal bleed, similar to a period.

On the 8th day, you have to start the new pack. It will be the same weekday as the one on which you started the previous 21-pill pack. As long as you take tablets regularly, the start date of a new strip will always be the same. The next pack should be started after 7 days, regardless of whether you are still bleeding.

Starting Femodette

Ideally, you should start taking Femodette on the first day of your period. This is known as day 1 of your menstrual cycle. However, if you start the combined pill on days 1 to 5 of your cycle, you will be protected from pregnancy straight away.

If you start Femodette after this time, you will not have immediate protection and will need to use additional contraception, like condoms, for the first 7 days.

What Do I Do if I Miss a Dose of the Femodette Pill?

If you have missed a Femodette pill, what you need to do will depend on how late you are taking your pill.

If you are less than 12 hours late taking Femodette, take the missed pill straight away, and continue taking your pills at the usual time, even if this means taking 2 pills in one day. You will still be protected against pregnancy.

If you are more than 12 hours late taking a Femodette pill or you have missed more than one pill, you may not be protected against pregnancy. You should:

• Take the most recently missed pill as soon as you remember, even if you have to take two pills at once, but leave any earlier missed pills in the pack.
• Keep taking one pill every day for seven days at the normal time.
• If you come to the end of the strip during these seven days, start the next strip without taking the usual 7-day pill-free break. You may not have a bleed until you finish the second strip – if you do not have a bleed, then take a pregnancy test.
• You will need to use condoms for 7 days after missing a pill.
• If you missed one or more pills in the first week of your strip and you had unprotected sex during that week, you could get pregnant. Speak to your clinician, family planning nurse, or pharmacist for more advice, as you may need emergency contraception.

If you start a new strip of pills late or make your pill-free break longer than seven days, you may not be protected against pregnancy. It’s therefore important to seek advice from a medical professional, as emergency contraception may be required. You should also use extra contraception, like condoms, for seven days.

What Should I Do if I Accidentally Take More Femodette Than I Should?

If you take more Femodette than you should. It is unlikely to cause you harm, but you may feel or be sick, or have vaginal bleeding. If you get any of these symptoms, speak to your clinician.

What Should I Do if I am Sick (Vomit) or Have Diarrhoea When Taking Femodette?

If you are sick (vomit) or have severe diarrhoea within 4 hours of taking the pill, it may not have been fully absorbed, and you could get pregnant. If you feel better within 12 hours of taking Femodette, you should follow the ‘lost pill’ guidance in the patient information leaflet that comes with your medication.

If you are still sick or have diarrhoea more than 12 hours after taking Femodette, you will need to follow the missed pill guidance. If your symptoms do not improve or get worse, speak to your clinician for more advice.

How to Switch to Femodette From Another Contraceptive Pill

It is possible to switch to Femodette from other types of contraceptive pills in the following ways:

Side Effects and Cautions of Femodette

Although Femodette pills are extremely effective, they may not be suitable for all circumstances. Everybody’s medical history and personal situation are unique, so it’s important to have a clear understanding of how a treatment can impact you so you can make a more informed decision about whether it is right for you. Your clinician will also be able to help with this.

Femodette Side Effects

Like all medicines, Femodette can cause side effects, though not everybody who takes Femodette will experience them. Before taking any new medicine, it is important to familiarise yourself with the associated risks and remain vigilant for any side effects or changes throughout your course of treatment. Potential Femodette side effects include:

This is not an exhaustive list of Femodette side effects. For further information, please refer to the Patient Information Leaflet.

If you experience any side effects, whether listed above or in the patient information leaflet, please inform your doctor or speak to a pharmacist for assistance. You can also report them via the MHRA’s Yellow Card scheme.

Allergic Reaction

Do not take Femodette if you are allergic to gestodene, ethinylestradiol, lactose or any of the other ingredients of Femodette listed in the Patient Information Leaflet.

Femodette contains 37.155mg of lactose and 19.660mg of sucrose per pill, so you should speak to your doctor or clinician before taking the medication if you are sensitive to some sugars. Sugar-coated pills can cause a spike in blood sugar and, therefore, may not be suitable for people who have trouble managing their blood sugar levels.

If you experience an allergic reaction to Femodette, stop taking the treatment immediately and seek emergency medical attention by going straight to the nearest accident and emergency department.

Signs of an allergic reaction include:

• Difficulty breathing (wheezing)
• Dry, red, cracked skin
• Itchy, red, watery eyes
• Raised, itchy, red rash (hives)
• Swelling of the lips, face, tongue or throat
• Tightness of the chest
• Tummy pain, nausea, vomiting or diarrhoea

In rare cases, Femodette can cause serious side effects that need urgent medical attention, such as:

• Blood clots in a vein or artery
• Breast cancer
• Cervical cancer
• Severe liver problems

Femodette and the Risk of Blood Clots

Combined oral contraceptive pills, like Femodette, increase your risk of developing blood clots compared to people who do not use them. Blood clots can develop in a vein or an artery.

The risk of developing a blood clot in the leg or lung with Femodette is small:

• 2 in every 10,000 women who are not taking the combined pill and are not pregnant will develop a blood clot each year
• 5-7 in every 10,000 women who are using a combined pill that contains levonorgestrel, norethisterone, or norgestimate will develop a blood clot each year
• The risk of developing a blood clot in women who use a combined pill that contains gestodene, like Femodette, is slightly increased to 9-12 out of 10,000 women each year

A clinician will discuss your medical history, including family history of blood clots, during your consultation to determine whether Femodette is safe for you to take.

You can find out more about the risk of blood clots when taking Femodette in section 4.4 of the Summary of Product Characteristics, available online. There is also detailed information in the Femodette Patient Information Leaflet, and the Medicines and Healthcare products Regulatory Authority (MHRA) provides guidance on the risk of blood clots associated with combined oral contraceptive pills. Another source of information is the College of Sexual & Reproductive Healthcare (CoSRH).

Femodette and Psychiatric Disorders

Depression and mood disorders have been reported by some women taking the combined pill, including Femodette. One study found that the first 2 years of taking oral contraception were linked with a 71% higher risk of developing depression compared to women who had never used it.

Depression is serious and, in some cases, can lead to suicidal thoughts or thoughts about harming yourself. If you get any of these symptoms, you should get urgent medical attention.

Femodette Interactions and Warnings

Femodette is not suitable for everyone, and there are several interactions and contraindications you should be aware of before taking it. Your clinician will assess whether Femodette is safe and suitable for you during your consultation, which is why you need a prescription to get it.

Do not take Femodette if you:

• Are allergic to any of Femodette’s ingredients
• Have or have ever had a blood clot in your legs, lungs, or other organs
• Have a blood-clotting disorder
• Have ever had a heart attack or stroke
• Have or have ever had angina pectoris or a transient ischaemic attack (TIA)
• Have any conditions that increase the chance of a blood clot in your arteries (severe diabetes with blood vessel damage, very high blood pressure, very high blood fat levels, hyperhomocysteinaemia)
• Have or have ever had a migraine with aura
• Have or have ever had breast cancer
• Have ever had severe liver disease and have been told your liver function test results are not yet back to normal
• Have ever had liver tumours

Before starting Femodette, you should let your clinician know about any other medical conditions you have that are not listed here. The combined pill may not be suitable for you if you smoke and are over 35, so you may need to consider the mini-pill instead.

Due to the enhanced risk of blood clots when taking combined contraceptive pills, it’s not recommended to use Femodette if you’re due to have elective surgery or are likely to be off your feet for a while. Speak to a clinician for advice about what to do in this situation. You can always start or resume Femodette when it is safe and suitable to do so.

Femodette and Other Medicines

Let your clinician know if you are taking any prescribed, over-the-counter, or herbal medications before starting Femodette. That’s because Femodette can affect how well some medicines work, and some can influence the levels of Femodette in your blood, particularly:

• Epilepsy medications
• HIV and hepatitis C medications
• Griseofulvin
• Certain antibiotics
• Some sedatives, like barbiturates
• St. John’s Wort

Do not take Femodette if you have hepatitis C and are taking any medicines that contain:

• Ombitasvir/paritaprevir/ritonavir
• Dasabuvir
• Glecaprevir/pibrentasvir
• Sofosbuvir/velpatasvir/voxilaprevir

You can also find more detailed information about how ethinylestradiol interacts with other medications on the National Institute for Health and Care Excellence (NICE) website.

Pregnancy and Breastfeeding

Do not take Femodette if you are pregnant, think you might be pregnant, or are breastfeeding. For further information, speak to your doctor or clinician.

If you become pregnant while taking the pill, cease taking Femodette and speak to your doctor urgently.

Other Safety Information

Always read the patient information leaflet before starting to take Femodette.

Do not take Femodette past the expiry date printed on the packaging. The date refers to the last day of that month.

Do not dispose of unused or expired medicine in household waste or down the drain. Take any unwanted or expired medicine to your local pharmacy and ask them to dispose of it safely on your behalf.

Always keep medicine out of sight and reach from children and pets.

Never share your medicine with anybody else, even if they are experiencing the same symptoms as you.

Frequently Asked Questions