Active ingredient
- ethinylestradiol
- gestodene
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00010/0530.
Femodene ED
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the user
Femodene® ED
Gestodene
Ethinylestradiol
Important things to know about combined hormonal contraceptives (CHCs):
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Femodene ED does
2. What you need to know before you use Femodene ED
3. Taking Femodene ED
3.3 A missed pill
4. Possible side effects
5. How to store Femodene ED
6. What is in Femodene ED and who makes it
1. What Femodene ED does
Femodene ED is a combined oral contraceptive pill (‘the Pill’). You take it to stop you getting pregnant.
This contraceptive contains two types of female sex hormones, oestrogen and progestogen. These hormones stop you getting pregnant by working in three ways: by preventing an egg being released from your ovaries; by making the fluid (mucus) in your cervix thicker, which makes it more difficult for sperm to enter the womb; and by preventing the lining of your womb thickening enough for an egg to grow in it.
Femodene ED is taken every day without a break. You take an ‘active pill’ each day for 21 days, followed by an ‘inactive pill’ each day for 7 days.
The benefits of taking the Pill include:
Femodene ED will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.
Femodene ED needs to be taken as directed to prevent pregnancy.
2. What you need to know before you use Femodene ED
General notes
Before you start using Femodene ED you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2.3 ‘Blood clots’.
It’s important that you understand the benefits and risks of taking the Pill before you start taking it, or when deciding whether to carry on taking it. Although the Pill is suitable for most healthy women it isn’t suitable for everyone.
Before you start taking the Pill
While you’re on the Pill
2.1 When you should not use Femodene ED
You should not use Femodene ED if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
Do not use Femodene ED:
Do not use Femodene ED if you have hepatitis C and are taking the medicinal products containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir (see also in section ‘Taking other medicines’)
2.2 When to take special care with Femodene ED
When should you contact your doctor?
Seek urgent medical attention
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Some of the conditions listed below can be made worse by taking the Pill. Or they may mean it is less suitable for you. You may still be able to take Femodene ED but you need to take special care and have check-ups more often.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Femodene ED, you should also tell your doctor.
2.3 Blood clots
Using a combined hormonal contraceptive such as Femodene ED increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block vessels and cause serious problems.
Blood clots can develop:
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of having a harmful blood clot due to Femodene ED is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs?
What are you possibly suffering from?
Deep vein thrombosis
Are you experiencing any of these signs?
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’).
What are you possibly suffering from?
Pulmonary embolism
Are you experiencing any of these signs?
Symptoms most commonly occur in one eye:
What are you possibly suffering from?
Retinal vein thrombosis (blood clot in the eye)
Are you experiencing any of these signs?
What are you possibly suffering from?
Heart attack
Are you experiencing any of these signs?
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
What are you possibly suffering from?
Stroke
Are you experiencing any of these signs?
What are you possibly suffering from?
Blood clots blocking other blood vessels
BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop Femodene ED your risk of a blood clot returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Femodene ED is small.
Women who are not using a combined hormonal pill and are not pregnant
Risk of developing a blood clot in a year - About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Risk of developing a blood clot in a year - About 5-7 out of 10,000 women
Women using Femodene ED
Risk of developing a blood clot in a year - About 9-12 out of 10,000 women
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Femodene ED is small but some conditions will increase the risk. Your risk is higher:
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Femodene ED needs to be stopped.
If any of the above conditions change while you are using Femodene ED, for example a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using Femodene ED is very small but can increase:
If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Femodene ED, for example you start smoking, a close family member experiences a thrombosis for no known reason, or you gain a lot of weight, tell your doctor.
2.4 The Pill and cancer
While high dose Pills reduce your risk of cancer of the ovary and womb if used in the long term, it is not clear whether lower dose Pills like Femodene ED also provide the same protective effects. However, it also seems that taking the Pill slightly increases your risk of cancer of the cervix – although this may be due to having sex without a condom, rather than the Pill. All women should have regular smear tests.
If you have breast cancer, or have had it in the past, you should not take the Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on the Pill, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Pill users is small. For example:
Your risk of breast cancer is higher:
Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely, the Pill has also been linked with some forms of liver cancer in women who have taken it for a long time.
2.5 Psychiatric disorders
Some women using hormonal contraceptives including Femodene ED have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
2.6 Taking other medicines
If you ever need to take another medicine at the same time as being on the Pill, always tell your doctor, pharmacist or dentist that you’re taking Femodene ED. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.
Some medicines can have an influence on the blood levels of Femodene ED and can stop it from working properly – for example:
If you do need to take one of these medicines, Femodene ED may not be suitable for you or you may need to use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.
Femodene ED can also affect how well other medicines work. Your doctor may need to adjust the dose of your other medicine.
In addition, Femodene ED can also interfere with the results of some blood tests, so always tell your doctor that you are taking Femodene ED if you have a blood test.
Do not use Femodene ED if you have hepatitis C and are taking the medicinal products containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glecaprevir / pibrentasvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Femodene ED can be restarted approximately 2 weeks after completion of treatment. See section ‘Do not use Femodene ED’).
2.7 Taking Femodene ED with food and drink
There are no special instructions about food and drink while on Femodene ED.
2.8 Pregnancy and breast-feeding
Do not use Femodene ED if you are pregnant. If you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Femodene ED.
If you are breast-feeding, your doctor or family planning nurse may advise you not to take Femodene ED. They will be able to suggest alternative contraception. Breast-feeding may not stop you getting pregnant.
2.9 Driving and using machines
Femodene ED has no known effect on the ability to drive or use machines.
2.10 Femodene ED contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Femodene ED.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. Taking Femodene ED
3.1 How to take it
To prevent pregnancy, always take Femodene ED as described below. Check with your doctor or family planning nurse if you are not sure.
This pack is designed to help you remember to take your pills. Your pack contains 3 foil memo strips with 3 sets of 7 self-adhesive strips showing the days of the week. Each foil memo strip contains 28 tablets: 21 small active tablets in 3 rows and 7 larger inactive tablets in the last row.
Take Femodene ED every day for 28 days
Then start your next strip
Start taking your next strip of Femodene ED the next day. Do not leave a gap between packs.
As long as you take Femodene ED correctly, you will always start each new strip on the same day of the week.
3.2 Starting Femodene ED
As a new user or starting the Pill again after a break
It is best to take your first Femodene ED pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.
Changing to Femodene ED from another contraceptive Pill
Starting Femodene ED after a miscarriage or abortion
If you have had a miscarriage or an abortion during the first three months of pregnancy, your doctor may tell you to start taking Femodene ED straight away. This means that you will have contraceptive protection with your first pill.
If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for advice. You may need to use extra contraception, such as condoms, for a short time.
Contraception after having a baby
If you have just had a baby, your doctor may advise you that Femodene ED should be started 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start Femodene ED and for the first 7 days of pill taking.
3.3 A missed pill
If you miss a pill, follow these instructions:
What kind of pill did you miss?
Inactive (large)
Active (small)
When were you due to take the missed pill?
Less that 12 hours ago
More than 12 hours ago, or you have missed more than one pill
If you have missed any of the pills in a strip, and you do not bleed while taking the large inactive pills, you may be pregnant. Contact your doctor or family planning clinic, or do a pregnancy test yourself.
If you start a new strip of pills late, you may not be protected from pregnancy.
If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as condoms, for seven days.
3.4 A lost pill
If you lose an active pill,
Either take the last active pill of the strip in place of the lost pill. Then take all the other pills on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection won’t be affected. After taking the large white inactive pills you will have a new starting day, one day earlier than before.
Or if you do not want to change the starting day of your cycle, take a pill from a spare strip. Then take all the other pills from your current strip as usual. You can then keep the opened spare strip in case you lose any more pills.
If you lose an inactive pill, don’t worry, just continue taking the remaining tablets at the correct time. Your contraceptive protection won’t be affected.
3.5 If you are sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea within 4 hours of taking the Pill, your body may not get its usual dose of hormones from that pill. If you are better within 12 hours of taking Femodene ED, follow the instructions in section 3.4 A lost pill.
If you are still sick or have diarrhoea more than 12 hours after taking Femodene ED, see section 3.3, A missed pill.
3.6 Missed a period – could you be pregnant?
Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the chemist or get a free test at your family planning clinic or doctors surgery. If you are pregnant, stop taking Femodene ED and see your doctor.
3.7 Taking more than one pill should not cause harm
It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding. Talk to your doctor if you have any of these symptoms.
3.8 When you want to get pregnant
If you are planning a baby, it’s best to use another method of contraception after stopping Femodene ED until you have had a proper period. Your doctor or midwife relies on the date of your last natural period to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away.
4. Possible side effects
Like all medicines, Femodene ED can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Femodene ED, please talk to your doctor.
An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present for all women using combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use Femodene ED”.
4.1 Serious side effects – see a doctor straight away
Rare side effects (between 1 and 10 in every 10,000 users may be affected)
The chance of having a blood clot may be higher if you have any other conditions that increase this risk (see section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).
Signs of a blood clot (see section 2.3 ‘Blood clots’)
Signs of a severe allergic reaction or worsening of hereditary angioedema:
Signs of breast cancer include:
Signs of cancer of the cervix include:
Signs of severe liver problems include:
4.2 Less serious side effects
Common side effects (between 100 and 1000 in every 10,000 users may be affected)
Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)
Rare side effects (between 1 and 10 in every 10,000 users may be affected)
Other side effects reported
4.3 Bleeding between periods should not last long
A few women have a little unexpected bleeding or spotting while they are taking Femodene ED, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Femodene ED as usual. The problem should disappear after the first few strips.
You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Femodene ED
Keep all medicines out of the sight and reach of children.
Do not use Femodene ED after the expiry date shown on the strip.
Do not store above 25°C and protect from light.
Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want. This will help to protect the environment.
6. What is in Femodene ED and who makes it
What is in Femodene ED
Each box of Femodene ED contains three strips of 28 tablets with three sets of 7 self-adhesive strips showing the days of the week.
Each strip of Femodene ED contains 21 white sugar-coated tablets containing 75 micrograms of the progestogen gestodene and 30 micrograms of the oestrogen ethinylestradiol and 7 larger, white, inactive tablets.
Femodene ED also contains the inactive ingredients:
Lactose, maize starch, povidone, sodium calcium edetate, magnesium stearate (E572), sucrose, macrogol 6000, calcium carbonate (E170), talc, montan glycol wax.
The company that holds the product licence for Femodene ED is:
Femodene ED is made by:
or
This leaflet was last updated in August 2021.
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