Femodette
(Ethinyl Estradiol/Gestodene)

What Femodette is and what it is used for

Femodette 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. Femodette is a 21-day Pill – you take one each day for 21 days, followed by 7 days when you take no pills. The benefits of taking the Pill include:
• it is one of the most reliable reversible methods of contraception if used correctly
• it doesn’t interrupt sex
• it usually makes your periods regular, lighter and less painful
• it may help with pre-menstrual symptoms. Femodette will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this. Femodette needs to be taken as directed to prevent pregnancy.

How to take Femodette

3.1 How to take it To prevent pregnancy, always take Femodette as described below. Check with your doctor or family planning nurse if you are not sure. Take Femodette every day for 21 days Femodette comes in strips of 21 pills, each marked with a day of the week.
• Take your pill at the same time every day.
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all 21 pills.
• Swallow each pill whole, with water if necessary. Do not chew the pill. Then have seven pill-free days After you have taken all 21 pills in the strip, you have seven days when you take no pills. So if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week. Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills. You don’t need to use extra contraception during these seven pillfree days – as long as you have taken your pills correctly and start the next strip of pills on time. Then start your next strip Start taking your next strip of Femodette after the seven pill-free days – even if you are still bleeding. Always start the new strip on time. As long as you take Femodette correctly, you will always start each new strip on the same day of the week. 3.2 Starting Femodette As a new user or starting the Pill again after a break Page 13 of 18 v016_0 It is best to take your first Femodette 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 Femodette from another contraceptive Pill
• If you are currently taking a 21-day Pill: start Femodette the next day after the end of the previous strip. You will have contraceptive protection with your first pill. You will not have a bleed until after your first strip of Femodette.
• If you are taking a 28-day Pill: start taking Femodette the day after your last active pill. You will have contraceptive protection with your first pill. You will not have a bleed until after your first strip of Femodette.
• Or, if you are taking a progestogen-only Pill (POP or ‘mini Pill’): start Femodette on the first day of bleeding, even if you have already taken the progestogen-only Pill for that day. You will have contraceptive cover straight away. Starting Femodette 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 Femodette 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 Femodette 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 Femodette and for the first 7 days of pill taking. 3.3 A missed pill If you are less than 12 hours late with a pill, take it straight away. Keep taking your pills at the usual time. This may mean taking two pills in one day. Don’t worry – your contraceptive protection should not be reduced. If you are more than 12 hours late with a pill, or you have missed more than one pill, your contraceptive protection may be reduced.
• Take the most recently missed pill as soon as you remember, even if it means taking two at once. Leave any earlier missed pills in the pack.
• Continue to take a pill every day for the next seven days at your usual time.
• If you come to the end of a strip of pills during these seven days, start the next strip without taking the usual seven day break. You probably won’t have a bleed until after you finish the second strip of pills, but don’t worry. If you finish the second strip of pills and don’t have a bleed, do a pregnancy test before starting another strip.
• Use extra contraception for seven days after missing a pill, such as condoms. Page 14 of 18 v016_0
• If you have missed one or more pills from the first week of your strip (days 1 to 7) and you had sex in that week, you could become pregnant. Contact your doctor, family planning nurse or pharmacist for advice as soon as possible. They may recommend you use emergency contraception. If you have missed any of the pills in a strip, and you do not bleed in the first pill-free break, 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, or make your ‘week off’ longer than seven days, 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 a condom, for seven days. 3.4 A lost pill If you lose a pill, Either take the last 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 your seven pill-free days 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 if you have one. 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. 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 Femodette, follow the instructions in section 3.4, A lost pill, which describes how to take another pill. If you are still sick or have diarrhoea more than 12 hours after taking Femodette, see section 3.3, A missed pill. ➜ Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception. 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 Femodette and see your doctor. Page 15 of 18 v016_0 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 Femodette 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.

Possible side effects

Like all medicines, Femodette 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 Femodette, 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 Femodette”. ➜ Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may be due to Femodette. 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)
• harmful blood clots in a vein or artery for example:
•in a leg or foot (i.e. DVT)
•in a lung (i.e. PE)
•heart attack
•stroke
•mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
•blood clots in the liver, stomach/intestine, kidneys or eye. 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: Page 16 of 18 v016_0
• swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongue/throat may lead to difficulty swallowing and breathing
• a red bumpy rash (hives) and itching. Signs of breast cancer include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel. Signs of cancer of the cervix include:
• vaginal discharge that smells and/or contains blood
• unusual vaginal bleeding
• pelvic pain
• painful sex. Signs of severe liver problems include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice)
• inflammation of the liver (hepatitis)
• your whole body starts itching. ➜ If you think you may have any of these, see a doctor straight away. You may need to stop taking Femodette. 4.2 Less serious side effects

Common side effects (between 100 and 1000 in every 10,000 users may be affected)
• feeling sick
• stomach ache
• putting on weight
• headaches
• depressive moods or mood swings
• sore or painful breasts

Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)
• being sick and stomach upsets
• fluid retention
• migraine
• loss of interest in sex
• breast enlargement
• skin rash, which may be itchy

Rare side effects (between 1 and 10 in every 10,000 users may be affected)
• poor tolerance of contact lenses
• losing weight
• increase of interest in sex
• vaginal or breast discharge Page 17 of 18 v016_0

Other side effects reported
• Bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to Femodette. If it continues, becomes heavy or starts again, contact your doctor (see section 4.3).
• Chloasma (yellow brown patches on the skin). This may happen even if you have been using Femodette for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps
• Conditions that may worsen during pregnancy or previous use of the Pill:
•yellowing of the skin (jaundice)
•persistent itching (pruritus)
•kidney or liver problems
•gall stones
•certain rare medical conditions such as systemic lupus erythematosus
•occurrence or deterioration of the movement disorder chorea
•blister-like rash (herpes gestationis) whilst pregnant
•an inherited form of deafness (otosclerosis)
•Crohn’s disease
•ulcerative colitis
•a personal or family history of a form of sickle cell disease
•swelling of body parts (hereditary angioedema)
•an inherited disease called porphyria
•cancer of the cervix ➜ Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which you think may be due to Femodette. Also tell them if any existing conditions get worse while you are taking Femodette. 4.3 Bleeding between periods should not last long A few women have a little unexpected bleeding or spotting while they are taking Femodette, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Femodette 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. ➜ Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:
• carries on for more than the first few months
• starts after you’ve been taking Femodette for a while
• carries on even after you’ve stopped taking Femodette. Page 18 of 18 v016_0

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. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Femodette

Keep all medicines out of the sight and reach of children. Do not use Femodette 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.