Femodene® ED - Open University



|Femodene® ED |oestrogen ethinyloestradiol (ethinylestradiol) and 7 larger, |

| |white, inactive tablets. Progestogen and oestrogen are both |

|This leaflet tells you about oral contraceptives in general |female types of hormone |

|and about Femodene ED in detail. Please read it carefully to |Femodene ED also contains the following inactive ingredients: |

|get the best from Femodene ED. If you are in any doubt about |lactose, maize starch, povidone, magnesium stearate (E572), |

|these instructions contact your doctor, pharmacist or Family |sucrose, macrogol 6000, sodium calcium edetate, calcium |

|Planning clinic. |carbonate (E170), talc, montan glycol wax. |

| |Each pack of Femodene ED contains 3 memo strips of 28 tablets |

|You and the pill |(21 active tablets and 7 larger, inactive tablets). Packs |

|How your body gets ready for pregnancy |containing 1 memo strip of 28 tablets are also available to |

|(the menstrual cycle) |doctors. |

|You can usually become pregnant (conceive) from when you start|Femodene ED is a combined oral contraceptive pill. Combined |

|to have periods, up until you are in your late 40s. Every |oral contraceptives contain two female types of hormone, |

|menstrual cycle takes about 28 days. About halfway through |oestrogen and progestogen. |

|this cycle an egg is released from one of your ovaries into a | |

|fallopian tube. This is called ovulation. |The product licence is held by |

|The egg travels down the fallopian tube towards your womb. |Schering Health Care Ltd |

|When you make love, your partner's penis releases millions of |The Brow, Burgess Hill, West Sussex, RH15 9NE |

|sperm into your vagina. Some of these sperm travel up through |Product licence number 0053/0180 |

|your womb into your fallopian tubes. If there is an egg in one|Femodene ED is manufactured by: Schering AG Berlin, Germany. |

|of these tubes, and a sperm reaches it, you can become |Uses |

|pregnant. This is called 'conception'. |Femodene ED is a low dose combined oral contraceptive. When |

|A fertilised egg gets embedded in the lining of your womb and |used as instructed you are very unlikely to become pregnant. |

|takes 9 months to grow into a baby. As an egg can live for up |Reasons for not taking Femodene ED |

|to 2 days, and sperm for up to 5 days, you can become pregnant|Before taking Femodene ED, tell your doctor if you have any of|

|if you have made love up to 5 days before ovulation and for |these: |

|some time afterwards. If a sperm does not fertilise an egg, |you are pregnant or think you may be pregnant. |

|the egg is lost at the end of the menstrual cycle with the |blood clots in the legs, lungs, eyes, or anywhere else or have|

|lining of your womb. This is called a 'period' |ever had these. If you have had a heart attack or if you have |

| |any medical condition which makes you more at risk of |

|How do natural hormones work? |developing blood clots. |

|Your menstrual cycle is controlled by two sex hormones made by|abnormal red blood cells (sickle-cell anaemia) |

|your ovaries: one called oestrogen the other progesterone (a |disorders of blood fat (lipid) metabolism. |

|progestogen). Oestrogen increases during the first half of |cancer of the breast or of the lining of the womb (mammary or |

|your menstrual cycle and makes your womb develop a thick |endometrial carcinoma) or have ever had either of these |

|lining, ready to receive the egg if conception happens. |conditions. |

|Progesterone comes later in the cycle and changes the lining |abnormal bleeding from your vagina of unknown cause. |

|of the womb still further to prepare it for pregnancy. |certain types of jaundice (Dubin-Johnson or Rotor syndromes). |

|If you do not become pregnant, you make less of these hormones|severe diabetes with changes to the blood vessels. |

|and this causes the lining of your womb to break down and the |liver tumours or have ever had these. |

|lining leaves your body as a period. But during pregnancy, |any other long or short-term liver disease. |

|your ovaries, and then the placenta (this attaches the growing|allergy to any of the ingredients of Femodene ED. |

|baby to the womb and gives it food), carry on making |Do not take Femodene ED if you have had any of these |

|progesterone and oestrogen to stop any more eggs being |conditions when you were pregnant: |

|released. |itching of your whole body (pruritus of pregnancy). |

| |the rash known as herpes gestationis. |

|How does the pill work? |worsening of inherited deafness (otosclerosis). |

|A pill such as Femodene ED contains hormones which are like |yellowing of the skin (jaundice). |

|those your body produces (oestrogen and progestogen). These | |

|help stop you from getting pregnant, just as your natural |What you should know before taking Femodene ED |

|hormones would stop you conceiving again when you are already |Before you start taking Femodene ED your pelvic organs, |

|pregnant. |breasts and blood pressure should be checked by your doctor |

|The combined contraceptive pill protects you against getting |and these checks should be repeated regularly. The doctor will|

|pregnant in 3 ways: |also make sure you are not pregnant. |

|No egg is released to be fertilised by sperm. |If anyone in your family has had any illness caused |

|The fluid in the neck of your womb thickens so it is more |by blood clots, or a heart attack, or a stroke at a young age,|

|difficult for sperm to enter it. |tell your doctor. |

|The lining of your womb does not thicken enough for an egg to |The following conditions need watching carefully |

|grow in it. |while you are taking the pill: |

| |If you have: |

|How effective is the pill? |severe depressive states, past or present. |

|The pill is one of the most effective contraceptives apart |varicose veins. |

|from sterilisation. But this can only be true when it is taken|diabetes (diabetes mellitus) or a tendency towards diabetes. |

|correctly. So you must follow your doctor's instructions and |high blood pressure (hypertension). |

|take the tablets exactly as it says in the next section of |fits (epilepsy). |

|this leaflet. |the inherited form of deafness known as otosclerosis. |

|Product information |the disease of the nervous system called multiple sclerosis. |

|The name of your medicine is: Femodene ED |the inherited disease called porphyria. |

|What does Femodene ED contain? |- calcium deficiency with cramps (tetany). |

|Each memo strip of Femodene ED contains 21 white sugar-coated |the movement disorder called Sydenham's chorea. |

|tablets containing 75 micrograms of the progestogen gestodene |breast problems, past or present. |

|and 30 micrograms of the | |

|diseases of the heart and blood vessels (cardio-vascular |you may not have a period until the end of two packs. If you |

|diseases). |do not have a period after the second pack, you must talk to |

|kidney diseases. |your doctor before starting the next pack. If your stomach |

|disturbed liver function. |upset continues for some time, consult your doctor who may |

|you are very overweight (obese). |consider another form of contraception. |

|an intolerance of contact lenses. | |

|systemic lupus erythematosus |Warnings |

|SLE (inflammation of connective tissue). |It has been suggested, on the basis of statistical evidence |

|asthma. |that the risk of developing various disorders of the |

|uterine fibroids (benign tumour of the womb). |circulation of the blood is slightly greater in women who take|

|gallstones. |the combined pill than in those who do not. This can lead to, |

|migraine. |for example, deep vein thrombosis (blood clot in the leg), |

|brown patches on the face and body (chloasma). This may be |strokes (blood clots and haemorrhages from the blood vessels |

|reduced by avoiding too much sunlight. |of the brain), heart attacks or pulmonary embolism (blood |

|any disease that is prone to worsen during pregnancy |clots blocking the arteries of the lungs). People do not |

|or, if; |always fully recover from these disorders, and, very rarely, |

|you have had inflamed veins (phlebitis). |they are fatal. Studies suggest that these disorders occur |

|anyone in your family has had breast cancer. |less often with modern low-dose oral contraceptives than with |

|anyone in your family has had any illness caused by blood |older pills. |

|clots, or a heart attack or stroke at a young age. |Certain conditions increase the risk of thrombosis. They |

|If any of these conditions gets worse or you have them for the|include: |

|first time, this may be a sign that you should stop taking |smoking. |

|Femodene ED. |obesity. |

|When you stop taking Femodene ED it may take some time for |some diseases of the heart and blood vessels. |

|your regular periods to return. |diabetes. |

| |migraine. |

|Taking other medicines with Femodene ED |a major operation or period of immobilisation (e.g. you are in|

|Some medicines may stop Femodene ED from working properly. |bed after an accident or operation or you have a plaster cast |

|If you are taking any other medicine while you are taking |on a broken leg). |

|Femodene ED, be sure to tell your doctor (or dentist). Your |if any members of your family have suffered from |

|doctor (or dentist) can tell you whether you should use extra |thromboembolic diseases (e.g. deep vein thrombosis, stroke or |

|contraceptive precautions and for how long. |heart attack) at a young age. |

|Medicines which can sometimes stop Femodene ED from working |varicose veins. |

|properly are antibiotics (such as ampicillin and rifampicin); |If any of these conditions apply to you before you decide to |

|griseofulvin (which is used to treat fungal infections); |take Femodene ED or while you are taking Femodene ED you must |

|phenylbutazone (which is used as an anti-inflammatory drug to |discuss them with your doctor. |

|treat some types of joint diseases); phenytoin, primidone, |The risk of arterial thrombosis (e.g. heart attack and stroke)|

|phenobarbitone and some other medicines used in people with |associated with the pill increases with age, and this risk is |

|epilepsy, and carbamazepine (which can be used to treat |increased by cigarette smoking. For this reason, the use of |

|epilepsy or other illnesses). |combined pills by women in the older age-group, especially |

|If you are taking any of these medicines you might still be |those who also smoke, is discouraged. |

|able to use Femodene ED, but you will also need to use an |Signs and symptoms of blood clots are given in the section |

|extra contraceptive method (condoms or cap plus spermicide) |"Reasons for stopping Femodene ED immediately". |

|while you are taking the other medicine and for 7 days after |The pill does give a substantial degree of protection against |

|you stop taking it. If these 7 days extend beyond the last |cancers of the ovary and the lining of the womb. An increased |

|active (small) tablets (i.e. the Friday just before the red |risk of cervical cancer in long-term users of the pill has |

|section) take the active tablets, throw away the large white |been reported in some studies. It is uncertain whether this |

|inactive tablets and start a new pack of Femodene ED by taking|increased risk is caused by the pill as it could be due to the|

|the Saturday tablet (small white) in the red section. |effects of sexual behaviour and other factors. |

|If you have to miss the large white inactive tablets you may |The evidence linking use of the pill and breast cancer is |

|not have a period until the end of two packs, but this is not |unclear. Some studies suggest an increased risk of breast |

|harmful. If you do not have a period after the second pack, |cancer in women below the age of 35, the risk increasing the |

|you must talk to your doctor before you start the next pack. |longer the pill is used. Any possible increased risk of breast|

|If you are taking rifampicin you will need to use another |cancer with combined pills is, however, likely to be small. |

|method of contraception as well as Femodene ED. You should do |The combination of ethinyloestradiol and gestodene, like other|

|this while you are taking the rifampicin and for 4 weeks after|contraceptives has been linked with an increased incidence of |

|you stop. |abnormal growths in the rat liver, but it is unclear whether |

|If you are diabetic your doctor may alter the dose of medicine|this could happen in humans. On rare occasions, the use of the|

|required to treat your diabetes. |pill has led to liver diseases such as jaundice and benign |

|If you are in doubt check with your doctor, pharmacist or |liver tumours, and, very rarely, it has been associated with |

|Family Planning clinic. |some forms of malignant liver tumours (cancer) in long-term |

| |users. Liver tumours may lead to life-threatening |

|Stomach upsets |intra-abdominal haemorrhage (bleeding in the abdomen). |

|Being sick or having very bad diarrhoea may stop Femodene ED |Therefore, if you have pain in the upper abdomen that does not|

|from working properly and make it less effective. Carry on |soon clear up tell your doctor. Also, if your skin becomes |

|taking Femodene ED as usual, and also use another method of |yellow (jaundice) you must tell your doctor. |

|contraception, (condom or cap plus spermicide) until 7 days |If you think you might be pregnant, stop taking Femodene ED |

|after you have recovered from the stomach upset. If these 7 |and consult your doctor immediately. Use another method of |

|days extend beyond the last active (small) tablet (i.e. the |contraception such as a condom until you see your doctor. |

|Friday just before the red section) throw away the large white|Certain conditions may sometimes get worse during |

|inactive tablets and start a new pack of Femodene ED by taking| |

|the Saturday tablet in the red section. If you have to miss | |

|the large inactive tablets | |

|use of the pill. The diseases are those listed under |Taking your first pack of Femodene ED |

|"What you should know before taking Femodene ED". |After taking your first pill, take one pill each day following|

|Reasons for stopping Femodene ED immediately |the direction of the arrows, until you have finished all 28 |

|If you experience any of the following conditions, take no |pills in the pack. |

|further tablets of Femodene ED and consult your doctor |You should try to take the pill at the same time every day, |

|immediately. In the meantime use another method of |for example, after breakfast. |

|contraception such as a condom. |Swallow each pill whole, with water if necessary. |

|migraine for the first time, or if existing migraine occurs |You should use another method of contraception, such as a |

|more often than before. |condom, for the first 14 days of tablet-taking. This is for |

|unusually bad headaches or if you have headaches more often |the first pack only. |

|than before. | |

|sudden changes to your eyesight, hearing, speech, sense of |Taking your next pack of Femodene ED |

|smell, taste or touch. |When you have finished the fist pack, start a new pack the |

|Unusual pains in your leg or unusual swelling of your arms or |next day by taking a pill from the red section of the new pack|

|legs, sharp pains in your chest or sudden shortness of breath,|marked with that day of the week. For example if you finish |

|crushing pains or feelings of heaviness in your chest, |your pack on a Tuesday start the next pack by taking a pill |

|coughing for no apparent reason, dizziness or fainting, or if |marked "Wed" in the red section. You will always start each |

|one side of your body suddenly becomes very weak or numb. |new pack on the same day of the week. |

|These may be symptoms of blood clot formation or symptoms of |A few days after you have taken the last active tablet from |

|an inflammation of veins combined with the formation of blood |each pack, you will have a period. Your periods will be |

|clots (thrombophlebitis}. |regular, probably lighter than before and almost always |

|your skin becomes yellow ( jaundice) you develop hepatitis |painless. The feelings that often make the last days before a |

|(inflammation of the liver) o; if your whole body starts |period unpleasant (called premenstrual syndrome) usually |

|itching. |disappear. |

|an increase in the number of fits (epileptic seizures). | |

|a large increase in your blood pressure. |Changing from another type of oral contraceptive 21-day |

|severe depression. |combined pill |

|severe upper abdominal pains or unusual swelling of your |If you are taking a 21-day contraceptive pill, finish that |

|abdomen. |pack and then start taking Femodene ED the next day starting |

|definite worsening of conditions which had got worse during a |with an appropriate pill in the red section for example |

|previous pregnancy or while taking the pill in the past. |Tuesday if you finished your other contraceptive pill on |

|pregnancy. |Monday. Then follow the instructions as described under |

|surgery or immobilisation. You must stop Femodene ED six weeks|"Taking your first pack of Femodene ED" and don't forget the |

|before a planned major operation (e.g. stomach surgery), if |14 days additional precautions. You may not have a period |

|you are having any surgery to the legs, or medical treatment |until the end of the first Femodene ED pack, but this is not |

|for varicose veins. Also if you are immobilised for a long |harmful. |

|time (e.g. you are in bed after an accident or operation or | |

|you have a plaster cast on a broken leg). Your doctor will |Mini pill (progestogen-only pill) |

|advise you when to start taking Femodene ED again. |The first Femodene ED tablet should be taken from the red |

|How to take Femodene ED |section on the first day of the period, even if you have |

|This pack is designed to help you remember to take your pills.|already taken a mini pill on that day. If the first day of |

|When to start |your period is a Tuesday, take the pill marked "Tue" in the |

|If you are new to the pill or are starting the pill again |red section. Return to your pharmacist any mini pills left in |

|after a break, take your first Femodene ED tablet on the first|your old pack. Follow the instructions as described under |

|day of bleeding of your next period. For other users, follow |"Taking your first pack of Femodene ED" and don't forget the |

|instructions for “Changing from another type of oral |14 days additional precautions. |

|contraceptive", "Starting Femodene ED after having a baby" or | |

|"Starting Femodene ED after a miscarriage or an abortion". |Starting Femodene ED after having a baby |

|The Femodene ED pack contains 28 tablets (21 |If you have just had a baby, your doctor may advise you to |

|active tablets and 7 inactive tablets). |start taking Femodene ED 21 days after delivery. You do not |

|On the day you start taking Femodene ED start with |have to wait for a period. You will need to use another method|

|a pill from the red section marked with that day of the week. |of contraception, such as a condom, until you start Femodene |

|For instance, if your period starts on a Wednesday, take a |ED and for the first 14 days of pill-taking. Follow the |

|pill from the red section marked "Wed" (see figure). |instructions as described under "Taking your first pack of |

| |Femodene ED. |

| |The use of Femodene ED du ring breast feeding may reduce the |

| |amount of m ilk that you produce. |

| |Very small amounts of the active ingredients of Femodene ED |

| |are found in breast milk. If you are breast feeding and want |

| |to take Femodene ED, you |

[pic]

|should discuss this with your doctor. Your doctor may decide |pill-taking, so try to take your pill at the same time every |

|to give you the minipill instead. |day. |

|Starting Femodene ED after a miscarriage or an abortion |Will you put on weight? |

|If you have just had a miscarriage or an abortion your doctor |Unless you usually have trouble keeping your weight down this |

|may advise you to start using Femodene ED immediately but you |is unlikely. But you may find you have a bigger appetite while|

|should use another method of contraception, such as a condom, |you are taking the pill, so it is wise to watch what you eat. |

|for the first 14 days of tablet taking. Follow the instruction|What if you want to have a baby? |

|as described under "Taking your first pack of Femodene ED". |The bleeding you have after each pack (including the last |

|While you are taking Femodene ED |pack) is not a true period. Your doctor relies on the date of |

|What to do if you miss a period |your last true period before you get pregnant to tell you when|

|Occasionally, you may miss a period. While this can mean you |your baby will be born. So, if you stop taking Femodene ED to |

|are pregnant, it is most unlikely if you have taken your pills|have a baby, use another method of contraception until you |

|correctly. Take your next pack as normal. If you think that |have had a true period. However, it will not be harmful if you|

|you might have put yourself at risk (e.g. missed pills, taking|become pregnant straight away. |

|other medicines) or if you miss a second period, see your |Are there any extra benefits of the pill? |

|doctor at once. |Your periods may become shorter, more regular and less |

|What to do if you forget to take an active pill (one of the 21|painful. Heavy periods may become lighter. The symptoms that |

|small tablets) |often make the last few days before a period so unpleasant |

|Look at your pill packet which contains 21 active tablets and |(known as premenstrual syndrome) usually disappear. Long-term |

|7 inactive tablets as in the figure. |use of the pill reduces your risk of cancers of the ovaries |

|If you forget to take an active pill please follow these |and of the lining of the womb. |

|instructions: |Overdosage |

|If you are more than 12 hours late in taking an active pill, |Overdosage may cause nausea, vomiting and, in females |

|or have missed more than one active pill contraceptive |withdrawal bleeding. You should consult your doctor who will |

|protection may be lower, so you must use extra protection. |be able to advise you what action, if any, is necessary. |

|Follow the instructions for the 7-day rule. |Possible side-effects |

|7-day rule |Sometimes unwanted effects occur with Femodene ED. These can |

|take the most recent 'late' pill and continue to take your |be mild or serious. |

|next pills at your normal times and |Mild reactions |

|use an extra contraceptive method (condoms or cap plus |Sometimes mild unwanted effects can occur in the first few |

|spermicide) for the next 7 days and |months after starting Femodene ED. |

|If these 7 days go beyond the last active (small) tablet (i.e.|bleeding and spotting between your periods can sometimes occur|

|the Friday just before the red section), take the small active|for the first few months but this usually stops once your body|

|tablets, throw away the large white inactive tablets and start|has adjusted to Femodene ED. If it continues, becomes heavy or|

|a new pack of Femodene ED the next day with the Saturday |starts again, contact your doctor. |

|tablet in the red section which will be a small active tablet.|headaches. |

|Continue to take the tablets as usual. You will not have a |feeling sick, being sick and stomach upsets. |

|period until you have finished the next pack, but this is not |sore breasts. |

|harmful. You may see some bleeding on active pill-taking days,|depressive moods, loss of interest in sex. |

|but do not worry. If you do not have a period after the second|changes in weight. |

|pack, you must talk to your doctor before you start the next |chloasma (yellow brown patches on the skin). This may happen |

|pack. |even if you have been using Femodene ED for a number of |

|If one pill is 12 hours late or less |months. Chloasma may be reduced by avoiding too much sunlight.|

|Don't worry. Contraceptive protection should not be affected |poor tolerance of contact lenses. |

|if you take the late pill at once, and keep taking your next |Serious reactions |

|pills at the usual time. This may mean taking two pills in one|More serious reactions have sometimes been associated with |

|day. |contraceptive pills that contain oestrogen and progestogen, |

|What to do if you forget to take one of the large white |for example thrombosis (the formation of a clot in blood |

|inactive pills? |vessels) or liver disease. These are explained more fully in |

|Don't worry. Take the tablet as soon as you can and then keep |the "Warnings" section. |

|taking your next pills at the usual time. This may mean taking|If you think that you have a serious adverse reaction to |

|two pills in one day. |Femodene ED stop taking your tablets and consult your doctor |

|What should you do if you lose one of the small white active |as soon as possible. |

|pills? |If you think you have an unwanted effect due to Femodene ED |

|Contact your doctor or pharmacist for advice as soon as |which is not included in this leaflet, tell your doctor or a |

|possible. |pharmacist about it. |

|What if you have bleeding between periods? |Effect on blood tests: The use of oral contraceptives may |

|A small number of women may have a little breakthrough |affect the results of certain laboratory tests. Always tell |

|bleeding or spotting while taking Femodene ED, especially |your doctor or the laboratory staff that you are using an oral|

|during the first few months. Normally, this bleeding is |contraceptive. |

|nothing to worry about, and will stop in a day or two. Keep |Expiry date: The expiry date is printed on the pack. Do not |

|taking the pills as usual and the problem should disappear |use after this date. |

|after the first few packs. |Storage: Store all medicines out of the reach of children. |

|If the bleeding keeps on returning, is annoying or |Date of last revision of this leaflet: 22 March 1996 |

|long-lasting, talk to your doctor. Also, if you start to have |® Femodene is a registered trademark of Schering AG. |

|breakthrough bleeding for the first time after being on | |

|Femodene ED for a long time, you should see your doctor. | |

|Unexpected bleeding may also be a sign of irregular | |

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