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Patient Information Booklet
Booklet not to be removed 2. Before you take Femodene 3. Take special care with Femodene Regular check-ups Tell your doctor immediately if Tell your doctor as soon as you can if Taking other medicines with Femodene Before you have any blood tests What else you need to know The pill and thrombosis The pill and cancer The pill and pregnancy 4. How to take Femodene Changing from another type of oral contraceptive Starting Femodene after having a baby, miscarriage or abortion 5. Possible side-effects Serious reactions 6. Storing Femodene You and the pill How your body gets ready for pregnancy (the menstrual cycle) You can usually become pregnant (conceive) from when you start to have periods, up until you are in your late 40s. Every menstrual cycle takes about 28 days. About halfway through this cycle an egg is released from one of your ovaries into a Fallopian tube. This is called ovulation. The egg travels down the Fallopian tube towards your womb. When you make love, your partner's penis releases millions of sperm into your vagina. Some of these sperm travel up through your womb into your Fallopian tubes. If there is an egg in one of these tubes, and a sperm reaches it, you can become pregnant. This is called 'conception'. A fertilised egg gets embedded in the lining of your womb and takes 9 months to grow into a baby. As an egg can live for up to 2 days, and sperm for up to 5 days, you can become pregnant if you have made love up to 5 days before ovulation and for some time afterwards. If a sperm does not fertilise an egg, the egg is lost at the end of the menstrual cycle with the lining of your womb. This is called a 'period'. How do natural hormones work? Your menstrual cycle is controlled by two sex hormones made by your ovaries: one called oestrogen, the other progesterone (a progestogen). Oestrogen increases during the first half of your menstrual cycle, and makes your womb develop a thick lining, ready to receive the egg if conception happens. Progesterone comes later in the cycle and changes the lining of the womb still further to prepare it for pregnancy. If you do not become pregnant, you make less of these hormones and this causes the lining of your womb to break down and the lining leaves your body as a period. But during pregnancy, your ovaries, and then the placenta (this attaches the growing baby to the womb and gives it food), carry on making progesterone and oestrogen to stop any more eggs being released. How does the pill work? A pill such as Femodene contains hormones which are like those your body produces (oestrogen and progestogen). These help stop you from getting pregnant, just as your natural hormones would stop you conceiving again when you are already pregnant. The combined contraceptive pill protects you against getting pregnant in 3 ways:
How effective is the pill? The pill is one of the most effective contraceptives apart from sterilisation. But this can only be true when it is taken correctly. So you must follow your doctor's instructions and take the tablets exactly as it says in the next section of this booklet. The name of your medicine is: Femodene Each memo strip of Femodene contains 21 white sugar-coated tablets containing 75 micrograms of the progestogen gestodene and 30 micrograms of the oestrogen ethinyloestradiol (ethinylestradiol). Progestogen and oestrogen are both female types of hormone. Femodene also contains the following inactive ingredients: lactose Schering Health Care Ltd Product licence number: 0053/0179 Femodene is manufactured by: Schering AG, Berlin, Germany, Schering GmbH & Co Produktions KG, Weimar, Germany, or Schering S.A., Lys-Lez-Lannoy, France. Each pack of Femodene contains 3 memo strips of 21 tablets. Packs containing 1 memo strip of 21 tablets are also available to doctors. 1. What Femodene is and what it is used for Femodene is a low dose combined oral contraceptive pill. Combined oral contraceptives contain two female types of hormone, oestrogen and progestogen. When used as instructed you are very unlikely to become pregnant. 2. Before you take Femodene Before taking Femodene tell your doctor if you have any of these:
Do not take Femodene if you have had any of these conditions when you were pregnant:
If any of the conditions mentioned here apply to you, you may be told that Femodene is not suitable for you and advised to use another method of contraception. 3. Take special care with Femodene Regular check-ups Before you start taking Femodene, your doctor should take a medical history by asking you some questions about yourself and also about other members of your family. Your doctor should also ask you these questions on a regular basis, for example, when you come back to see your doctor for more pills. Your doctor will also take your blood pressure and may check your breasts, abdomen and pelvic organs if this is considered necessary. You may also need to have a cervical smear test. Your doctor will also make sure you are not pregnant. Tell your doctor immediately if: If you experience any of the following conditions take no further tablets of Femodene and consult your doctor immediately. In the meantime use another method of contraception such as a condom.
Tell your doctor as soon as you can if: If you know you suffer from the following conditions be sure to tell your doctor as these conditions may get worse while you are taking the pill. If the condition does get worse tell your doctor as soon as you can.
or, if:
If any of these conditions gets worse or you have them for the first time, this may be a sign that you should stop taking Femodene. When you stop taking Femodene it may take some time for your regular periods to return. Taking other medicines with Femodene Some medicines may stop Femodene from working properly. Medicines which can sometimes stop Femodene from working properly are antibiotics (such as ampicillin and rifampicin); griseofulvin (which is used to treat fungal infections); phenylbutazone (which is used as an anti-inflammatory drug to treat some types of joint diseases); phenytoin, primidone, phenobarbitone and some other medicines used in people with epilepsy, and carbamazepine (which can be used to treat epilepsy or other illnesses). If you are taking any of these medicines you might still be able to use Femodene, but you will also need to use an extra contraceptive method (condoms or cap plus spermicide) while you are taking the other medicine and for 7 days after you stop taking it. If your present pack ends before these 7 days, start the next pack the next day without a break. This means taking a pill every day during your normal 7 pill-free days. If you run two packs together you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before you start the next pack. If you are taking rifampicin you will need to use another method of contraception as well as Femodene. You should do this while you are taking the rifampicin and for 4 weeks after you stop. If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes. The herbal remedy St John's wort (Hypericum perforatum) should not be taken at the same time as Femodene. If you already take a St John's wort preparation, stop taking the St John's wort and mention it to your doctor at your next visit. If you are in doubt check with your doctor, pharmacist or Family Planning clinic. Before you have any blood tests Tell your doctor or the laboratory staff that you are taking the pill, because oral contraceptives can affect the results of some tests. What else you need to know Risks associated with taking medicines are varied but largely depend on the individual taking the medicine. These differences in risk are explained more fully here. The pill and thrombosis Some studies have suggested that the risk of developing various disorders of the circulation of the blood is slightly greater in women who take the combined pill than in those who do not. This can lead to a thrombosis. A thrombosis is when you have a blood clot which may block a blood vessel. It may form in the veins (venous thrombosis) or in the arteries (arterial thrombosis). Most blood clots can be treated, with no long-term danger. However, a thrombosis may cause serious permanent disabilities or could even kill you. This is very rare. A thrombosis sometimes happens in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a "pulmonary embolism". Deep venous thrombosis is a rare condition. Blood clots can also happen very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). In extremely rare cases blood clots can happen in other places such as the liver, gut, kidney or eye. A thrombosis can develop whether or not you are taking the pill. It can also happen if you become pregnant. The risk is higher in people who take the pill than in people who don't take the pill, but is not as high as the risk during pregnancy. A thrombosis is most likely in the first year of taking any combined pill. In healthy non-pregnant women not taking the pill:
about 5 cases of thrombosis occur per 100,000 women per year. In pregnant women: about 60 cases of thrombosis occur per 100,000 pregnancies per year. That is 2 to 4 times the risk of being on the pill. Remember the differences between the risks for the type of pills mentioned here are very small (0.01%) and your doctor will have chosen the pill that most suits your needs. You should also remember that certain conditions increase the risk of thrombosis. They include:
The risk of having a deep venous thrombosis temporarily increases after an operation or during a period when you can't move around as normal (for example, when you have your leg or legs in plaster or splints). In women who use the pill, the risk could be higher. Tell your doctor you are using the pill well before you expect to be admitted into hospital or have surgery. Your doctor may tell you to stop taking the pill several weeks before surgery or after an operation. Your doctor will also tell you when you can start taking the pill again after you are back on your feet. If any of these conditions of increased risk apply to you before you decide to take Femodene, or while you are taking it, you must discuss them with your doctor straight away. If you notice possible signs of a thrombosis, stop taking the pill and consult your doctor immediately (see "Tell your doctor immediately if"). In the meantime use another method of contraception such as a condom. The pill and cancer The pill does give a substantial degree of protection against cancers of the ovary and the lining of the womb. An increased risk of cervical cancer in long-term users of the pill has been reported in some studies. It is uncertain whether this increased risk is caused by the pill as it could be due to the effects of sexual behaviour and other factors. Every woman is at risk of breast cancer whether or not she takes the Pill. Breast cancer is rare under the age of 40 years, but the risk increases as a woman gets older. Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill this reduces the risk so that 10 years after stopping the Pill, the risk of finding breast cancer is the same as for women who have never taken the Pill. Breast cancer seems less likely to have spread when found in women who take the Pill than in women who do not take the Pill. It is not certain whether the Pill causes the increased risk of breast cancer. It may be that women taking the Pill are examined more often, so that breast cancer is noticed earlier. The risk of finding breast cancer is not affected by how long a woman takes the Pill but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman gets older. The chart below shows the background chances of breast cancer at various ages for 10,000 women who have never taken the Pill (pink bars) and for 10,000 women whilst taking the Pill and during the 10 years after stopping it (blue bars). The small extra risk of finding breast cancer can be seen for each age group. This small possible additional risk in women who take the Pill has to be balanced against the fact that the Pill is a very effective contraceptive and it may also help prevent cancer of the womb or ovary. [img]http://www.ts-is.org/ts-is/ArticlePictures/femodene_1.gif[/img] The combination of ethinyloestradiol and gestodene, like other contraceptives, has been linked with an increased incidence of abnormal growths in the rat liver, but it is unclear whether this could happen in humans. On rare occasions, the use of the pill has led to liver diseases such as jaundice and benign liver tumours, and, very rarely, it has been associated with some forms of malignant liver tumours (cancer) in long-term users. Liver tumours may lead to life-threatening intra-abdominal haemorrhage (bleeding in the abdomen). Therefore, if you have pain in the upper abdomen that does not soon clear up, tell your doctor. Also, if your skin becomes yellow (jaundice) you must tell your doctor. The pill and pregnancy If you think you might be pregnant, stop taking Femodene and consult your doctor immediately. Use another method of contraception such as a condom until you see your doctor. Remember: Certain conditions may sometimes get worse during use of the pill. The diseases are those listed under "Take special care with Femodene". 4. How to take Femodene This pack is designed to help you remember to take your pills. When to start
Taking your first pack of Femodene
Your seven pill-free days After you have taken all 21 tablets, you have 7 days when you take no tablets. A few days after you have taken the last pill from each pack, you will have a period. Your periods will be regular, probably lighter than before and almost always painless. The feelings that often make the last days before a period unpleasant (called premenstrual syndrome) usually disappear. You will not have to take extra precautions during the 7 day break from taking the pill as long as you have taken your pills correctly and start the next pack on time. Taking your next pack of Femodene Start taking your next pack of Femodene after 7 pill-free days. Each new pack will begin on the same day of the week as the one before, so it is easy to remember when to start again. You should start taking your next pack of Femodene after 7 days, even if you are still bleeding. The table "How to take Femodene" should help you to take the pills properly (see figure). Changing from another type of oral contraceptive If you are taking a 21 day contraceptive pill, finish that pack and then start taking Femodene the next day. Do not leave a gap between packs. Start with a pill marked with the correct day of the week. Then follow the instructions as described before. (see "Taking your first pack of Femodene"). By starting in this way you will have contraceptive protection at once. You may not have a period until the end of the first Femodene pack, but this is not harmful. You may have some bleeding on pill-taking days, but do not worry. Femodene should be started after taking the last active tablet from the Every Day pill pack. If you are not sure which tablets are the active ones, ask your doctor or pharmacist. The first Femodene tablet is taken the next day which means that you do not leave a gap between packs. Start with a pill marked with the correct day of the week. Return to your pharmacist any remaining inactive tablets from your old Every Day pack. Then follow the instructions as before (see "Taking your first pack of Femodene"). By starting in this way you will have contraceptive protection at once. You may not have a period until the end of the first Femodene pack, but this is not harmful. You may have some bleeding on pill-taking days, but do not worry. The first Femodene tablet should be taken on the first day of the period, even if you have already taken a mini pill on that day. Return to your pharmacist any mini pills left in your old pack. Start with a pill marked with the correct day of the week. Follow the instructions as before (see "Taking your first pack of Femodene"). By starting in this way you will have contraceptive protection at once. If you have just had a baby, your doctor may advise you to start taking Femodene 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. [b]You will need to use another method of contraception, such as a condom, until you start Femodene and for the first 7 days of pill taking.[/b] Follow the instructions as before (see "Taking your first pack of Femodene"). The use of Femodene during breast feeding may reduce the amount of milk that you produce. Very small amounts of the active ingredients of Femodene are found in breast milk. If you are breast feeding and want to take Femodene, you should discuss this with your doctor. Your doctor may decide to give you the mini-pill instead. Starting Femodene after a miscarriage or an abortion If you have just had a miscarriage or an abortion your doctor may advise you to start using Femodene immediately. Follow the instructions as before (see "Taking your first pack of Femodene"). While you are taking Femodene What to do if you miss a period Occasionally, you may miss a period. While this can mean you are pregnant, it is most unlikely if you have taken your pills correctly. Take your next pack as normal. If you think that you might have put yourself at risk (e.g. missed pills, taking other medicines) or if you miss a second period, see your doctor at once. What to do if you take more Femodene than you should An accidental overdose is unlikely to be harmful but may cause nausea, vomiting and in females, withdrawal bleeding. You should consult your doctor who will be able to tell you what action, if any, is necessary. What to do if you forget to take a pill If you forget to take a pill please follow these instructions: 1. If you are more than 12 hours late in taking a pill, or have missed more than one pill Contraceptive protection may be lower, so you must use extra protection. Follow the instructions for the 7-day rule. 7-day rule
2. If one pill is 12 hours late or less Don't worry. Contraceptive protection should not be affected if you take the late pill at once, and keep taking your next pills at the usual time. This may mean taking two pills in one day. Stomach upsets Being sick or having very bad diarrhoea may stop Femodene from working properly and make it less effective. Carry on taking Femodene as usual, and also use another method of contraception, (condom or cap plus spermicide) until 7 days after you have recovered from the stomach upset. If you finish your pack before these 7 days, start the next pack the next day without a break. This means taking a pill every day during your normal 7 pill-free days. If you run two packs together you may not have a period until the end of two packs, but this is not harmful. If you do not have a period after the second pack, you must talk to your doctor before starting the next pack. If your stomach upset continues for some time, consult your doctor who may consider another form of contraception. What should you do if you lose a pill? If you lose a pill, the easiest thing to do is to take the last pill of the pack 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 contraceptive protection is not affected. After your 7 pill-free days you will have a new starting-day, one day earlier than before. Should you lose a pack of pills halfway through, ask your doctor or pharmacist what to do. What if you have bleeding between periods? A small number of women may have a little breakthrough bleeding or spotting while taking Femodene, especially during the first few months. Normally, this bleeding is nothing to worry about, and will stop in a day or two. Keep taking the pills as usual, and the problem should disappear after the first few packs. If the bleeding keeps on returning, is annoying or long-lasting, talk to your doctor. Also, if you start to have breakthrough bleeding for the first time after being on Femodene for a long time, you should see your doctor. Unexpected bleeding may also be a sign of irregular pill-taking, so try to take your pill at the same time every day. Will you put on weight? Unless you usually have trouble keeping your weight down this is unlikely. But you may find you have a bigger appetite while you are taking the pill, so it is wise to watch what you eat. What if you want to have a baby? The bleeding you have after each pack (including the last pack) is not a true period. Your doctor relies on the date of your last true period before you get pregnant to tell you when your baby will be born. So, if you stop taking Femodene to have a baby, use another method of contraception until you have had a true period. However, it will not be harmful if you become pregnant straight away. Are there any extra benefits of the pill? Your periods may become shorter, more regular and less painful. Heavy periods may become lighter. The symptoms that often make the last few days before a period so unpleasant (known as premenstrual syndrome) usually disappear. Long-term use of the pill reduces your risk of cancers of the ovaries and of the lining of the womb. 5. Possible side-effects Sometimes unwanted effects occur with Femodene. These can be mild or serious. Serious reactions Like all medicines Femodene can have side-effects. More serious reactions have sometimes been associated with contraceptive pills that contain oestrogen and progestogen, for example thrombosis (the formation of a clot in blood vessels) or liver disease. These are listed in Section 3 under "Tell your doctor immediately if". If you think that you have a serious adverse reaction to Femodene, stop taking your tablets and consult your doctor immediately. In the meantime use another method of contraception such as a condom. Mild reactions Sometimes mild unwanted effects can occur in the first few months after starting Femodene.
If you think you have an unwanted effect due to Femodene even if it is not included in this booklet, tell your doctor or a pharmacist about it. 6. Storing Femodene |
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