Logynon® ED - WebResources



|Logynon® ED |containing 75 micrograms levonorgestrel and 40 micrograms |

| |ethinyloestradiol (NN ethinylestradiol) and 7 larger, white, |

|This leaflet tells you about oral contraceptives in general |inactive tablets. Levonorgestrel is a progestogen and |

|and about Logynon ED in detail. Please read it carefully to |ethinyloestradiol is an oestrogen Progestogen oestrogen |

|get the best from Logynon ED. If you are in any doubt about |ethinyloestradiol (ethinylestradiol) and 7 larger, white, |

|these instructions contact your doctor, pharmacist or Family |inactive tablets. Progestogen and oestrogen are both female |

|Planning clinic. |types of hormone. |

| |Logynon ED also contains the following inactive ingredients: |

|You and the pill |lactose, maize starch, povidone, magnesium stearate (E572), |

|How your body gets ready for pregnancy |sucrose, polyethylene glycol 6000, calcium carbonate (E170), |

|(the menstrual cycle) |talc, montan glycol wax, glycerin (E422), titanium dioxide |

|You can usually become pregnant (conceive) from when you start|(E171), ferric oxide pigment red and yellow (E172). |

|to have periods, up until you are in your late 40s. Every |Each pack of Logynon ED contains 1 memo strip of 28 tablets |

|menstrual cycle takes about 28 days. About halfway through |(21 active tablets and 7 larger, inactive tablets). |

|this cycle an egg is released from one of your ovaries into a |Logynon ED is a combined oral contraceptive pill. Combined |

|fallopian tube. This is called ovulation. |oral contraceptives contain two female types of hormone, |

|The egg travels down the fallopian tube towards your womb. |oestrogen and progestogen. |

|When you make love, your partner's penis releases millions of | |

|sperm into your vagina. Some of these sperm travel up through |The product licence is held by |

|your womb into your fallopian tubes. If there is an egg in one|Schering Health Care Ltd |

|of these tubes, and a sperm reaches it, you can become |The Brow, Burgess Hill, West Sussex, RH15 9NE |

|pregnant. This is called 'conception'. |Product licence number 0053/0085 |

|A fertilised egg gets embedded in the lining of your womb and |Logynon ED is manufactured by: Schering AG Berlin, Germany. |

|takes 9 months to grow into a baby. As an egg can live for up |Uses |

|to 2 days, and sperm for up to 5 days, you can become pregnant|Logynon ED is a low dose combined oral contraceptive. When |

|if you have made love up to 5 days before ovulation and for |used as instructed you are very unlikely to become pregnant. |

|some time afterwards. If a sperm does not fertilise an egg, |Reasons for not taking Logynon ED |

|the egg is lost at the end of the menstrual cycle with the |Before taking Logynon ED, tell your doctor if you have any of |

|lining of your womb. This is called a 'period' |these: |

| |you are pregnant or think you may be pregnant. |

|How do natural hormones work? |blood clots in the legs, lungs, eyes, or anywhere else or have|

|Your menstrual cycle is controlled by two sex hormones made by|ever had these. If you have had a heart attack or if you have |

|your ovaries: one called oestrogen the other progesterone (a |any medical condition which makes you more at risk of |

|progestogen). Oestrogen increases during the first half of |developing blood clots. |

|your menstrual cycle and makes your womb develop a thick |abnormal red blood cells (sickle-cell anaemia) |

|lining, ready to receive the egg if conception happens. |disorders of blood fat (lipid) metabolism. |

|Progesterone comes later in the cycle and changes the lining |cancer of the breast or of the lining of the womb (mammary or |

|of the womb still further to prepare it for pregnancy. |endometrial carcinoma) or have ever had either of these |

|If you do not become pregnant, you make less of these hormones|conditions. |

|and this causes the lining of your womb to break down and the |abnormal bleeding from your vagina of unknown cause. |

|lining leaves your body as a period. But during pregnancy, |certain types of jaundice (Dubin-Johnson or Rotor syndromes). |

|your ovaries, and then the placenta (this attaches the growing|severe diabetes with changes to the blood vessels. |

|baby to the womb and gives it food), carry on making |liver tumours or have ever had these. |

|progesterone and oestrogen to stop any more eggs being |any other long or short-term liver disease. |

|released. |allergy to any of the ingredients of Logynon ED. |

| |Do not take Logynon ED if you have had any of these conditions|

|How does the pill work? |when you were pregnant: |

|A pill such as Logynon ED contains hormones which are like |itching of your whole body (pruritus of pregnancy). |

|those your body produces (oestrogen and progestogen). These |the rash known as herpes gestationis. |

|help stop you from getting pregnant, just as your natural |worsening of inherited deafness (otosclerosis). |

|hormones would stop you conceiving again when you are already |yellowing of the skin (jaundice). |

|pregnant. | |

|The combined contraceptive pill protects you against getting |What you should know before taking Logynon ED |

|pregnant in 3 ways: |Before you start taking Logynon ED your pelvic organs, breasts|

|No egg is released to be fertilised by sperm. |and blood pressure should be checked by your doctor and these |

|The fluid in the neck of your womb thickens so it is more |checks should be repeated regularly. The doctor will also make|

|difficult for sperm to enter it. |sure you are not pregnant. |

|The lining of your womb does not thicken enough for an egg to |If anyone in your family has had any illness caused |

|grow in it. |by blood clots, or a heart attack, or a stroke at a young age,|

| |tell your doctor. |

|How effective is the pill? |The following conditions need watching carefully |

|The pill is one of the most effective contraceptives apart |while you are taking the pill: |

|from sterilisation. But this can only be true when it is taken|If you have: |

|correctly. So you must follow your doctor's instructions and |severe depressive states, past or present. |

|take the tablets exactly as it says in the next section of |varicose veins. |

|this leaflet. |diabetes (diabetes mellitus) or a tendency towards diabetes. |

|Product information |high blood pressure (hypertension). |

|The name of your medicine is: Logynon ED |fits (epilepsy). |

|What does Logynon ED contain? |the inherited form of deafness known as otosclerosis. |

|Each memo strip of Logynon ED contains 6 light-brown tablets |the disease of the nervous system called multiple sclerosis. |

|containing 50 micrograms levonorgestrel and 30 micrograms | |

|ethinyloestradiol, 5 white tablets | |

|the inherited disease called porphyria. |large white inactive tablets and start a new pack of Logynon |

|calcium deficiency with cramps. |ED by taking the Saturday tablet in the red section. If you |

|the movement disorder called Sydenham’s chorea. |have to miss the large inactive tablets you may not have a |

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

|diseases). |after the second pack, you must talk to your doctor before |

|kidney diseases. |starting the next pack. If your stomach upset continues for |

|disturbed liver function. |some time, consult your doctor who may consider another form |

|you are very overweight (obese). |of contraception. |

|an intolerance of contact lenses. | |

|systemic lupus erythematosus - SLE (inflammation of connective|Warnings |

|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. |

|Logynon ED. |obesity. |

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

|regular periods to return. |diabetes. |

|Taking other medicines with Logynon ED |migraine. |

|Some medicines may stop Logynon ED from working properly. |a major operation or period of immobilisation (e.g. you are in|

|If you are taking any other medicine while you are taking |bed after an accident or operation or you have a plaster cast |

|Logynon ED, be sure to tell your doctor (or dentist). Your |on a broken leg). |

|doctor (or dentist) can tell you whether you should use extra |if any members of your family have suffered from |

|contraceptive precautions and for how long. |thromboembolic diseases (e.g. deep vein thrombosis, stroke or |

|Medicines which can sometimes stop Logynon ED from working |heart attack) at a young age. |

|properly are antibiotics (such as ampicillin and rifampicin); |varicose veins. |

|griseofulvin (which is used to treat fungal infections); |If any of these conditions apply to you before you decide to |

|phenylbutazone (which is used as an anti-inflammatory drug to |take Logynon ED or while you are taking Logynon ED you must |

|treat some types of joint diseases); phenytoin, primidone, |discuss them with your doctor. |

|phenobarbitone and some other medicines used in people with |The risk of arterial thrombosis (e.g. heart attack and stroke)|

|epilepsy, and carbamazepine (which can be used to treat |associated with the pill increases with age, and this risk is |

|epilepsy or other illnesses). |increased by cigarette smoking. For this reason, the use of |

|If you are taking any of these medicines you might still be |combined pills by women in the older age-group, especially |

|able to use Logynon ED, but you will also need to use an extra|those who also smoke, is discouraged. |

|contraceptive method (condoms or cap plus spermicide) while |Signs and symptoms of blood clots are given in the section |

|you are taking the other medicine and for 7 days after you |"Reasons for stopping Logynon ED immediately". |

|stop taking it. If these 7 days extend beyond the last active |The pill does give a substantial degree of protection against |

|(small) tablets (i.e. the Friday just before the red section) |cancers of the ovary and the lining of the womb. An increased |

|take the active tablets, throw away the large white inactive |risk of cervical cancer in long-term users of the pill has |

|tablets and start a new pack of Logynon ED by taking the |been reported in some studies. It is uncertain whether this |

|Saturday tablet (small white) in the red section. |increased risk is caused by the pill as it could be due to the|

|If you have to miss the large white inactive tablets you may |effects of sexual behaviour and other factors. |

|not have a period until the end of two packs, but this is not |The evidence linking use of the pill and breast cancer is |

|harmful. If you do not have a period after the second pack, |unclear. Some studies suggest an increased risk of breast |

|you must talk to your doctor before you start the next pack. |cancer in women below the age of 35, the risk increasing the |

|If you are taking rifampicin you will need to use another |longer the pill is used. Any possible increased risk of breast|

|method of contraception as well as Logynon ED. You should do |cancer with combined pills is, however, likely to be small. |

|this while you are taking the rifampicin and for 4 weeks after|On rare occasions, the use of the pill has led to liver |

|you stop. |diseases such as jaundice and benign liver tumours, and, very |

|If you are diabetic your doctor may alter the dose of medicine|rarely, it has been associated with some forms of malignant |

|required to treat your diabetes. |liver tumours (cancer) in long-term users. Liver tumours may |

|If you are in doubt check with your doctor, pharmacist or |lead to life-threatening intra-abdominal haemorrhage (bleeding|

|Family Planning clinic. |in the abdomen). Therefore, if you have pain in the upper |

|Stomach upsets |abdomen that does not soon clear up tell your doctor. Also, if|

|Being sick or having very bad diarrhoea may stop Logynon ED |your skin becomes yellow (jaundice) you must tell your doctor.|

|from working properly and make it less effective. Carry on |If you think you might be pregnant, stop taking Logynon ED and|

|taking Logynon ED as usual, and also use another method of |consult your doctor immediately. Use another method of |

|contraception, (condom or cap plus spermicide) until 7 days |contraception such as a condom until you see your doctor. |

|after you have recovered from the stomach upset. If these 7 |Certain conditions may sometimes get worse during use of the |

|days extend beyond the last active (small) tablet (i.e. the |pill. The diseases are those listed under “What you should |

|Friday just before the red section) throw away the |know before taking Logynon ED”. |

|Reasons for stopping Logynon ED immediately |Taking your first pack of Logynon ED |

|If you experience any of the following conditions, take no |After taking your first pill, take one pill each day following|

|further tablets of Logynon ED and consult your doctor |the direction of the arrows, until you have finished all 28 |

|immediately. In the meantime use another method of |pills in the pack. |

|contraception such as a condom. |You should try to take the pill at the same time every day, |

|migraine for the first time, or if existing migraine occurs |for example, after breakfast. |

|more often than before. |Swallow each pill whole, with water if necessary. |

|unusually bad headaches or if you have headaches more often |You should use another method of contraception, such as a |

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

|sudden changes to your eyesight, hearing, speech, sense of |the first pack only. |

|smell, taste or touch. | |

|Unusual pains in your leg or unusual swelling of your arms or |Taking your next pack of Logynon ED |

|legs, sharp pains in your chest or sudden shortness of breath,|When you have finished the fist pack, start a new pack the |

|crushing pains or feelings of heaviness in your chest, |next day by taking a pill from the red section of the new pack|

|coughing for no apparent reason, dizziness or fainting, or if |marked with that day of the week. For example if you finish |

|one side of your body suddenly becomes very weak or numb. |your pack on a Tuesday start the next pack by taking a pill |

|These may be symptoms of blood clot formation or symptoms of |marked "Wed" in the red section. You will always start each |

|an inflammation of veins combined with the formation of blood |new pack on the same day of the week. |

|clots (thrombophlebitis}. |A few days after you have taken the last active tablet from |

|your skin becomes yellow ( jaundice) you develop hepatitis |each pack, you will have a period. Your periods will be |

|(inflammation of the liver) o; if your whole body starts |regular, probably lighter than before and almost always |

|itching. |painless. The feelings that often make the last days before a |

|an increase in the number of fits (epileptic seizures). |period unpleasant (called premenstrual syndrome) usually |

|a large increase in your blood pressure. |disappear. |

|severe depression. | |

|severe upper abdominal pains or unusual swelling of your |Changing from another type of oral contraceptive 21-day |

|abdomen. |combined pill |

|definite worsening of conditions which had got worse during a |If you are taking a 21-day contraceptive pill, finish that |

|previous pregnancy or while taking the pill in the past. |pack and then start taking Logynon ED the next day starting |

|pregnancy. |with an appropriate pill in the red section for example |

|surgery or immobilisation. You must stop Logynon ED six weeks |Tuesday if you finished your other contraceptive pill on |

|before a planned major operation (e.g. stomach surgery), if |Monday. Then follow the instructions as described under |

|you are having any surgery to the legs, or medical treatment |"Taking your first pack of Logynon ED" and don't forget the 14|

|for varicose veins. Also if you are immobilised for a long |days additional precautions. You may not have a period until |

|time (e.g. you are in bed after an accident or operation or |the end of the first Logynon ED pack, but this is not harmful.|

|you have a plaster cast on a broken leg). Your doctor will | |

|advise you when to start taking Logynon ED again. |Mini pill (progestogen-only pill) |

|How to take Logynon ED |The first Logynon ED tablet should be taken from the red |

|This pack is designed to help you remember to take your pills.|section on the first day of the period, even if you have |

|When to start |already taken a mini pill on that day. If the first day of |

|If you are new to the pill or are starting the pill again |your period is a Tuesday, take the pill marked "Tue" in the |

|after a break, take your first Logynon ED tablet on the first |red section. Return to your pharmacist any mini pills left in |

|day of bleeding of your next period. For other users, follow |your old pack. Follow the instructions as described under |

|instructions for “Changing from another type of oral |"Taking your first pack of Logynon ED" and don't forget the 14|

|contraceptive", "Starting Logynon ED after having a baby" or |days additional precautions. |

|"Starting Logynon ED after a miscarriage or an abortion". | |

|The Logynon ED pack contains 28 tablets (21 |Starting Logynon ED after having a baby |

|active tablets and 7 inactive tablets). |If you have just had a baby, your doctor may advise you to |

|On the day you start taking Logynon ED start with |start taking Logynon ED 21 days after delivery. You do not |

|a pill from the red section marked with that day of the week. |have to wait for a period. You will need to use another method|

|For instance, if your period starts on a Wednesday, take a |of contraception, such as a condom, until you start Logynon ED|

|pill from the red section marked "Wed" (see figure). |and for the first 14 days of pill-taking. Follow the |

| |instructions as described under "Taking your first pack of |

| |Logynon ED. |

| |The use of Logynon ED during breast feeding may reduce the |

| |amount of milk that you produce. |

| |Very small amounts of the active ingredients of Logynon ED are|

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

| |take Logynon ED, you should |

[pic]

|discuss this with your doctor. Your doctor may decide to give |Will you put on weight? |

|you the minipill instead. |Unless you usually have trouble keeping your weight down this |

|Starting Femodene ED after a miscarriage or an abortion |is unlikely. But you may find you have a bigger appetite while|

|If you have just had a miscarriage or an abortion your doctor |you are taking the pill, so it is wise to watch what you eat. |

|may advise you to start using Femodene ED immediately but you |What if you want to have a baby? |

|should use another method of contraception, such as a condom, |The bleeding you have after each pack (including the last |

|for the first 14 days of tablet taking. Follow the instruction|pack) is not a true period. Your doctor relies on the date of |

|as described under "Taking your first pack of Femodene ED". |your last true period before you get pregnant to tell you when|

|While you are taking Femodene ED |your baby will be born. So, if you stop taking Logynon ED to |

|What to do if you miss a period |have a baby, use another method of contraception until you |

|Occasionally, you may miss a period. While this can mean you |have had a true period. However, it will not be harmful if you|

|are pregnant, it is most unlikely if you have taken your pills|become pregnant straight away. |

|correctly. Take your next pack as normal. If you think that |Are there any extra benefits of the pill? |

|you might have put yourself at risk (e.g. missed pills, taking|Your periods may become shorter, more regular and less |

|other medicines) or if you miss a second period, see your |painful. Heavy periods may become lighter. The symptoms that |

|doctor at once. |often make the last few days before a period so unpleasant |

|What to do if you forget to take an active pill (one of the 21|(known as premenstrual syndrome) usually disappear. Long-term |

|small tablets) |use of the pill reduces your risk of cancers of the ovaries |

|Look at your pill packet which contains 21 active tablets and |and of the lining of the womb. |

|7 inactive tablets as in the figure. |Overdosage |

|If you forget to take an active pill please follow these |Overdosage may cause nausea, vomiting and, in females |

|instructions: |withdrawal bleeding. You should consult your doctor who will |

|If you are more than 12 hours late in taking an active pill, |be able to advise you what action, if any, is necessary. |

|or have missed more than one active pill contraceptive |Possible side-effects |

|protection may be lower, so you must use extra protection. |Sometimes unwanted effects occur with Logynon ED. These can be|

|Follow the instructions for the 7-day rule. |mild or serious. |

|7-day rule |Mild reactions |

|take the most recent 'late' pill and continue to take your |Sometimes mild unwanted effects can occur in the first few |

|next pills at your normal times and |months after starting Logynon ED. |

|use an extra contraceptive method (condoms or cap plus |bleeding and spotting between your periods can sometimes occur|

|spermicide) for the next 7 days and |for the first few months but this usually stops once your body|

|If these 7 days go beyond the last active (small) tablet (i.e.|has adjusted to Logynon ED. If it continues, becomes heavy or |

|the Friday just before the red section), take the small active|starts again, contact your doctor. |

|tablets, throw away the large white inactive tablets and start|headaches. |

|a new pack of Logynon ED the next day with the Saturday tablet|feeling sick, being sick and stomach upsets. |

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

|Continue to take the tablets as usual. You will not have a |depressive moods, loss of interest in sex. |

|period until you have finished the next pack, but this is not |changes in weight. |

|harmful. You may see some bleeding on active pill-taking days,|chloasma (yellow brown patches on the skin). This may happen |

|but do not worry. If you do not have a period after the second|even if you have been using Logynon ED for a number of months.|

|pack, you must talk to your doctor before you start the next |Chloasma may be reduced by avoiding too much sunlight. |

|pack. |poor tolerance of contact lenses. |

|If one pill is 12 hours late or less |Serious reactions |

|Don't worry. Contraceptive protection should not be affected |More serious reactions have sometimes been associated with |

|if you take the late pill at once, and keep taking your next |contraceptive pills that contain oestrogen and progestogen, |

|pills at the usual time. This may mean taking two pills in one|for example thrombosis (the formation of a clot in blood |

|day. |vessels) or liver disease. These are explained more fully in |

|What to do if you forget to take one of the large white |the "Warnings" section. |

|inactive pills? |If you think that you have a serious adverse reaction to |

|Don't worry. Take the tablet as soon as you can and then keep |Logynon ED stop taking your tablets and consult your doctor as|

|taking your next pills at the usual time. This may mean taking|soon as possible. |

|two pills in one day. |If you think you have an unwanted effect due to Logynon ED |

|What if you have bleeding between periods? |which is not included in this leaflet, tell your doctor or a |

|A small number of women may have a little breakthrough |pharmacist about it. |

|bleeding or spotting while taking Logynon ED, especially |Effect on blood tests: The use of oral contraceptives may |

|during the first few months. Normally, this bleeding is |affect the results of certain laboratory tests. Always tell |

|nothing to worry about, and will stop in a day or two. Keep |your doctor or the laboratory staff that you are using an oral|

|taking the pills as usual and the problem should disappear |contraceptive. |

|after the first few packs. |Expiry date: The expiry date is printed on the pack. Do not |

|If the bleeding keeps on returning, is annoying or |use after this date. |

|long-lasting, talk to your doctor. Also, if you start to have |Storage: Store all medicines out of the reach of children. |

|breakthrough bleeding for the first time after being on |Date of last revision of this leaflet: 24 November 1995 |

|Logynon ED for a long time, you should see your doctor. |® Logynon is a registered trademark of Schering AG. |

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

|pill-taking, so try to take your pill at the same time every | |

|day. | |

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