Microlut. BAYER MIDDLE EAST

Transcription

1 08-15 MICROLUT 0.03 mg BAYER MIDDLE EAST coated tablets Active ingredient: Levonorgestrel 1. What is Microlut and what is it used for? 1.1 Microlut is a hormonal contraceptive belonging to the group of so-called minipills. In contrast to the combined pills (combined oral contraceptives), which contain two hormones, an estrogen and a corpus luteum hormone (progestogen), minipills contain only one hormone, and also in a low dose. 1.2 Microlut is used for contraception. 2. What must you consider before using Microlut? 2.1 Microlut must not be taken if you are hypersensitive (allergic) to levonorgestrel or any other constituent of Microlut. if you are pregnant or suspect you are, if there is a blood clot in the veins, e.g. in a leg (deep vein thrombosis) or in the lungs (pulmonary embolism) (cf. section The minipill and thrombosis ), if the arterial blood vessels are or were once diseased, such as cardiac infarction, stroke or ischemic heart condition (angina pectoris) (cf. section The minipill and thrombosis ), if you have sugar diabetes and vascular changes have occurred, if you have a severe liver disorder or had one in the past and liver values have not yet returned to normal, if you have or have had a benign or malignant liver tumor, if you have or have had a malignant tumor that is dependent on sex hormones, such as breast cancer or genital cancer, or if you suspect that you have any of these diseases, in case of vaginal bleeding, the cause of which has not been clarified. If any of the above cases occurs when Microlut is being taken, you must stop taking the drug immediately and see your doctor. In the meantime you should use a different, nonhormonal contraception method. Refer also to section 2.2 Special care is needed when taking Microlut. 2.2 Microlut must be used with special care This section describes when you must immediately stop taking the minipill or when the reliability of the minipill might be impaired. In these cases you should either not have sexual intercourse or use other, nonhormonal contraception methods, e.g. condoms or other barrier methods. Do not, however, use the calendar or temperature methods. These methods may fail because taking the minipill can influence the monthly variations in body temperature and the uterine mucous membranes. Like any oral contraceptives Microlut offers no protection at all against HIV infection (AIDS) or other sexually transmitted diseases Medical examination/checkup Before starting or resuming the taking of Microlut a full history must be taken of the diseases you and your close relatives have had; and pregnancy must be ruled out. The medical examination (including pelvis and breast) should reflect this medical history, the contraindications and warnings concerning this medicinal product. During the course of treatment regular checkups adapted to your personal state of health with respect to frequency and nature are recommended. Checkups, including breasts (mammography), should be conducted in line with current preventive practice and according to your personal state of health Particularly careful monitoring by the physician is needed, if you have only one fallopian tube, once had inflammation of the fallopian tubes or a tubal pregnancy (see section The minipill and tubal pregnancy) BAYER-MICROLUT 0.03 mg - p.1/8

2 BAYER-MICROLUT 0.03 mg - p.2/8 you smoke (see section The minipill and thrombosis ) you have sugar diabetes (see section The minipill and other diseases ) you are seriously overweight (body mass index above 30 kg/m 2 ; see The minipill and thrombosis ) you or a close relative had a vascular occlusion in the veins (when still young) (see section The minipill and thrombosis ) you have high blood pressure (see section The minipill and other diseases ) breast cancer occurred in close relatives (see section The minipill and cancer ) you have a liver condition (see section The minipill and cancer and section The minipill and other diseases ) you are prone to the appearance of pigmentation spots (see section The minipill and other diseases ) The minipill and thrombosis The term thrombosis refers to the formation of a thrombus (blood clot) that can plug a blood vessel. Thromboses occur, among other places, in the deep veins of the lower leg (deep vein thrombosis). If such a blood clot breaks loose, it can travel in the bloodstream to the lung arteries and there obstruct a blood vessel (pulmonary embolism). Deep vein thromboses are rare. They can occur irrespective of whether you take the minipill or not. They may also occur during pregnancy. A thrombosis does not always heal up completely and sometimes leaves lasting handicaps. A thrombosis can even be fatal. Large-scale surveys point to a correlation between the use of combined pills and a more frequent occurrence of deep leg vein thromboses, other deep vein thromboses and pulmonary embolisms. The thrombosis risk is somewhat higher in women taking these drugs than in those women who do not use the combined pill for contraception. The significance of these findings for minipills like Microlut is not clear. It is known that the risk of suffering a venous thromboembolism increases with age. Moreover the risk increases, if you are seriously overweight (body mass index above 30 kg/m 2 ) or if you or a close relative of yours (sibling or parents at a relative young age) had a venous thromboembolic condition. The risk of deep leg vein thrombosis may be temporarily enhanced if you undergo surgery, are rigidly confined to bed or cannot walk (e.g. if a leg is in plaster). In this case you should inform your doctor in good time that you are taking the minipill. Your doctor will then advise you to stop taking the minipill several weeks prior to the operation, at the start of bed rest or immobilization. He will also tell you when you can start taking the minipill again after you are on your feet again. Likewise, the risk of a blood clot occurring may be higher after childbirth. A thrombosis can also occur in an artery (arterial thrombosis), e.g. in the coronary arteries of the heart or the arteries supplying the brain, thus leading to a cardiac infarction or stroke. Clinical observation studies showed very few signs of any link between the use of the minipill and an enhanced risk of suffering a cardiac infarction or stroke. The known risk factors for the occurrence of such conditions are advancing age, high blood pressure and smoking. The risk of suffering a stroke might be slightly higher in women with high blood pressure taking the minipill. If you have high blood pressure when taking Microlut you may be advised to stop taking the drug and possibly to use a different method of contraception. The following symptoms may be signs of a venous or arterial thrombosis. If you notice any of these symptoms in yourself, stop taking the tablets immediately and see a doctor right away. unusual pain or swellings in a leg, pain and a crushed feeling in the chest, possibly radiating to the left arm, suddenly occurring shortness of breath, a sudden severe coughing bout, unusually severe or persistent headache, suddenly occurring partial or complete loss of vision, double vision, slurred speech or problems articulating,

3 BAYER-MICROLUT 0.03 mg - p.3/8 dizziness, collapse, possibly connected with an epileptic fit, sudden weakness or numbness in one half or part of the body, disturbed movements (motor disturbances), severe, intolerable abdominal pain The minipill and cancer Breast Breast cancer is found somewhat more often in women who take the combined pill than in women of the same age who do not use the combined pill for contraception. It is not known whether this is due to the combined pill. The difference may be due to the fact that women who take the combined pill get examined more regularly and thoroughly, so that any breast cancer is discovered earlier. The difference may be due to a combination of the two (factors). Since breast cancer is rare in women below the age of 40, the number of additional cases of breast cancer diagnosed in current or previous users of combined pills is low in comparison to the overall risk. After the combined pill is no longer taken, breast cancer figures gradually get closer to each other, and after 10 years no difference can be detected between previous users of the combined pill and other women. In women taking the minipill the risk is possibly of the same order of magnitude as for the combined pill, albeit the data situation is less conclusive for the minipill. In women who took oral contraceptives it appears that the developmental stage of any breast cancer diagnosed was clinically less advanced than cancer diagnosed in nonusers. Liver In rare cases benign liver tumors, and even more rarely, malignant liver tumors have been discovered in users of the combined pill. In a few isolated cases these tumors have led to life-threatening inner hemorrhage. If you suddenly have severe abdominal pain, you must see your doctor right away The minipill and other diseases In general the minipill appears to have no effect on blood pressure in healthy women. If, however, a persistent rise in blood pressure should develop during the use of Microlut, the latter should be discontinued. The use of Microlut must be discontinued if itching over the whole body (pruritus caused by cholestasis) or bile retention (cholestatic icterus) occurs. Particular caution is needed, if these conditions already occurred in a past pregnancy or when taking hormones. If you have sugar diabetes the requisite dose of the drug used to treat the diabetes may change when you take Microlut. Diabetics and women who had diabetes in a past pregnancy must therefore be carefully monitored, especially during the initial stages of use. Yellowish brown skin pigmentation spots (chloasma) may sometimes occur, especially in women who experienced this during pregnancy. Women who are susceptible to this should therefore not expose themselves to direct sunlight or ultraviolet light (e.g. solarium) when taking Microlut The minipill and tubal pregnancy In those exceptional cases when a woman becomes pregnant when taking the minipill, there is a higher probability that a tubal pregnancy will be present in women taking the minipill than in the users of the combined pill. For this reason women who had a tubal pregnancy in the past, are suffering or once suffered from inflammation of the ovaries, should only take Microlut after the doctor has carefully weighed up the risks and benefits in the specific case. If unexplained pain in the lower abdomen occurs with an irregular cycle (no bleeding or a stretch of time without bleeding followed by continuous bleeding), the possibility of a tubal pregnancy must be considered. In this case you must see your doctor at once The minipill and persistent ovarian cysts During the use of the minipill persisting ovarian follicles (often also called functional ovarian cysts) may occur. The majority of these follicles cause no complaints, but some may lead to pain in the lower abdomen or during sexual intercourse (dyspareunia).

4 BAYER-MICROLUT 0.03 mg - p.4/8 In most cases these enlarged follicles disappear of their own accord during two to three months of observation In the following cases you should see your doctor as soon as possible: changes in your health, e.g. occurrence of conditions described elsewhere in these instructions for use (see section 2.1 When must you not take Microlut? and section 2.2 When taking Microlut special care is needed ; consider also any cases occurring in close relatives of yours), lumps in the breast, continuing or increasing irregular bleeding, if you forgot to take tablets or took them late and had sexual intercourse, if your monthly bleeding fails to occur for six weeks in a row (only start on a new blister pack when it is certain that you are not pregnant), if you have unexplained pain in the lower abdomen in combination with an irregular bleeding pattern (menstrual bleeding does not occur or if the bleeding fails to occur and then irregular bleeding occurs, see section The minipill and tubal pregnancy ), if you notice possible signs of a thrombosis (see section The minipill and thrombosis ) Impaired efficacy The efficacy of Microlut may be impaired, if one or several tablets are missed or taken late (see section 3.4 If you forgot to take Microlut ), vomiting or severe diarrhea occurs (see section 3.5 What to do in case of vomiting and/or diarrhea ), certain other drugs are taken at the same time (see section 2.3 Taking Microlut with other drugs ). If Microlut and preparations containing St-John s wort are taken at the same time, it is recommended to employ an additional barrier method of contraception (see section 2.3 Taking Microlut with other drugs ) Cycle disturbances Menstrual bleeding In the majority of cases when the minipill is taken bleeding is at normal intervals, of normal duration and intensity. Nevertheless, shorter or longer intervals have also been observed between bleeding periods. These changes mainly occur in the initial months of use. Later on during use the bleeding pattern settles down and in most cases an individual pattern is established. You should always record bleeding in a calendar. What to do in the case of intermenstrual bleeding Intermenstrual bleeding of varying intensity can occur, especially in the initial months. From the medical point of view this is no reason to stop taking Microlut. You should, however, tell your doctor so that organic causes for such bleeding can be ruled out. Withdrawal bleeding does not occur It might happen that monthly bleeding fails to occur, but in most cases this applies only to one or two cycles. In rare cases the failure to bleed may persist for longer periods. If bleeding fails to occur again within six weeks from the last bleeding, you must see your doctor so that pregnancy can be ruled out before further tablets are taken. 2.3 Taking Microlut with other drugs Please inform your doctor or pharmacist if you are presently or were recently on other drugs, even if they are non-prescription drugs. Please note that this may also apply to drugs used recently. The effect of Microlut may be impaired if any of the following drugs or classes of preparations are taken at the same time. The occurrence of breakthrough bleeding may be an initial sign of this. These include: drugs to treat epilepsy, such as hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, oxcarbazepine, topiramate and felbamate drugs to treat tuberculosis (e.g. rifampicin) ritonavir, rifabutin, efavirenz, nevirapine, nelfinavir, griseofulvin, herbal drugs containing St. John s wort (Hypericum perforatum).

5 BAYER-MICROLUT 0.03 mg - p.5/8 If you receive treatment with any of the above-mentioned drugs for a short period (up to one week) you must use barrier methods (e.g. condom) in addition to the Microlut both during the treatment period with such drugs and for another 28 days beyond that. If you need to take such drugs for longer periods, please ask your doctor in attendance for advice. Depending on the case you might have to use a different, nonhormonal contraception method. Taking antibiotics such as ampicillin or tetracyclines at the same time may impair the effect of Microlut. Taking activated charcoal can diminish the absorption of the active substance of the minipill, thus reducing contraceptive reliability. In this case refer to the explanations in section 3.4 If you have forgotten to take Microlut. Hormonal contraceptives can impair the metabolism of other drugs. Consequently the blood and tissue levels (e.g. of cyclosporin) can be impaired. Note: You should refer to the instructions for use of the respective concomitant medication for any possible interactions. Inform any doctor or dentist who prescribes drugs for you that you are taking Microlut. They will be able to tell you whether and for how long you must use additional, nonhormonal contraception. Impairment of laboratory findings Use of the minipill may impair the results of certain laboratory tests, including the findings for liver, thyroid, adrenal gland and kidney functions, as well as the amounts of certain blood proteins, e.g. proteins which affect lipid metabolism, carbohydrate metabolism or coagulation and fibrinolysis. These changes, however, generally remain within the normal range. 2.4 Pregnancy and lactation Ask your doctor or pharmacist for advice before taking/using any medicines Pregnancy You must not be pregnant before you start taking Microlut. If pregnancy occurs while you are on the drug you must stop taking Microlut immediately. Undesired hormonal effects on the development of urinary and sex organs cannot be completely ruled out, but most of the scientific studies carried out to date do not indicate any enhanced risk of deformities occurring in the offspring of mothers who took contraceptives prior to pregnancy, nor are there any indications of a deformitycausing effect coming about through accidental ingestion of corpus luteum hormone at doses like those contained in Microlut during pregnancy Lactation The taking of the minipill should be avoided in the breastfeeding period. Nevertheless the minipill is regarded as being the method of choice second to nonhormonal contraception methods. If the use of the minipill starts six weeks after the birth, there appear to be no detrimental effects on the growth and development of the breastfed infant. There is no evidence to suggest that the minipill impairs either quality or quantity of breast milk, although small amounts of the active substance are excreted with the milk. 2.5 Fitness to drive and operate machinery No special precautions are needed. 2.6 Important information about certain other constituents of Microlut This medicinal product contains sugar (sucrose) and milk sugar (lactose). Please consult your doctor before taking Microlut, if you know that you are allergic to certain types of sugar. 3. How is Microlut to be taken? Always take Microlut exactly as instructed by the doctor. Please ask your doctor or pharmacist if you are not quite sure. 3.1 Mode of use This medicinal product is to be taken by mouth. Please take the tablets whole with sufficient liquid (preferably a glass of water). 3.2 Unless the doctor prescribes otherwise, the usual dose is: One tablet daily. Microlut is taken continuously, i.e. without any break in tablet-taking. This means that on the very next after you have taken all the tablets from one blister pack you start taking tablets from the subsequent blister pack.

6 BAYER-MICROLUT 0.03 mg - p.6/8 Microlut must be taken at the same time every day, as near as possible to the exact time of day and on a continuous basis without any tablet-free break, irrespective of whether any bleeding occurs (menstrual bleeding or even intermenstrual bleeding). The interval between two consecutive tablets should be as close as possible to 24 hours. To avoid jeopardizing the contraceptive effect this time must not be exceeded by more than three hours at all events. The maximum reliability of Microlut can only be guaranteed if the time between tablet-taking is kept as close as possible to 24 hours. When should you start taking tablets from the first blister pack? If you were not taking any pill for contraception in the previous month: Start taking Microlut on the first day of your cycle, i.e. on the first day of your menstrual bleeding. The first tablet is removed from a well marked with the abbreviated day of the week for the start of tablet-taking (e.g. Mo for Monday). Continue taking the tablets in the direction of the arrows until all 35 tablets of the blister pack have been used up. Then start taking tablets from the next blister on the day after that. If you start taking Microlut later than on the first day of menstruation, an additional barrier method of contraception is to be used in the first seven days. If you proceed as described earlier, however, contraception is guaranteed from the start of tablet-taking. Switching from a combined pill : Start taking Microlut on the same day you take the last tablet of the combined pill that contained active ingredients. If the pack of the previous pill also contains tablets without active ingredients, you must not take them. If you do not know which is the last tablet containing an active ingredient, ask your doctor or pharmacist. If you proceed as described earlier, uninterrupted contraception is guaranteed. Switching from another minipill: You can stop taking the previous minipill on any particular day and start taking Microlut from the very next day. If you take the tablets correctly it is not necessary to take any additional contraceptive measures. Switching from an injection or implant: Start taking Microlut at the time the next injection would otherwise have to be done, or on the day the implant is removed. When switching from an implant or injectable product an additional barrier method of contraception must be employed during the first seven days. After childbirth: Women who are not breastfeeding can start taking the tablets 21 days after a birth. During the first seven days an additional barrier method must be used. If sexual intercourse has already taken place, pregnancy must be ruled out before you start taking Microlut, or the first menstrual bleeding must be waited for. After a miscarriage or an abortion: Please ask your doctor when you should start. Use in breastfeeding women: see section 2.4 Pregnancy and lactation 3.3 If you have taken more Microlut than you should: There have been no reports of serious deleterious effects on health from a single ingestion of several Microlut tablets. If several tablets are taken at the same time nausea, vomiting and also slight vaginal bleeding may occur. If you discover that a child has taken several tablets by accident, please see a doctor. 3.4 If you forgot to take Microlut : Even if only one tablet was taken late (i.e. if more than 27 hours have elapsed since the last tablet was taken) or if one tablet was forgotten, contraceptive protection may be impaired. The missed tablet should be taken as soon as possible, even if this means having to take two tablets at the same time. After this, tablet-taking is resumed at the normal time of day. In addition, a barrier method is to be used for the next seven days. If sexual intercourse has taken place in the previous seven days, pregnancy might possibly have come about. In this case please inform your doctor. The

7 BAYER-MICROLUT 0.03 mg - p.7/8 risk of pregnancy occurring increases with the number of tablets missed. 3.5 If you vomit or have diarrhea: If you have to vomit within the first three to four hours of taking the tablet and/or have diarrhea, the active ingredient of the tablet may not have been completely absorbed by the body. The situation is comparable to having forgotten to take a tablet. In such a case please follow the advice given in the previous section. An additional barrier method of contraception is to be used in the following seven days. Any replacement tablet(s) should be taken from the end of the blister pack so that one retains an overview of daily tablet-taking from the days of the week shown on the blister pack. 3.6 If you stop taking Microlut : You can stop taking Microlut at any time. If you do not want to become pregnant, ask your doctor about other reliable birth control methods. If you have any further queries about using this drug, ask your doctor or pharmacist. 4. What side effects are possible? Like any drug, Microlut can have side effects, but not necessarily with every user. In the assessment of side effects the following frequency brackets are used: Very common occurring in more than one out of 10 users Common occurring in fewer than one out of 10, but more than one out of 100 users Uncommon occurring in less than one out of 100, but more than one out of 1,000 users Rare occurring in less than one out of 1,000, but more than one out of 10,000 users Very rare occurring in less than one out of 10,000 users, or unknown The following side effects have been reported after the taking of Microlut : Incidence of side effect Very common Common Uncommon Rare Organ system Immune system disorders hypersensitivity reactions. Psychiatric conditions depressive moods, changes in sex drive (libido) Nervous system disorders headache, dizziness, nervousness Ophthalmic conditions Gastrointestinal disorders nausea, vomiting Skin and subcutaneous tissue disorders Acne yellowish brown skin pigmentation spots (chloasma) Disorders of the sex organs and mammary gland bleeding disturbances like spotting, or no menstrual bleeding breast pain, breast tension, painful menstruation, vaginal inflammation, prolonged menstrual bleeding*, more prolonged intermenstrual bleeding* poor tolerance of contact lenses more maletype hair growth (hirsutism), skin conditions* changes in vaginal secretions General diseases fluid retention in the tissues Checkups changes in body weight * applies generally to preparations containing only one corpus luteum hormone See section 2.2 Microlut must be used with special care for other serious side effects such as bloodclotting, liver tumors, breast cancer or cervical cancer. Tubal pregnancies occur more frequently in users of minipills than in users of combined oral contraceptives (cf. section The minipill and tubal pregnancy.

8 BAYER-MICROLUT 0.03 mg - p.8/8 During the use of Microlut persistent ovarian cysts (functional ovarian cysts) may occur (cf. section The minipill and persistent ovarian cysts ). Please inform your doctor or pharmacist if any of the side effects listed affect you seriously or if you notice side effects which have not been listed in these directions for use. 5. How is Microlut to be kept? Medicine, keep out of children s reach. You must not use the drug after the expiry date indicated on the folding box and blister pack under. Storage conditions: Do not store above 30 C 6. Further information What Microlut contains: The active substance is levonorgestrel. 1 coated tablet contains 0.03 mg levonorgestrel. The other constituents are: Lactose monohydrate, maize starch, polyvidone K25, talc, magnesium stearate (Ph. Eur.), sucrose, polyvidone K90, macrogol 6 000, calcium carbonate, montanglycol wax. What Microlut looks like and what the pack contains: Microlut is available in packs containing one blister pack containing 35 coated tablets, and three blister packs, each containing 35 coated tablets. Manufacturer: Bayer Schering Pharma AG D Berlin These directions for use were last revised in July 2007.