Information about. östradiolvalerat och dienogest

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1 Information about östradiolvalerat och dienogest

2 This leaflet provides information about your new oral contraceptive, Qlaira. It is important that you read this leaflet before starting to take the tablets. More information about Qlaira can be found in the package insert that is included in the package.

3 Oral contraceptives a wise choice You have chosen to use oral contraceptives ( the pill ) as your method of contraception. Oral contraceptives are one of the safest methods to protect against unwanted pregnancy, provided that they are used correctly. We have compiled this leaflet to help you: it provides the most important information you should know about Qlaira and oral contraceptives, and how they affect your body. Consult your midwife or doctor if you have any questions. Oral contraceptives have been used for nearly 50 years, and the hormone doses they contained were previously significantly higher than they are today. The hormones that are components of the contraceptive pills are oestrogen and a gestagen (which is a synthetic version of a hormone produced by the corpus luteum). These hormones control your normal menstrual cycle (more information is given below: The hormones that control menstruation, Page 9). These hormones have been developed and improved through the years such that they give as few side effects as possible while at the same time giving effective protection against pregnancy.

4 Advantages of combined oral contraceptives Many women experience oral contraceptives as practical and positive since they: ensure regular menstruation reduce the volume of blood lost during menstruation, which reduces the risk of iron deficiency reduce period pain make it possible to delay menstruation often help to reduce acne in women who have problems with it. Protection against diseases The use of oral contraceptives protects against a number of diseases. Their use reduces the risk of, for example: ovarian and cervical cancer inflammation of the fallopian tubes ovarian cysts benign breast lumps. Some of these diseases can lead to infertility, and thus the use of combined oral contraceptives protects a woman s ability to have children. Does Qlaira have any side effects? In common with all oral contraceptives, Qlaira can cause side effects. Common side effects are changes in the pattern of bleeding, tense or sensitive breasts, period pain, acne, weight gain and headache. The effects are normally mild, and usually pass after a few months of use. Contact your midwife or doctor if the side effects do not disappear. All combined contraceptive preparations give rise to a somewhat higher risk of blood clots forming. The risk of developing a blood clot, however, is very low, and it is significantly lower than the risk of developing a blood clot if you become pregnant.

5 Development has produced Qlaira the first oral contraceptive that gives natural oestrogen Qlaira contains estradiol valerate and a gestagen known as dienogest. The estradiol valerate breaks down in the intestines and is converted to natural oestrogen, oestradiol. The quantities of sex hormones in the body vary throughout the menstrual cycle. It is these variations that Qlaira attempts to simulate. In order for this to be possible while at the same time providing accurate control of bleeding, research has developed a dynamic dosage regimen. This consists of 26 hormone tablets with different colours and two white tablets that do not contain any hormones. The hormones that control menstruation It will be easier to understand how Qlaira affects your body if you first know something about your body and about the menstrual cycle. Structures known as ovarian follicles are created in the ovaries during foetal development. These mature during puberty, and each month thereafter one (normally) egg is released, which then may be fertilised by a sperm. The female sex hormones oestrogen and progesterone (a natural hormone from the corpus luteum) are also formed in the ovaries. These hormones cause the lining of the uterus to grow and become ready to receive a fertilised egg. If fertilisation does not occur, part of the lining is sloughed off and menstrual bleeding takes place. The maturation of an egg, ovulation and menstruation take place in this way, cyclically, every month. This is why it is called the menstrual cycle. Each woman has her own individual menstrual cycle, and the duration of bleeding differs from one woman to the next. How does Qlaira protect against unwanted pregnancy? Qlaira protects you in three different ways: 1. ovulation does not occur 2. the lining of the uterus remains thin, which means that a fertilised egg cannot embed in it 3. the secretions in the cervix become thicker and impenetrable for sperm.

6 When starting to use Qlaira Qlaira protects against pregnancy from the first day you take it, but only if you take the tablets in the correct manner. You must, therefore, follow these instructions carefully. If you have not taken oral contraceptives during the preceding month: Start taking Qlaira on the first day of your period, the first day on which bleeding takes place. If the first day of bleeding is, for example, a Friday, attach the strip that has Fre as its starting day at the top of the package of tablets, and take the first pill. Then continue to take the tablets following the arrow. If you are changing to Qlaira from another oral contraceptive: Continue taking your current oral contraceptive pills until the active tablets are finished. If you have previously used a package containing 21 pills, start taking Qlaira on the day after you take the final active tablet of the previous package. If you have previously used a package containing 28 pills, do not take the last seven hormone-free tablets, and start taking Qlaira immediately after the final active tablet. If you are changing to Qlaira from a mini-pill: You can stop taking the mini-pills and start taking Qlaira on any day at all. You should use an additional contraceptive method, a condom for example, during the first nine days. After taking emergency contraception (the morning-after pill ): Start taking Qlaira on the day on which you take the morning-after pill. You should use an additional contraceptive method, a condom for example, during the first nine days. Following pregnancy, miscarriage or abortion: Follow the recommendations of your midwife or doctor.

7 Taking Qlaira Each package of pills contains 26 active hormone tablets and two white hormone-free tablets. Each package has a label with the days of the week printed on it. Each label consists of seven strips showing the days of the week. Select the correct strip the one that starts with the day of the week on which you take the first tablet. Attach the strip at the top of the package of pills. Take one tablet each day from the package until it is empty. Start a new package as soon as you finish a package: there are no tablet-free days when taking Qlaira. Menstruation-like bleeding will usually take place during the last two days of one package or at the beginning of the next. Start taking tablets from the next package on the same day of the week as the preceding package, even if the bleeding has not stopped. So if you started taking tablets on a Friday, for example, you will always start a new package on a Friday. Qlaira protects against pregnancy from the first day you take it, if you take the tablets correctly. You are protected against pregnancy also on the days on which you take the hormone-free tablets. Qlaira is the only combined contraceptive pill with 26 active tablets and two hormonefree tablets. Other combined contraceptive pills have 21 or 24 active tablets in each package. Qlaira contains the gestagen dienogest, which has anti-androgen properties (which can reduce the activity of the sebaceous glands).

8 Some common questions concerning oral contraceptives and Qlaira, and their answers How can I delay menstruation? You can delay the period of bleeding by not taking the last four tablets in the package (two dark red and two white) and then jumping over the seven first tablets in the next package (two yellow and five light red). Start the next package by taking the Day 8 tablet (light yellow). Continue to take one tablet every day until the package is finished. You will then probably experience bleeding within the next few days. It is the light yellow tablets (tablets 8-24) that can be used to delay your menstruation. Minor bleeding (breakthrough bleeding) may sometimes take place during the delay. What should I do if I have vomiting or diarrhoea? If you vomit or have severe diarrhoea within 3-4 hours of taking one of the active hormone tablets, there is a risk that Qlaira will not protect you from pregnancy. You should therefore take a new tablet from one of the extra packages as soon as you can, preferably within 12 hours. If more than 12 hours pass before you take the extra tablet, follow the advice given below under What happens if I forget to take one or more Qlaira tablets? What happens if I forget to take one or more Qlaira tablets? Qlaira can only function as a safe method of contraception if you take the tablets regularly, every morning, for example, or every evening. If you forget to take one or more of the tablets, you should take the tablet as soon as you can, and then continue to take the remaining tablets at the normal time. A simple precaution is to use a condom as extra protection for nine days after forgetting to take a tablet. If you have forgotten to take tablets and your period does not come as expected, it is possible that you are pregnant. Contact your midwife or doctor before starting the next package of tablets.

9 A simple precaution is to use a condom as extra protection for nine days after forgetting to take a tablet. If less than 12 hours have passed since you should have taken the tablet, take the tablet as soon as you remember it. You are still protected against pregnancy. Take the next tablet at the normal time. If more than 12 hours have passed since you should have taken the tablet it is possible that you are no longer protected against pregnancy. Take the tablet as soon as you remember, even if this means that you take two tablets at the same time. Continue then to take the tablets at the normal time. Use a condom as extra protection during the following nine days. If you forget to take more than one tablet from a package, contact your midwife or doctor for advice. Can I take Qlaira while taking other medicines? Certain medicines impair the effect of oral contraceptives and increase the risk of becoming pregnant. Examples are of such medicines are antibiotics, anti-epileptic drugs, drugs to combat tuberculosis, and St John s wort. Always tell your midwife or doctor if you are taking other medicines. If you contact the medical services for any other reason, always inform the doctor that you are taking oral contraceptives. Irregular bleeding It may happen during the first few months of taking oral contraceptives that you experience minor bleeding (spotting, or breakthrough bleeding). This usually passes, but you should contact a midwife or doctor if it continues. Continue to take the tablets regularly.

10 Is there a risk that I am pregnant if I do not experience bleeding during the hormone-free period? If you know that you have taken the tablets according to the instructions, there is no need to worry if you do not experience bleeding during the period of hormone-free tablets (or the first days of the next package). Clinical studies of Qlaira have shown that it is not uncommon that bleeding does not occur (in approximately 15% of menstrual cycles). If the menstruation-like bleeding does not occur during the period of hormone-free tablets (or during the first days of the next package), and you know that you have either forgotten to take a tablet or had vomiting or diarrhoea, contact your midwife or doctor for a pregnancy test. Stop taking Qlaira if you are pregnant. What should I do if I want to become pregnant? If you plan to become pregnant, complete taking the current package of tablets. What should I consider before taking Qlaira? There are no long-term studies of the effects of taking oral contraceptives that contain estradiol or estradiol valerate. The following safety advice is based on clinical and epidemiology results for combined oral contraceptives that contain ethinyl estradiol. It is not known whether this safety advice applies also to Qlaira. Always discuss with your midwife or doctor before starting to take Qlaira if: you have had a blood clot or know that you have a tendency to form blood clots (for example, if your parents or siblings have been affected by blood clots) you have liver or kidney disease you suffer from seriously high blood pressure you have diabetes with complications you suffer from uterine bleeding of unknown cause you suffer from migraine with associated disturbances or loss of vision you smoke and are older than 35 years.

11 When should I contact my midwife or doctor? It is very unusual that taking oral contraceptives gives any serious or long-lasting side effects. You should, however, contact your midwife or doctor if you experience any of the following symptoms: sudden swelling or aching in the calves repeated migraine-like headaches (that you have not experienced previously) sudden disturbances or loss of vision constriction in the chest or difficulties in breathing severe itching dizziness if you are affected by jaundice or believe that you may be pregnant. NOTE! Always inform your doctor when you visit that you are taking oral contraceptives. Keep the tablets out of the reach of children. Oral contraceptives are prescribed for a specific person. Do not pass your tablets onto another person. Oral contraceptives do not protect against HIV infection or other sexually transmitted diseases, so always have condoms available, to be on the safe side. Qlaira is a prescription medicine and may only be used following its prescription by a midwife or doctor.

12 Indication: Hormonal contraceptives for systemic use G03A Package: 3 x 28, Rx. See for more information. SPC 6 March 2009 L.SE ekelund&wik april 2010 Bayer AB, Box 606, Solna, tel

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