USER PACKAGE LEAFLET: INFORMATION FOR THE USER Exluton, tablets 0.5 mg Lynestrenol

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1 Lynestrenol 0.5mg tablets, (N.V.Organon), RH021 WHOPAR part 3 supplier s translation of original SRA approved text May 2012 USER PACKAGE LEAFLET: INFORMATION FOR THE USER Exluton, Lynestrenol Read this entire leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you personally. Do not pass this medicine on to others. This medicine may cause them harm, even if their symptoms are the same as the symptoms you received the medicine for. If any of the side effects gets serious, or if a side effect not listed in this leaflet occurs, please tell your doctor or your pharmacist. In this leaflet: 1. What is Exluton and what is it used for 2. What you should know before you take Exluton 3. How do you take Exluton 4. Possible side effects 5. How to store Exluton 6. Supplementary information 1. WHAT IS EXLUTON AND WHAT IS IT USED FOR How does Exluton work? Exluton contains only one female sex hormone, the progestogen lynestrenol. For this reason Exluton is also called a mini-pill. Contrary to combined pills, mini-pills do not contain an estrogen hormone besides the progestogen. The two main ways of action of Exluton are: Prevention of the sperm cells from entering the womb. Prevention of egg cells from ripening (in 70% of the women). In contrast to the combined pills, Exluton can be used by women who do not tolerate estrogens and by women who are breast-feeding. A disadvantage of Exluton is that the monthly vaginal bleeding may occur at irregular intervals. There is also a chance that these bleedings do not occur at all. Why do you use Exluton? To prevent pregnancy. If Exluton is taken correctly (without missing tablets), the chance of becoming pregnant is very small.

2 USER PACKAGE LEAFLET 2 EXLUTON 2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE EXLUTON General remarks In this leaflet, several situations are described in which you should discontinue taking Exluton, or where the reliability of Exluton may be decreased. In these situations you should not have sex or you should take an extra non-hormonal contraceptive precaution. In general, a condom or another barrier method are suitable. Do not use the rhythm or temperature method. These can be unreliable because the pill influences the monthly changes in body temperature and cervical mucus. The pill, and thus also Exluton, does not protect against HIV infection (AIDS) and neither against any other sexually transmitted disease. Do not use Exluton Do not use Exluton in any of the conditions listed below. If any of these conditions apply to you, tell your doctor before you start to use Exluton. Your doctor may advise you to use a nonhormonal method of birth control. If you have a thrombosis. Thrombosis is the formation of a blood clot, which may block a blood vessel [e.g. in the legs (deep venous thrombosis) or in the lungs (pulmonary embolism)]. If you have jaundice (yellowing of the skin) or if you have or have had a severe liver disease and your liver function is not normal yet. If you have or if you are suspected to have a form of cancer that is sensitive to sex hormones, such as certain types of breast cancer. If you have unusual vaginal bleeding of which the cause has not been determined. If you are allergic (hypersensitive) to lynestrenol or to any of the other excipients of Exluton. If any of these conditions appear for the first time while using Exluton you should consult your doctor immediately. Take special care with Exluton Under certain circumstances it can be necessary to be kept under close surveillance while using Exluton. Your doctor can explain to you what to do. If any of these conditions apply to you, you should tell your doctor before starting to use Exluton: you have or have had breast cancer; you have liver cancer; you have ever had a thrombosis; you have diabetes; you have ever had a pregnancy outside the womb; you have or have had an infection or surgery of your fallopian tubes; you have epilepsy; you have high blood pressure;

3 USER PACKAGE LEAFLET 3 EXLUTON you have or have had chloasma (yellowish-brown pigmentation patches on the skin, so called pregnancy patches, particularly on the face); if this is the case, it is sensible to avoid direct exposure to the sun or ultraviolet radiation. If one or more of the above conditions appear for the first time, recur or worsen while using Exluton, you should contact your doctor. Breast cancer 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. When women stop taking the pill, the risk gradually decreases, so that 10 years after stopping, the risk is the same as for women who have never taken the pill. Breast cancer is rare in women under 40 years of age but the risk increases with age. Therefore, the number of extra cases of breast cancer diagnosed is higher among women who use the pill at a higher age. How long the pill is used is less important. In every women who take the pill for 5 years but stop taking it by the age of 20, less than 1 extra case of breast cancer would be found up to 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group. Likewise, in women who take the pill for 5 years but stop taking it by the age of 30, there would be 5 extra cases of breast cancer in addition to the 44 cases normally diagnosed. In women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed. The risk of breast cancer in users of the mini-pill like Exluton is believed to be similar to that the risk in women who use the combined pill, but the evidence is less conclusive. Cases of breast cancers found in pill users, are usually in a less advanced stage than in women who do not take the pill. It is not known whether the difference in breast cancer risk is caused by the pill. It may be that the pill users were examined more often, so that the breast cancer was discovered earlier. Thrombosis Thrombosis is the formation of a blood clot, which may block a blood vessel. Thrombosis sometimes occurs in the deep veins of the lower leg (deep venous thrombosis). If this clot breaks loose, it may reach and block the arteries of the lungs (pulmonary embolism). This can be fatal. Deep venous thrombosis is a rare condition. It can occur in pill-users and nonusers. It can also occur during pregnancy. The risk of thrombosis is slightly higher in pill-users than in non-users, and above all, higher in users with a history of symptoms of thrombosis. It is unknown whether this also applies to pills such as Exluton, which only contain a progestogen hormone. In any case, the risk is less than during pregnancy. If you suddenly notice possible signs of a thrombosis, you should contact your doctor immediately. (See also When should you contact your doctor during Exluton use?) Ovarian cysts During the use of low-dose hormonal contraceptives (such as the mini-pill), small fluid-filled sacs may develop in the ovaries. These sacs are called ovarian cysts. They usually disappear on their own, but sometimes they cause abdominal pain. Only rarely, they may lead to more serious problems.

4 USER PACKAGE LEAFLET 4 EXLUTON Vaginal bleeding During the first months, vaginal bleeding may occur at irregular intervals. This may be just slight staining, or heavier bleeding, which is similar to a light menstrual bleeding and requires sanitary protection. There is also a chance that you may not have any bleeding at all. This is not a sign that the protection against pregnancy is decreased. In general, you do not need to take any action; just continue to take Exluton. If, however, bleeding is heavy or prolonged contact your doctor. Using other medicines Some medicines may keep Exluton from working properly. These include among others medicines used for the treatment of epilepsy (e.g., carbamazepine, oxcarbazepine, felbamate, primidone, phenytoin, phenobarbital, topiramate) or tuberculosis (e.g., rifampicin), HIV infections (e.g., ritonavir, nelfinavir), or other infectious diseases (griseofulvin); active charcoal used for gastro-intestinal disturbances. Exluton may also increase (e.g. cyclosporin) or decrease the efficacy of other medicines. Therefore, inform your doctor who prescribes you the pill which medicines you are taking. Also tell any other doctor or dentist who prescribes medicine (or pharmacist) that you use Exluton. They can tell you if you need to take additional non-hormonal contraceptive precautions and if so, for how long. You should not use herbal remedies that contain St. John s Wort (mainly used to treat mild depression) concurrently with Exluton. There have been reports of breakthrough bleeding and unintended pregnancies as a result of concurrently use. The reduced efficacy may last at least for two weeks after the treatment with St. John s Wort has been stopped. Contact your doctor first when you intend to use herbal remedies while using Exluton. Pregnancy and breastfeeding Pregnancy Exluton must not be used by women who are pregnant, or think they may be pregnant. Breastfeeding Exluton does not influence the production or the quality of breast milk. Small amounts (0.14 % of the amount ingested by the mother) of the active substance and Exluton metabolites pass through to breast milk, but there are no indications of any risk for the baby. Tell your doctor if your baby shows any signs or symptoms which you think might be related to the use of Exluton. Driving and using machines There are no indications that concentration and alertness are affected by the use of Exluton. Important information about some of the ingredients of Exluton Exluton contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before starting with Exluton.

5 USER PACKAGE LEAFLET 5 EXLUTON When should you contact your doctor during use of Exluton? Regular check-ups Your doctor will tell you to return for regular check-ups. The frequency and nature of these check-ups will depend on your personal situation. Contact your doctor as soon as possible if: you notice possible signs of a thrombosis (e.g. severe pain and/or swelling in either of the legs, unexplained chest pain, breathlessness, sudden unusual coughs, especially if you cough up blood); you have a sudden, severe abdominal pain or look jaundiced (indicating possible liver problems); you feel a lump in your breast; you have a sudden, severe pain in the lower part of your abdomen or the stomach area (possibly indicating a pregnancy outside the womb); at least four weeks in advance you are to have surgery or when you are confined to bed or are not allowed to walk; you have unexplained, heavy and prolonged vaginal bleeding; you suspect that you are pregnant. 3. HOW DO YOU TAKE EXLUTON When and how to take the tablets? The Exluton strip contains 28 tablets. On the back side of the strip, the days of the week are printed, with arrows printed in between. Each day corresponds with a tablet. Each time you start a new strip, take a tablet in the top row. Make sure that you start with the correct tablet. For example if you start on a Wednesday, you must take the tablet from the top row marked (at the back) with WED. You continue to take one tablet a day until the strip is empty, following the direction indicated by the arrows. By looking at the back of the strip, you can easily check whether you have taken your daily tablet. Take the tablets at about the same time each day, with some water. You may have some bleeding that resembles menstrual bleedings during the use of Exluton, but you should continue taking your tablets as directed. When a strip is empty, you must start with a new strip of Exluton on the next day - thus without interruption and without waiting for a bleed. When to start your first strip? You did not use hormonal contraceptives in the past month Wait for your menstrual bleeding. Start taking the first Exluton tablet on the first day of your menstrual bleeding. Then it is not necessary to use an additional contraceptive method. You may also start on days 2-5 of your menstrual bleeding, but in that case make sure you use an additional contraceptive method (a condom) if you have sex. This condom advice applies to the first 7 days of Exluton use, in the first cycle. You change from a combined hormonal contraceptive (combined pill, vaginal ring, or contraceptive transdermal patch)

6 USER PACKAGE LEAFLET 6 EXLUTON Start taking Exluton on the day after you take the last tablet from your present pill strip, or on the day of removal of your vaginal ring or patch (this means no tablet-, ring-, or patch-free break). If your present pill strip also contains placebo tablets (tablets without hormones) you can start Exluton on the day after taking the last active tablet (if you are not sure what tablet this is, ask your doctor or pharmacist for advice). It is not necessary to use an additional contraceptive method. You change from contraceptive progestogen-only pill You may switch on any day and start taking Exluton. You do not need to take additional contraceptive precautions. You change from an injectable, implant or a progestogen-releasing intrauterine device (IUD) Start using Exluton when your next injection is due or on the day that your implant or your IUD is removed. You do not need to take additional contraceptive precautions. After having a baby If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking Exluton. Sometimes it is possible to start sooner. Your doctor will advise you. After a miscarriage, or an abortion Your doctor will advise you. What you should do if you have taken more Exluton tablets then you should There have been no reports of serious harmful effects from taking too many Exluton tablets at one time. If you have taken a number of tablets at one time, you can possibly suffer from nausea and vomiting. In women and girls, slight vaginal bleeding may occur. For more information ask your doctor. What you should do if you have forgotten to take Exluton If you are less than 3 hours late in taking a tablet, the efficacy of Exluton is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times. If you are more than 3 hours late in taking any tablet, the efficacy of Exluton may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. Take the last missed tablet as soon as you remember and take the next tablets at the usual times. Also use a condom for the next 7 days of tablettaking. If you missed one or more tablets of the first strip and had sex in the 7 days prior to missing the tablets, there is a possibility of becoming pregnant. Ask your doctor for advice. What you should in case of gastro-intestinal disturbances (e.g., vomiting, severe diarrhoea) If you vomited, took active charcoal or have had severe diarrhoea within 3-4 hours after ingestion of a tablet, there is a chance that the active ingredient may not have been completely absorbed. Follow the advice for missed tablets in the section above. When you stop taking Exluton You can stop taking Exluton at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.

7 USER PACKAGE LEAFLET 7 EXLUTON If you stop Exluton because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. 4. POSSIBLE SIDE EFFECTS Like all medicines, Exluton can have side effects, although not everybody gets them. If any of the side effects get severe or if you notice a side effect not listed in this leaflet, please consult your doctor or pharmacist. Serious side effects Some serious side effects associated with the use of the pill are described in What you should know before you take Exluton? Please read this section for additional information and contact your doctor instantly when appropriate. Other possible side effects Side effects that are common (more than 1%) in users of Exluton or of hormonal contraceptives in general are: headache, migraine, nausea, abdominal pain, acne, rash, painful blue-red lumps (erythema nodosum), rash with irregular red patches (erythema multiforme), sensitivity to sun light, yellowish brown pigmentation patches (chloasma), increase in body weight, irregular vaginal bleeding, breast tenderness or pain, discharge from the nipple, no menstruation, mood changes, depressive mood, decreased sexual drive and fluid retention. Side effects that are uncommon (less than 1%) in users of Exluton or of hormonal contraceptives in general are: vomiting, diarrhoea, breast enlargement, ovarian cysts (small fluid-filled sacs in the ovaries), dryness of the vagina, vaginal discharge, irritation of the eyes when using contact lenses. Side effects that are rare (less than 0.1%) in users of Exluton or of hormonal contraceptives in general are: hives (urticaria), decrease in body weight, increased sexual drive and hypersensitivity. 5. HOW TO STORE EXLUTON Keep out of reach and sight of children Store below 30 C. Do not store in the refrigerator or freezer. Store in the original package. Do not use Exluton after the expiry date stated on the package and on the strip behind 'Do not use after:'. Do not use Exluton if you notice that the colour of the tablets has changed or the tablets are disintegrated, or if you notice other signs of deterioration of the quality. 6. SUPPLEMENTARY INFORMATION

8 USER PACKAGE LEAFLET 8 EXLUTON What Exluton contains The active substance is: lynestrenol (500 microgram) The other ingredients are: potato starch, amylopectin, lactose monohydrate and magnesium stearate. What Exluton looks like and contents of the package One strip of Exluton contains 28 white, round tablets with a beveled-edge. The tablets are coded TT above 2 on one side and ORGANON* on the reverse side. Each carton box contains 1 or 3 strips. Not all package sizes are available on the market. Marketing Authorisation Holder and Manufacturer N.V. Organon, Kloosterstraat 6, Oss In case of correspondence/information contact Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem Tel , medicalinfo.nl@merck.com Registered under number RVG This leaflet was last revised in December 2010