YAZ PIL
Contents
1. Some medicines can make Flexyess less effective in preventing pregnancy or can cause unexpected bleeding These include e medicines used for the treatment of O epilepsy e g primidone phenytoin barbiturates carbamazepine oxcarbazepine O tuberculosis e g rifampicin o HIV infections ritonavir nevirapine or other infections antibiotics such as griseofulvin penicillin tetracyclines O high blood pressure in the blood vessels in the lungs bosentan Page 6 of 13 Flexyess PIL e the herbal remedy St John s wort Flexyess may influence the effect of other medicines e g O medicines containing ciclosporin O the anti epileptic lamotrigine this could lead to an increased frequency of seizures Ask your doctor or pharmacist for advice before taking any medicine Taking Flexyess with food and drink Flexyess may be taken with or without food if necessary with a small amount of water Laboratory tests If you need a blood test tell your doctor or the laboratory staff that you are taking the pill because hormonal contraceptives can affect the results of some tests Pregnancy If you are pregnant you must not take Flexyess If you become pregnant while taking Flexyess you must stop immediately and contact your doctor If you want to become pregnant you can stop taking Flexyess at any time see also If you want to stop taking Flexyess on page X Ask your doctor or pharmacist for advice before taking any med2. Page 1 of 13 Flexyess PIL PACKAGE LEAFLET INFORMATION FOR THE USER Flexyess 0 02 mg 3 mg film coated tablets Ethinylestradiol Drospirenone Read all of this 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 pharmacist e This medicine has been prescribed for you do not pass it on to others It may harm them If any of the side effects gets serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist In this leaflet 1 WHAT FLEXYESS IS AND WHAT IT IS USED FOR ener 2 2 BEFORE YOUTARE FLEXYESS s macte exordia tea redi TOR 2 General Otesi acoge taii bot dest oed oe dt S Led sc ca oe eS Eu d 2 When you should not use Flexyess sesssesesseesseesseesseesseessstesseessteseeessseesseesstesseresseesssresseesse 2 When do you need to take special care with Flexyess eee 3 Flexyess and venous and arterial blood clots eseseeseeeeeeeeeeeeneneee nene 3 Flex yess abd CANCE cos osarte tt om p ette oa teas nafci uta tuf ctm rur ICs P Paso ei sh Ege 5 Bleeding between periods oec ect epe A n tust IA a Sad cence A E 2 What to do if no bleeding occurs during the 4 day tablet free interval 5 Flexyess and using other medicines lt is cscccaiss deae tta a eee deat lecto Sec ict e and
3. mg 3 mg film coated tablets This leaflet was last approved in To be inserted upon approval
4. 0 the tablets can be taken continuously up to a maximum of 120 days Within this period you may decide yourself when to take the 4 day tablet free interval This will usually cause bleeding During the flexible phase the Clyk tablet dispenser allows you to initiate a 4 day tablet free interval at any time If you do not initiate the 4 day tablet free interval yourself the Clyk dispenser automatically initiates a 4 day tablet free interval after 120 days of continuous tablet intake In the event of continued bleeding three consecutive days during days 25 120 it is advisable to take the 4 day tablet free interval This will reduce the total number of days with bleeding Tablet free interval A tablet free interval should never be longer than 4 days and it should only be started if tablet taking has been continuous for 24 days During the 4 day tablet free interval bleeding usually occurs and may not have finished before you start the next tablet intake cycle After each 4 day tablet free interval you will start a new intake cycle of a minimum of 24 days to a maximum of 120 days After the mandatory phase of 24 days of continuous tablet taking you again may choose when to have the tablet free 4 day interval between days 25 and 120 Preparing the Clyk tablet dispenser for use Flexyess can only be used in combination with the Clyk dispenser The separate document instructions for use of the Clyk dispenser should be car
5. aking Flexyess and wait for a menstrual period before trying to become pregnant You will be able to calculate the expected delivery date more easily If you have any further questions on the use of this product ask your doctor or pharmacist 4 POSSIBLE SIDE EFFECTS Like all medicines Flexyess can cause side effects although not everybody gets them The following is a list of the side effects that have been linked with the use of Flexyess Common side effects affects 1 to 10 users in 100 e mood swings depression decreased interest in or loss of interest in sex headache migraine nausea breast pain problems with your periods such as irregular periods absence of periods Page 11 of 13 Flexyess PIL Uncommon side effects affects 1 to 10 users in 1 000 nervousness sleepiness dizziness pins and needles migraine varicose veins increased blood pressure stomach ache vomiting indigestion intestinal gas inflammation of the stomach diarrhoea acne itching rash aches and pains e g back pain limb pain muscle cramps vaginal fungal infection pelvic pain breast enlargement benign breast lumps uterine vaginal bleeding which usually subsides during continued treatment genital discharge hot flushes inflammation of the vagina vaginitis problems with your periods painful periods reduced periods very heavy periods vaginal dryness abnormal cervical smear e lack of energy increased sweating fluid rete
6. d clot in a year the exact number is unknown Of 100 000 women who are pregnant around 60 may have a blood clot in a year A blood clot in the veins may travel to the lungs and may block blood vessels called a lung embolus Formation of blood clots in the veins may be fatal in 1 2 of cases The level of risk may vary according to the type of pill you take Discuss with your doctor the available options The use of combination pills has been connected with an increase of the risk of an arterial blood clot arterial thrombosis for example in the blood vessels of the heart heart attack or the brain stroke The risk of an arterial blood clot in users of combination pills increases e if you smoke You are strongly advised to stop smoking when you use Flexyess especially if you are older than 35 years if you have high levels of blood cholesterol or triglycerides if you are overweight if one of your close relatives had a heart attack or stroke at a young age if you have high blood pressure if you suffer from migraine if you have a problem with your heart valve disorder a disturbance of the cardiac rhythm Stop taking Flexyess and contact your doctor immediately if you notice possible signs of a blood clot such as e severe pain and or swelling in one of your legs e sudden severe pain in the chest which may reach the left arm e sudden breathlessness e sudden cough without an obvious cause e any unusual severe o
7. d on your Clyk dispenser s home screen and follow the above instructions If you are unsure what to do ask your doctor for advice e 1 tablet missed during Day 1 7 You should take the last missed tablet as soon as you remember even if this means taking two tablets at the same time Then continue to take tablets at the usual time In addition check if the Use an additional method of contraception symbol an exclamation mark in a box is displayed on your Clyk dispenser s home screen and follow the above instructions If you have had sex in the week before forgetting the tablet you must realize that there is a risk of pregnancy In that case contact your doctor e 1 tablet missed during Day 8 24 You should take the last missed tablet as soon as you remember even if this means taking two tablets at the same time Then continue to take tablets at your usual time If you have taken your tablets correctly in the 7 days preceding the first missed tablet there is no need to use extra contraceptive precautions However if this is not the case or if you have missed more than 1 tablet you should Page 10 of 13 Flexyess PIL check if the Use an additional method of contraception symbol an exclamation mark in a box is displayed on your Clyk dispenser s home screen and follow the above instructions If you are unsure what to do ask your doctor for advice e 1 tablet missed during Day 25 120 You may choose either of the following o
8. doctor what to do if you are not sure when to start If you take more Flexyess than you should There are no reports of serious harmful results of taking too many Flexyess tablets If you take several tablets at once then you may have symptoms of nausea or vomiting Young girls may have bleeding from the vagina If you have taken too many Flexyess tablets or you discover that a child has taken some ask your doctor or pharmacist for advice If you forget to take Flexyess IMPORTANT If you have missed one or more pills check if the Use an additional method of contraception symbol an exclamation mark in a box is displayed on your Clyk dispenser s home screen Whenever the home screen displays the exclamation mark you should use an additional non hormonal method of contraception e g condoms You should use an additional method of non hormonal contraception until the exclamation mark disappears Management of missed tablets e If you are less than 24 hours late when taking a tablet the protection against pregnancy is not reduced Take the tablet as soon as you remember and then continue taking the tablets again at the usual time e If you are more than 24 hours late in taking any tablet your protection against pregnancy may be reduced The following advice can be given in daily practice e More than one tablet forgotten Check if the Use an additional method of contraception symbol an exclamation mark in a box is displaye
9. efully read before and during use 1 Remove the OC dispenser from its package Remove a cartridge containing 30 tablets from its blister immediately prior to insertion 3 Hold the dispenser in the palm of your hand so you see the viewing window for the tablets see picture 4 Hold the cartridge in your other hand so that you can see the tablets 5 Insert the cartridge in the dispenser pushing it in all the way and leave in The tablets are now visible through the viewing window 13 Page 8 of 13 Flexyess PIL 6 Turn the dispenser over to view the display screen on the front This now tells you that your OC dispenser is turned on and ready to use E E a8 d E N N 5 A y N b Replacing an empty cartridge with a new cartridge When the cartridge is empty release it from the tablet dispenser by pressing the cartridge release button the button with a blue circle on it Only remove the new cartridge from its blister immediately prior to insertion Dispose of the empty cartridge and insert a new one as described above When can you start with Flexyess If you have not used a contraceptive with hormones in the previous month Begin with Flexyess on the first day of the cycle that is the first day of your period If you start Flexyess on the first day of your period you are immediately protected against pregnancy You may also begin on day 2 5 of the cycle but then you must u
10. gainst HIV infection AIDS or any other sexually transmitted disease When you should not use Flexyess e If you have or have ever had a blood clot in a blood vessel of the leg thrombosis of the lung pulmonary embolism or other organs e if you have or have ever had a heart attack or stroke e if you have or have ever had a disease that can be an indicator of a heart attack in the future for example angina pectoris which causes severe pain in the chest or of a stroke for example a passing slight stroke with no residual effects e if you have a disease that may increase the risk of a clot in the arteries This applies to the following diseases o diabetes with damaged blood vessels o very high blood pressure o avery high level of fat in the blood cholesterol or triglycerides Page 3 of 13 Flexyess PIL if you have a disturbance of blood clotting for example protein C deficiency if you have or have ever had a certain form of migraine with so called focal neurological symptoms if you have or have ever had liver disease and your liver function is still not normal if your kidneys are not working well renal failure if you have or have ever had a tumour in the liver if you have or have ever had or if you are suspected of having breast cancer or cancer of the genital organs if you have any unexplained bleeding from the vagina if you are allergic to ethinylestradiol or drospirenone or any of the ot
11. heir frequency cannot be estimated from the available data hypersensitivity erythema multiforme rash with target shaped reddening or sores If any of the side effects gets serious or if you notice any side effects not listed in this leaflet or if you think that this may be the case please tell your doctor or pharmacist 5 HOW TO STORE FLEXYESS Keep Flexyess out of the reach and sight of children This medicinal product does not require any special storage conditions Page 12 of 13 Flexyess PIL The tablet dispenser is not watertight and should always be kept dry Expiry date Do not take Flexyess after the expiry date which is stated on the folding box and the blister of the cartridge see EXP Once you have removed the cartridge from the blister insert it immediately into the dispenser and take the tablets within 40 days Medicines should not be disposed of via wastewater or household waste Ask your pharmacist how to dispose medicines no longer required These measures will help to protect the environment 6 FURTHER INFORMATION What Flexyess contains e The active substances are ethinylestradiol as betadex clathrate and drospirenone Each tablet contains 0 020 milligram ethinylestradiol as betadex clathrate and 3 milligram drospirenone e The other ingredients are Tablet core lactose monohydrate maize starch magnesium stearate E470b Tablet film coating hypromellose E464 talc E553b titanium di
12. her ingredients of Flexyess This may cause itching rash or swelling When do you need to take special care with Flexyess In some situations you need to take special care while using Flexyess or any other combination pill and your doctor may need to examine you regularly Also if any of the following conditions applies to you you must inform your doctor before starting to use Flexyess If any of the following conditions develops or worsens while you are using Flexyess you must consult your doctor if a close relative has or has ever had breast cancer if you have a disease of the liver or the gallbladder if you have diabetes if you have depression if you have Crohn s disease or inflammatory bowel disease ulcerative colitis if you have a blood disease called HUS haemolytic uraemic syndrome that causes kidney damage if you have a blood disease called sickle cell anaemia if you have epilepsy see page X Flexyess and using other medicines if you have a disease of the immune system called SLE systemic lupus erythematosus if you have a disease that first appeared during pregnancy or earlier use of sex hormones for example hearing loss a blood disease called porphyria skin rash with blisters during pregnancy gestational herpes a nerve disease causing sudden movements of the body Sydenham s chorea If you have or have ever had golden brown pigment patches chloasma so called pregnancy patches especially on the face If t
13. his is the case avoid direct exposure to sunlight or ultraviolet light if you have hereditary angioedema products containing oestrogens may cause or worsen the symptoms You should see your doctor immediately if you experience symptoms of angioedema such as swollen face tongue and or pharynx and or difficulty swallowing or hives together with difficulty breathing Flexyess and venous and arterial blood clots The use of any combination pill including Flexyess increases a woman s risk of developing a venous blood clot venous thrombosis compared with women who do not take any contraceptive pill The risk of venous thrombosis in users of combination pills increases with increasing age if you are overweight if one of your close relatives ever had a blood clot in the leg lung pulmonary embolism or other organ at a young age if you must have surgery if you have had a serious accident or if you are immobilized for a long time It is important to tell your doctor in advance that you are using Flexyess as the treatment may Page 4 of 13 Flexyess PIL have to be stopped Your doctor will tell you when to start Flexyess again This is usually about two weeks after you are back on your feet Your chances of having a blood clot are increased by taking the pill Of 100 000 women who are not on the pill and not pregnant about 5 10 may have a blood clot in a year Of 100 000 women taking a pill like Flexyess 30 40 may have a bloo
14. icine Breast feeding Use of Flexyess is generally not advisable when a woman is breast feeding If you want to take the pill while you are breast feeding you should contact your doctor Ask your doctor or pharmacist for advice before taking any medicine Driving and using machines There is no information suggesting that use of Flexyess affects driving or use of machines Important information about some of the ingredients of Flexyess Flexyess contains lactose If you cannot tolerate certain sugars contact your doctor before you take Flexyess 3 HOW TO TAKE FLEXYESS General advice Always use Flexyess exactly as your doctor has told you You should check with your doctor or pharmacist if you are not sure The Clyk tablet dispenser will guide you through the regimen Take one tablet of Flexyess every day if necessary with a small amount of water You may take the tablets with or without food but you should take the tablets every day around the same time Page 7 of Flexyess PIL Tablet intake 1 Mandatory phase day 1 24 When starting Flexyess tablets must be taken continuously for a minimum of 24 days after which you can either stop taking tablets for a 4 day tablet free interval or continue taking them for up to 120 days see flexible phase During the first 24 days the Clyk tablet dispenser does not allow a 4 day tablet free interval 2 Flexible phase day 25 120 During days 25 12
15. is 5 Taking Flexyess with food and drink 3 2 3 estes da eai ec cere ea e dec o utu eee 6 IAG ALOR LOSES seco pe E nM ED UU GE 6 Presnatie 4 chide els eun DM oM LM E C a a el as eme COE eo td eh EET 6 Breast feeding cocco ui ton de Di a ARES V NON UR nay DU M eset ade dei toT pcc au bte aude 6 Driving and using machines uoie erii terea e eet ierra deo es dk ee aided Up ca c De Pelea rade 6 Important information about some of the ingredients of Flexyess esses 6 Dec HOW TO TAKE FLEXYESS inneni Mm Du DU Md a e cena Mi tcp sd 6 Preparing the Clyk tablet dispenser for use essen nennen nennen 7 Replacing an empty cartridge with a new cartridge sese 8 When can you start with Plex yess iieseiatodiesee s ss oeste ent e e REN ea neo Sea Fb een decansaeenavensdaase 8 If you take more Hlexyess than you should eet o Ete dr ear eo c gebe ade 9 If you forget to take Flexyessau eerte ie etm ee tastes Feste h act iia urna 9 What to do in the case of vomiting or severe diarrhoea seen 10 If y want te stop taking EIexyessiibiscn laoree isisisi etant qal tei e aes 10 4 POSSIBLE SIDE EFFECTS ortae ee tert ONE Tra ETRAS PETRAM RUE IN End De A AE 10 Page 2 of 13 Flexyess PIL 9x HOW TOS TOR Be BIE XVI SS scat es fara edo staat etait tit I TM DUS 11 Expiry daterar ea oak ode pO Mb edi dat in ewer end ae dati Neo ges a ene 12 6 FURTHER INFORMATION 4 ttes tois v eoo e
16. mark DK Flexyess 0 02 mg 3 mg filmovertrukne tabletter Estonia EE Yvidually 0 02 mg 3 mg hukese pol meerikattega tabletid Finland FI Flexyess 0 02 mg 3 mg tabletti kalvop llysteinen France FR Flexyess 0 02 mg 3 mg comprim pellicul Germany DE Flexyess 0 02 mg 3 mg Filmtabletten Greece EL Flexyess 0 02 mg 3 mg emKka vuu va ue Aent DHEVLO Otok a Hungary HU Flexyess 0 02 mg 3 mg filmtabletta Iceland IS Flexyess 0 02 mg 3 mg filmuhudadar t flur Ireland IE Flexyess 0 02 mg 3 mg film coated tablets Italy TT Yvidually 0 02 mg 3 mg compresse rivestite con film Latvia LV Y vidually 0 02 mg 3 mg apvalkotas tabletes Lithuania LT Flexyess 0 02 mg 3 mg pl vele dengtos tablet s Luxembourg LU Flexyess 0 02 mg 3 mg comprim s pellicul s Malta MT Flexyess 0 02 mg 3 mg film coated tablets The Netherlands NL Yvidually 0 02 mg 3 mg filmomhulde tabletten Norway NO Flexyess 0 02 mg 3 mg tabletter filmdrasjerte Poland PL Flexyess 0 02 mg 3 mg tabletki powlekane Portugal PT Flexyess 3 mg 0 02 mg comprimido revestido por pel cula Romania RO Yvidually 0 02 mg 3 mg comprimate filmate Slovak Republic SK Flexyess 0 02 mg 3 mg filmom obalen tableta Slovenia SI Flexyess 0 02 mg 3 mg filmsko oblozene tablete Spain ES Flexyess 0 02 mg 3 mg comprimidos recubiertos con pel cula Sweden SE Flexyess 0 02 mg 3 mg filmdragerade tabletter United Kingdom UK Flexyess 0 02
17. ntion e weight increase Rare side effects affects 1 to 10 users in 10 000 candida fungal infection anemia increase in the number of platelets in the blood allergic reaction hormonal endocrine disorder increased appetite loss of appetite abnormally high concentration of potassium in the blood abnormally low concentration of sodium in the blood failure to experience an orgasm insomnia giddiness tremor eye disorders e g inflammation of the eyelid dry eyes abnormally rapid heartbeat inflammation of a vein nosebleed fainting enlarged abdomen bowel disorder feeling bloated stomach hernia fungal infection of the mouth constipation dry mouth pain of bile ducts or the gallbladder inflammation of the gallbladder e yellow brown patches on the skin eczema hair loss acne like inflammation of the skin dry skin lumpy inflammation of the skin excessive hair growth skin disorder stretch marks on the skin skin inflammation light sensitive skin inflammation skin nodules e difficult or painful sex inflammation of the vagina vulvovaginitis bleeding following intercourse withdrawal bleeding breast cyst increased number of breast cells hyperplasia malignant lumps in the breast abnormal growth on the mucosal surface of the neck of the womb shrinkage or wasting of the lining of the womb ovarian cysts enlargement of the womb e feeling generally unwell e weight loss The following side effects have also been reported but t
18. oxide E171 and red iron oxide E172 What Flexyess looks like and contents of the pack e The Flexyess tablet is light pink round with convex surfaces one side is embossed with the letters DS in a regular hexagon The tablets are presented in a cartridge which is then packed in a blister e The Starter pack for Flexyess contains 1 carton box with 1 blister containing 1 cartridge with 30 tablets and 1 carton box containing 1 dispenser e The refill packs for Flexyess contain 1 3 4 or 12 blisters each containing a cartridge with 30 tablets Marketing Authorisation Holder Bayer Limited The Atrium Blackthorn Road Dublin 18 In case of questions about the use of the tablet dispenser please contact the local BAYER subsidiary Manufacturer Bayer Pharma AG and Bayer Weimar GmbH and Co KG Berlin Germany Weimar Germany This medicinal product is authorised in the Member States of the EEA under the following names Country Proposed invented name strength and pharmaceutical form Austria AT Flexyess 0 02 mg 3 mg Filmtabletten Belgium BE Yvidually 0 02 mg 3 mg filmomhulde tabletten Bulgaria BG Flexyess 0 02 mg 3 mg dusmMupann ra nerku Cyprus CY Flexyess 0 02 mg 3 mg emKka vuu va ue Aent DHEVLO Otok a Page 13 of 13 Flexyess PIL Czech Republic CZ Flexyess 0 02 mg 3 mg potahovan tablety Den
19. p eI en Pt a ve eee E Ae usus ate eaa 12 MW Hate xyes COM AUS seenen oceans aet ada S OE 12 What Flexyess looks like and contents of the pack see 12 Marketing Authorisation Holder 4e Geo eed os esee de anb ie e ados es a 12 Man tact rer EPI lieved ote ee ll Ree i ee 12 1 WHAT FLEXYESS IS AND WHAT IT IS USED FOR e Flexyess is a contraceptive pill and is used to prevent pregnancy e Each tablet contains a small amount of two different female hormones namely drospirenone and ethinylestradiol e Contraceptive pills that contain two hormones are called combination pills 2 BEFORE YOU TAKE FLEXYESS General notes Before you can begin taking Flexyess your doctor will ask you some questions about your personal health history and that of your close relatives The doctor will also measure your blood pressure and depending upon your personal situation may also carry out some other tests In this leaflet several situations are described where you should stop using Flexyess or where the reliability of Flexyess may be decreased In such situations you should either not have sex or you should take extra non hormonal contraceptive precautions e g use a condom or another barrier method Do not use rhythm or temperature methods These methods can be unreliable because Flexyess alters the monthly changes of body temperature and of cervical mucus Flexyess like other hormonal contraceptives does not protect a
20. ptions without the need for extra contraceptive precautions 1 Take the missed tablet as soon as you remember even if this means taking two tablets at the same time and take the next tablets at the usual time until you have taken at least 7 tablets in a row without interruption or 2 Stop taking tablets have a 4 day pill free break also count the day you missed your tablet and continue with a new intake cycle of Flexyess e If you have forgotten tablets and you do not have a bleeding during your 4 day pill free break you may be pregnant Contact your doctor before you continue to take the tablets see also section What to do if no bleeding occurs during the 4 day interval What to do in the case of vomiting or severe diarrhoea If you vomit within 3 4 hours of taking a tablet or you have severe diarrhoea there is a risk that the active substances in the pill will not be fully taken up by your body The situation is almost the same as forgetting a tablet After vomiting or diarrhoea take another tablet as soon as possible If possible take it within 24 hours of when you normally take your pill If this is not possible or 24 hours have passed use extra protection e g a condom for the next 7 days If you want to stop taking Flexyess You can stop taking Flexyess whenever you want If you do not want to become pregnant ask your doctor for advice about other reliable methods of birth control If you want to become pregnant stop t
21. r long lasting headache or worsening of migraine e partial or complete blindness or double vision e difficulty in speaking or inability to speak e giddiness or fainting e weakness strange feeling or numbness in any part of the body Page 5 of 13 Flexyess PIL Flexyess and cancer Breast cancer has been observed slightly more often in women using combination pills but it is not known whether this is caused by the treatment For example it may be that more tumours are detected in women on combination pills because they are examined by their doctor more often The occurrence of breast tumours becomes gradually less after stopping the combination hormonal contraceptives It is important to regularly check your breasts and you should contact your doctor if you feel any lump In rare cases benign liver tumours and in even fewer cases malignant liver tumours have been reported in contraceptive pill users In isolated cases these tumors have led to life threatening internal bleeding Contact your doctor if you have unusually severe abdominal pain Some studies suggest that long term use of the pill increases a woman s risk of developing cervical cancer However it is not clear to what extent sexual behaviour or other factors such as Human Papilloma Virus HPV increases this risk Bleeding between periods During the first few months that you are taking Flexyess you may have unexpected bleeding bleeding outside the tablet free da
22. se extra protective measures for example a condom for the first 7 days Changing from another combined hormonal contraceptive or combined contraceptive vaginal ring or patch You can start Flexyess preferably on the day after the last tablet free interval or after the last hormone free tablet of your previous pill When changing from a combined contraceptive vaginal ring or patch follow the advice of your doctor Changing from a progestogen only method progestogen only pill injection implant or a progestogen releasing IUD You may switch any day from the progestogen only pill from an implant or an IUS on the day of its removal from an injectable when the next injection would be due but in all of these cases use extra protective measures for example a condom for the first 7 days of tablet taking After a miscarriage or abortion Follow the advice of your doctor After having a baby Page 9 of 13 Flexyess PIL You can start Flexyess between 21 and 28 days after having a baby If you start later than day 28 you must use a so called barrier method for example a condom during the first seven days of Flexyess use If after having a baby you have had sex before starting Flexyess again you must first be sure that you are not pregnant or you must wait until your next period e f you are breast feeding and want to start Flexyess again after having a baby Read the section on Breast feeding on page X Ask your
23. ys If this bleeding occurs for more than a few months or if it begins after some months your doctor must find out what is wrong What to do if no bleeding occurs during the 4 day tablet free interval If you have taken all the tablets correctly have not had vomiting or severe diarrhoea and you have not taken any other medicines it is highly unlikely that you are pregnant Continue to take Flexyess as usual If you have taken the tablets incorrectly or if you have taken tablets correctly but the expected bleeding does not happen twice in a row you may be pregnant Contact your doctor immediately Bleeding under treatment with Flexyess normally does not occur every 4 weeks but at reduced frequency with intervals of up to 120 days Unexpected pregnancy may be difficult to recognize If for some reason you think you may be pregnant do a pregnancy test If the test is positive or you are still unsure contact your doctor Do not continue with tablet taking until you are sure that you are not pregnant In the meantime use non hormonal contraceptive measures See also under Pregnancy Flexyess and using other medicines Always tell your doctor which medicines or herbal products you are already using Also tell any other doctor or dentist who prescribes another medicine or the pharmacist that you take Flexyess They can tell you if you need to take additional contraceptive precautions for example condoms and if so for how long
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