Yvidually PIL 1. What Yvidually is and what it is used for
Contents
1. Page 1 of 19 Yvidually PIL Package Leaflet Information for the user Yvidually 0 02 mg 3 mg filmomhulde tabletten ethinylestradiol drospirenone Read all of this leaflet carefully before you start taking this medicine because it contains important information for you Keep this leaflet You may need to read it again If you have any further questions ask your doctor or pharmacist This medicine has been prescribed for you only Do not pass it on to others It may harm them If you get any side effects talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet See section 4 Important things to know about combined hormonal contraceptives CHCs They are one of the most reliable reversible methods of contraception if used correctly They slightly increase the risk of having a blood clot in the veins and arteries especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks Please be alert and see your doctor if you think you may have symptoms of a blood clot see section 2 Blood clots What is in this leaflet 1 What Yvidually is and what it is used for e ces obersten et date seec ond ghey ive lose ieu e Ro e Paese dus 2 2 What you need to know before you take Yvidually eene 2 General niofes sos o cite obe e dais uetus te eee ert eee beaut aset etae STEN ue Unida 3 When you should not use2. Women using Yvidually About 9 12 out of 10 000 women Yvidually PL 082015 BEC 6087 Page 8 of 19 Yvidually PIL Factors that increase your risk of a blood clot in a vein The risk of a blood clot with Yvidually is small but some conditions will increase the risk Your risk is higher e if you are very overweight body mass index or BMI over 30kg m e if one of your immediate family has had a blood clot in the leg lung or other organ at a young age eg below the age of about 50 In this case you could have a hereditary blood clotting disorder e if you need to have an operation or if you are off your feet for a long time because of an injury or illness or you have your leg in a cast The use of Yvidually may need to be stopped several weeks before surgery or while you are less mobile If you need to stop Yvidually ask your doctor when you can start using it again e as you get older particularly above about 35 years e if you gave birth less than a few weeks ago The risk of developing a blood clot increases the more conditions you have Air travel 24 hours may temporarily increase your risk of a blood clot particularly if you have some of the other factors listed It is important to tell your doctor if any of these conditions apply to you even if you are unsure Your doctor may decide that Yvidually needs to be stopped If any of the above conditions change while you are using Y vidually for example a clo
3. Y viduallye sesto tcrtio prs te e He o El eee ev yes Pow osos edu e tatscanenste 3 Warnings and precautions is casn y ERES DITE Lesen A E ted ea leo En o 4 isdem T 5 Yvidually and Caner Por 9 Bleeding between DertOds ees codo ME a a e een a a 9 What to do if no bleeding occurs during the 4 day tablet free interval 9 Otliermedicimes and VV UCU ose at cad tsi lace iquat eap toa Ne el nd aa 10 Yvid ally with fogd and dEUE oi os se dee caven snsich nates casi Saou qe a A E E ov tee enne ie tout ee EI ER 10 Laboratory Te SES Qood ueniat atado oats net nanan ag sa aac Aaah oe Eo ayaa ite 10 PIE ST ANC Y EAEE EET TE AE cul GG E ote os Ld io e uS 10 Breastfeeding p A 11 Driving and USING fnacbilesu obe eor iae oet sg ctia tosas i Poe uss Feeder tenta coc E an 11 3 How todake Y vidually iacet stet etel qox ea eceinti see a aide cia enco il fucstoti betta tup cca o 11 Preparing the Clyk tablet dispenser for USE enis jet tesa qe teslis ia eae ane EU rm seu 12 Yvidually PL 082015 BEC 6087 Page 2 of Yvidually PIL Replacing an empty cartridge with a new cartridge sese When can you start with Y vidually cete deett bete eet i detis mappe t build oe If you take more Yvidually than you should It you forget to take Y vidually csere e e rdi ee ed duse Be iae pda What to do in the case of vomiting or severe diarrhoea
4. 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 Y vidually e f you have not used a contraceptive with hormones in the previous month Begin with Y vidually on the first day of the cycle that is the first day of your period If you start Yvidually 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 use extra protective measures for example a condom for the first 7 days e Changing from another combined hormonal contraceptive or combined contraceptive vaginal ring or patch You can start Yvidually 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 e 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 e After a miscarriage or abortion Follow the advice of your doctor e After having a baby You can star
5. 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 Yvidually can only be used in combination with the Clyk dispenser The separate document instructions for use of the Clyk dispenser should be carefully read before and during use 1 Remove the OC dispenser from its package 2 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 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 Yvidually PL 082015 BEC 6087 19 Page 13 of 19 Yvidually PIL d NJ T T Wek E m UUCDDDUDOCODCDDUDUCDDDCDODDUULA 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
6. eee If you stop taking Y vidually etii p epe tee ite ora dee e pt P coute De pedi eet CBE Possible D FOI NETTEN We kee Reporting or sile e Hebts coco er Ut otia a N ecc iie enu d cei 2s OH to store Y yiduallys aces eene EE M Ls Do not take this medicine 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 A Oia Score ue Ipae totes bases icai Damit ol det berto es E EE 6 Contents of the pack and other information 4 die epe coi Rex sane ao cn HR vad awn E axe eee pni ep tne What Yvidu lly CODES a scsoetiu osetob neo a itle ops a SEES What Y vidually looks like and contents of the pack eeee Marketing Authorisation Holder 5 eI ese tego aset aed NEAN Re ee SEEN NIRE E PER eA Manufacture nn ade t EHE reete at ee dy E d doas 1 What Yvidually is and what it is used for e Yvidually 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 Yvidually PL 082015 BEC 6087 19 13 17 Page 3 of 19 Yvidually PIL 2 What you need to know before you take Y vidually General notes Before you start using Yvidually you should read the
7. measures will help protect the environment 6 Contents of the pack and other information What Yvidually 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 dioxide E171 and red iron oxide E172 What Yvidually looks like and contents of the pack e The Yvidually 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 Yvidually 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 Yvidually contain 1 3 4 or 12 blisters each containing a cartridge with 30 tablets Yvidually PL 082015 BEC 6087 Page 18 of 19 Yvidually PIL Marketing Authorisation Holder Bayer B V Energieweg 1 3641 RT Mijdrecht For information Bayer B V Postbus 80 3640 AB Mijdrecht tel 0297 280 666 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 Wei
8. or if any of them are particularly severe the risk of developing a blood clot may be increased even more If any of the above conditions change while you are using Y vidually for example you start smoking a close family member experiences a thrombosis for no known reason or you gain a lot of weight tell your doctor Yvidually 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 Yvidually you may have unexpect
9. after a break of 4 weeks or more After the first year the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive When you stop Yvidually your risk of a blood clot returns to normal within a few weeks What is the risk of developing a blood clot The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking The overall risk of a blood clot in the leg or lung DVT or PE with Yvidually is small e Out of 10 000 women who are not using any combined hormonal contraceptive and are not pregnant about 2 will develop blood clot in a year e Out of 10 000 women who are using a combined hormonal contraceptive that contains levonorgestrel norethisterone or norgestimate about 5 7 will develop a blood clot in a year e Out of 10 000 women who are using a combined hormonal contraceptive that contains drospirenone such as Yvidually between about 9 and 12 women will develop a blood clot in a year e The risk of having a blood clot will vary according to your personal medical history See Factors that increase your risk of a blood clot below Risk of developing a blood clot in a year Women who are not using a combined hormonal pill and About 2 out of 10 000 women are not pregnant Women using a combined hormonal contraceptive pill About 5 7 out of 10 000 women containing levonorgestrel norethisterone or norgestimate
10. at you need to know before you take Y vidually The following is a list of the side effects that have been linked with the use of Yvidually 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 Yvidually PL 082015 BEC 6087 Page 16 of 19 Yvidually 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 lack of energy increased sweating fluid retention 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
11. blic 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 United Kingdom UK Flexyess 0 02 mg 3 mg film coated tablets Deze bijsluiter is voor het laatst goedgekeurd in juli 2015 Yvidually PL 082015 BEC 6087
12. 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 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 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 feeling generally unwell weight loss harmful blood clots in a vein or artery for example in a leg or foot i e DVT in a lung i e PE heart attack stroke mini stroke or temporary stroke like symptoms known as a transient ischaemic attack TIA blood clots in the liver stomach intestine kidneys or eye OnO O O Or The chance of having a blo
13. e 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 stop taking Y vidually You can stop taking Yvidually 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 taking Yvidually 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 this medicine can cause side effects although not everybody gets them If you get any side effect particularly if severe and persistent or have any change to your health that you think may be due to Yvidually please talk to your doctor An increased risk of blood clots in your veins venous thromboembolism VTE or blood clots in your arteries arterial thromboembolism ATE is present for all women taking combined hormonal contraceptives For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 Wh
14. ecause hormonal contraceptives can affect the results of some tests Pregnancy If you are pregnant you must not take Yvidually If you become pregnant while taking Y vidually you must stop immediately and contact your doctor If you want to become pregnant you can stop taking Y vidually at any time see also If you want to stop taking Y vidually on page X Ask your doctor or pharmacist for advice before taking any medicine Yvidually PL 082015 BEC 6087 Page 11 of 19 Yvidually PIL Breast feeding Use of Yvidually 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 Yvidually affects driving or use of machines Yvidually contains lactose If you cannot tolerate certain sugars contact your doctor before you take Yvidually 3 How to take Yvidually General advice Always use Yvidually 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 Yvidually 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 Tablet intake 1 Mandator
15. ed bleeding bleeding outside the tablet free days 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 Y vidually 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 Yvidually 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 Yvidually PL 082015 BEC 6087 Page 10 of 19 Yvidually PIL 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 Other medicines and Yvidually 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 Yvidually They ca
16. f angioedema such as swollen face tongue and or pharynx and or difficulty swallowing or hives together with difficulty breathing Blood clots Using a combined hormonal contraceptive such as Yvidually increases your risk of developing a blood clot compared with not using one In rare cases a blood clot can block vessels and cause serious problems Blood clots can develop e in veins referred to as a venous thrombosis venous thromboembolism or VTE e inthe arteries referred to as an arterial thrombosis arterial thromboembolism or ATE Recovery from blood clots is not always complete Rarely there may be serious lasting effects or very rarely they may be fatal It is important to remember that the overall risk of a harmful blood clot due to Yvidually is small HOW TO RECOGNISE A BLOOD CLOT Seek urgent medical attention if you notice any of the following signs or symptoms Are you experiencing any of these signs What are you possibly suffering from e swelling of one leg or along a vein in the leg or foot Deep vein thrombosis especially when accompanied by e pain or tenderness in the leg which may be felt only when standing or walking e increased warmth in the affected leg e change in colour of the skin on the leg e g turning pale red or blue e sudden unexplained breathlessness or rapid breathing Pulmonary embolism e sudden cough without an obvious cause which may bring up bl
17. information on blood clots in section 2 It is particularly important to read the symptoms of a blood clot see section 2 Blood clots Before you can begin taking Y vidually 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 Yvidually or where the reliability of Yvidually 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 Y vidually alters the monthly changes of body temperature and of cervical mucus Yvidually like other hormonal contraceptives does not protect against HIV infection AIDS or any other sexually transmitted disease When you should not use Yvidually You should not use Yvidually if you have any of the conditions listed below If you do have any of the conditions listed below you must tell your doctor Your doctor will discuss with you what other form of birth control would be more appropriate Do not take Y vidually e If you have or have ever had a blood clot in a blood vessel of your legs deep vein thrombosis DVT your lungs pulmonary emb
18. l 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 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 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 y
19. mar Germany In het register ingeschreven onder nummer RVG 108807 This medicinal product is authorised in the Member States of the EEA under the following names Country 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 Czech Republic CZ Flexyess 0 02 mg 3 mg potahovan tablety Estonia EE Yvidually 0 02 mg 3 mg hukese pol meerikattega tabletid Finland FI Flexyess 0 02 mg 3 mg tabletti kalvop llysteinen Germany DE Flexyess 0 02 mg 3 mg Filmtabletten Hungary HU Flexyess 0 02 mg 3 mg filmtabletta Ireland IE Flexyess 0 02 mg 3 mg film coated tablets Italy IT 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 Poland PL Flexyess 0 02 mg 3 mg tabletki powlekane Portugal PT Flexyess 3 mg 0 02 mg comprimido revestido por pel cula Yvidually PL 082015 BEC 6087 Page 19 of 19 Yvidually PIL Romania RO Yvidually 0 02 mg 3 mg comprimate filmate Slovak Repu
20. n tell you if you need to take additional contraceptive precautions for example condoms and if so for how long or whether the use of another medicine you need must be changed Some medicines e can have an influence on the blood levels of Yvidually e can make it less effective in preventing pregnancy 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 and Hepatitis C Virus infections so called protease inhibitors and non nucleoside reverse transcriptase inhibitors such as ritonavir nevirapine efavirenz O fungal infections e g griseofulvin ketoconazole O arthritis arthrosis etoricoxib O high blood pressure in the blood vessels in the lungs bosentan e the herbal remedy St John s wort Y vidually may influence the effect of other medicines e g O medicines containing ciclosporin O theanti epileptic lamotrigine this could lead to an increased frequency of seizures O theophylline used to treat breathing problems O tizanidine used to treat muscle pain and or muscle cramps Ask your doctor or pharmacist for advice before taking any medicine Yvidually with food and drink Yvidually 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 b
21. od clot may be higher if you have any other conditions that increase this risk See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot Yvidually PL 082015 BEC 6087 Page 17 of 19 Yvidually PIL The following side effects have also been reported but their frequency cannot be estimated from the available data hypersensitivity erythema multiforme rash with target shaped reddening or sores Reporting of side effects If you get any side effects talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet You can also report side effects directly via het Nederlands Bijwerkingen Centrum Lareb website www lareb nl By reporting side effects you can help provide more information on the safety of this medicine 5 How to store Yvidually Keep this medicine out of the sight and reach of children This medicinal product does not require any special storage conditions The tablet dispenser is not watertight and should always be kept dry Do not take this medicine 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 Do not throw away any medicines via wastewater or household waste Ask your pharmacist how to throw away medicines you no longer use These
22. olus PE or other organs e if you know you have a disorder affecting your blood clotting for instance protein C deficiency protein S deficiency antithrombin III deficiency Factor V Leiden or antiphospholipid antibodies e if you need an operation or if you are off your feet for a long time see section Blood clots e if you have ever had a heart attack or stroke e if you have or have ever had angina pectoris a condition that causes severe chest pain and may be a first sign of a heart attack or transient ischaemic attack TIA temporary stroke symptoms e if you have any of the following diseases that may increase yourrisk of a clot in the arteries o severe diabetes with blood vessel damage o very high blood pressure o avery high level of fat in the blood cholesterol or triglycerides o acondition known as hyperhomocysteinaemia if you have or have ever had atypeof migraine called migraine with aura 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 Yvidually PL 082015 BEC 6087 Page 4 of 19 Yvidually PIL 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 other ingredien
23. ood e sharp chest pain which may increase with deep breathing e severe light headedness or dizziness e rapid or irregular heartbeat e severe pain in your stomach If you are unsure talk to a doctor as some of these symptoms Yvidually PL 082015 BEC 6087 Page 6 of Yvidually PIL Are you experiencing any of these signs What are you possibly suffering from such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection e g a common cold Symptoms most commonly occur in one eye Retinal vein thrombosis i blood clot in the eye e immediate loss of vision or ye e painless blurring of vision which can progress to loss of vision e chest pain discomfort pressure heaviness Heart attack e sensation of squeezing or fullness in the chest arm or below the breastbone e fullness indigestion or choking feeling e upper body discomfort radiating to the back jaw throat arm and stomach e sweating nausea vomiting or dizziness e extreme weakness anxiety or shortness of breath e rapid or irregular heartbeats e sudden weakness or numbness of the face arm or leg Stroke especially on one side of the body e sudden confusion trouble speaking or understanding e sudden trouble seeing in one or both eyes e sudden trouble walking dizziness loss of balance or coordination e sudden severe or prolonged headache
24. ood hypertriglyceridaemia or a positive family history for this condition Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis inflammation of the pancreas if you need an operation or you are off your feet for a long time see in section 2 Blood clots if you have just given birth you are at an increased risk of blood clots You should ask your doctor how soon after delivery you can start taking Yvidually If you have an inflammation in the veins under the skin superficial thrombophlebitis If you have varicose veins if you have epilepsy see page X Other medicines and Yvidually 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 Yvidually PL 082015 BEC 6087 Page 5 of 19 Yvidually PIL e f you have or have ever had golden brown pigment patches chloasma so called pregnancy patches especially on the face If this is the case avoid direct exposure to sunlight or ultraviolet light e if you have hereditary angioedema products containing oestrogens may cause or worsen the symptoms You should see your doctor immediately if you experience symptoms o
25. ou 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 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 Yvidually PL 082015 BEC 6087 Page 15 of 19 Yvidually PIL e 1 tablet missed during Day 25 120 You may choose either of the following options 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 Yvidually 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 th
26. se family member experiences a thrombosis for no known reason or you gain a lot of weight tell your doctor BLOOD CLOTS IN AN ARTERY What can happen if a blood clot forms in an artery Like a blood clot in a vein a clot in an artery can cause serious problems For example it can cause a heart attack or a stroke Factors that increase your risk of a blood clot in an artery It is important to note that the risk of a heart attack or stroke from using Yvidually is very small but can increase e with increasing age beyond about 35 years e if you smoke When using a combined hormonal contraceptive like Y vidually you are advised to stop smoking If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive e if you are overweight e if you have high blood pressure e ifamember of your immediate family has had a heart attack or stroke at a young age less than about 50 In this case you could also have a higher risk of having a heart attack or stroke Yvidually PL 082015 BEC 6087 Page 9 of 19 Yvidually PIL e if you or someone in your immediate family have a high level of fat in the blood cholesterol or triglycerides e if you get migraines especially migraines with aura e if you have a problem with your heart valve disorder disturbance of the rhythm called atrial fibrillation e if you have diabetes If you have more than one of these conditions
27. t Yvidually 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 Yvidually use Yvidually PL 082015 BEC 6087 Page 14 of 19 Yvidually PIL If after having a baby you have had sex before starting Y vidually again you must first be sure that you are not pregnant or you must wait until your next period e If you are breast feeding and want to start Yvidually again after having a baby Read the section on Breast feeding on page X Ask your doctor what to do if you are not sure when to start If you take more Yvidually than you should There are no reports of serious harmful results of taking too many Yvidually 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 Yvidually tablets or you discover that a child has taken some ask your doctor or pharmacist for advice If you forget to take Yvidually 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 unti
28. ts of this medicine listed in section 6 This may cause itching rash or swelling Warnings and precautions When should you contact your doctor Seek urgent medical attention For a description of the symptoms of these serious side effects please go to How to recognise a blood clot if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg i e deep vein thrombosis a blood clot in the lung i e pulmonary embolism a heart attack or a stroke see Blood clots section below Tell your doctor if any of the following conditions apply to you In some situations you need to take special care while using Yvidually or any other combination pill and your doctor may need to examine you regularly If the condition develops or gets worse while you are using Yvidually you should also tell 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 ulcerative colitis chronic inflammatory bowel disease if you have systemic lupus erythematosus SLE a disease affecting your natural defence system if you have haemolytic uraemic syndrome HUS a disorder of blood clotting causing failure of the kidneys if you have sickle cell anaemia an inherited disease of the red blood cells if you have elevated levels of fat in the bl
29. with no known cause e loss of consciousness or fainting with or without seizure Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery but you should still seek urgent medical attention as you may be at risk of another stroke e swelling and slight blue discolouration of an extremity Blood clots blocking other 2 blood vessels e severe pain in your stomach acute abdomen BLOOD CLOTS IN A VEIN What can happen if a blood clot forms in a vein e The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein venous thrombosis However these side effects are rare Most frequently they occur in the first year of use of a combined hormonal contraceptive Yvidually PL 082015 BEC 6087 Page 7 of 19 Yvidually PIL e Ifa blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis DVT e Ifa blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism e Very rarely a clot may form in a vein in another organ such as the eye retinal vein thrombosis When is the risk of developing a blood clot in a vein highest The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time The risk may also be higher if you restart taking a combined hormonal contraceptive the same product or a different product
30. y phase day 1 24 When starting Yvidually 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 Yvidually PL 082015 BEC 6087 Page 12 of Yvidually PIL 2 Flexible phase day 25 120 During days 25 120 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
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