Qlaira Tablets 84 (3 x 28)

  Information General Information QLAIRA®Contraceptive tablets for women.Oestradiol valerate and Dienogest tablets--------------------------------------------------------------------------------Consumer Medicine InformationIntroductionThis leaflet answers some common questions about Qlaira. The information and instructions it contains may be different to information for other oral contraceptives you may have taken in the past. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.All medicines have risks and benefits. Your doctor has weighed the risks of you taking Qlaira against the benefits they expect it will have for you.If you have any concerns, or are unsure about taking this medicine, ask your doctor or pharmacist for more advice.Keep this leaflet with the medicine. You may need to read it again.What is Qlaira?Qlaira is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’Qlaira is used to prevent pregnancyEach coloured, active tablet contains a small amount of female hormones, either oestradiol valerate, or oestradiol valerate combined with dienogestThe 2 white tablets contain no active substances and are called inactive tablets.How Qlaira worksWhen taken correctly, it prevents you from becoming pregnant in several ways:Inhibiting the egg release by stopping it maturingChanging the cervical mucus consistency, making it more difficult for the sperm to reach the eggChanging the lining of the uterus, making it less suitable for implantation.What Qlaira looks likeQlaira tablets are film-coated tablets. The core of the tablet is covered with a coating. The tablets are either dark yellow, medium red, light yellow, dark red or white. They are round with biconvex faces, one side embossed with the letters ‘DD’ or ‘DJ’ or ‘DH’ or ‘DN’ or ‘DT’, respectively in a regular hexagon.Qlaira comes in a pack containing either 1 or 3 wallets. Each wallet contains 26 coloured active tablets and 2 white inactive tablets.What Qlaira containsEach wallet of Qlaira contains 26 differently coloured active tablets in rows 1, 2, 3 and 4 and 2 white inactive tablets in row 4.Composition of the differently coloured tablets containing one or two active ingredients:2 dark yellow tablets each containing 3mg oestradiol valerate5 medium red tablets each containing 2mg oestradiol valerate and 2mg dienogest17 light yellow tablets each containing 2mg oestradiol valerate and 3mg dienogest2 dark red tablets each containing 1mg oestradiol valerate.Other ingredients in the coloured active tablets are:lactosemaize starchpregelatinised maize starchpovidonemagnesium stearatehypromellosemacrogol 6000talctitanium dioxideiron oxide yellow and/or iron oxide red.Composition of the white inactive tablets:These tablets do not contain active ingredient. The ingredients are:lactosemaize starchpregelatinised maize starchpovidonemagnesium stearatehypromellosetalctitanium dioxide.Qlaira contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Qlaira.Tablets are gluten free.Before you take QlairaGeneral notes:Before you can begin taking Qlaira, 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 on your personal situation, may also carry out some other tests.In this leaflet, several situations are described where you should stop using Qlaira, or where the reliability of Qlaira 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 Qlaira alters the monthly changes of body temperature and cervical mucus.Consult your doctorTell your doctor if you are planning to become pregnant or are breast-feeding.Tell your doctor ifyou have allergies to any other medicines, foods, preservatives or dyesyou smokeyou are overweightyou or anyone in your immediate family has had blood clots in the legs (thrombosis), a heart attack, a stroke, breast cancer or high cholesterol.Tell your doctor if you have, or have haddiabeteshigh blood pressureheart valve disorders or certain heart rhythm disordersinflammation of your veins (superficial phlebitis)varicose veinsmigraineepilepsyrecent surgery or a prolonged period of immobilisationHPV infectionWhen to take special care with Qlaira In some situations you need to take special care while taking Qlaira or any other combined pill, and your doctor may need to examine you regularly.Consult your doctor before starting to use Qlaira if any of the following conditions apply to you or if any of them develop or worsen while you are taking Qlaira:high cholesterol or triglyceridesliver diseasegall bladder diseaseCrohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)systemic lupus erythematosus (SLE - a disease affecting the skin, joints and kidneys)haemolytic uraemic syndrome (HUS - a disorder of blood coagulation causing failure of the kidneys)sickle cell diseasea condition that occurred for the first time, or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham’s chorea)chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face) – if so, avoid too much exposure to the sun or ultraviolet radiationhereditary angioedema – you should see your doctor immediately if you experience symptoms of angio-oedema, such as swollen face, tongue and/or pharynx and/or difficulty swallowing, or hives together with difficulty in breathingdepressioncardiac or renal insufficiencydeep vein thrombosis, symptoms may include: swelling of one leg or along a vein in a leg; pain or tenderness in a leg; increased warmth in a leg; red or discoloured skin on a legpulmonary embolism, symptoms may include: sudden shortness of breath or rapid breathing; sudden coughing which may bring up blood; sharp chest pain which may increase with deep breathing; sense of anxiety; severe light-headedness or dizziness; rapid or irregular heartbeatstroke, symptoms may include: sudden numbness or weakness of the face, arm or leg; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, dizziness, loss of balance or coordination; sudden headache with no known cause; loss of consciousness or fainting with or without seizureblood clots blocking other arterial blood vesselsheart attack, symptoms may include: pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm, or below the breastbone; discomfort radiating to the back, jaw, throat, arm, stomach; fullness, indigestion or choking feeling; sweating, nausea, vomiting or dizziness; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeatsIf any of the above conditions appear for the first time, or recur or worsen while using Qlaira, you should contact your doctor.This is not a full list of possible symptoms, so if you have any unusual symptoms, contact your doctor.What to do if you vomit or have diarrhoeaIf you vomit within 3-4 hours of taking an active tablet or you have severe diarrhoea, there is a risk that the active substances in the pill are not fully absorbed by your body. The situation is almost the same as forgetting a tablet. After vomiting or having diarrhoea, take the next tablet as soon as possible. You should follow the advice given under “If you forget to take Qlaira”. If the vomiting or diarrhoea continues, contact your doctor for advice.When you must not take QlairaDo not take Qlaira if you have an allergy to:any medicine containing oestradiol valerate and/or dienogestany of the ingredients listed at the start of this leaflet.Some of the symptoms of an allergic reaction may include:rash, itching or hives on the skinswelling of the face, lips, tongue or other parts of the bodyshortness of breath, wheezing or difficulty in breathingDo not take Qlaira if you have or have had a blood clot in:the blood vessels of the legs (deep vein thrombosis)the lungs (pulmonary embolism)the heart (heart attack)the brain (stroke)other organs or parts of the body.Do not take Qlaira if you are concerned about an increased risk of blood clots. Blood clots are rare. Very occasionally blood clots may cause serious permanent disabilities, or may even be fatal. You are more at risk of having a blood clot when you take the Pill. But the risk of a venous blood clot when taking the Pill is less than the risk during pregnancy.Do not take Qlaira if you are concerned about an increased risk of blood clots because of age or smoking. The risk of having a heart attack or stroke increases as you get older. It also increases if you smoke; have increased cholesterol, triglycerides; are overweight or have high blood pressure. You should stop smoking when using the Pill, especially if you are older than 35 years of age.Do not take Qlaira if you have, or have had:angina pectoris or chest painsevere kidney insufficiency or an acute failure of your kidneymigraine, accompanied by visual symptoms, speech disability, or weakness or numbness in any part of your bodydiabetes mellitus with blood vessel damagepancreatitis (an inflammation of the pancreas) associated with high levels of fatty substances in your bloodjaundice (yellowing of the skin)severe liver diseasecancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)benign or malignant liver tumourunexplained vaginal bleeding.Do not take this medicine if you are pregnant or think you might be pregnant.Do not take Qlaira if you are breastfeeding. In general Qlaira is not recommended while breastfeeding. If you want to take the pill while breastfeeding you should talk to your doctor.Do not give this medicine to a child. Qlaira is not intended for use in females whose periods have not yet started.Qlaira is not intended for use after menopause.Do not take this medicine after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering. If this medicine has expired or is damaged, return it to your pharmacist for disposal.If you are not sure whether you should start taking this medicine, talk to your doctor.Taking other medicinesTell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.Some medicines and Qlaira may interfere with each other. These include:medicines used to treat tuberculosis such as rifampicin, rifabutinmedicines used to treat epilepsy such as phenytoin, primidone, barbiturates (e.g. phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotriginemedicines used to treat HIV, such as ritonavir or nevirapineantibiotics (penicillin, ampicillin, erythromycin, tetracycline)medicines used to treat fungal infections, such as ketoconazole and griseofulvincyclosporin, an immunosuppressant medicineherbal medicines containing St John’s Wortmedicines used to treat high blood pressure (verapamil, diltiazem)medicines used for the treatment of depression (antidepressants)cimetidine, a medicine used to treat reflux and ulcersgrapefruit juiceThese medicines may be affected by Qlaira, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.You may need to use additional barrier methods of contraception (such as condoms or a diaphragm) while you are taking any of these medicines and for some time after stopping them. Your doctor will be able to advise you about how long you will need to use additional contraceptive methods.Your doctor and pharmacist have more information on medicines that you need to be careful with or avoid while taking this medicine.How to take QlairaEach wallet contains 26 coloured active tablets and 2 white inactive tablets.Take one tablet of Qlaira every day, if necessary with a small amount of water. You may take the tablets with or without food.You must take Qlaira every day at around the same time every day. You must take Qlaira every day even if you do not have sex very often.Usually so-called withdrawal bleeding starts when you are taking the second dark red tablet or the white tablets and may not have finished before you start the next wallet. Some women still experience bleeding after taking the first tablets of the new wallet.Start the following wallet without a gap, in other words the day after you have finished your current wallet, even if the bleeding has not stopped. This means that you should start your following wallet on the same day of the week as the current wallet and that the withdrawal bleed should occur on the same days each month.Preparation of the walletTo help you keep track, there are 7 weekday sticker strips marked with the 7 days of the week.Choose the weekday sticker strip that starts with the day you begin taking the tablets. For example, if you start on a Wednesday, use the weekday sticker strip that starts with “WED”. Remember to use the same weekday sticker strip (for example, “WED”) for your next pack.Stick the weekday sticker strip along the top of the Qlaira wallet where it reads “Place weekday sticker strip here”, so that the first day is above the tablet marked “1”.There is now a day shown above every tablet and you can see whether you have taken a pill on a particular day. Follow the direction of the arrow on the wallet until all 28 tablets have been taken.Discard the unused sticker strips.When to start taking QlairaIf you have not used a contraceptive with hormones during the previous month:Start taking Qlaira on the first day of your period, i.e. on the first day of your menstrual bleeding. If you use Qlaira in this manner, you are protected against pregnancy including during the 2 days when you are taking a placebo tablet.Changing from another combined hormonal contraceptive pill, or combined contraceptive vaginal ring or patch:Start Qlaira on the day after taking the last active tablet (the last tablet containing the active substances) of your previous pill. When changing from a combined contraceptive vaginal ring or patch, start using Qlaira on the day of removal or, follow the advice of your doctor. If you use Qlaira in this manner, you are protected against pregnancy.Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing ‘IUS’, intrauterine system):You may switch from the progestogen-only pill any day (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) during the first 9 days of Qlaira use.After a miscarriage:Follow the advice of your doctor.After having a baby:You can start Qlaira between 21 and 28 days after having a baby. If you start later than day 28, use a barrier method (for example, a condom) during the first 9 days of Qlaira use.If, after having a baby, you have had sex before re-starting Qlaira, be sure that you are not pregnant or wait until the next menstrual period.Ask your doctor what to do if you are not sure when to start.Ask your doctor or pharmacist if you are not sure which the active tablets were in your previous Pill pack. Your previous Pill pack may have different colour tablets to those of Qlaira.If you forget to take QlairaInactive tablets:If you miss a white tablet (2 tablets at the end of the wallet), you do not need to take them later because they do not contain any active ingredients. However, it is important that you discard the missed white tablet(s) to make sure that the number of days when you take inactive tablets is not increased as this would increase the risk of pregnancy. Continue with the next tablet at the usual time.Active tablets:Depending on the day of the cycle on which one active tablet has been missed, you may need to take additional contraceptive precautions, for example a barrier method such as a condom. Take the tablets according to the following principles. See also the ‘missed pill chart’ for details.If you are less than 12 hours late 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.If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. Depending on the day of the cycle on which one tablet has been missed, use additional contraceptive precautions e.g. a barrier method such as a condom. See also the ‘missed pill chart’ for details.More than one tablet forgotten in this wallet, contact your doctor.Do not take more than 2 active tablets on a given day.If you have forgotten to start a new wallet, or if you have missed one or more tablets during days 3 - 9 of your wallet, there is a risk that you are already pregnant (if you had sex in the 7 days before forgetting the tablet). In that case, contact your doctor. The more tablets you have forgotten (especially those on days 3 – 24) and the closer they are to the inactive tablet phase, the greater is the risk that the protection from pregnancy is reduced. See also the ‘missed pill chart’ for details.If you have forgotten any of the active tablets in a wallet, and you have no bleeding at the end of a wallet, you may be pregnant. Contact your doctor before you go on to the next wallet.Ask your doctor or pharmacist to answer any questions you may have.Please refer to the diagram on the last page of this leaflet for a ‘Summary of advice if you missed a tablet’.If you take too much (overdose)If you think that you or anyone else may have taken too much Qlaira, immediatelytelephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia or 0800 poison or 0800 764 766 0800 764 766 in New Zealand) for advice, orgo to the Emergency Department at your nearest hospital.Do this even if there are no signs of discomfort or poisoning. You may need medical attention.While you are using QlairaWhat you must doTell any doctors, dentists and pharmacists who treat you that you are taking this medicine.Have regular check ups with your doctor When you are using the Pill, your doctor will tell you to return for regular check ups, including getting a pap smear test. Your doctor will advise how often you need a pap smear test. A pap smear test can detect abnormal cells lining the cervix. Sometimes abnormal cells can progress to cancer.If you are about to start on any new medicine, remind your doctor and pharmacist that you are taking Qlaira.If you need a blood test or other laboratory tests, tell your doctor or the laboratory staff that you are taking the pill. Oral contraceptives can affect the results of some tests.If you are going to have surgery, tell the surgeon or anaesthetist beforehand that you are taking this medicine. The risk of having deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. The excess risk of thrombosis is highest during the first year a woman uses a combined oral contraceptive. Your doctor may tell you to stop taking the Pill several weeks before surgery, or at the time of immobilisation, and when you can start taking the Pill again. If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.Consult your doctor if you develop high blood pressure while using Qlaira – you may be told to stop using it. While on Qlaira ask your doctor to check your blood pressure when you have your woman’s health check up.If you become pregnant while taking this medicine, tell your doctor immediately.If you have unexpected bleeding and it continues, becomes heavy, or occurs again, tell your doctor.When using these tablets for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the Pill, usually after about 3 months.If you have missed a period, but you have taken all your tablets, it is very unlikely that you are pregnant. If you have not vomited, had severe diarrhoea, been on any other medication, and have taken the coloured active tablets at the right time (without using any other medicines), then continue to take Qlaira as usual.If you miss your period twice in a row, you may be pregnant and you should seek advice from you doctor. Do not start the next pack of Qlaira until your doctor has checked that you are not pregnant.To protect yourself from sexually transmitted diseases (STDs), you will need to use additional barrier contraceptives (e.g. condoms). Qlaira will not protect you from HIV-AIDs or any other STDs, such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, human papilloma virus and syphilis.What to do if you vomit or have diarrhoeaIf you vomit within 3-4 hours of taking an active tablet or you have severe diarrhoea, there is a risk that the active substances in the pill are not fully absorbed by your body. The situation is almost the same as forgetting a tablet. After vomiting or having diarrhoea, take the next tablet as soon as possible. You should follow the advice given under “If you forget to take Qlaira”. If the vomiting or diarrhoea continues, contact your doctor for advice.If you want to stop taking QlairaYou can stop taking Qlaira at any time. 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 Qlaira and wait for a menstrual period before starting to try 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.What you must not doDo not take Qlaira to treat any other conditions, unless your doctor tells you to.Do not give your medicine to anyone else.Do not stop taking your medicine or change the dosage without checking with your doctor. You may become pregnant if you are not using any other contraceptive and you stop taking Qlaira, or do not take a tablet every day.Side effectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Qlaira. This medicine helps most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.Do not be alarmed by the following lists of side effects. You may not experience any of them.Ask your doctor or pharmacist to answer any questions you may have.Tell your doctor or pharmacist if you feel unwell. Other side effects not listed on the following pages may also occur in some people. 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.If you notice any of the following side effects and they worry you, tell your doctor or pharmacist:headacheabdominal painacnebreast pain or discomfortno periods, painful periods, irregular bleeding (heavy irregular bleeding)weight changesThe above list includes common side effects of your medicine. These are usually mild and lessen with time.If you experience any of the following, tell your doctor immediately, or go to the Emergency Department at your nearest hospital:any chest painbreathlessness and/or difficulty breathingpainful swelling in your leg(s)weakness, numbness or bad ‘pins and needles’ of an arm or legsevere abdominal painsa bad fainting attack, or you collapseunusual headaches or migraines that are worse than usualsudden problems with your speech or eyesightjaundice (yellowing skin or yellowing eyes)you cough up bloodbreast lumpsunexplained vaginal bleeding.The above list includes possible serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.Cancer and the PillBreast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after women stop using the Pill.It is not known whether the difference is caused by the Pill. It may be that these women were examined more often, so that the breast cancer was noticed earlier. 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, even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your abdomen.Cervical cancer has been reported to occur more often in women who have been using the Pill for a long time. This finding may not be caused by the Pill, but may be related to sexual behaviour and other factors.How to store QlairaKeep your tablets in the wallet until it is time to take them.Keep your tablets in a cool dry place where the temperature stays below 30 °C.Do not store Qlaira in the bathroom or near a sink. Do not leave this medicine on a window sill or in the car. Heat and dampness can destroy some medicines.Keep Qlaira where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.Further information If you require further information contact your doctor or pharmacist.SupplierMade in Germany for:Bayer Australia LimitedABN 22 000 138 714875Pacific HighwayPymble NSW 2073Bayer New Zealand Ltd3 Argus PlaceHillcrest, North Shore Auckland 0627New ZealandAustralian Registration NumberAUST R 149319Date of PreparationApril 2010See TGA website (www.tga.gov.au) for latest Australian Consumer Medicine Information.See MEDSAFE website(www.medsafe.govt.nz) for latest New Zealand Consumer Medicine Information.® Registered Trademark of the Bayer group, Germany© Bayer Australia Ltd. 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