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Kliovance® Estradiol/Norethisterone Acetate

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Kliovance® Estradiol/Norethisterone Acetate Kliovance® Estradiol/Norethisterone acetate Consumer Medicine Information medroxyprogesterone acetate (MPA). Prevention of loss of bone mineral What is in this leaflet The researchers stopped the study after density 5 years when it was determined the risks ® After the menopause some women may When you must not use Kliovance 1 were greater than the benefits in this develop fragile bones (osteoporosis). ® group. The Women’s Health Initiative What Kliovance is used for ........... 1 You should discuss all available options Memory Study indicated increased risk ® with your doctor. Before you take Kliovance ............ 1 of dementia in women aged 65-79 years How to take Kliovance® .................. 4 taking conjugated estrogens and MPA. If you are at an increased risk of There are no comparable data currently fractures due to osteoporosis and other While you are taking Kliovance® ... 4 available for other doses of conjugated medicines are not suitable for you, you estrogens and MPA or other ® Side effects ........................................ 4 can use Kliovance to prevent loss of combinations of estrogens and bone mineral density after menopause. Storage .............................................. 6 progestagens. Therefore, you should ® assume the risks will be similar for other Kliovance is prescribed for women Product Description ........................ 6 medicines containing estrogen and who have not had their womb removed, and whose periods stopped more than a Further information ........................ 6 progestagen combinations. year ago. User instructions .............................. 7 Talk regularly with your doctor about whether you still need treatment with How it works This leaflet answers some common ® questions about Kliovance®, the Kliovance . The menopause, a woman's last menopause (the ‘change of life’), and Treatment with estrogens, with or menstrual period, usually occurs hormone therapy. It does not contain all without progestagens, should be used at between the ages of 45 and 55 years. the available information. It does not the lowest effective dose and for the During this natural life transition, a take the place of talking to your doctor shortest period of time. woman slowly stops producing two or pharmacist. female hormones called estrogen and ® progesterone. Menstrual periods All medicines have risks and benefits. What Kliovance is become less frequent until they finally Your doctor has weighed the risks of used for stop. you using Kliovance® against the benefits they expect it will have for you. The falling hormone levels may cause Kliovance® is a type of hormone you to experience uncomfortable Ask your doctor or pharmacist if you replacement therapy (HRT). symptoms such as hot flushes or night have any concerns about using this Kliovance® contains two types of sweats. medicine. female hormone, an estrogen (estradiol) ® The estrogen in Kliovance relieves the and a progestagen (norethisterone Keep this leaflet with the medicine. symptoms caused by a lack of estrogen. acetate). The estradiol in Kliovance® is You may need to read it again. The progestagen protects the lining of identical to the estradiol produced in the your womb from overstimulation by Kliovance® is available only by ovaries of women, and is classified as a estrogen. prescription at pharmacies. natural estrogen. Norethisterone acetate is a synthetic progestagen which acts in Your doctor may have prescribed ® When you must not use a similar manner as progesterone, Kliovance for another reason. ® another important female sex hormone. Ask your doctor if you have any Kliovance ® Kliovance® is used for: questions about why Kliovance has been prescribed for you. Do not use Kliovance® or other Relief of symptoms occurring after estrogens, with or without a menopause progestagen, to prevent heart attacks, Before you take ® stroke or dementia. During the menopause, the amount of Kliovance the estrogen produced by a woman’s A study called the Women’s Health body drops. This can cause symptoms Initiative indicated increased risk of such as hot face, neck and chest (‘hot When you must not take it ® heart attack, stroke, breast cancer, and flushes’). Kliovance alleviates these Do not take Kliovance® if any of the blood clots in the legs or lungs in symptoms after menopause. You will following applies to you. Talk to your ® women receiving treatment with a only be prescribed Kliovance if your doctor before taking Kliovance® if product containing conjugated estrogens symptoms seriously hinder your daily 0.625 mg and the progestagen life. Kliovance® Page 1 of 7 Klvcmi8.docx you are not sure about any of the Talk to your doctor if you have a • asthma points below. premature menopause. • a disease affecting the eardrum and Do not take Kliovance®: The experience in treating women with hearing (otosclerosis) a premature menopause (due to ovarian if you have, have had or suspect • a very high level of fat in your failure or surgery) is limited. If you blood (triglycerides) having breast cancer have a premature menopause the risks if you have, have had or suspect of using HRT may be different. • fluid retention due to cardiac or having cancer of the womb lining kidney problems Before you start (or restart) HRT, your (endometrial cancer), or any other • lactose intolerance. estrogen dependent cancer doctor will ask about your own and your family´s medical history. Your doctor Stop taking Kliovance® and see a doctor if you have any unexplained vaginal may decide to perform a physical immediately bleeding examination. This may include an Stop taking Kliovance® and see a if you have excessive thickening of examination of your breasts and/or an doctor immediately if you notice any the womb lining (endometrial internal examination, if necessary. of the following when taking HRT: hyperplasia) that is not being ® treated Once you have started on Kliovance • any of the conditions mentioned in you should see your doctor for regular the When you must not take it if you have or have ever had a check-ups (at least once a year). section. blood clot in a vein (venous thromboembolism), such as in the At these check-ups, discuss with your • yellowing of your skin or the legs (e.g. deep vein thrombosis), or doctor the benefits and risks of whites of your eyes (jaundice). ® the lungs (pulmonary embolism) continuing with Kliovance . These may be signs of a liver if you have a blood clotting Go for regular breast screening as disease. disorder (such as protein C, protein recommended by your doctor. • a large rise in your blood pressure S or antithrombin deficiency) The experience of treating women older (symptoms may be headache, if you have or previously have had than 65 years’ is limited. tiredness, dizziness) a disease caused by blood clots in Warnings and precautions • migraine-like headaches which the arteries, such as a heart attack, happen for the first time stroke or angina Tell your doctor if you have ever had any of the following problems, before • if you become pregnant if you have or have ever had a liver disease and your blood test results you start the treatment, as these may • if you notice signs of a blood clot, have not returned to normal return or become worse during such as: treatment with Kliovance®. if you have a rare blood problem – painful swelling and redness of called ‘porphyria’ which is passed If so, you should see your doctor more the legs down in families (inherited) often for check-ups: – sudden chest pain if you are allergic (hypersensitive) • fibroids inside your womb – difficulty in breathing to estradiol, norethisterone acetate • growth of the womb lining outside For more information, see Blood clots in or any of the other ingredients of your womb (endometriosis) or a ® a vein (venous thromboembolism). Kliovance (listed in the history of excessive growth of the ® Ingredients section of this leaflet) womb lining (endometrial Note: Kliovance is not a contraceptive. if you are pregnant or suspect you hyperplasia) If it is less than 12 months since your may be pregnant, or you are breast- • increased risk of developing blood last menstrual period or you are under 50 years’ old, you may still need to use feeding clots (see Blood clots in a vein additional contraception to prevent if you have kidney disease (venous thromboembolism)) pregnancy. Speak to your doctor for if it is after the expiry date • increased risk of getting a advice. (‘Expiry’) printed on the pack estrogen-sensitive cancer (such as if the packaging is torn or shows having a mother, sister or HRT and cancer signs of tampering grandmother who has had breast Excessive thickening of the lining of the Stop taking Kliovance® at once and cancer) womb (endometrial hyperplasia) and consult your doctor immediately if • high blood pressure cancer of the lining of the womb (endometrial cancer) any of the above conditions appear • a liver disorder, such as a benign for the first time while taking this liver tumour Taking estrogen-only HRT will increase medicine. • diabetes the risk of excessive thickening of the Before you start to take it lining of the womb (endometrial • gallstones hyperplasia) and cancer of the womb Medical history and regular check-ups • migraine or severe headaches lining (endometrial cancer). The use of HRT carries risks which • a disease of the immune system The progestagen in Kliovance® reduces need to be considered when deciding that affects many organs of the this extra risk. whether to start taking it, or whether to body (systemic lupus carry on taking it. erythematosus, SLE) • epilepsy Kliovance® Page 2 of 7 Klvcmi8.docx Compare use HRT, as this medication may Looking at women in their 50s who are In women who still have a womb and increase the density of your breasts not taking HRT, on average, over a 5- who are not taking HRT, on average, 5 which may affect the outcome of the year period, 4 to 7 in 1,000 would be in 1,000 will be diagnosed with mammogram.
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