{"id":25004,"date":"2022-09-05T08:26:40","date_gmt":"2022-09-05T08:26:40","guid":{"rendered":"https:\/\/zeepedia.com\/?p=25004"},"modified":"2022-09-06T07:05:16","modified_gmt":"2022-09-06T07:05:16","slug":"tibolone-mylan","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/tibolone-mylan\/","title":{"rendered":"Tibolone Mylan &#8211; Tibolone uses, dose and side effects"},"content":{"rendered":"\n<p>2.5 mg&nbsp;tablets<br>tibolone<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Tibolon Mylan is and what it is used for<\/h2>\n\n\n\n<p>Tibolone Mylan 2.5 mg tablets<\/p>\n\n\n\n<p>The active substance is tibolone.<\/p>\n\n\n\n<p>Tibolone Mylan is used as hormone replacement therapy (&nbsp;HRT&nbsp;).&nbsp;Tibolone Mylan is used in women whose menstruation has stopped (&nbsp;menopause&nbsp;), at least 12 months after their last natural period.<\/p>\n\n\n\n<p>Tibolone Mylan is used to:<\/p>\n\n\n\n<p><strong>Relieve symptoms during and after menopause<\/strong><\/p>\n\n\n\n<p>When menstruation stops (\u00a0menopause\u00a0), the woman&#8217;s\u00a0estrogen\u00a0drops.\u00a0It can cause problems such as sweating and hot flashes.\u00a0Tibolone Mylan relieves these symptoms after\u00a0menopause.\u00a0Tibolone Mylan should only be used if the symptoms cause problems in daily life.<\/p>\n\n\n\n<p><strong>Prevent osteoporosis<\/strong><\/p>\n\n\n\n<p>After\u00a0menopause, some women suffer from\u00a0osteoporosis.\u00a0Discuss all possible options with your doctor.<\/p>\n\n\n\n<p>If you have an increased risk of\u00a0fractures\u00a0(broken bones) and other medicines are not suitable for you, you can use Tibolon Mylan to prevent osteoporosis after\u00a0menopause.<\/p>\n\n\n\n<p>The tibolone contained in Tibolon Mylan may also be approved to treat other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before taking Tibolon Mylan<\/h2>\n\n\n\n<p><strong>Medical background and regular check-ups<\/strong><\/p>\n\n\n\n<p>The use of\u00a0HRT\u00a0or Tibolon Mylan involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.<\/p>\n\n\n\n<p>Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been surgically removed).&nbsp;If you belong to that group, the risks of&nbsp;HRT&nbsp;or Tibolon Mylan may be different.&nbsp;Talk to your doctor.<\/p>\n\n\n\n<p><strong>Before starting treatment (or resuming treatment) with&nbsp;HRT&nbsp;or Tibolon Mylan<\/strong><\/p>\n\n\n\n<p>Your doctor will ask about your own, and your family&#8217;s, medical background.&nbsp;Your doctor may want to perform a physical exam.&nbsp;This may include an examination of your breasts and\/or a gynecological examination, if necessary.<\/p>\n\n\n\n<p>\u2192 Tell the doctor if you have any medical conditions or illnesses.<\/p>\n\n\n\n<p><strong>Regular checks<\/strong><\/p>\n\n\n\n<p>When you have started treatment with Tibolon Mylan, you must go for regular medical\u00a0check-ups, at least once a year.\u00a0During these checks, you must discuss with the doctor the benefits and risks of continued treatment.<\/p>\n\n\n\n<p>Do regular breast examinations as recommended by your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Do not take Tibolone Mylan<\/h2>\n\n\n\n<p>If any of the following apply to you, you should not take this medicine.&nbsp;<strong>Talk to your doctor<\/strong>&nbsp;before taking Tibolon Mylan if you are not sure.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>If you have or have had\u00a0<strong>breast cancer<\/strong>\u00a0or there is a suspicion that you may have it<\/li><li>If you have or have had\u00a0<strong>estrogen-dependent<\/strong> cancer, such as cancer of the lining of the womb (endometrium), or if such cancer is suspected.<\/li><li>If you have\u00a0unexpected vaginal bleeding.<\/li><li>If you have\u00a0endometrial hyperplasia\u00a0(\u00a0severe thickening of the lining of the uterus\u00a0) and are not being treated for it.<\/li><li>If you have or have had\u00a0blood clots in a vein\u00a0(venous\u00a0thromboembolism\u00a0), in the legs (deep\u00a0vein thrombosis\u00a0), or the lungs (\u00a0pulmonary embolism\u00a0).<\/li><li>If you have a\u00a0coagulation disorder, a condition with an increased risk of blood clots (lack of\u00a0protein\u00a0C,\u00a0protein\u00a0S, or antithrombin).<\/li><li>If you have or have recently had a disease caused by blood clots in the\u00a0arteries, such as a\u00a0heart attack,\u00a0stroke,\u00a0or\u00a0angina pectoris.<\/li><li>If you have or have had any\u00a0liver disease\u00a0and still have abnormal liver values.<\/li><li>If you have\u00a0porphyria, a rare inherited blood disorder.<\/li><li>If you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6).<\/li><\/ul>\n\n\n\n<p>If any of the above affects you the first time you use Tibolon Mylan, stop taking Tibolon Mylan and contact your doctor immediately.<\/p>\n\n\n\n<p>If you have entered menopause, you should not take Tibolon Mylan until 12 months have passed since your last natural period.&nbsp;If you take it earlier than that, you may have irregular bleeding.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and precautions<\/h2>\n\n\n\n<p>Talk to your doctor if you have or have had any of the following problems before starting treatment.&nbsp;They may recur or worsen during treatment with Tibolon Mylan.&nbsp;Should this occur, you should have more frequent check-ups with a doctor:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>muscle knots in the uterus (\u00a0myoma\u00a0)<\/li><li>growth of the lining of the uterus outside the uterus (\u00a0endometriosis\u00a0) or previously had a strong thickening of the lining of the uterus (\u00a0endometrial hyperplasia\u00a0)<\/li><li>if you have an increased risk of blood clots (see below &#8220;Blood clots in a vein (\u00a0thrombosis\u00a0)&#8221;)<\/li><li>increased risk of getting estrogen-sensitive cancer (mother, sister, or grandmother who has had breast cancer)<\/li><li>high\u00a0blood pressure<\/li><li>liver disease, such as a benign liver tumor<\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/diabetes-type-1\/\">diabetes<\/a><\/li><li>gallstone<\/li><li>migraine\u00a0or severe headache<\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/sle\/\">systemic lupus erythematosus<\/a> (\u00a0<a href=\"https:\/\/zeepedia.com\/medical\/diseases\/sle\/\">SLE<\/a>\u00a0) &#8211; is an\u00a0autoimmune\u00a0disease that attacks many organs in the body<\/li><li>epilepsy<\/li><li>asthma<\/li><li>a disease that affects the eardrum and hearing (otosclerosis)<\/li><li>a very high level of blood fats (\u00a0triglycerides\u00a0)<\/li><li>fluid retention due to heart or kidney disease.<\/li><\/ul>\n\n\n\n<p><strong>You should immediately contact a doctor and stop treatment if any of the following occur:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Any of the things mentioned in the section &#8216;Do not take Tibolon Mylan&#8217;<\/li><li>If the skin or whites of the eyes turn yellow (jaundice);\u00a0it could be symptoms of liver disease<\/li><li>If your\u00a0blood pressure\u00a0rises sharply (symptoms may include headache, tiredness, or dizziness)<\/li><li>If you get a migraine-like headache for the first time<\/li><li>If you become pregnant<\/li><li>If you get symptoms of blood clots, such as<ul><li>painful swelling and redness of the legs<\/li><li>sudden chest pain<\/li><li>breathing difficulties.\u00a0For further information, see below &#8220;Blood clots in a vein (\u00a0thrombosis\u00a0)&#8221;<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>Please note:<\/strong>&nbsp;Tibolon Mylan is not a contraceptive.&nbsp;If it has been less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy.&nbsp;Consult your doctor.<\/p>\n\n\n\n<p><strong>HRT&nbsp;and cancer<\/strong><\/p>\n\n\n\n<p><strong>Strong thickening of the lining of the uterus (&nbsp;<\/strong><strong>endometrial hyperplasia&nbsp;) and cancer of the lining of the uterus (endometrial cancer)<\/strong><\/p>\n\n\n\n<p>There are reports of increased cell growth or endometrial cancer in women using Tibolon Mylan.&nbsp;The risk of endometrial cancer increases the longer you take the medicine.<\/p>\n\n\n\n<p><strong>Irregular bleeding<\/strong><\/p>\n\n\n\n<p>Irregular spotting or spotting may occur during the first 3-6 months of taking Tibolon Mylan.&nbsp;But about the bleeding:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>lasts longer than 6 months<\/li><li>starts after you have taken Tibolon Mylan for 6 months<\/li><li>continues after you stop taking Tibolon Mylan<\/li><\/ul>\n\n\n\n<p><strong>you should see a doctor as soon as possible.<\/strong><\/p>\n\n\n\n<p><strong>Breast cancer<\/strong><\/p>\n\n\n\n<p>Data show that treatment with tibolone increases the risk of breast cancer.\u00a0The risk depends on the treatment time.\u00a0The extra risk depends on how long you use tibolone.\u00a0In studies with\u00a0HRT, once treatment is stopped the additional risk decreases over time, but it may persist for 10 years or more if you have been using\u00a0HRT\u00a0for more than 5 years.\u00a0There are no data on whether there is a residual risk after discontinuation of tibolone but a similar pattern cannot be excluded.<\/p>\n\n\n\n<p>Comparison<\/p>\n\n\n\n<p>Women using Tibolon Mylan have a lower risk than those using combined\u00a0HRT\u00a0and a comparable risk to\u00a0estrogen-only\u00a0HRT.<\/p>\n\n\n\n<p><strong>Check your breasts regularly.&nbsp;Contact a doctor if you notice changes such as<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>indentations or pits<\/li><li>nipple changes<\/li><li>lumps you can see or feel<\/li><\/ul>\n\n\n\n<p><strong>Ovarian cancer<\/strong><\/p>\n\n\n\n<p>Ovarian cancer is rare &#8211; much rarer than breast cancer.\u00a0The use of\u00a0estrogen-only\u00a0or combined\u00a0estrogen-progestogen HRT\u00a0has\u00a0been associated with a slightly increased risk of ovarian cancer.<\/p>\n\n\n\n<p>The risk of ovarian cancer varies with age.\u00a0For example, the diagnosis of ovarian cancer will be given to around 2 women out of 2,000 aged 50 to 54 over 5 years.\u00a0For women who have been taking\u00a0HRT\u00a0for 5 years, there will be 3 cases per 2,000 users (ie about 1 extra case).<\/p>\n\n\n\n<p>When using Tibolon Mylan, the increased risk of ovarian cancer was similar to that of other types of\u00a0HRT.<\/p>\n\n\n\n<p><strong>How&nbsp;HRT&nbsp;affects the heart and blood circulation<\/strong><\/p>\n\n\n\n<p><strong>Blood clots in a vein (&nbsp;thrombosis&nbsp;)<\/strong><\/p>\n\n\n\n<p>The risk of blood clots in the veins is 1.3-3 times higher for women who take&nbsp;HRT&nbsp;than for those who do not, especially during the first year of treatment.<\/p>\n\n\n\n<p>Blood clots can be serious.\u00a0If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, fainting, or even death.<\/p>\n\n\n\n<p>The risk of a blood clot in a vein increases with age and if any of the following applies to you.&nbsp;Tell your doctor if any of the following apply to you:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are pregnant or have recently given birth<\/li><li>if you\u00a0use\u00a0estrogen<\/li><li>if you cannot walk or stand for a long time due to a major operation, injury or illness (see also section 3, &#8220;If you need an operation&#8221;)<\/li><li>if you are severely overweight (\u00a0BMI\u00a0over 30 kg\/m\u00a0<sup>2<\/sup>\u00a0)<\/li><li>if you have a coagulation disorder that requires long-term treatment with medicines that prevent blood clots<\/li><li>if a close relative has had a blood clot in a leg, lung, or another organ<\/li><li>if you have\u00a0SLE\u00a0(systemic lupus erythematosus)<\/li><li>if you have cancer.<\/li><\/ul>\n\n\n\n<p>The symptoms of blood clots are described in the section &#8220;You should immediately contact a doctor and stop the treatment&#8221;.<\/p>\n\n\n\n<p>Comparison<\/p>\n\n\n\n<p>For women in their 50s who do not take\u00a0HRT, over a 5-year period an average of 4-7 in 1,000 are expected to have a blood clot in a vein.<\/p>\n\n\n\n<p>For women in their 50s who have been taking\u00a0estrogen-progestogen\u00a0HRT\u00a0for\u00a0more than 5 years, 9-12 out of 1,000 users are expected to have a blood clot in a vein (ie 5 extra cases).<\/p>\n\n\n\n<p>For women using Tibolon Mylan, the increased risk of getting a blood clot in a vein is lower than for other types of\u00a0HRT.<\/p>\n\n\n\n<p><strong>Heart disease (heart attack)<\/strong><\/p>\n\n\n\n<p>There is no evidence that&nbsp;HRT&nbsp;or Tibolon Mylan prevents heart attacks.<\/p>\n\n\n\n<p>For women over 60 who take\u00a0HRT\u00a0with\u00a0estrogen-progestogen, the risk of developing heart disease is slightly higher than for those who do not take\u00a0HRT.\u00a0As the risk of heart disease is strongly age-dependent, the number of extra cases of heart disease due to the use of\u00a0HRT\u00a0with\u00a0estrogen-progestin is\u00a0deficient in healthy women close to\u00a0menopause\u00a0but increases with increasing age.\u00a0There is no evidence that the risk of heart attack with tibolone differs from the risk of other\u00a0HRT.<\/p>\n\n\n\n<p><strong>Stroke<\/strong><\/p>\n\n\n\n<p>Recent research indicates that\u00a0HRT\u00a0and tibolone slightly increase the risk of having a\u00a0stroke.\u00a0The increased risk is seen above all in women over 60.<\/p>\n\n\n\n<p>Comparison<\/p>\n\n\n\n<p>For women in their 50s, who do not take tibolone, over 5 years, an average of 3 in 1,000 are expected to have a\u00a0stroke.\u00a0For women in their 50s taking tibolone, the corresponding figure is 7 in 1,000 (ie 4 extra cases).<\/p>\n\n\n\n<p>For women\u00a0<strong>in their 60s<\/strong>, who do not take tibolone, over 5 years, an average of\u00a011 in 1,000\u00a0are expected to have a\u00a0stroke.\u00a0For women\u00a0<strong>in their 60s<\/strong>\u00a0taking tibolone, the corresponding figure is\u00a0<strong>24 out of 1,000<\/strong>\u00a0(ie 13 extra cases).<\/p>\n\n\n\n<p><strong>Other conditions and Tibolone Mylan<\/strong><\/p>\n\n\n\n<p>HRT&nbsp;use&nbsp;does not prevent memory loss.&nbsp;The risk of memory loss may be slightly higher in women who start using&nbsp;HRT&nbsp;after the age of 65.&nbsp;Consult your doctor.<\/p>\n\n\n\n<p>Tibolone Mylan is not intended as a contraceptive.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Tibolon Mylan<\/h2>\n\n\n\n<p>Some medicines can affect the effect of Tibolon Mylan, which can lead to irregular bleeding.&nbsp;This applies to the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>anti-clotting<\/strong>\u00a0drugs\u00a0(eg\u00a0warfarin\u00a0)<\/li><li>mdrugsfor\u00a0epilepsy\u00a0(eg phenobarbital,\u00a0phenytoin,\u00a0and carbamazepine)<\/li><li>medicines for\u00a0HIV\u00a0infection\u00a0(eg nevirapine\u00a0, efavirenz, ritonavir and nelfinavir)<\/li><li>anti-tuberculosis\u00a0medicines\u00a0(eg rifampicin)<\/li><li>herbal medicines containing\u00a0<strong>St. John&#8217;s wort<\/strong>\u00a0(\u00a0<em>Hypericum perforatum<\/em>\u00a0).<\/li><\/ul>\n\n\n\n<p>Tibolone Mylan can affect the effectiveness of certain medicines such as midazolam.<\/p>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0This also applies to non-prescription drugs and herbal remedies.<\/p>\n\n\n\n<p><strong>Results from blood test analyses<\/strong><\/p>\n\n\n\n<p>If you need to have a blood test, you should tell the doctor, or whoever is taking the blood test, that you are taking Tibolon Mylan as it may affect the results of some tests.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Tibolone Mylan is intended for women whose menstruation has stopped.\u00a0If you should become pregnant, stop taking Tibolon Mylan and contact your doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving ability and use of machinery<\/h2>\n\n\n\n<p>Tibolone Mylan has no known effect on the ability to drive or use machines.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Tibolone Mylan contains lactose<\/h2>\n\n\n\n<p>If you have an intolerance to some sugars, you should contact your doctor before taking this medicine.<\/p>\n\n\n\n<p>Talk to your doctor about the risks and benefits of hormone replacement therapy if anything in this section worries you.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to take Tibolon Mylan<\/h2>\n\n\n\n<p>Always take this medicine as directed by your doctor or pharmacist.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p><strong>How much Tibolon Mylan you should take and how often<\/strong><\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;is one tablet daily, preferably at the same time each day.<\/p>\n\n\n\n<p>The doctor aims for you to take the lowest&nbsp;dose&nbsp;that gives you symptom relief and for you to use Tibolon Mylan for the shortest possible time.&nbsp;Talk to your doctor if you do not get any relief from your symptoms, or feel that&nbsp;dose&nbsp;one would be too high.<\/p>\n\n\n\n<p>Do not take any progestagen preparation while taking Tibolon Mylan.<\/p>\n\n\n\n<p><strong>How to take Tibolone Mylan<\/strong><\/p>\n\n\n\n<p>You should take the tablets with some water or other drink, without chewing, at about the same time each day.<\/p>\n\n\n\n<p>What you should consider before starting treatment with Tibolon Mylan:<\/p>\n\n\n\n<p>If the menopause occurred naturally, you should take Tibolon Mylan no earlier than 1 year after your last natural bleeding.&nbsp;If your ovaries have been surgically removed, you can start treatment with Tibolon Mylan immediately.<\/p>\n\n\n\n<p>If you wish to take Tibolon Mylan and have had irregular or unexpected vaginal bleeding, contact your treating physician before starting treatment with Tibolon Mylan.&nbsp;This is to rule out malignant disease.<\/p>\n\n\n\n<p>If you want to switch to Tibolon Mylan from a medicine that contains\u00a0estrogen\u00a0or\u00a0progestagen, contact your doctor.<\/p>\n\n\n\n<p><strong>If you need surgery<\/strong><\/p>\n\n\n\n<p>If you are going to have surgery, you must inform the operating doctor that you are taking Tibolon Mylan.&nbsp;You may need to stop taking Tibolon Mylan for 4 to 6 weeks before surgery to avoid the risk of blood clots, see section 2, \u201cBlood clots in a vein (&nbsp;thrombosis&nbsp;).&nbsp;Ask the doctor when it is appropriate to start taking Tibolon Mylan again.<\/p>\n\n\n\n<p>If you feel that the effect of Tibolon Mylan is too strong or weak, consult your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you have taken too much Tibolon Mylan<\/h2>\n\n\n\n<p>If you have ingested too much medicine or for example,\u00a0a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n<p>Poisoning symptoms are not expected to occur even when several tablets are taken at the same time.\u00a0In case of\u00a0acute\u00a0overdose, you may experience nausea, vomiting, and bleeding from the vagina.\u00a0If necessary, contact your doctor so that these symptoms can be treated.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to take Tibolon Mylan<\/h2>\n\n\n\n<p>If you forget to take a tablet, take it as soon as possible if it has been less than 12 hours since you should have taken it.&nbsp;If more than 12 hours have passed, skip the tablet and take the next tablet at the usual time.<\/p>\n\n\n\n<p>Do not take a double\u00a0dose\u00a0to make up for a missed\u00a0dose.<\/p>\n\n\n\n<p>If you have any further questions about this medicine, ask your doctor or pharmacist.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0<strong>Most\u00a0side effects\u00a0are mild.<\/strong><\/p>\n\n\n\n<p>The following diseases are more common in women who take&nbsp;HRT&nbsp;than those who do not:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Breast cancer<\/li><li>Severe thickening of the lining of the uterus (&nbsp;endometrial hyperplasia&nbsp;) or cancer of the lining of the uterus (endometrial cancer)<\/li><li>Ovarian cancer (&nbsp;ovarian cancer&nbsp;)<\/li><li>Blood clots in veins in legs or lungs (venous&nbsp;thromboembolism&nbsp;)<\/li><li>Heart disease<\/li><li>Stroke<\/li><li>Probable memory loss, if treatment with&nbsp;HRT&nbsp;is started after the age of 65<\/li><\/ul>\n\n\n\n<p>See section 2 for more information about these\u00a0side effects.<\/p>\n\n\n\n<p><strong>Tell your doctor or pharmacist<\/strong>&nbsp;if you are worried about any&nbsp;side effects&nbsp;that you think may be due to Tibolon Mylan (see also section 2, You should contact your doctor immediately and stop treatment).<\/p>\n\n\n\n<p><strong>Serious&nbsp;side effects&nbsp;&#8211; seek medical attention immediately<\/strong><\/p>\n\n\n\n<p>If you think you have signs of a serious\u00a0side effect, see a doctor immediately.<\/p>\n\n\n\n<p>You may need to stop taking Tibolon Mylan:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if your&nbsp;blood pressure&nbsp;rises<\/li><li>if your skin or the whites of your eyes turn yellow (jaundice)<\/li><li>if you suddenly get a migraine-like headache (see section 2 above)<\/li><li>if you get signs of a blood clot (see section 2 above)<\/li><li>if you get any of the problems listed in section 2 (Do not take Tibolon Mylan).<\/li><\/ul>\n\n\n\n<p><strong>Other\u00a0side effects\u00a0ar<\/strong><\/p>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 women):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>pains in the chest<\/li><li>pain in the stomach or pelvis<\/li><li>abnormal hair growth<\/li><li>bleeding from the vagina or spotting. This is usually nothing to worry about during the first few months of hormone replacement therapy.\u00a0If the bleeding continues, or if it starts after you have been taking hormone replacement therapy for a while, read section 2.<\/li><li>problems in the vagina such as increased discharge,\u00a0itching, irritation, and fungal infection<\/li><li>thickened\u00a0lining\u00a0of the uterus or cervix<\/li><li>weight gain.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect up to 1 in 100 women):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>swelling of the hands, ankles, or feet &#8211; signs of fluid retention<\/li><li>stomach upset<\/li><li>acne<\/li><li>nipple pain or breast discomfort<\/li><li>infection\u00a0in the vagina.<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(may affect up to 1 in 1,000 women):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>skin itching<\/li><\/ul>\n\n\n\n<p>Some women taking Tibolon Mylan have also reported:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>depression, dizziness, headache<\/li><li>joint or muscle pain<\/li><li>skin problems such as rash or&nbsp;itching<\/li><li><a href=\"https:\/\/zeepedia.com\/medical\/diseases\/visual-impairment\/\">visual impairment<\/a> or blurred vision<\/li><li>changed liver values<\/li><li>point-shaped bleeding in the skin (&nbsp;vascular&nbsp;purpura)<\/li><\/ul>\n\n\n\n<p>There are reports of breast cancer and increased cell growth or endometrial cancer in women using Tibolon Mylan.<\/p>\n\n\n\n<p>\u2192 Tell the doctor if any of the side effects&nbsp;mentioned above&nbsp;do not stop or become troublesome.<\/p>\n\n\n\n<p>The following&nbsp;side effects&nbsp;have been reported for other HRT:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Gallbladder disease<\/li><li>Various skin diseases:<ul><li>dark skin spots, especially on the face and neck, so-called &#8220;pregnancy spots&#8221; (chloasma)<\/li><li>painful red-purple bumps on the skin (erythema nodosum)<\/li><li>ring-shaped reddened or ulcerated rash (erythema multiforme)<\/li><\/ul><\/li><\/ul>\n\n\n\n<p>If you experience\u00a0side effects, talk to your doctor or pharmacist.\u00a0This also applies to any\u00a0side effects\u00a0that are not mentioned in this information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Tibolon Mylan<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Use before the expiry date stated on the carton\/blister after Exp.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Do not use this medicine if the blister pack is damaged or missing, even if the outer packaging is intact.<\/p>\n\n\n\n<p>Medicines must not be thrown into the drain or among the household waste.\u00a0Ask the pharmacist how to dispose of medicines that are no longer used.\u00a0These measures will help to protect the environment.<\/p>\n\n\n\n<p>This medicine has no special storage instructions.<a><\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Contents declaration<\/h2>\n\n\n\n<p>The active substance is tibolone.<\/p>\n\n\n\n<p>Each tablet contains 2.5 mg of tibolone.<\/p>\n\n\n\n<p>Other ingredients are potato starch,\u00a0<a href=\"https:\/\/zeepedia.com\/medical\/diseases\/lactose-intolerance\/\">lactose<\/a> monohydrate, magnesium stearate, and ascorbyl palmitate.\u00a0See section 2, &#8220;Tibolon Mylan contains lactose&#8221;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Appearance and package sizes of the medicine<\/h2>\n\n\n\n<p>Tibolone Mylan is a white to whitish, flat, and round tablet with a diameter of approximately 6 mm.<\/p>\n\n\n\n<p>Tibolone Mylan is available in\u00a0calendar\u00a0packs of 28 tablets, 30 tablets, and 3 x 28 tablets.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Mylan AB<\/p>\n\n\n\n<p>Box 23033<\/p>\n\n\n\n<p>113 35 Stockholm<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Aristo Pharma GmbH<\/p>\n\n\n\n<p>Wallenroder Str. 8-10<\/p>\n\n\n\n<p>13435 berlin<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<p>and<\/p>\n\n\n\n<p>Mylan Hungary Kft.\/Ltd.<\/p>\n\n\n\n<p>Mylan utca 1.<\/p>\n\n\n\n<p>2900 Kom\u00e1ron<\/p>\n\n\n\n<p>Hungary<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tibolone Mylan is used as hormone replacement therapy (\u00a0HRT\u00a0).\u00a0Tibolone Mylan is used in women whose menstruation has stopped (\u00a0menopause\u00a0), at least 12 months after their last natural period.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,22500],"tags":[16252,25829,25833,25832,16256,16255,16253,25830,16254,25831],"class_list":["post-25004","post","type-post","status-publish","format-standard","hentry","category-medicines","category-t","tag-tibolone","tag-tibolone-mylan","tag-tibolone-mylan-side-effects","tag-tibolone-mylan-tablet","tag-tibolone-side-effects","tag-tibolone-tablet","tag-what-is-tibolone","tag-what-is-tibolone-mylan","tag-what-tibolone-is-used-for","tag-what-tibolone-mylan-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/25004","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=25004"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/25004\/revisions"}],"predecessor-version":[{"id":25039,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/25004\/revisions\/25039"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=25004"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=25004"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=25004"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}