{"id":4733,"date":"2020-11-30T09:10:22","date_gmt":"2020-11-30T09:10:22","guid":{"rendered":"https:\/\/zeepedia.com\/?p=4733"},"modified":"2021-08-21T07:27:59","modified_gmt":"2021-08-21T07:27:59","slug":"activelle","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/activelle\/","title":{"rendered":"Activelle – Estradiol \/ Noretisterone uses, dose and side effects"},"content":{"rendered":"\n

Film-coated tabletsEstradiol Noretisterone<\/p>\n\n\n\n

1. What Activelle is and what it is used for<\/h2>\n\n\n\n

Activelle\u00ae is the preparation that is used for continuous hormonal substitution therapy ( Hormone Replacement Therapy, HRT ). It contains two female sex hormones; estrogen and progestogen. Activelle is used for women whose period has stopped ( menopause ), at least 1 year after their last natural menstrual period<\/p>\n\n\n\n

Activelle is used to:<\/p>\n\n\n\n

Relieve symptoms during and after menopause<\/strong><\/p>\n\n\n\n

When menstruation ceases ( menopause ), a woman’s estrogen drops. It can cause problems such as sweating and hot flashes. Activelle relieves these symptoms after menopause. Activelle should only be used if the problems cause problems in daily life.<\/p>\n\n\n\n

Prevent osteoporosis<\/strong><\/p>\n\n\n\n

After menopause, some women suffer from osteoporosis. Discuss all possible options with your doctor.<\/p>\n\n\n\n

If you have an increased risk of fractures (bone fractures) and other medicines that are not suitable for you, you can use Activelle to prevent osteoporosis after menopause.<\/p>\n\n\n\n

Activelle is prescribed to women who have their uterus left and who had their last period more than a year ago.<\/p>\n\n\n\n

Experience in the treatment of women over 65 years of age with Activelle is limited.
<\/p>\n\n\n\n

2. What you need to know before taking Activelle<\/h2>\n\n\n\n

Medical background and regular check-ups<\/strong><\/p>\n\n\n\n

The use of HRT involves risks that must be taken into account when deciding to start treatment or continue an ongoing treatment.<\/p>\n\n\n\n

Experience is limited for the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed). If you belong to that group, the risks of HRT may be different. Talk to your doctor.<\/p>\n\n\n\n

Before starting treatment (or resuming treatment), your doctor will ask about your own, and your family’s, medical background. Your doctor may do a general medical and gynecological examination, which also includes an examination of your breasts.
<\/p>\n\n\n\n

Once you have started treatment with Activelle, you should have regular medical check-ups, at least once a year. During these check-ups, you should discuss with your doctor the benefits and risks of continued treatment.<\/p>\n\n\n\n

Perform regular breast examinations according to your doctor’s recommendations.<\/p>\n\n\n\n

Do not take Activelle<\/strong><\/p>\n\n\n\n

if any of the following apply to you. If you are not sure, talk to your doctor<\/strong> before taking Activelle.<\/p>\n\n\n\n

Do not take Activelle:<\/p>\n\n\n\n

  • if you have or have had breast cancer<\/strong> or there is a suspicion that you may have it.<\/li>
  • if you have or have had estrogen-dependent cancer,<\/strong> such as cancer of the uterine lining (endometrium) or if there is a suspicion of such cancer.<\/li>
  • if you have unexpected genital bleeding<\/strong> that has not been investigated by a doctor.<\/li>
  • if you have severe thickening of the uterine lining<\/strong> ( endometrial hyperplasia ) and are not treated for it.<\/li>
  • if you have or have had a blood clot in a vein<\/strong> ( thrombosis ) in your legs (deep vein thrombosis ) or in your lungs ( pulmonary embolism ).<\/li>
  • if you have a coagulation disorder,<\/strong> a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin).<\/strong><\/li>
  • if you have or have had a disease caused by blood clots in the arteries are as heart attack, stroke (stroke),<\/strong> or angina.<\/strong><\/li>
  • if you have or have had any liver disease<\/strong> and still have abnormal liver values.<\/li>
  • if you have porphyria<\/strong>, a rare inherited blood disorder.<\/li>
  • if you are allergic (hypersensitive) to estradiol, norethisterone acetate, or any of the other ingredients of Activelle (see section 6 \u201cContents of the pack and other information\u201d).<\/li><\/ul>\n\n\n\n

    If any of the above happens to you the first time you use Activelle, stop taking Activelle, and contact your doctor immediately.<\/p>\n\n\n\n

    Warnings and cautions<\/h2>\n\n\n\n

    Talk to your doctor if you have or have had any of the following problems before starting treatment. They may recur or worsen during treatment with Activelle. If this happens, check with your doctor more often:
    <\/p>\n\n\n\n

    • If you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis, or have had endometrial hyperplasia (severe thickening of the uterine lining).<\/li>
    • If you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)<\/li>
    • If a close relative has had breast cancer or other estrogen-dependent cancer.<\/li>
    • High blood pressure<\/li>
    • Liver disease eg liver adenoma (benign tumor )<\/li>
    • Diabetes<\/li>
    • Gallstone disease<\/li>
    • If you get a migraine or severe headache<\/li>
    • If you have systemic lupus erythematosus, ( SLE ) – an autoimmune disease that affects many organs in the body<\/li>
    • Epilepsy<\/li>
    • Asthma<\/li>
    • Otosclerosis (ossification of the middle ear leading to a hearing loss)<\/li>
    • Hypertriglyceridemia (elevated blood lipids)<\/li>
    • Fluid retention due to heart or kidney disease<\/li>
    • Lactose intolerance.<\/li><\/ul>\n\n\n\n

      You should contact a doctor immediately and discontinue treatment with Activelle<\/strong><\/p>\n\n\n\n

      if any of the following occurs:<\/p>\n\n\n\n

      • Some of what is mentioned in the section “Do not take Activelle”<\/li>
      • If skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease<\/li>
      • If your blood pressure rises sharply (symptoms may include headache, fatigue, or dizziness)<\/li>
      • If you are experiencing migraine-like headaches for the first time<\/li>
      • If you become pregnant<\/li>
      • If you get symptoms of a blood clot, such as:<\/li><\/ul>\n\n\n\n

        – painful swelling and redness of the legs<\/p>\n\n\n\n

        – sudden chest pain<\/p>\n\n\n\n

        – difficulty breathing.<\/p>\n\n\n\n

        For more information, see below “Blood clots in a vein ( thrombosis )”.<\/p>\n\n\n\n

        Note:<\/strong> Activelle is not a contraceptive. If it is less than 12 months since your last period, or if you are under 50, you may still need to use contraception to avoid pregnancy. Consult your doctor.<\/p>\n\n\n\n

        HRT and cancer<\/strong><\/p>\n\n\n\n

        Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)<\/strong>
        <\/p>\n\n\n\n

        Use of HRT with estrogen alone increases the risk of severe thickening of the uterine lining and cancer of the uterine lining.<\/p>\n\n\n\n

        The progestogen in Activelle protects you against this extra risk.
        <\/p>\n\n\n\n

        Irregular bleeding<\/strong><\/p>\n\n\n\n

        Irregular spotting or spotting may occur during the first 3-6 months of taking Activelle.<\/p>\n\n\n\n

        But about the bleeding:<\/p>\n\n\n\n

        • lasts longer than 6 months<\/li>
        • starts after taking Activelle for 6 months<\/li>
        • continues after you stop taking Activelle<\/li><\/ul>\n\n\n\n

          you should see a doctor as soon as possible.
          <\/p>\n\n\n\n

          Breast cancer<\/strong><\/p>\n\n\n\n

          Data suggest that treatment with combined estrogen-progestogen and possibly also with estrogen alone increases the risk of breast cancer. The extra risk depends on how long you take HRT. The increased risk is seen within a few years but returns to normal within a few years (maximum 5 years) after treatment has stopped.<\/p>\n\n\n\n

          Comparison<\/em><\/p>\n\n\n\n

          For women aged 50\u201379, who do not take HRT, an average of 9\u201317 out of 1,000 will be diagnosed with breast cancer over a 5-year period.<\/p>\n\n\n\n

          For women aged 50\u201379 who take estrogen – the progestogen HRT for 5 years, 13\u201323 out of 1,000 users will be diagnosed (ie 4\u20136 extra cases).
          <\/p>\n\n\n\n

          Check your breasts regularly. Contact a doctor if you notice changes such as:<\/strong><\/p>\n\n\n\n

          • indentations or pits<\/li>
          • changes of the nipple<\/li>
          • nodules you can see or feel.<\/li><\/ul>\n\n\n\n

            It is also recommended that you participate in a mammography examination when you are called to do so. At the mammogram, it is important that you tell the nurse\/healthcare professional who performs the examination that you are using HRT, as this medicine may increase the density of the breasts. An increased density in the breasts can make it more difficult to detect lumps on the mammography images.<\/p>\n\n\n\n

            Ovarian cancer ( ovarian cancer )<\/strong><\/p>\n\n\n\n

            Ovarian cancer is rare – much more rare than breast cancer. Use of HRT with estrogen alone or combined estrogen – progestogens have been associated with a slightly increased risk of ovarian cancer.<\/p>\n\n\n\n

            The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2000 aged 50 to 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be about 3 cases per 2000 users (ie about 1 extra case).<\/p>\n\n\n\n

            How HRT affects the heart and blood circulation<\/strong>
            <\/p>\n\n\n\n

            Blood clots in a vein ( thrombosis )<\/strong>
            <\/p>\n\n\n\n

            The risk of blood clots in the veins<\/strong> is 1.3\u20133 times higher for women who take HRT than for those who do not, especially during the first year of treatment.<\/p>\n\n\n\n

            Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse, or even lead to death.<\/p>\n\n\n\n

            You are more likely to get a blood clot in a vein if any of the following apply to you. Tell your doctor if any of the following apply to you:<\/p>\n\n\n\n

            • You have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, \u201cIf you need surgery\u201d)<\/li>
            • You are severely overweight ( BMI over 30 kg \/ m 2<\/sup> )<\/li>
            • You have a coagulation disorder that requires long-term treatment with drugs that prevent blood clots<\/li>
            • If a close relative has had a blood clot in the bone, lung, or another organ<\/li>
            • You have SLE (systemic lupus erythematosus)<\/li>
            • You have cancer.<\/li><\/ul>\n\n\n\n

              The symptoms of blood clots are described in the section “You should contact a doctor immediately and discontinue treatment with Activelle”.<\/p>\n\n\n\n

              Comparison<\/em><\/p>\n\n\n\n

              For women in their 50s who do not take HRT, an average of 4-7 out of 1,000 people are expected to have a blood clot in a vein over a 5-year period.<\/p>\n\n\n\n

              For women in their 50s who have taken HRT with estrogen-progestogen for more than 5 years, 9-12 out of 1,000 users are expected to get a blood clot in a vein (ie 5 extra cases).<\/p>\n\n\n\n

              Heart disease (heart attack)<\/strong><\/p>\n\n\n\n

              There is no evidence that HRT prevents heart attacks.<\/p>\n\n\n\n

              For women over the age of 60 who take HRT with estrogen-progestin, the risk of developing heart disease is slightly higher than those who do not take HRT.<\/p>\n\n\n\n

              Stroke (apoplexy)<\/strong><\/p>\n\n\n\n

              The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.
              <\/p>\n\n\n\n

              Comparison<\/em><\/p>\n\n\n\n

              For women in their 50s who do not take HRT, an average of 8 out of 1,000 people is expected to have a stroke over a 5-year period.<\/p>\n\n\n\n

              For women in their 50s who take HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases).<\/p>\n\n\n\n

              Other conditions<\/strong><\/p>\n\n\n\n

              The use of HRT preparations does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using HRT after the age of 65. Consult your doctor.<\/p>\n\n\n\n

              Other medicines and Activelle<\/h2>\n\n\n\n

              Some medicines may affect the effect of Activelle, which may lead to irregular bleeding. The following applies:<\/p>\n\n\n\n