Now that your Doctor has prescribed Livial for you

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1 Now that your Doctor has prescribed Livial for you This educational brochure is only for use by patients prescribed LIVIAL

2 The Menopause The term menopause refers to the very last menstrual period a woman will ever have. For most women, menopause occurs between 45 and 55 years of age with the average age of menopause at around 50 years. Menopause may occur early due to unexpected ovarian failure, chemotherapy or following surgical removal of the ovaries. The end of menstrual periods is one of many changes that a woman may experience at menopause. Although every woman will experience her menopause differently, common complaints at this time include hot flushes, night sweats, mood changes, irritability, loss of libido and irregular bleeding. Some women may begin to experience these symptoms five to six years before their periods finally stop; this is called the peri-menopause. A woman is said to be post menopausal when it has been one year since her last period, although some women will continue to experience menopausal symptoms for years after their periods cease.

3 Menopause occurs when the ovaries stop functioning and no longer produce the hormones such as oestrogen, progesterone and testosterone. It is the lack of these hormones that causes the symptoms of menopause, and why hormone replacement therapy (HRT) may relieve these symptoms. Testosterone plays an important role in mood and libido. Oestrogen is important to the long-term health of your bones, brain, vagina and bladder. Too little sex hormones may cause thinning of the bones (osteoporosis).

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5 What is Livial? LIVIAL (tibolone 2.5 mg) is a HRT designed to relieve menopausal symptoms in post menopausal women. If you are at an increased risk of fractures due to osteoporosis but are unable to take other hormones or if other therapies prove to be ineffective, LIVIAL may also be used for this purpose. LIVIAL contains tibolone, a synthetic hormone derived from the Mexican yam. LIVIAL does not contain oestrogen, but mimics the action of the hormones produced by the ovaries prior to menopause. How does Livial work? LIVIAL has some similar effects to oestrogen in the body, however it works in a different way because it is not oestrogen. LIVIAL is converted or broken down in the body in to three other substances, which act like oestrogen, progesterone or testosterone, depending on what part of the body the substance is in. LIVIAL acts like oestrogen in the brain, bone and in vaginal tissue. LIVIAL also acts like progesterone in the uterus to prevent overgrowth of the lining that may result in bleeding. LIVIAL also has testosterone like activity that appears to play a role in enhancing a women s mood and libido.

6 How does Livial differ from oestrogen? LIVIAL is used for short-term relief of menopausal symptoms in the same way as oestrogen is used. LIVIAL does not act like oestrogen on the lining of the uterus. As a result some women may experience bleeding and spotting initially. For most women this subsides after the first few months of treatment. In addition, as LIVIAL does not cause significant increase in the density of breast tissue, it makes mammograms easier to read. LIVIAL has also been shown to have a beneficial effect on mood and sexual desire. How do I take Livial? LIVIAL is a small white tablet that is taken by mouth at the same time each day. It can be taken with or without food. Do not leave a break between strips or packs of LIVIAL.

7 When can I start taking Livial? LIVIAL is intended for postmenopausal women. If it has been less than one year since your last period, your doctor will be able to advise you as to whether LIVIAL is suitable for you. When you can start taking LIVIAL depends on whether or not you are currently taking HRT or have had a hysterectomy: If you are not currently taking HRT, or you have had a hysterectomy, you can start any time. If you take HRT that contains the same amount of oestrogen and progestogen every day of the month, you can start LIVIAL the day after you stop your current HRT.

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9 What if I forget to take a dose? If you forget to take a tablet, take it as soon as you remember, unless you are more than 12 hours late. If you are more than 12 hours late, skip the dose you missed and take your next dose when you are meant to. Please read the Consumer Medicine Information (CMI) or consult with your doctor or pharmacist. Do not take a double dose to make up for the forgotten dose. Will Livial interfere with any other medications I may be taking? The only drugs known to have an interaction with LIVIAL are medications used to thin the blood after a blood clot eg warfarin. However, epilepsy medication, some sleeping pills and tuberculosis treatments may interfere with the effectiveness of LIVIAL. It is important to tell 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.

10 Can I use Livial if I had a hysterectomy? Yes. For women who do not have a uterus, LIVIAL may still offer relief of menopausal symptoms. What are the potential side-effects of LIVIAL? LIVIAL helps most women with menopausal symptoms, 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. Do not be alarmed by the following lists of side effects. You may not experience any of them. Side effects observed in clinical studies were: vaginal bleeding or spotting, abdominal pain, weight gain, breast pain, unnatural hair growth, vaginal symptoms (such as discharge, itching, and irritation) and acne. Other side effects that have been reported since the product was launched are: dizziness, headache, migraine, depression, rash or itching, visual disturbances, gastrointestinal vupset, fluid retention, joint pain, muscle pain and changes in liver function There have been reports of breast cancer and of an increased cell growth or cancer of the lining of the womb in women using LIVIAL.

11 You should stop taking LIVIAL and contact your doctor immediately if you experience: signs of thrombosis (headache, migraine or pain elsewhere in your body, dizziness, vertigo, fainting, disturbances in vision, swollen ankle or leg) jaundice (yellowing of the eyes or skin) an allergic reaction (symptoms may include shortness of breath wheezing or troubled breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin). Tell your doctor and your surgeon if you are to be hospitalized or undergo surgery. You may need to stop taking LIVIAL about 4-6 weeks before surgery, to reduce the risk of a blood clot. Your doctor will tell you when you can start taking LIVIAL again. It is a good idea to discuss with your doctor or pharmacist any side effects, including prolonged bleeding or spotting, which continue or become troublesome.

12 Will I put on weight if I take LIVIAL? It depends. As women get older, their metabolic rate decreases. This means that it is harder to burn the calories that are consumed. Some women may find that their weight increases with LIVIAL treatment. A healthy diet and lifestyle, including regular exercise, may lower your risk for many health problems associated with ageing.

13 Who should not take Livial? You should not take LIVIAL if you are pregnant or breastfeeding you currently have or have had breast cancer, or if breast cancer is suspected you currently have or it is suspected that you have an oestrogen dependent tumour such as cancer of the lining of your womb you have abnormal vaginal bleeding that has not been evaluated you have abnormal thickening of the lining of your womb (endometrial hyperplasia) you have a blood circulation disorder such as blood clots you have had a heart condition (such as angina or a heart attack) or a stroke you currently have or have had liver disease and your liver function tests are not back to normal you have an inherited disease called porphyria you have an allergy to tibolone or any of the ingredients of the product

14 Summary: LIVIAL is as effective as conventional HRT at relieving hot flushes, night sweats and vaginal dryness associated with loss of natural oestrogen. Improvement of symptoms generally occurs within a few weeks and maximum effect is usually seen when therapy is continued for at least 3 months. HRT should be prescribed at the lowest effective dose, for the shortest duration necessary. Your doctor can advise you how long you may need to take LIVIAL. Discuss with your doctor whether you need to continue LIVIAL after 6 months of treatment. Some women using LIVIAL experience minimal breast pain and tenderness. LIVIAL does not significantly increase breast density. This means that when you have a mammogram, it may be easier for the doctor to see changes in the breast. Be sure to regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. In women taking LIVIAL, any bleeding or spotting usually subsides after the first few months of treatment. LIVIAL does not act as an oestrogen on the lining of the uterus. LIVIAL improves thinning of the vaginal wall and also relieves vaginal-related symptoms such as discomfort, dryness and pain during intercourse. For further information please discuss with your doctoror pharmacist. You can also read the Consumer Medicine Information for LIVIAL which is available from your doctor or pharmacist. There is also a copy inserted in every prescribed LIVIAL pack. References: 1. Consumer Medicine Information for LIVIAL. 2. P. Kenemans, L. Speroff, Tibolone: Clinical recommendations and practical guidelines. A report of the International Tibolone Consensus Group, Maturitas 51 (2005) Australian Menopause Society. What is Menopause? Information Sheets [documents on the Internet] East Melbourne VIC 8002; 2010 [cited 2011 Dec 21]. Available from: information-sheets/528-what-is-menopause. 4. Australian Menopause Society. Tibolone for post menopause. Information Sheets [documents on the Internet] East Melbourne VIC 8002; 2010 [cited 2011 Dec 21]. Available from: women. 5. Australian Menopause Society. Healthy Ageing & Lifestyle Information Sheets [documents on the Internet] East Melbourne VIC 8002; 2010 [cited 2011 Dec 21]. Available from: org.au/consumers/information-sheets/31-healthy-ageing-and lifestyle. 6. Australian Menopause Society. Weight Gain Information Sheets [documents on the Internet] East Melbourne VIC 8002; 2010 [cited 2011 Dec 21]. Available from:

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16 /medicine/alfred/womenshealth /docs/about-menopause.pdf Copyright 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. Merck Sharp & Dohme (Australia) Pty Limited. Level 4, 66 Waterloo Road, North Ryde NSW WOMN First issued April

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