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The eMC  

Last Updated 27 Jul 2015

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Livial 2.5mg tablets

Livial (Liv-vee-al) is a medicine which is used in hormone replacement therapy and preventing osteoporosis in women after the menopause. Livial contains tibolone. It is supplied by Merck Sharp & Dohme Limited.

The information in this Medicine Guide for Livial varies according to the condition being treated and the particular preparation used.

Livial 2.5mg tablets

Information specific to Livial 2.5mg tablets when used in hormone replacement therapy

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Your medicine

Livial contains a hormone which is similar to the hormone oestrogen that is produced by the body. When women go through the menopause, levels of oestrogen become low. This leads to symptoms such as hot flushes, night sweats and dryness of the vagina. Livial helps to replace the low levels of oestrogen which may help to relieve the symptoms of the menopause. This is known as hormone replacement therapy.

Livial may also be used to prevent osteoporosis from occurring after the menopause. People with osteoporosis have thin bones and have a higher chance of having bone fractures. Livial helps to prevent bone loss which may slow down the development of osteoporosis. It is only used when other medicines to prevent osteoporosis are not suitable.

Livial helps to treat the symptoms of the menopause but it may also increase the chances of getting certain types of cancers and certain heart or circulatory problems.

You and your prescriber will need to weigh up the risks and benefits of hormone replacement therapy. Your prescriber will review your treatment on a regular basis.

Women who are on hormone replacement therapy will be advised by their prescriber to watch out for any symptoms of breast, endometrial or ovarian cancer. They may be advised to regularly examine their breasts for any changes or lumps or report any unusual vaginal bleeding to their prescriber.

Treatment with hormone replacement therapy needs to be tailored to each individual. For more information about different types of hormone replacement therapy, and the risks and benefits of having hormone replacement therapy, you should talk to your prescriber.

Other information about Livial:

  • it is important for some people to start taking this medicine on a particular day. This depends on several factors such as whether that person has had hormone replacement therapy before, whether they are changing from a different preparation to this one or whether they are still getting regular periods. For more information about when you should start to take this medicine, ask your prescriber, pharmacist or read the patient information leaflet that comes with your medicine
  • you should start a new pack the day after you finish the current one. Do not have a break between packs
  • your prescriber will try to find the lowest dose of your medicine which can control your condition

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

In the case of Livial:

  • this medicine should be taken at the same time each day
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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Livial:

If you are having problems taking this form of Livial, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or call 111 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

If you are having any problems taking your medicine you must speak to your prescriber. If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or call 111.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. You should keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Livial:

  • do not store in temperatures above 25°C
  • protect your medicine from light
  • protect your medicine from moisture

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Livial is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Livial can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Livial has become unsuitable, it is important that the prescriber is contacted immediately.

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A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Common: More than 1 in 100 people who take Livial:

  • bleeding or spotting - this may happen within the first few months of starting treatment with Livial or if you forget to take your tablet. Seek medical advice if bleeding happens for the first time after you have taken Livial for at least six months, continues to happen once Livial has been taken for more than six months or after you have stopped taking Livial
  • breast tenderness
  • cervical problems
  • endometrial hyperplasia
  • genital itching or discharge
  • hair overgrowth
  • pain at the lower part of the stomach
  • pelvic pain
  • vaginal problems including infection, bleeding or discharge
  • weight gain

Uncommon: More than 1 in 1000 people who take Livial:

  • acne
  • breast discomfort
  • nipple pain
  • oedema
  • stomach discomfort

Rare: More than 1 in 10,000 people who take Livial:

The frequency of these side-effects is unknown:

  • abnormal laboratory test results
  • blurred vision
  • breast cancer
  • certain types of dermatitis
  • depression
  • endometrial cancer
  • eye or eyesight problems
  • feeling dizzy
  • headaches – seek immediate medical advice if you have an unusually bad headache
  • heart attack
  • heart or circulation problems
  • liver problems - seek immediate medical advice if you develop jaundice
  • may affect the results for certain tests
  • migraine – seek immediate medical advice if you get a migraine-type headache for the first time
  • muscle, bone or joint problems such as muscle pain and tenderness or joint pain
  • ovarian cancer - this may occur if Livial is taken for a long period of time
  • raised blood pressure
  • skin rash or rashes
  • some conditions may get worse or return during treatment with Livial. Examples include: uterine fibroids, endometriosis, thromboembolic problems, oestrogen-dependent tumours, high blood pressure, liver problems, diabetes, gallstones, migraine, headaches, systemic lupus erythematosus, endometrial hyperplasia, epilepsy, asthma or otosclerosis
  • stroke

The frequency of these side-effects is unknown and have been reported in women who have taken oestrogens and progestogens :

  • dementia – this has only been reported in women over 65 years of age
  • fluid retention
  • gallbladder problems
  • high levels of cholesterol or other lipids in the blood which may lead to pancreatitis
  • reduced levels of good cholesterol
  • skin problems such as erythema multiforme, chloasma or unexplained bleeding or bruising of the skin
  • thromboembolic problems such as deep vein thrombosis or pulmonary embolism - seek immediate medical advice if you have a painful and swollen leg or develop breathing difficulties or sudden chest pain

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Livial:

The following types of medicine may interact with Livial:

If you are taking Livial and one of the above medicines or types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

Medicines can interact with complementary preparations and vitamins.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Livial:

If you have been prescribed Livial you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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Driving and operating machinery

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Livial can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

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Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Livial:

  • there are no specific foods that you must exclude from your diet when taking Livial
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Alcohol can interact with certain medicines.

In the case of Livial:

  • there are no known interactions between alcohol and Livial
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Family planning and pregnancy

This medicine is only given to post-menopausal women so its effects in pregnancy are not relevant.

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This medicine is only given to post-menopausal women so its effects in breast-feeding are not relevant.

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Ingredients of your medicine

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Livial contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Livial before, do not take Livial. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Livial, Version 8, last updated 27 Jul 2015