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The eMC  

Last Updated 03 Jun 2014

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Kliofem tablets

Kliofem (Klee-oh-fem) is a medicine which is used in hormone replacement therapy and preventing osteoporosis in women after the menopause. Kliofem contains estradiol/norethisterone acetate. It is supplied by Novo Nordisk Limited.

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

Kliofem tablets

Information specific to Kliofem tablets when used in hormone replacement therapy

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Your medicine

Kliofem contains two medicines, estradiol and norethisterone acetate. Estradiol is an oestrogen hormone, norethisterone acetate is a progestogen hormone. Both of these hormones are used in hormone replacement therapy.

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. Taking oestrogen to relieve the symptoms of the menopause is known as hormone replacement therapy. Kliofem is not used to treat symptoms in the first year after the menopause but may be used thereafter.

Oestrogen 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. Oestrogen 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.

Hormone replacement therapy 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. Progestogen helps to reduce the chances of getting endometrial cancer. Women who have a uterus or who have had endometriosis need to take progestogen as well as oestrogen. You and your prescriber will need to weigh up the benefits and risks of you having Kliofem. Once you have started to have 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.

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 Kliofem:

  • 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 Kliofem:

  • this medicine should be taken at the same time each day
  • if you miss a dose and it is within 12 hours of the time that you would usually take Kliofem, take your medicine as soon as possible. If you miss a dose and it is more than 12 hours after the time that you would usually take Kliofem, do not take the missed dose. Forgetting a dose may increase the likelihood of breakthrough bleeding or spotting
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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. 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 Kliofem:

If you are having problems taking this form of Kliofem, 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 Kliofem:

  • you must not put this medicine in a fridge
  • store the medicine in the outer carton to protect it from light

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

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

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Side-effects

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.

Very common: More than 1 in 10 people who take Kliofem:

  • bleeding from the vagina including bleeding or spotting between menstrual periods. Bleeding or spotting between menstrual periods may happen within the first few months of starting treatment with Kliofem or if you forget to take your tablet. If this continues to happen once Kliofem has been taken for some time or after Kliofem has been stopped you seek medical advice
  • breast pain or tenderness

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

  • back pain
  • breast enlargement or breast oedema
  • cramps in the legs
  • depression or worsening of depression
  • distension of the stomach
  • fluid retention
  • genital infections
  • headaches – seek immediate medical advice if you have an unusually bad headache
  • irritation or inflammation of the vagina
  • migraine or worsening of migraine seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • oedema of the extremities
  • stomach pain or discomfort
  • uterine fibroids - uterine fibroids may also worsen or return during treatment with Kliofem
  • weight gain

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

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

  • thromboembolic problems such as pulmonary embolism or a deep vein thrombosis - seek immediate medical advice if you have a painful and swollen leg or develop breathing difficulties or sudden chest pain

Very rare: Fewer than 1 in 10,000 people who take Kliofem:

  • anaphylactic reactions or shock
  • angioedema
  • changes in libido
  • difficulty sleeping
  • endometrial cancer
  • endometrial hyperplasia
  • eye or eyesight problems
  • feeling anxious
  • feeling dizzy
  • gallbladder problems
  • gallstones
  • heart attack
  • indigestion
  • raised blood pressure
  • seborrhoea
  • skin rash or rashes
  • some conditions may get worse or return during treatment with Kliofem. Examples include: uterine fibroids, endometriosis, thromboembolic problems, oestrogen-dependent tumours, breast cancer, raised blood pressure, liver problems, diabetes, gallstones, migraine, headaches, systemic lupus erythematosus, endometrial hyperplasia, epilepsy, asthma or otosclerosis
  • stroke
  • vaginal or vulval itching
  • vomiting
  • weight loss

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

  • breast cancer
  • dementia – this has only been reported in women over 65 years of age
  • heart or circulation problems
  • high levels of cholesterol or other lipids in the blood which may lead to pancreatitis
  • may affect the results for certain tests
  • oestrogen-dependent tumours such as endometrial cancer
  • ovarian cancer - this may occur if Kliofem is taken for a long period of time
  • skin problems such as erythema multiforme, unexplained or easy bruising of the skin or dark patches on the face or neck
  • worsening of angioedema

The frequency of these side-effects is unknown:

  • jaundice - you should seek immediate medical advice if you develop jaundice

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 Kliofem:

The following types of medicine may interact with Kliofem:

If you are taking Kliofem 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 Kliofem:

If you have been prescribed Kliofem 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 Kliofem 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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Diet

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 Kliofem:

  • there are no specific foods that you must exclude from your diet when taking Kliofem
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Alcohol

Alcohol can interact with certain medicines.

In the case of Kliofem:

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

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Kliofem:

  • do not take this medicine during pregnancy

It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

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Breast-feeding

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Kliofem:

  • women who are breast-feeding must not take this medicine

For information about Kliofem and breast-feeding, contact your prescriber.

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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.

Kliofem 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 Kliofem before, do not take Kliofem. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Kliofem, Version 7, last updated 03 Jun 2014